US FDA clearance for Abbott's molecular diagnostic test for detection of chlamydia & gonorrhoea infections

Abbott announced that it has received 510(k) clearance from the US Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the nation's most prevalent sexually transmitted diseases (STDs), gonorrhoea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden...............& more

Data Entry Operator

Experience 0-3 Years

Location:Hyderabad / Secunderabad

Education: UG - Any Graduate -life sciences,pharmacy PG - Any PG Course -life sciences,pharmacy
company name : one of our client

Industry Type:Pharma/ Biotech/Clinical Research

Role:  Data Entry Operator  Functional Area:Healthcare, Medical, R&D

Desired Candidate Profile

Should have good experience in entry of data from paper records to software.
for more details contact us at satish@clinilife.com

chiron pharmaseuticals

Chiron Corporation is a leading biotechnology company focusing on cancer, infectious diseases, and cardiovascular diseases. In the area of biopharmaceuticals, Chiron's therapeutic drugs include Proleukin, used to treat metastatic kidney cancer and metastatic melanoma, and Betaseron, a treatment for a specific form of multiple sclerosis
for vacancies at chiron pharmaseuticals........click here

Clinical Study Programmer

Experience  0 - 2 Years
Location: Bengaluru/Bangalore, Hyderabad / Secunderabad
Education: UG - B.Pharma - Pharmacy,B.Sc - Any Specialization PG - M.Pharma - Pharmacy,M.Sc - Any Specialization Industry Type:Pharma/ Biotech/Clinical Research
Role: Clinical Research Mgr
Company Name: One of our Client
Functional Area: Healthcare, Medical, R&DDesired Candidate Profile Skills: At least one year of experience; well versed in SAS basic programming or well-versed with use of PL/SQL (preferably both).
Keywords:  Study set up programmer, CDM, Clinical data Management
 for more details   Contact us at   satish@clinilife.com

FDA probes prostate meds for diabetes, heart risks

The FDA announced that it's reviewing the safety of a class of prostate cancer drugs, following up on data that suggest an increased risk of diabetes and certain heart problems.The agency is sifting data from published studies of drugs that fight gonadotropin-releasing hormone, used to treat men with prostate cancer. At issue: whether the GnRH agonists carry an increased risk of diabetes or heart trouble compared with other prostate meds. The products involved in the probe are Abbott Laboratories' Lupron, AstraZeneca's Zoladex, Watson Pharmaceuticals' Trelstar, Endo Pharmaceutical Holdings' Vantas, Sanofi-Aventis' Eligard and Pfizer's Synarel..........................& more.

Bharat Serum And Vaccines

Bharat Serums And Vaccines Limited (BSV) was incorporated to pursue an ambitious goal of introducing specialized healthcare products to meet the needs of a quality conscious market.The Company manufactures and markets biological, pharmaceutical and biotechnology products. Today, BSV holds a formidable market share in India for plasma derivatives and is constantly expanding its range of products by introducing new and improved therapies based on strong research and development initiatives and efforts.
Bharat Serums And Vaccines Limited (BSV) was incorporated to pursue an ambitious goal of introducing specialized healthcare products to meet the needs of a quality conscious market.
for vacancies at Bharat Serum........click here

Research Associate

Experience:0 - 1 Years
Location:Hyderabad / Secunderabad
Education:B.Pharm/M.Pharm  or UG - B.Sc - Bio-Chemistry, Microbiology PG - M.Sc - Bio-Chemistry, Microbiology

Role:Bio-Clinical  Research Associate/Scientist
Company Name:One of our Client

Desired Candidate Profile• Familiarity with analytical techniques like HPLC, Spectroscopy, Biochemical analyses (gel electrophoresis).Proficiency inEnglish language.Preferably with at least a year's experience.
for more details  Contact us at   satish@clinilife.com

FDA Approves Rapid Test for Antibodies to Hepatitis C Virus

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.
The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer............& more

Zydus Cadila

Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The group’s operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets.
For vacancies at Zydus Cadila ............click here

SAS notes by SAS Institute

SAS Course :This course is for users who want to learn how to write SAS programs. It is the entry point to learning SAS programming and is a prerequisite to many other SAS courses.

Learn how to
navigate the SAS windowing environment
read various types of data into SAS data sets
validate and clean SAS data sets
create SAS variables and subset data
combine SAS data sets
create and enhance listing and summary reports

Books:
SAS® Programming I: Manipulating Data with the DATA Step
SAS® Programming I:Essentials
SAS® Programming III:Advanced Techniques and Efficiencies
SQL Processing with the SAS® System Course Notes


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Important pharma Links

Hi all,
Herewith download some important pharma industry and information links .

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History of Clinical Trials

The evolution of clinical research traverses a long and fascinating journey.
From the first recorded trial of  legumes in biblical times to the first randomized controlled of trial of streptomycin in 1946, the history of clinical trial covers a wide variety of challenges – scientific, ethical and regulatory. The famous 1747 scurvy trial conducted by James Lind contained most elements of a controlled trial. .......Download to Read more

Clinical Research Associates, Clinical Data Management Executives

Experience:0 Years

Location:Bengaluru/Bangalore, Hyderabad / Secunderabad

Compensation:Best in the industry

Education:UG - B.Pharma - Pharmacy,B.Sc - Any Specialization PG - Any PG Course - Any Specialization,Post Graduation Not Required

