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Multaq approved for atrial fibrillation by FDA

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.

7 Jul 2009

NDA for Exenatide once weekly accepted for FDA review

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).

7 Jul 2009

WSJ examines pharmaceutical companies expansion into developing countries

The Wall Street Journal examines the "strategic shift in the $770 billion pharmaceutical industry to target the working poor in the developing world" through the eyes of a Pfizer pharmaceutical representative working in the slums overlooking Caracas, Venezuela.

7 Jul 2009

Shire files treatment protocol for Velaglucerase Alfa for Gaucher’s disease

Shire plc has announced that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher’s disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher’s disease.

7 Jul 2009

FDA approves Alimta (pemetrexed) for advanced lung cancer

The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.

6 Jul 2009

Warnings about ‘over-use’ of paracetamol

A panel of experts in the United States has raised new concerns about the popular painkiller paracetamol and are calling for the Food and Drug Administration (FDA) to reduce the maximum dose of paracetamol allowed because they say 'over-use' can cause serious liver damage.

5 Jul 2009

Question marks on credibility of some published clinical trials

Randomised Controlled Trials (RCTs) are considered the 'gold standard' research method for assessing new medical treatments. But research published in BioMed Central's open access journal Trials shows that the design of a remarkable 93 percent of 2235 so-called RCTs published in some Chinese medical journals during 1994 to 2005 was flawed, casting doubt on the reliability of research that is likely to influence medical decision-makers.

2 Jul 2009

FDA approves Multaq tablets (dronedarone) to treat atrial fibrillation

The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.

2 Jul 2009

Chantix and Zyban to get boxed warnings on serious mental health events

The U.S. Food and Drug Administration has announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

1 Jul 2009

Sinovac receives revised Chinese approvals for Panflu

Sinovac Biotech Ltd. has announced that it has received a revised Drug Supplementary Application Approval for Panflu, Sinovac's pandemic influenza vaccine from the China State Food and Drug Administration (SFDA), based on the Phase IIb clinical trial, Under the revised approval, the age group eligible for use of the whole viron inactivated pandemic influenza vaccine was expanded to 18 years old and over, whereas it was previously 18 to 60 years of age, enabling Sinovac to reach a much broader percentage of the population.

30 Jun 2009

Hospira receives FDA approval for Azithromycin for injection

Hospira, Inc has announced it has received U.S. Food and Drug Administration (FDA) approval for a 500 mg vial of azithromycin for injection in the ADD-Vantage System.

30 Jun 2009

White House: Shield biotech drugs from generics for only seven years

White House officials said Thursday that biotech drugs (also known as biologics) should only be protected from generics competition for seven years, Reuters reports.

29 Jun 2009

Drug companies increasingly use medical science liaisons

The Wall Street Journal reports that drug companies are increasingly using medical science liaisons: "Pharmaceutical companies are barred by the Food and Drug Administration from promoting unapproved drug uses, called off-label use, but they are using employees called 'medical science liaisons,' who are often physicians and pharmacists, as a legal way to discuss those uses.

29 Jun 2009

Australian swine flu vaccine ready in months

A vaccine developed 'in record time' by Australian scientists to protect against the influenza A H1N1 virus (swine flu) may not be available just yet because this swine flu vaccine, developed by University of Queensland (UQ) scientists, is not yet registered for use in Australia.

28 Jun 2009

Roche files MabThera as a first-line biologic treatment for rheumatoid arthritis in Europe

Roche has announced that it has submitted a combined filing to the European health authorities (the European Medicines Agency) for three new indications to extend the label for MabThera to use as a first-line biologic therapy for patients with rheumatoid arthritis (RA).

28 Jun 2009

Lancet Infectious Diseases examines spread of XDR-TB

The journal Lancet Infectious Diseases examines the worldwide spread of extensively drug-resistant tuberculosis (XDR-TB). Currently, about 500,000 of the 9 million new cases of TB that are identified each year are strains of XDR-TB. "Drug resistance is largely man-made - it is vitally important to review antibiotic treatment strategies and to ensure the Stop TB Strategy is fully applied to prevent further selection of drug-resistant mutants," Leonard Amaral of Universidade Nova de Lisboa said.

24 Jun 2009

HHS awards $35 million contract to company in hopes of faster flu vaccine production

The HHS on Tuesday announced its decision to award a $35 million contract to a U.S. company using "insect cell technology" to develop flu vaccines, AFP/Google.com reports (AFP/Google.com, 6/23).

24 Jun 2009

FDA approves generic emergency contraceptive Plan B (levonorgestrel) tablets

The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.

24 Jun 2009

Americans come up with first swine flu vaccine

The company based in Connecticut, Protein Sciences Corporation, won a $35-million government contract to develop an influenza vaccine using insect cell technology and Protein Sciences's director Dan Adams says the first batch of about 100,000 doses were produced last week and the manufacture of the vaccine continues.

24 Jun 2009

Good bet in market pullback: health-care shares

"As sentiment and the stock market increasingly look bearish, look for the recent outperformance in health care to continue," The Wall Street Journal reports.

23 Jun 2009