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The Hill examines Presidential candidates' positions on prescription drug issues

The Hill on Tuesday examined how Democratic presidential nominee Sen. Barack Obama (Ill.) and Republican presidential nominee Sen. John McCain (Ariz.) are perceived by the drug and biotech industries.

10 Sep 2008

GlaxoSmithKline and Cellzome announce major strategic alliance

Cellzome Inc. and GlaxoSmithKline have announced the signing of a worldwide strategic alliance to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases.

10 Sep 2008

Pfizer to withdraw global marketing applications for Dalbavancin to conduct a new trial

Pfizer Inc today announced it will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. new drug application (NDA) and the European marketing authorization application (MAA).

9 Sep 2008

Supreme Court to consider whether to bar liability lawsuits against pharmaceutical companies

The U.S. Supreme Court in November will consider whether to shield the makers of prescription and over-the-counter drugs from liability lawsuits, the Los Angeles Times reports.

9 Sep 2008

FDA posts names of prescription drugs being investigated for potential safety problems

FDA officials on Friday said the agency will begin publishing quarterly a list of drugs being investigated for potential safety risks, the Washington Post reports.

9 Sep 2008

VivaGel coated condoms - Starpharma and SSL International in business

Starpharma Holdings Limited has announced that a full licence agreement has been signed with SSL International plc in relation to the VivaGel coated condom. SSL manufactures and sells Durex condoms, the market-leading condom brand worldwide.

9 Sep 2008

Orexo and Boehringer Ingelheim extend collaboration

Orexo AB, the Swedish pharmaceutical company and Boehringer Ingelheim, the international pharmaceutical company headquartered in Ingelheim, Germany, have extended their existing three year research collaboration for a further 12 months from November 2008.

8 Sep 2008

About 85% of insurers' marketing materials for prescription drug plans do not meet Medicare guidelines, audit finds

Nearly 85% of the marketing materials used by private prescription drug plans to reach Medicare beneficiaries do not fully meet CMS guidelines, according to a report released Thursday by the HHS Office of Inspector General, CQ HealthBeat reports.

7 Sep 2008

Simple hardness test detects fake medicines

The fight against fake medicines could soon be aided by a small, portable device that quickly measures the hardness of a tablet, revealing whether it is counterfeit, according to research presented at the British Pharmaceutical Conference (BPC) in Manchester.

7 Sep 2008

FDA to post quarterly report of potential drug safety issues

The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

7 Sep 2008

Free drug samples may end up costing uninsured more

Free drug samples provided to physicians by pharmaceutical companies could actually be costing uninsured patients more in the long run, according to a study done by researchers at Wake Forest University Baptist Medical Center and colleagues.

7 Sep 2008

FDA forces manufacturers of TNF-blockers to highlight risk of fungal infections

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

5 Sep 2008

Nanotherapeutics files INDA for NanoDOX hydrogel to treat type of diabetic ulcers

Nanotherapeutics announced today that it has submitted its first Investigational New Drug (IND) application to the FDA for a phase IIa clinical study for its product NanoDOX Hydrogel, a topical doxycycline hydrogel for chronic wounds.

4 Sep 2008

Unsuccessful drug against anxiety opens a novel gateway for the treatment of cancer

According a new study, unsatisfying drug for anxiety reveals scientists a promising novel anti-cancer drug target.

4 Sep 2008

FDA 'fast track' granted to BioMS Medical for lead drug, dirucotide for the treatment of multiple sclerosis

BioMS Medical Corp has announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

4 Sep 2008

FDA assigns priority review to ATryn from GTC Biotherapeutics

The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.'s Biologic License Application, or BLA, for ATryn.

4 Sep 2008

Celgene receives FDA 'fast track' for Amrubicin in small cell lung cancer after first-line chemotherapy

Celgene Corporation today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy.

4 Sep 2008

Anadis to commercialise "BioGard" adjunctive therapy for HIV/AIDS

Anadis announced today its commercialization of a new product, BioGard, intended to maintain gastrointestinal and immune system health. The specific formulation may be of particular clinical benefit in persons undergoing antiretroviral therapy for HIV/AIDS.

4 Sep 2008

Merck Serono and Ablynx to jointly develop nanobodies

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that it has entered into an agreement with Ablynx, to co-discover and co-develop Nanobodies against two targets in oncology and immunology. The agreement includes an upfront cash payment to Ablynx of EUR10 million.

4 Sep 2008

Vimpat (lacosamide) approved in Europe

UCB announced today that the European Commission (EC) has approved Vimpat (lacosamide) as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. Vimpat is the first new antiepileptic drug (AED) for partial-onset seizures in three years and offers a new treatment option for European patients living with uncontrolled partial-onset epilepsy.

3 Sep 2008

Pharmaceutical News

The Hill examines Presidential candidates' positions on prescription drug issues

GlaxoSmithKline and Cellzome announce major strategic alliance

Pfizer to withdraw global marketing applications for Dalbavancin to conduct a new trial

Supreme Court to consider whether to bar liability lawsuits against pharmaceutical companies

FDA posts names of prescription drugs being investigated for potential safety problems

VivaGel coated condoms - Starpharma and SSL International in business

Orexo and Boehringer Ingelheim extend collaboration

About 85% of insurers' marketing materials for prescription drug plans do not meet Medicare guidelines, audit finds

Simple hardness test detects fake medicines

FDA to post quarterly report of potential drug safety issues

Free drug samples may end up costing uninsured more

FDA forces manufacturers of TNF-blockers to highlight risk of fungal infections

Nanotherapeutics files INDA for NanoDOX hydrogel to treat type of diabetic ulcers

Unsuccessful drug against anxiety opens a novel gateway for the treatment of cancer

FDA 'fast track' granted to BioMS Medical for lead drug, dirucotide for the treatment of multiple sclerosis

FDA assigns priority review to ATryn from GTC Biotherapeutics

Celgene receives FDA 'fast track' for Amrubicin in small cell lung cancer after first-line chemotherapy

Anadis to commercialise "BioGard" adjunctive therapy for HIV/AIDS

Merck Serono and Ablynx to jointly develop nanobodies

Vimpat (lacosamide) approved in Europe

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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