Industry Type:Pharma/ Biotech/Clinical Research

Role:Clinical Researcher

Functional Area:Healthcare, Medical, R&D

Desired Candidate Profile Good communication skills, Good Clinical Practices knowledge, Science and Pharma graduates/post graduates  ..........& more

for more job alerts log on to www.clinilife.com

FDA okays Merck's Dulera for asthma

FDA approved Merck's Dulera, a combination inhaler, for asthma patients 12 years and older, the company announced today. Dulera consists of an inhaled corticosteroid and a long-acting beta agonist, and shares an active ingredient with Merck's Asmanex and Nasonex (mometasone furoate), and Foradil (formoterol fumarate). Dulera carries FDA's most severe safety warning, the black box label, which in this case warns patients about the potential for asthma-related death associated with long-acting beta agonists, or LABAs. .................& more

BD Biosciences, Delhi

BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. BD is headquartered in the United States and has offices in nearly 50 countries worldwide.
for vacancies at BD Biosciences, Delhi ........click here
http://www.bd.com/careers/

Actimus Biosciences Pvt. Ltd

Actimus Biosciences provides its services in chemistry, analytical and computational aided discovery through its innovative solutions for biotech, pharma and chemistry organizations.ActimusBio is a Contract Research Organization to provide its quality services to become global leader in chemistry and life sciences services industry.
For vacancies at Actimus Biosciences Pvt. Ltd ......click here

FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies

The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.
The highly sensitive assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the ARCHITECT HIV Ag/Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies. Most tests used today in the diagnostic setting detect HIV antibodies only. Although direct detection of the virus itself by nucleic acid testing is available, it is not widely used in diagnostic settings...............& MORE

advanced program in clinical research

Advanced Program in ClinicalResearch/Trials/DataManagement/
Data Analysis
CLINILIFE
Class Room Training fee Rs.12,000/-
MODE: Class Room Based Training
DURATION: 65 Days ( Daily 90-120 MINS)
ELIGIBILITY: Graduate/Post Graduate Degree in Science, Pharmacy, Laboratory, medical, Nursing, Biochemistry, Microbiology, Biotechno, MD, MBBS, BHMS, BAMS.
CERTIFICATE : Certificate would be awarded at the end of the program by CLINILIFE
PROGRAM INFO :-CliniLife has developed this training program to provide a practical experience to learn the drug development process. Objective of our training program is to introduce Clinical Trial Management System. Our unique training program helps professional and students from all related areas to understand ,how they can fit into innovations of Clinical Research Team.
TRAINING MATERIAL : Soft Copy (Material),Hard Copy
Comprehensive package of Clinical research /Trials ,Data Management, Data Analysis and a Live Project*)
For more info click www.clinilife.com
OFFICE:CliniLife RESEARCH LABS
II floor,Sri Ganesha Plaza
Besides Markaji High School
Lashkar Bazar,Hanamkonda
WARANGAL
Contact : 8008059958 or 9030587727

Clinical Data Management Associate

Desired Candidate Profile  : At least 1 yr of experience in Clinical Data Management; familiar with use of SAS basic programming.
Edu Qualifications : B.Pharm /M.Pharm
Contact -CliniLife
e-mail :satish@clinilife.com
Call us @ 8008059958

FDA struggles to track foreign drug trials

The Food and Drug Administration is reviewing only a fraction of foreign drug trials, as companies increasingly move drug testing overseas to reduce costs, a report by agency overseers said Tuesday.
The FDA inspected about one percent of foreign drug testing sites in fiscal year 2008, according to a report issued Tuesday by the Inspector General for the Department of Health and Human Services. The FDA is responsible for looking out for the safety of patients enrolled in studies of all drugs destined for the U.S. market...........& more

Ipca labprataries limited

Ipca’s Research and Development comprises of two sections:
1.Active Pharmaceutical Ingredients and Drug Intermediates
2.Formulation Development
Both the departments are supported by the Analytical Development cells which are fully equiped with all modern instruments (like NMR, LC-MSMS, GCMS etc) required to carry out research on day-to-day basis. Units are geared to continuously innovate and remain competitive by developing/acquiring abilities to find simple and effective solutions to practical problems, solutions which are free from Patent Infringement issues.
For vacancies at ipca labprataries limited .........click here 

Guide to Clinical Research

CliniLife offers e-library to download free e-books .

"Guide to Clinical Research"

Download 

Area Sales Manager

Experience:1- 4 Years Location:Warangal
Education:UG - Any Graduate - Any Specialization PG - Post Graduation Not Required
Industry Type:Pharma/ Biotech/Clinical Research
Role: Sales/BD Mgr
Functional Area:Sales, BD
Posted Date:16 Jun
Job Description
- Achievement of Area Sales & collection Target
-DCR in respect of Doctors, Chemists & Nursing Homes/
Company Profile
one of our clients

FDA Panel Recommends Approval of Emergency Contraceptive Ella

The FDA’s Reproductive Health Drugs Advisory Committee has recommended approving HRA Pharma’s emergency contraceptive Ella. The committee voted 11–0 Thursday that Ella (ulipristal acetate) was both safe and effective, saying that HRA provided sufficient information to conclude that the drug reduces the likelihood of pregnancy when taken within 120 hours (five days) after unprotected intercourse or contraceptive failure. Panel members also voted unanimously that there was no need for the FDA to impose measures beyond product labeling and healthcare provider education to address potential off-label use of the drug............& more

chembiotek CRO

Chembiotek is a contract research organisation with a Mission To provide outstanding drug discovery research and development services paving the way for novel drugs by maintaining the needs of quality, time and cost.

