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House panel passes protection for drug makers

The House Energy and Commerce Committee passed an amendment to their broad health reform bill giving drug makers 12 years of exclusive rights to market new biologic drugs, "a setback" to the administration and consumer advocates who hoped to make generic drugs more widely available, the Wall Street Journal reports.

3 Aug 2009

FDA approves Avastin plus interferon-alfa for people with metastatic renal cell carcinoma

Genentech, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Avastin (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer. According to the American Cancer Society, kidney cancer is the eighth most commonly diagnosed cancer in the United States. In 2009, approximately 13,000 Americans will die from the disease.

3 Aug 2009

US FDA approves Lipsovir for cold sores

The US Food and Drug Administration (FDA) has now approved Lipsovir, i.e. granted Medivir's New Drug Application (NDA) for the use of acyclovir and hydrocortisone for early treatment of recurrent cold sores to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented.

3 Aug 2009

FDA approves Invega Sustenna for schizophrenia

The U.S. Food and Drug Administration today approved Invega Sustenna (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults.

2 Aug 2009

FDA approves Onglyza (saxagliptin) for type 2 diabetes

The U.S. Food and Drug Administration has approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

2 Aug 2009

U.S. decision on use of adjuvants could reduce world supply of H1N1 vaccine, says Lancet editorial

"A U.S. plan to rely on swine flu vaccines without ingredients to stretch the supply [known as adjuvants] would reduce the number of available shots just when other countries need them most, the British journal Lancet said in an editorial," Bloomberg writes.

31 Jul 2009

Industry lobby wars heighten as reform efforts progress

"Healthcare companies are spending millions of dollars and marshaling armies of lobbyists to influence a landmark debate in the U.S. Congress that could dramatically change the way they do business," Reuters reports.

31 Jul 2009

Medicago announces positive results for H1N1 pandemic vaccine candidate

Medicago today announced that it has achieved additional positive results with its vaccine candidate for the Influenza A (H1N1) virus, also known as Swine flu. Results showed that a single dose of 5 micrograms induced a positive immune response against a new emerging strain of this virus in 100% of vaccinated animals.

31 Jul 2009

New guidelines issued for H1N1 vaccine campaign by Federal Advisory Committee

During a meeting in Atlanta on Wednesday, a "federal advisory committee issued sweeping guidelines … for a vaccination campaign against the pandemic swine flu strain, identifying more than half the U.S. population as targets for the first round of vaccinations," CNN reports (Hellerman, 7/29).

30 Jul 2009

Colchicine approved for acute gout, Mediterranean fever

The U.S. Food and Drug Administration has approved Colcrys to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication's active ingredient is colchicine, a complex compound derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale).

30 Jul 2009

Covance enters strategic genomic services agreement with Merck

Covance has announced it has entered into a definitive agreement with Merck & Co., Inc. relating to the supply of genomic analysis services.

30 Jul 2009

Malaria vaccine in the pipeline

Australian scientists have developed the first genetically-engineered malaria vaccine and the vaccine will be trialled in humans early next year.

29 Jul 2009

Swine Flu - getting drugs to the market more rapidly

The pharmaceutical industry has been up in arms this year. Giants such as Pfizer, GSK and AstraZeneca are looking for deals in the downturn whilst competing against increasing generic competition as some of the best selling medicines are coming off patent. In addition to the sectors ever-changing landscape companies are under tremendous pressure from governments to combat the Swine flu pandemic that has gripped the world.

29 Jul 2009

Children needed for Australian swine flu vaccine trial

The child vaccine is similar to the adult one and two types of dose strengths and amounts will be tested in order to determine the correct dosage and the safety of the vaccine - it will be tested on children aged between six months and eight years in Melbourne, Adelaide, Perth, Sydney and Brisbane.

28 Jul 2009

World's first genetically-modified strain of malaria parasite

Walter and Eliza Hall Institute scientists have created a weakened strain of the malaria parasite that will be used as a live vaccine against the disease. The vaccine, developed in collaboration with researchers from the US, Japan and Canada, will be trialled in humans from early next year.

28 Jul 2009

Amgen and GlaxoSmithKline to collaborate on Denosumab for postmenopausal osteoporosis

Amgen and GlaxoSmithKline (GSK) today announced a collaboration in which the companies will share commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico once the product is approved in these countries.

28 Jul 2009

Age-prioritized use of antivirals during an influenza pandemic

A model of influenza transmission and treatment suggests that, if the current swine flu pandemic behaves like the 1918 flu, antiviral treatment should be reserved for the young.

27 Jul 2009

Merck reports proposed settlement involving merger with Schering-Plough

Merck & Co., Inc. has announced a proposed settlement, subject to Court approval, to resolve litigation challenging the planned merger between Merck and Schering-Plough Corporation and seeking other forms of relief.

26 Jul 2009

Global health officials working to prevent H1N1 spread

"Global health officials are scrambling to try to prevent the spread of the H1N1 swine flu virus, with U.S. officials moving Thursday with a recommendation that the Food and Drug Administration (FDA) approve or license a [new H1N1] vaccine," without waiting on the results from "clinical trials to test its safety and efficacy," Wall Street Journal reports (Dooren/Winning, 7/24).

24 Jul 2009

Schering-Plough reports proposed settlement in planned merger with Merck

Schering-Plough Corporation today reported a proposed settlement, subject to Court approval, to resolve litigation seeking to enjoin the planned merger with Merck & Co., Inc., and other forms of relief.

24 Jul 2009