EuroPharma Today

How Will U.S. Healthcare Reform Impact European Pharma?

Health reform has dominated the U.S. political agenda throughout 2009, with President Obama and Congressional leaders working to effect a substantial overhaul of the health care system. The stakes are high, both for U.S.-based and European-based biopharma companies.

European Pharma Innovation May Be Outpacing U.S.

As many Americans from the halls of Congress to home district town halls are debating how much health reform should preserve the current system's status quo, the journal Health Affairs has published an article questioning how U.S. pharma innovation stacks up with other nations.

P&G Kisses Pharma Business Goodbye In $3.1 Billion Deal With Warner Chilcott

Warner Chilcott's $3.1 billion acquisition of Proctor & Gamble's pharmaceuticals business on Aug. 24 significantly bolsters the Irish drug maker's sales force and adds to its already lucrative women's health portfolio with the addition of Asacol HD and Actonel ,while freeing P&G to focus on consumer health.

Basilea is Vindicated as J&J Gets FDA Warning Letter on Zevtera

In what could be categorized as the silver lining in an otherwise black cloud for Swiss-based biotech Basilea, the FDA has issued a warning letter to Johnson&Johnson, the biotech's partner on Phase III anti-infective ceftobiprole. The letter--dated Aug 10--lists a range of concerns over J&J's trial conduct and site monitoring, including failure to follow study protocol.

Danish Biotech Genmab in Trouble as Arzerra Disappoints in NHL

Genmab and partner GlaxoSmithKline reported late on August 17 disappointing top-line results from a Phase II study of their anti-CD 20 antibody Arzerra in rituximab-refractory follicular non-Hodgkin's lymphoma (NHL), calling into question the biotech's future as an independent entity.

Early-Bird Discount For PharmAsia Summit Expires Aug. 31 - Hear China & India Case Studies From Industry Leaders

As pharma looks to broaden its capabilities beyond its four walls and spread the risk and rewards of drug development, companies are looking east to the multi-billion dollar Asian market, especially emerging markets like China and India.

Start-Up Profile: Immune Targeting Systems Ltd. - Synthetic Vaccines Against Mutating Viruses

London-based Immune Targeting Systems Ltd. is developing synthetic peptide-based vaccines against rapidly mutating viruses. The company, which was founded by CEO Carlton Brown and CSO Bertrand Georges in October 2003, uses its antigen identification and fluoropeptide antigen delivery technology platforms to create vaccines designed to stimulate T-cell-based immunity rather than the antibody-based immune responses triggered by most conventional vaccines.

EMEA and FDA to Share Clinical Trial Inspections Under Pilot Program

An initiative by FDA and the European Medicines Agency to share duties related to oversight of clinical trials may also reduce the resource burden on sponsors.

A pilot program focusing on human drugs will begin Sept. 1 to determine whether information produced by each other's inspections is sufficient to allow each agency to make its own decisions about compliance with good clinical practices.

NicOx Buys Back Glaucoma Drug Rights From Pfizer

After nearly a year of uncertainty regarding its mid-stage clinical glaucoma drug, PF-03187207, the French biotech NicOx announced August 6 that it was buying back the development and commercialization rights to the nitric-oxide donating prostaglandin analog from its long-time partner Pfizer.

No US Liraglutide News from Novo, but Victoza European Rollout Continues

Analysts had been expecting further clarity on the progress of Novo Nordisk's highly-anticipated GLP-1 analog liraglutide at FDA during the company's first-half results announcement on August 6. The Danish company disappointed on that front. But liraglutide (Victoza)'s European rollout is ongoing, and Novo's hoping it might help revive flagging insulin sales in the region.