For career with Chembiotek .:click here

Glaxo SmithKline Pharmaceuticals Ltd,

Glaxo SmithKline  scientists are working hard to discover new ways of treating and preventing diseases. Our success depends on a vibrant and productive R&D function that encourages creativity and facilitates the accelerated discovery and development of new medicines.
for vacancies in Glaxo SmithKline..........click here

Clinical Research Analyst /HR

Job Description
presenting trial protocols to a steering committee coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects;
Keywords: Clinical Research Associate/ Pharma / UG - Lifesciences/ Life sciences/ clinical research/ source data document verification SDV/
Experience:0 - 5 Years
Location:Bengaluru/Bangalore
Address: FALIX SOFT
#25, 2ND FLOOR, 4TH CROSS,
OPP. TO SWARNA BHARATI CO-OPERATIVE BANK'
JAYANAGAR 7TH BLOCK WEST, K.R ROAD,
BANGALORE-560082
Website:https://www.falixsoft.com

Clinical Data Management Associate

Experience:0 - 5 Years

Location:Bengaluru/Bangalore, Hyderabad / Secunderabad, Kolkata
Education: UG - Any Graduate - Any Specialization
PG - Any PG Course - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Role: Bio/Pharma Informatics-Associate/Scientist
company:one of our clients
Functional Area: Healthcare, Medical, R&D
Desired Candidate Profile
All Biotechnology& pharmacy Fresher and Experienced professionals are invited to apply and work for our Company. Should be enthusiastic.
for more information contact us at satish@clinilife.com

Bharat Biotech International Limited

 Bharat Biotech International Limited (BBIL/Bharat Biotech), Hyderabad, India, is a multidimensional biotechnology company specialising in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat Biotech, established in the year 1996 by Dr. Krishna M. Ella & Mrs. Suchitra K. Ella as the Founder Directors, is engaged in developing next-generation vaccines and bio-therapeutics through innovative and collaborative research.
for vacancies in bharatj biotech.........click here

Trius Therapeutics Obtains Special Protocol Assessment With FDA For Phase 3 Study Of Torezolid Phosphate

Trius Therapeutics, announced that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study for the oral dosage form of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI). The double-blind pivotal study will compare the efficacy and safety of once-daily oral administration of 200 milligrams of torezolid phosphate over six days of treatment to twice-daily oral administration of 600 milligrams of linezolid (Zyvox) for 10 days of treatment.............& more

FDA Approves New Treatment for Advanced Prostate Cancer

The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.
In prostate cancer, the male sex hormone testosterone can cause prostate tumors to grow. Drugs, surgery, or other hormones are used to reduce testosterone production or to block it. Some men have hormone refractory prostate cancer, meaning the prostate cancer cells continue to grow, despite testosterone suppression. Different treatments are needed for men with this type of cancer.......................& more.

Avra Laboratories

Avra Laboratories is a Hyderabad based contract research & manufacturing services (CRAMS) company. Amongst the first companies in India to focus on high-end contract research, custom synthesis of complex chemicals and difficult to manufacture intermediates and APIs
The company’s aim is to become a one-stop destination for international pharmaceutical companies that require chemistry based support
for vacancies in avra laborataries .................click here

Vitamin B6, amino acid tied to reduced lung cancer risk

Smokers with higher levels of vitamin B6 and a certain essential amino acid have less risk of developing lung cancer than those lacking the nutrients, cancer experts said
A study of nearly 400,000 participants that included current and former smokers in 10 European countries found that people with high levels of vitamin B6 and the essential amino acid methionine -- found in most protein -- were at least half as likely of getting lung cancer..............& more

Pediatric Pharmacology Europe Conference, 13-14th September, 2010, Brussels, Belgium

This will be a two-day meeting for clinical pharmacologists, scientists and pediatricians to discuss overcoming the scientific challenges using tools such as models & simulations and PK & PD studies to optimise the development of new pediatric medicines.It is well known that recent regulatory changes in the USA and Europe have made it mandatory to further development of medicines for children. Many previous discussions have taken place on the impact these regulatory changes have had or the difficult topics of locating willing pediatric populations and informed consent......................& more.

Apothecaries Pvt. Ltd.

 

Apothecaries Pvt. Ltd. provides clinical research services to the pharmaceutical industry. It offers project management, site management, biostatistics related, data management, medical writing, regulatory affairs, and drug registration services. Apothecaries Pvt. Ltd. was founded in 1983 and is based in New Delhi, India.

for vacancies in Apothecaries Pvt. Ltd............................click here

Accutest Research Laboratories (I) Pvt. Ltd

1. Accutest Research Laboratories (I) Pvt. Ltd.provides clinical research services for the pharmaceutical adrug development companies. It offers clinical projecmanagement services, such as investigational sites and investigators, protocol planning and development, presentation of protocol at investigators meetings, documentation, investigational materials management, source data verification at sites, safety management, and close out visits, as well as designing case record forms, informed consent forms, and investigator manuals and other documents; herbal analysis

for vancies in Accutest Research Laboratories ....click here

Reliance Clinical Research Services (RCRS) is a clinical research organisation (CRO) set up by the Reliance Group aimed at providing world-class clinical research services to pharmaceutical, biotechnology and medical device companies.

For vacancies in Reliance  :  click here

FDA to post risk summaries of newly approved drugs online

The FDA announced Tuesday that it will begin posting to its website summaries of the safety risks of recently approved drugs. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research, commented that the summaries provide "an early detection mechanism for potentially serious risks and complements the FDA’s analysis of safety data during drug development and the agency’s routine monitoring of safety information after product approval."

