Pharmaceutical industry

Protein Marker Test Aids in the Early Diagnosis of Kidney Injury and Reduces Wait Time from Days to Hours

October 06, 2009 -- Abbott Park, Illinois (NYSE: ABT) — Abbott announced today it has received CE Marking (Conformité Européene) for a new diagnostic test that detects an important protein in urine, neutrophil gelatinase-associated lipocalin (NGAL), an early marker or indicator for patients with, or at risk of, acute kidney injury (AKI).    » read more »

Interim data from European studies confirm that one dose of Panenza® or Humenza® pandemic influenza vaccines induces robust seroprotective antibody response in children and adults

Lyon, France – October 8, 2009 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that a single dose of influenza A (H1N1) 2009 monovalent vaccines, Panenza® (15 mcg dose, non-adjuvanted) or Humenza® (3.8 mcg dose, adjuvanted), administered to children (3 years of age and older) and adults induces a robust immune response, according to results from clinical trials conducted in Europe.    » read more »

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 »

If you have a cold, or the flu, antibiotics won't work for you

Pharmacists around the nation are joining the Centers for Disease Control and Prevention to educate consumers about the appropriate use of antibiotics during this influenza season. Antibiotics are intended to treat bacterial infections, not viruses like the flu. The CDC is observing the second annual Get Smart About Antibiotics Week October 5-11, 2009.

The Get Smart: Know When Antibiotics Work program reaches parents, pharmacists and health care providers through print advertisements, fact sheets, brochures, posters, radio and print public service announcements, podcasts, and mainstream media interviews.    » 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 »

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 »

WHO grants prequalification to Cervarix®: GSK’s vaccine to help combat cervical cancer in developing nations

9 July 2009, London, UK -- The World Health Organization (WHO) has awarded prequalification to Cervarix®, GlaxoSmithKline’s cervical cancer vaccine. The WHO decision is necessary for UN agencies and the GAVI Alliance to purchase the vaccine in partnership with developing countries and will help speed access to Cervarix globally.

More than 80 percent of the 280,000 cervical cancer deaths a year occur in resource-poor nations.[i] Cervical cancer affects poor women in the least developed countries more often and more aggressively due to a lack of available screening services and the high prevalence of other serious health conditions such as HIV/AIDS. [ii], [iii]    » 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 »

Kohl bill would save consumers $3.5 billion per year, according to FTC

6/23/09 -- WASHINGTON, D.C. – U.S. Senator Herb Kohl today released the following statement on the announcement from the U.S. Federal Trade Commission Chairman Jon Leibowitz that banning for pay-for-delay settlements that keep generic drugs off the market would save consumers at least $3.5 billion per year, and provide significant cost savings for federal government, which pays approximately one-third of all prescription drug costs.    » read more »

Will Help Curb Cost of Health Care Reform

June 22, 2009 -- Washington, D.C. -- Today, U.S. Senators Olympia J. Snowe (R-Maine) and Byron Dorgan (D-N.D.), sponsors of the Pharmaceutical Market Access and Drug Safety Act, welcomed the decision of the Pharmaceutical Research and Manufacturers of America (PhRMA) to contribute $80 billion over the next 10 years to improve drug benefits for seniors under Medicare. The Senators said this was a first step, and urged Congress to continue to work to reduce prescription drug costs for Americans.    » read more »