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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

Details remain unclear on Medicare drug deal

The White House formally announced the drug manufacturers' plan to lower Medicare drug prices Monday. While details still remain unclear, it appears drug companies may benefit from the deal.

23 Jun 2009

Merck partners with non-profit for neglected diseases initiative

The pharmaceutical company, Merck, announced Monday it was partnering with the non-profit Drugs for Neglected Diseases initiative (DNDi) in an effort to improve treatments for neglected tropical diseases (NTD), the AP/CNBC reports.

23 Jun 2009

Obama, AARP announce agreement to cut prescription drug costs

On Monday, President Barack Obama joined with AARP chief Barry Rand to announce "an agreement among pharmaceutical companies to cut prescription drug costs for seniors - and inject some energy into his efforts at comprehensive health care reform," Politico reports. Obama said the companies' goal is to "to reduce the punishing inflation in health care while improving patient care."

22 Jun 2009

PEPFAR and IDUs; economic crisis and health; human-rights and pharmaceutical companies

Although PEPFAR has helped to provide "antiretroviral therapy to 2.1 million people with HIV, almost all of whom live in sub-Saharan Africa, and has spent more than US$18 billion on the continent" it has failed to reach "thousands of injecting drug users in PEPFAR countries in Africa, many of whom have HIV," according to the authors of a recent comment in the journal Lancet.

21 Jun 2009

Sanofi-Aventis, GlaxoSmithKline will donate influenza vaccines to WHO

The drugmaker Sanofi-Aventis will donate millions of doses of a vaccine that offers protection against the H1N1 (swine flu) virus to the WHO once the vaccine is ready, the company's chief executive officer announced Tuesday, Reuters reports (Elsner, Reuters, 6/17).

18 Jun 2009

Tibotec, TB Alliance join to expedite development of promising tuberculosis drug

The pharmaceutical company Tibotec said it will join with the non-profit Global Alliance for Tuberculosis Development (TB Alliance) to speed up the development of the experimental TB drug TMC207, Health-e/IOL reports (Thom, Health-e/IOL, 6/18). Tibotec, which is a subsidiary of Johnson & Johnson, announced the news on Wednesday at the Pacific Health Summit in Seattle (Doughton, Seattle Times, 6/18).

18 Jun 2009

The Federal Government should have limited, but crucial, role in comparative effectiveness

Federal officials are expected to offer recommendations this month on one of the first installments of health reform - a new initiative to compare the value and merits of competing medical treatments.

18 Jun 2009

A long ‘to-do’ list for FDA Chief Hamburg

The Washington Post details Food and Drug Administration Commissioner Margaret Hamburg’s to-do list, noting that during her brief tenure the agency has announced nearly-daily warnings about various consumer products and created an internal task force to recommend ways to release more information about FDA decisions and policies.

18 Jun 2009