The summaries, which will be based on reports by manufacturers, providers, consumers and others to the FDA’s adverse event reporting system could include information on any potentially serious, previously unidentified risks, as well as known side effects that occur more often than during clinical studies. The postings will also include an overview of any steps the agency is taking to address these issues.

According to the agency, the summaries will be prepared within 18 months of a product’s approval, or after a drug has been used by 10 000 patients, whichever comes later. The first summaries will be based on drugs approved since September 2007. 

Reference Articles

Drugs' risks emerging after clinical trials to be shown on US website - (Bloomberg)

FDA to communicate safety monitoring activities to consumers and health care professionals - (FDA)

US FDA to post risk summaries for newer drugs - (Interactive Investor)

FDA to post safety issues online for new drugs - (MSNBC)

FDA releases first set of drug, biologic safety reviews (free preview) - (The Wall Street Journal)

Clinical Research monitor

Experience: 0 - 2 YearsJob Description :We are looking for a Junior Science Graduates/ B. Pharm with certification in Clinical Research or  Clinical Data Management for multiple openings in Clinical Research – Regional CRA, CDM, Drug Safety Associate based in Delhi NCR area and ideally someone who can start immediately.   

Location: Delhi/NCR
Compensation: Rupees 1,00,000 - negotiable

Contact :
CliniLife Research Labs
Www.clinilife.com
www.clinilife.webs.com   
e-mail : clinilife@gmail.com

Research facility creates 65 jobs in Deeside

pharmaceutical facility, which will create 65 new research and development jobs and safeguard 19 more, is to be opened in Deeside.Quay Pharma is a specialist in testing and designing new products for the industry.
The industrial park site, near Shotton, will be opened by Deputy First Minister Ieuan Wyn Jones, who announced £784,000 in funding for the facility last year.The healthcare and bioscience sector employs 15,000 people in Wales.Mr Jones said the sector was worth £1.3 billion every year to Wales.
He added: "I am therefore especially pleased that we have been able to offer assistance to the company to facilitate their expansion programme and I hope that their research and development funding will be of further assistance."...........& more.

Ranbaxy Launches Antiplatelet Agent Prasugrel in India

Daiichi Sankyo Company Limited ("Daiichi Sankyo") and Ranbaxy Laboratories Limited ("Ranbaxy") announced today that Ranbaxy has launched a generic version of prasugrel in India. The product, called Prasita, is an antiplatelet agent for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Prasita is solely marketed by Ranbaxy in India.Following the April 2009 launch of Olvance (olmesartan medoxomil), an antihypertensive originally discovered by Daiichi Sankyo, Prasita is the second product from the Daiichi Sankyo portfolio to be introduced in India through the strong Ranbaxy business network. Ranbaxy will create awareness, understanding and acceptance of the new antiplatelet therapy among the target audiences in the country. ...............& more

Blood Pressure Pills Could Raise Cancer Risk

Some of the world's most popular blood pressure pills may slightly increase your risk of getting cancer, but doctors say it's too soon to ditch the drugs, according to new research.In an analysis of five previous studies following about 60,000 patients, experts found a link between people taking medicines known as angiotensin-receptor blockers, or ARBs, and cancer. The drugs are taken by millions of people worldwide for conditions like high blood pressure, heart problems and diabetic kidney disease.n the analysis, researchers found that people who took the drugs had about a 1 percent higher risk of getting cancer than people who weren't on the drugs. This included a whole range of cancers -- prostate, breast and a noticable spike in lung cancer......................& more

RIL may foray into power, finance and pharma

It has not even been two weeks since the two Ambani brothers signed a non compete clause and already Reliance Industries Ltd chairman Mukesh Ambani is powering into every area which until now was out of bounds. First it was telecom now it is power, finance and pharma!
NDTV has learnt that RIL's entry into power production will be marked by its participation in bidding of Ultra Mega Power project (UMPP) in Orissa with 4000 MW capacity, which is enough to power whole city like Delhi.
RIL, India's most valued private firm, also plans to expand its captive power plant in Jamnagar refinery for commercial purpose......................& more

WHO: more blood donations needed in poor countries

The World Health Organization says people make a total of 93 million blood donations worldwide every year, but the rate of donation in poor countries is far too low.The agency says one percent of a country's population has to give blood to collect enough for the basic needs for blood transfusions. WHO says the donation rate is below 1 percent in 77 countries.It says half of the global blood donations are collected in developed nations, home to only 16 percent of the world's population.WHO says only 47 percent of blood donations in developing countries are properly screened for infections.The agency published the figures Friday before World Blood Donor Day on June 14...................& more

Companies to Stop Marketing Unapproved Nitroglycerin Tablets

FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA. Glenmark Generics and Konec Inc., have been selling unapproved nitroglycerin in 0.3, 0.4, and 0.6 mg dosages. FDA has seen significant problems with the quality and efficacy of nitroglycerin tablets that are not approved.
Although Glenmark Generics and Konec must stop shipping these drugs by September 2010, there should not be a supply problem. Pfizer's Nitrostat tablets, which are FDA-approved, come in the same dosages....................& more

Novartis investigational treatment FTY720 (fingolimod) has received unanimous FDA approval for the treatment of patients with relapsing multiple scler

