US FDA clearance for Abbott's molecular diagnostic test for detection of chlamydia & gonorrhoea infections
company name : one of our client
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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
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
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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
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.
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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
For vacancies at Zydus Cadila ............click here
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
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
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
for vacancies at BD Biosciences, Delhi ........click here
For vacancies at Actimus Biosciences Pvt. Ltd ......click here
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
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
Contact : 8008059958 or 9030587727
Edu Qualifications : B.Pharm /M.Pharm
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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
1.Active Pharmaceutical Ingredients and Drug Intermediates
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
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
- Achievement of Area Sales & collection Target
-DCR in respect of Doctors, Chemists & Nursing Homes/
one of our clients
For career with Chembiotek .:click here
for vacancies in Glaxo SmithKline..........click here
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
Address: FALIX SOFT
#25, 2ND FLOOR, 4TH CROSS,
OPP. TO SWARNA BHARATI CO-OPERATIVE BANK'
JAYANAGAR 7TH BLOCK WEST, K.R ROAD,
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 firstname.lastname@example.org
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
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.
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
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
- 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 vacancies in Reliance : click here
|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)|
Compensation: Rupees 1,00,000 - negotiable
CliniLife Research Labs
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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.
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
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
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
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
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
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.
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 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 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
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
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
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
Giving meds sequentially, not concurrently, gives survival edge for those with early stage disease, study findsFor 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.
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
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 $1.8 billion for the twelve months ending March 2010, according to IMS Health. Valacyclovir hydrochloride tablets are indicated for treatment of cold sores (herpes labialis), initial episodes of genital herpes in immunocompetent adults, recurrent episodes of genital herpes in immunocompetent adults, chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults, the reduction of transmission of genital herpes in immunocompetent adults, and the treatment of herpes zoster (shingles) in immunocompetent adults.....................&more
Levadex, which is inhaled, is in late-stage clinical testing. The drugmaker said it has completed enrollment in a trial evaluating safety for patients receiving six or 12 months of treatment........................&more
Clinical Research is one of the best things to have happened to Indian science graduates. Any medical graduate or a graduate with life sciences or pharmacology who is armed with a diploma from a good clinical research institute has the potential to join the field and earn much more than his counterparts from other industries. A Clinical Researcher’s job entails the effect of drugs on human beings. There are several stages in clinical research, the purpose of which is to prioritise the safety of drugs. In the first phase, the testing is done on healthy human beings. In the second and third phases, the efficacy of the new drug is tested as compared to other drugs or placebos. After all these studies are conducted, a drug may be given an authorisation. However, the research does not stop here. Trials and post-marketing surveillance continue. These are done to highlight the rare side effects that the drug may have on some.
According to a recent McKinsey study, Indian institutes at present train about 1,000 clinical research professionals every year. “By 2010-11, the country will require the services of 50,000 professionals. Global pharmaceutical majors will spend around US$ 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?
"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 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.
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
(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.