Pharmaceuticals

06 October 2009, London, UK -- GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain.

The company today provided an update on orders received for its pandemic (H1N1) adjuvanted vaccine.

On the 4th August, GSK confirmed that it had contracts in place to supply 291 million doses of the vaccine and had a variety of agreements in place with the US Government to supply pandemic products worth $250 million.

Since that date, 22 government orders have been agreed to supply a further 149 million doses of the vaccine. This now brings the total number of doses ordered for GSK’s pandemic vaccines to 440 million. Discussions continue with governments for further supplies.    » read more »

27 million doses shipped to US market by Novartis - providing more seasonal flu vaccine earlier than in any previous year

Basel, October 6, 2009 - Novartis announced today that the company has completed its entire shipment of seasonal influenza vaccine to the United States for the 2009/2010 season. As previously anticipated, the company delivered 27 million doses of Fluvirin® influenza virus vaccine, which has been approved by the U.S. Food and Drug Administration (FDA).

Novartis completed this season's shipment earlier than in previous years, in anticipation of demand for earlier vaccination with seasonal influenza vaccine created by the current global A(H1N1) influenza pandemic.    » read more »

October 6, 2009 -- CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.    » read more »

October 6, 2009 -- HELENA – Montana's two U.S. Senators and Attorney General have joined forces to combat the growing misuse of over-the-counter and prescription drugs.

Sens. Max Baucus and Jon Tester along with Attorney General Steve Bullock announced their support Tuesday for designating October as National Medical Abuse Awareness Month. Baucus and Tester have signed on as co-sponsors of a measure in the Senate that will raise awareness of the misuse of over-the-counter and prescription medications and urge communities to implement educational programs associated with medicinal abuse.    » read more »

Cantwell Amendment Included in Finance Committee Health Care Bill to Require Pharmacy Benefit Managers to Report Pricing, Other Information to Government

September 25, 2009 -- Washington, DC – The Senate Finance Committee today approved an amendment authored by U.S. Senator Maria Cantwell (D-WA) to require reporting by pharmacy benefit managers (PBMs) to ensure that savings from drug price negotiations are being passed on to consumers and not contributing more to pharmaceuticals’ bottom lines.    » read more »

Brown says creation of approval process for biogenerics and shorter monopoly period will lower health costs, improve medical care

July 7, 2009 -- WASHINGTON, DC — U.S. Senator Sherrod Brown (D-OH) today spoke on the Senate floor regarding legislation to improve access to generic biologic drugs. A video of the speech can be viewed below.

Biologic drugs, which treat cancer, Parkinson’s, diabetes, rheumatoid arthritis, Alzheimer’s, and multiple sclerosis, are expected to make up 50 percent of the pharmaceutical marketplace by 2020. Despite this, there is no approval process for generic biologics, leading to monopolies which cause high drug prices and stifle innovation.    » read more »

First company to join the pool since creation in March 2009

8 July 2009, Cambridge, Massachusetts and London UK -- GlaxoSmithKline (GSK) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced today that Alnylam will contribute more than 1500 issued or pending patents on its RNA interference (RNAi) technology patent estate to the patent pool established by GSK earlier this year.    » read more »

Receives Fast Track Designation from FDA for PEGylated Interferon Beta-1a for Relapsing Multiple Sclerosis

CAMBRIDGE, Mass., Jul 08, 2009 -- Biogen Idec (NASDAQ: BIIB) today announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.    » read more »

IRESSA (Gefitinib) receives marketing authorization for the treatment of non-small cell lung cancer in Europe

01 July 2009 -- AstraZeneca announced today that the European Commission has granted marketing authorisation for the oral anti-cancer drug, IRESSA for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase) across all lines of therapy. The authorisation is based on a submission package including two pivotal Phase III studies comparing IRESSA with chemotherapy, IPASS and INTEREST.    » read more »

Biogen Idec and Acorda Therapeutics announce collaboration agreement to develop and commercialize MS therapy Fampridine-SR in markets outside the U.S.

Acorda to Continue to Develop and Commercialize Fampridine-SR in the U.S. -- CAMBRIDGE, MA and HAWTHORNE, NY, July 1, 2009 – Biogen Idec (NASDAQ: BIIB) and Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced that they have entered into an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR, a multiple sclerosis (MS) therapy, in markets outside the United States.    » read more »

23 June 2009, London UK -- GlaxoSmithKline (LSE: GSK) and Chroma Therapeutics Limited announced today a collaboration to develop macrophage-targeted compounds using Chroma’s proprietary esterase-sensitive motif (ESM) technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process.    » read more »

Statement from President Obama on Agreement to Bring Down Drug Prices for Americans Seniors

June 20, 2009 -- "I am pleased to announce that an agreement has been reached between Senator Max Baucus and the nation's pharmaceutical companies that will bring down health care costs and reduce the price of prescription drugs for millions of America's seniors.    » read more »

Merck Statement in Response to the FDA's June 12, 2009 Communication with Updated Information on Leukotriene Inhibitors, Including SINGULAIR® (montelukast sodium)

WHITEHOUSE STATION, N.J., June 12, 2009 - Merck & Co., Inc. issued the following statement in response to today's communication from the U.S. Food & Drug Administration (FDA) addressing updated information on leukotriene inhibitors, including SINGULAIR® (montelukast sodium).    » read more »

Biogen Idec Announces First Patient Enrolled in the Global Phase III Study of PEGylated Interferon Beta-1a for Relapsing Multiple Sclerosis

CAMBRIDGE, Mass. -- Jun. 22, 2009 -- Biogen Idec (NASDAQ: BIIB) today announced enrollment of the first patient in a Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a (BIIB017) in patients with relapsing multiple sclerosis (RMS). The trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS.    » read more »

Phase III data show rapid and sustained remission in more than 90% of Ilaris-treated patients with cryopyrin-associated periodic syndrome (CAPS)[1]

Basel, June 18, 2009 - The US Food and Drug Administration (FDA) has approved Ilaris® (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders with debilitating symptoms and limited treatment options[1],[2],[3],[4]. The FDA granted priority review to Ilaris based on its potential to meet an important clinical need for patients with CAPS.    » read more »