The advisory committee of FDA, that reviews and decides whether to approve a new treatment, has voted that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5mg dose justified approval.Novartis said that the committee has assessed data from the clinical trial program which provided evidence of superior efficacy of FTY720 over ointerferon beta-1a IM (Avonex), and to placebo, in reducing relapses and brain lesions (a measure of disease activity).Reportedly, the two-year placebo-controlled study showed FTY720 delayed disability progression. The advisory committee discussed monitoring parameters for the therapeutic use of FTY720 and also recommended post-marketing collection of additional safety data and evaluation of a lower dose..................& more

Pfizer voluntarily recall 3 new Indian drugs

The world’s largest drugmaker, Pfizer Inc, is voluntarily recalling three intravenous (IV) drugs manufactured by Indian drugmaker Claris Lifesciences from the US market. Of these, Metronidazole and Ciprofloxacin injections are IV antibiotics used to treat infections. The third, Ondansetron injection, is used in nausea and vomiting associated with chemotherapy or surgery.
Additionally, Pfizer has also decided to halt distribution of all sterile injectable products in intravenous bags licensed from Claris to ensure patient safety. Pfizer, which started distributing these products in the US this year, had entered into a licensing agreement with Claris in May 2009 to market 15 injectables in multiple geographies. However, industry sources believe that Claris has till now supplied only the three above-mentioned drugs to Pfizer as part of the arrangement. Experts feel that a single incident such as this may not make the well thought strategy of big pharma companies to collaborate with generic firms. ...............& more

Eat less for a longer, healthier life, new research suggests

A UK-US research team has discovered that restricting calorie content can lengthen life. The results of the study, published in the journal Science, show that eating fewer calories can lead not only to a longer life, but a healthier one too, avoiding much of the disease that often plagues people in their later years.

The team, from University College London, UK, the University of Southern California (USC) Davis School of Gerontology and Washington University School of Medicine in St Louis, US, carried out calorie restriction tests on rodents and found that restricting their food intake had a significant effect on the molecular pathways that are related to the ageing process..............& more

Clinical Trials and YouTube

YouTube would be a great means by which people could be recruited for clinical trials. There was some budding hope of that when NIH posted some videos about clinical trials on its apparently abandoned YouTube channel NIH4Health (NIH has apparently not posted any video for a year).The reasons I think video is a good way to expose people to learning about clinical trials are multiple. First, it allows me as a prospective clinical trial participant to learn about a clinical trials when I want to learn about it and where I want to learn about it - a hallmark of social media. Second, it is private - I can learn from a video that can be developed to address a wide range of issues - issues that I might not be so comfortable addressing with a live person. ...............& more

Gene causes Alzheimer’s brain ‘garbage’

A brain mechanism that acts like a recycling plant for toxic proteins goes haywire in people with a gene mutation linked with Alzheimer's disease, U.S. researchers said on Thursday, unveiling a discovery offering a new lead for drug companies.They said the gene presenilin 1, which is linked to the early development of Alzheimer's, plays a role in digesting toxic proteins...................& more.

Bombay HC approves Fem Care-Dabur merger

The Bombay High Court has approved the merger of cosmetic maker Fem Care Pharma with Dabur India. The approval marks the final step towards the completion of Fem Care Pharma’s amalgamation with Dabur India.
Earlier, the company had received approval from equity shareholders, secured and unsecured creditors, the Ministry of Corporate Affairs, and the Delhi High Court, for the merger
...........& more

Bafna receives UK MHRA approval for Paracetamol, Loperamide

Bafna Pharmaceuticals received approval from the UK Medicines and Healthcare products Regulatory Agency (UK MHRA) for manufacturing Paracetamol Tablets and Loperamide capsules. This is the eighth formulation approval received from UK MHRA for a product by Bafna Pharma for contract manufacturing.
The approval from UK MHRA for Paracetamol and Loperamide would further help Bafna to strengthen its business in the European market. The UK MHRA approval will enable Bafna Pharma to widen the customer base in Europe. Following the recent launch of our FR&D facility in Chennai, India, we will be filing dossiers for the ever-growing UK and the European markets...................& more.

Aurobindo Pharma gets final USFDA approval

Aurobindo Pharma on Thursday announced that it had received final approval from the United States Food and Drug Administration for its product Ceftazideme injection in different dosages. A company press release said Ceftazideme was indicated for treatment of infections caused by susceptible gram-negative bacilli such as septicemis, lower respiratory tract infections, abdominal cavity, biliary tract and complex urinary tract infections. With this approval, Aurobindo Pharma claimed it had 89 final approvals and 30 tentative approvals for its drugs.

Brain can control cholesterol levels

Cholesterol in the blood stream is partially regulated by the brain and not just controlled by what we eat, a study has suggested.The researchers looked for genes with similar patterns of behaviour to those already known to be involved in cholesterol regulation.
They then tested the activity of the 100 most promising candidates with a scientific technique called RNA interference (RNAi).
The technique uses tiny bits of the genetic molecule RNA to block the protein-making "instructions" issued by genes. In this way, the function of genes can be assessed by effectively switching them off.
The strategy identified 20 genes described as "immediately relevant" for maintaining cellular levels of cholesterol.
Some them are thought to influence levels of low-density lipoprotein, or "bad" cholesterol, in the blood, a major heart disease risk factor.............&more

Merck Reveals New Trial Network for Oncology

Merck announced that it has launched a clinical trial network to increase the productivity and effectiveness of its growing oncology division. Rather than hire a new team of investigators for every clinical trial it conducts, Merck created a network of experienced investigators who have had the opportunity to see many of the company’s molecules, know the patient community very well, and are aware of the problems Merck is trying to solve.Merck also gains access to the investigator’s intellectual skills and capabilities as well as access to new technologies and ideas.“We wanted to have a longitudinal relationship with the investigators, where they would get to know our pipeline well and can help us evaluate it—not just run one-off clinical trials,” said Eliav Barr, vice president of projects and pipeline management, Oncology, Merck Research Laboratories. “If they know the drugs really well, and they know what we have in the pipeline, and they know our personalized medicine needs—both in the short and long term—then we can develop programs that are designed to compare drugs better or to pick the winners from drugs entering Phase I trials.”.............&more

Abbott new ovarian cancer test gets FDA clearance

Abbott's Architect HE4 (Human Epididymis Protein 4) assay, a new diagnostic test to monitor ovarian cancer, has received FDA clearance. It is an automated test available in the US, which uses a simple blood test to aid in monitoring for the recurrence or progression of ovarian cancer.

Abbott has collaborated with Fujirebio Diagnostics in the development of the assay. The Architect HE4 assay is also approved for use in Europe, as well as in other countries in Asia Pacific and Latin America. ...................& more

Pfizer forced to sell Chinese rights to a vaccine

In order to clear its way with Chinese regulators, Pfizer has been forced to sell one of its pig vaccines to a Chinese company for about $50 million. And observers say that the move signifies a general toughening on the part of regulators in the increasingly important Chinese market.

Chinese officials forced the sale of RespiSure, a mycoplasma hyopneumoniae vaccine, to Harbin after they raised red flags over the dominant market position Pfizer would be left with in the wake of its merger with Wyeth. And now Pfizer will be required to provide Harbin with technical assistance and training on the new vaccine, which is currently made in Nebraska...........& more

Inhibiting key enzyme will reduce deaths from septic shock

Zeroing in on an enzyme--SphK1--triggered by septic shock, researchers in Glasgow say that new drugs that can safely block it will significantly reduce the number of deaths caused by that condition.

The group had earlier concluded that immune cells mass produce the enzyme during sepsis. The investigative team either silenced a key gene or used an experimental drug dubbed 5c to inhibit the enzyme. Testing their theory in mice, the team found that they were not only able to reduce the risk of death, they also reduced the number of organ failures and found that the mice were able to clear out bacterial infections better....................& more

Life Technologies (LIFE) Spending $100 Million In Synthetic Biology

SGI and its founders are world leaders in the design and construction of synthetic genomes, where DNA can be assembled in the laboratory and used to create or modify cells and whole genomes. Synthetic biology can have applications across a number of fields, from the development of new sources of fuel, to products such as new vaccines that will improve human health. While the initial business focus of SGI has centered on bioenergy, the company has now extended its focus to the areas of food production, clean water and vaccine development. One of SGI’s main business programs is with Exxon Mobil Research and Engineering Group, a long term research and development alliance focused on finding and optimizing algae to efficiently produce biological crude oil replacements. The program utilizes both synthetic genome techniques as well as other more traditional metabolic engineering techniques. SGI was founded by Dr. J. Craig Venter and Nobel Laureate Hamilton Smith.......................&more

FDA panel rejects AZ's new RSV drug in key setback

AstraZeneca's (NYSE: AZN) attempt to come up with a successor to its blockbuster RSV drug Synagis has run into some heavy flak, with an FDA panel turning their thumbs down on motavizumab in a lopsided vote.

The experimental drug had been in MedImmune's pipeline as a successor to Synagis when AstraZeneca bought up the Maryland biotech three years ago. But by a vote of 14 to 3 the FDA experts raised a red flag on data linking motavizumab to a higher number of allergic reactions while criticizing the lack of proof of improved efficacy over Synagis--which loses patent protection in 2015. Synagis earns slightly more than a billion dollars a year. RSV is a respiratory illness that afflicts some 125,000 babies each year.................................&more

Stem cells used to build new blood vessels

Pointing the way to the development of customized blood vessel grafts for heart and kidney disease, researchers have taken stem cells from muscle tissue to make the blood vessel grafts in rats. The stem cells were allowed to develop on elastic tubes within days of extraction. The researchers were able to seed millions of the stem cells on a tube that was 1.2 mm in diameter. Gaining direction from surrounding tissue on blood pressure and other physical traits, the stem cells formed a mature artery. One distinct plus: these grafts did not develop deadly clots that sometimes occur in other grafts. David Vorp at the University of Pittsburgh School of Medicine says he will next attempt to replicate these results in pigs, which bear a closer physical resemblance to humans........................&more

USV research & development

USV has evolved from a reliable producer of Dosage Forms and APIs to a process-driven and research-focused company with an emerging global base.The focus of our research is on Biosimilars, Peptides, Chemical Processes and Drug Delivery. Our Analytical Support Facility provides documentation and validation of test results as per ICH guidelines as well as standardization and characterization of in-house reference standards.
for vacancies at USV research & development....click here.

Data Mining in Drug Safety: Review of Published Threshold Criteria for Defining Signals of Disproportionate Reporting

Data mining is used in pharmacovigilance as an adjunct to traditional pharmacovigilance practices. There remains ongoing debate as to the impact automated signal detection would have on pharmacovigilance resources. An important component of this debate is the value of each statistical alert or signal of disproportional reporting (SDR) and the resources needed to evaluate SDRs that are clinically unimportant. Using the terminology of diagnostic testing, such SDRs are called false positives as they are statistically positive but are clinically negative. Based on the clinical testing paradigm, a more stringent threshold increases the sensitivity of the test by lowering the number of false positives; however, the trade off of increased sensitivity is a reduced specificity, i.e. potentially missing clinically relevant problems.

In developing the protocol to assess the clinical validity of an SDR, a literature search was conducted to determine what threshold(s) were commonly used for data mining adverse event databases. Of the more than 100 manuscripts identified, 41 published the results of data mining excursions with a clearly identified threshold for significance. The commonly used data mining algorithms were proportional reporting ratio (PRR), reporting odds ratio (ROR), multi-item gamma Poisson shrinker (MGPS) and Bayesian confidence propagation neural network ...................&more

Longer Drug Regimen Still Best Against Breast Cancer

Giving meds sequentially, not concurrently, gives survival edge for those with early stage disease, study finds

For patients with early stage breast cancer, taking chemotherapy drugs sequentially over six months helps improve their survival compared to taking them at the same time over a shorter three-month span, a new study found.

The new findings will probably come as a relief to doctors, most of whom already follow the sequential protocol, said Dr. Bhuvaneswari Ramaswamy, a breast oncologist with the Ohio State University Comprehensive Cancer Center--Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus.But the "most exciting and surprising finding," said study lead author Dr. Sandra M. Swain, was that younger women who went into early menopause because of their chemotherapy -- in other words, those who stopped having periods -- were more likely to live longer."That's something that's not been reported," added Swain, who is medical director of the Washington Cancer Institute, Washington Hospital Center in Washington, D.C.............................&more

6/4 International Clinical Trial Network, Built to Speed Studies

Merck creates new collaboration to find cancer treatments ... The network will be made up of leading cancer research centers, stretching from Brazil to Taiwan and the U.S. ... [Star-Ledger]The drug maker said today it will launch a pioneering clinical trial effort — the oncology collaborative trials network — that will focus on developing drug and vaccine candidates to treat and prevent different cancers.The network will be made up of leading cancer research centers, stretching from Brazil to Taiwan and the U.S. The centers will partner with Merck to speed up the development of innovative cancer therapies...........................&more

Dr. Reddy's announces the Launch of Amlodipine Benazepril in US market

Dr. Reddy's Laboratories (NYSE: RDY) announced today that it launched amlodipine benazepril capsules (2.5mg/10mg, 5mg/10mg, 5mg/20mg, 10mg/20mg), a bioequivalent generic version of Lotrel® Capsules*, in the US market on April 23, 2010. In September 2009, Dr. Reddy's had entered into a patent settlement with Novartis on amlodipine benazepril stipulating the dismissal of the lawsuits in the United States. The United States Food & Drug Administration (USFDA) granted an approval of Dr. Reddy's ANDA for amlodipine benazepril on April 15, 2010.

Amlodipine benazepril is indicated for the treatment of hypertension in patients not adequately controlled with either agent and is taken once daily. Dr. Reddy's product is available in bottles of 100 count capsules..............................&more

Printer Friendly Version Watson's Generic VALTREX(R) 500 mg and 1000 mg Receives FDA Approval

MORRISTOWN, N.J., May 24, 2010 /PRNewswire via COMTEX/ --Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths, the generic equivalent to GlaxoSmithKline, LLC's VALTREX(R) tablets. Watson intends to begin shipping the product shortly.

VALTREX(R) 500 and 1000 mg had total U.S. sales of approximately $1.8 billion for the twelve months ending March 2010, according to IMS Health. Valacyclovir hydrochloride tablets are indicated for treatment of cold sores (herpes labialis), initial episodes of genital herpes in immunocompetent adults, recurrent episodes of genital herpes in immunocompetent adults, chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults, the reduction of transmission of genital herpes in immunocompetent adults, and the treatment of herpes zoster (shingles) in immunocompetent adults.....................&more

MAP Pharma reports migraine drug trial progress

MAP Pharmaceuticals will seek federal approval for its migraine treatment candidate in the first half of next year, the company said Tuesday.

Levadex, which is inhaled, is in late-stage clinical testing. The drugmaker said it has completed enrollment in a trial evaluating safety for patients receiving six or 12 months of treatment........................&more

By 2010-11, the country will require the services of 50,000 clinical research professionals. The scope is immense

Clinical Research is one of the best things to have happened to Indian science graduates. Any medical graduate or a graduate with life sciences or pharmacology who is armed with a diploma from a good clinical research institute has the potential to join the field and earn much more than his counterparts from other industries. A Clinical Researcher’s job entails the effect of drugs on human beings. There are several stages in clinical research, the purpose of which is to prioritise the safety of drugs. In the first phase, the testing is done on healthy human beings. In the second and third phases, the efficacy of the new drug is tested as compared to other drugs or placebos. After all these studies are conducted, a drug may be given an authorisation. However, the research does not stop here. Trials and post-marketing surveillance continue. These are done to highlight the rare side effects that the drug may have on some.
According to a recent McKinsey study, Indian institutes at present train about 1,000 clinical research professionals every year. “By 2010-11, the country will require the services of 50,000 professionals. Global pharmaceutical majors will spend around US$ 1.6 billion for drug trials across the world in coming four years. At present, pharmaceutical companies invest about US$ 300 million. The potential is therefore, immense,” says Dr. S. K. Gupta, Director and Dean, Institute of Clinical Research (India).
So, if you are planning on taking up the profession, the ability to work in a team is important as you will have to interact daily with clinical personnel based elsewhere in India and abroad. You must also be a skilled negotiator.
Undergraduate and postgraduate degree holders in life sciences, including nursing, physiology, biochemistry, molecular biology or pharmacy, are eligible for entry-level positions in clinical research. Courses in various institutes range from six months to one year. The Institute of Clinical Research, for instance, conducts a one-year and a two-year M.Sc in Clinical Research, PG Diploma in Advanced Clinical Research and M.Sc in Clinical Research Management. Mumbai-based Clinical Research Educa-tion and Management Academy (CREMA), with branches in Delhi, Bengaluru and Hyderabad, runs a full-time course, Advanced Postgraduate Diploma in Clinical Research and three part-time PG diplomas in Pharmacovigilance, Clinical Data Management and Clinical Research. “Besides enriched modules of clinical research, we have focused on management and soft skills in these courses to make students perform better in corporate set-ups,” says Dr. S.M. Sapatnekar, Dean, CREMA.
India is fast emerging as an attractive destination for global clinical trials. This is because of the availability of a vast pool of patients and also well-trained medical professionals. The fact that the entire documentation of medicine in India is in English, is an added attraction.
A clinical research fresher is usually inducted as a Research Executive, during which his salary ranges between Rs. 2.5 and 4 lakh per annum. After that he becomes a Clinical Research Advisor. At this time, his salary ranges between Rs. 6 and 9 lakh per annum. A Project Manager earns Rs. 15 to 18 lakh annually while a Group Project Manager’s earnings are between Rs. 35 to 50 lakh per annum. At the top of the hierarchy is the Operations Director who earns in the range of Rs. 60 to 80 lakh per annum. With lucrative earning prospects, clinical research is an exciting career option. Any takers?

PERD's new capsule on tuberculosis could reduce treatment time

B V Patel Pharmaceutical Educational and Research Development (PERD) Centre here has developed a new capsule for the treatment of tuberculosis which they claim could cut short treatment duration from an average six months to three.

"The capsule comprising new formulation of Rifampacin and Isoniazid is designed for targeted drug delivery in stomach and intestine respectively of the patients, and its initial trials have shown very encouraging results," PERD Honorary Director, Prof C J Shishoo told PTI.

"The drug was tested on 12 healthy volunteers here, where we checked how much drug is reaching in their blood," he said. "The clinical trials of this new drug are now scheduled to begin at All India Institute of Medical Sciences (AIIMS) at New Delhi,....................&more

A.P. Pharma Receives FDA Complete Response Letter for APF530

A Complete Response Letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. The primary points raised in the FDA Complete Response Letter are discussed below

:Dosing System- The FDA expressed concerns relating to A.P. Pharma's two-syringe administration system, including potential issues with the transfer of material from one syringe to the other syringe prior to patient administration, certain components used in the dosing system and the potential risk of improper administration of the drug product.

Chemistry, Manufacturing and Control- The FDA has completed inspections of A.P. Pharma and several of its contract manufacturing facilities. The Agency identified certain deficiencies during these inspections, and satisfactory resolution of these deficiencies will be required for approval.- During the NDA review, the FDA asked that the Company determine if terminal sterilization with gamma irradiation is a feasible approach to enhance the assurance of sterility. A.P. Pharma has subsequently demonstrated that terminal sterilization is feasible, and the FDA has requested the Company change to terminal sterilization prior to approval.-- The FDA requested clarification and revision of certain analytical specifications proposed in the Company's NDA.....................&more.

US FDA ‘Satisfied’ With Indian Pharma’s Manufacturing Facility

Indian pharma major Lupin says the US FDA is now satisfied with the corrective actions taken at its Mandideep facility in Madhya Pradesh. An official communication has been received from the US agency on the issue.
In May last year, the FDA had warned the company that no new product would be approved until it took corrective action to address the deficiencies in the Mandideep manufacturing plant. It is Lupin’s only plant manufacturing cephalosporins, which contribute about 45% of its total revenue.
The FDA inspection found several deficiencies in the Good Manufacturing Standards (GMP) standards set by the agency and issued Inspectional Observations also known as Form 483 listing all the deviations.
It cited Lupin’s failure to maintain production, control, or distribution records and failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products to be sterile....................&more

Ministry completes national fake drug study

The ministry of health and family welfare‘s nationwide survey on the extent of fake drugs in India is finally complete. The official report will be submitted to the Drug Controller General of India early next week. ―We collected and tested more than 24,000 samples to find out if they are spurious (or fake), counterfeit or sub-standard. Our suggestion to the center will be to have an ongoing study and not just end here,‖ said D. Roy, deputy drug controller, north zone, who led the survey. According to trade journal ‗Pharmabiz‘, of the 24,000 samples, only around 10 were found to be spurious. This is on a par with another study conducted by SEARPharm, which had put spurious drugs at 0.3% of the 10,000 samples it collected. Based on a model prepared by the Indian Statistical Institute, Hyderabad, the survey spread over a year and collected medicine samples from every state.

who

The World Health Organization
(WHO) has warned over the rising instance of tobacco consumption among youth in India which has in turn led to a spike in cases of oral cancer
According to the stats released by WHO, the percentage of children aged between 13-15 years who smoke has risen to 5.8 percent among males and 2.4 percent in females while the overall consumption of tobacco among children is around 16.2 percent.
Prasad Oak who is the counselor at the Anandvan Bahuddeshiya Sanstha said that children often start consuming tobacco by watching their parents. “The children mostly inherit the habit from their parents. Among slum dwellers, consumption of tobacco by children is not usually considered a bad habit as the adults themselves are unaware of concomitant effects of tobacco”, he said.................&more.