“FDA Advisory Committee To Review Human Genome Sciences’ Anthrax Treatment” (The Pink Sheet)
Human Genome Sciences’ anthrax treatment ABthrax (raxibacumab), which has already been sold to the U.S. government, is moving through the final review process at FDA.
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“Larry D’Andrea Joins Spartan Bioscience as CEO” (News Blaze)
“Don’t count on a bid for AstraZeneca” (City Wire)
Posted in Industry Stories
“Xolair Push For Younger Patients Could Test Power Of Risk Management” (The Pink Sheet)
Xolair may be a test of how risk management programs can create enough regulatory comfort with a product to allow it to be promoted for new populations.
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“AstraZeneca gets new Seroquel thumbs-up in Europe” (PharmaTimes)
“GSK pulls Rezonic files, signs Brazil and China deals” (PharmaTimes)
Posted in Industry Stories
“Pfizer and Eisai Will Continue to Promote Aricept, but add Lyrica to the Collaboration” (The Pink Sheet)
A potential sticking point in Pfizer’s acquisition of Wyeth has been resolved – the big drug maker and Eisai have agreed to continue co-promoting Aricept (donepezil) in the U.S., Europe and Japan. However, Eisai will regain full Japanese rights to the Alzheimer’s blockbuster at the end of 2012, while the rest of the collaboration will remain in place until 2022.
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“Pfizer Expects Speedy Integration Of Wyeth, R&D Head Mackay Says” (The Pink Sheet)
Drug sponsors trying to gauge how FDA’s new leadership might handle controversies surrounding their NDAs received some sobering insight when the agency released its internal assessment of the approval of ReGen Biologics’ Menaflex knee repair device.
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“Abbott, Johnson & Johnson bulk up in Europe” (EuroInvestor)
Posted in Industry Stories
“Biosimilars Would Have Reimbursement Parity With Innovators Under Health Reform Bill” (The Pink Sheet)
The potential for physicians to favor innovator biologics over follow-on biologics because of a reimbursement advantage would be eliminated under an amendment to health care reform legislation adopted by the Senate Finance Committee Sept. 23.
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“Frances D. Fergusson And John P. Mascotte Elected To Pfizer’s Board Of Directors” (Stockpoint)
“Pfizer and Eisai settle dispute over Aricept rights; Lyrica deal” (PharmaTimes)
Posted in Industry Stories
Posted in Industry Stories
“BioSante Pharmaceuticals and Cell Genesys Announce Final Exchange Ratio for Merger” (Pharmalive)
“Glaxo’s Strategy For Drug Performance Units Is Showing Promise, Slaoui Says” (The Pink Sheet)
One year after GlaxoSmithKline shook up its R&D organization with the creation of drug performance units, or DPUs, R&D Chair Moncef Slaoui said the changes have resulted in a renewed focus on science and accountability that is yielding results. Slaoui outlined details of the strategy Sept. 22 during Windhover’s Pharmaceutical Strategic Alliance Conference in New York City.
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“LEO Pharma Repurchases Product Rights From Warner Chilcott” (Pharmalive)
Posted in Industry Stories
“Pfizer Again Named To Working Mother 100 Best Companies List” (Business Wire)
“Lilly Announces New U.S. Affiliate Leader” (PharmaLive)
Posted in Industry Stories
“AstraZeneca signs $735 million pact with Nektar” (PharmaTimes)
“Reports claim Nycomed has bid for Solvay drug division” (PharmaTimes)
“GSK to buy a $150 million stake in Dr Reddy’s?” (PharmaTimes)
Posted in Industry Stories
“Omeros Commences Initial Public Offering of Common Stock” (pharmalive.com)
“Elan seals J&J pact as Tysabri battle with Biogen is resolved” (pharmatimes.com)
“The New Ghostbuster: Elsevier Reviews Articles On Wyeth Drugs” (The Pink Sheet)
As part of an effort to prevent ghostwriting in its medical journals, Elsevier is reviewing seven articles it has published on Wyeth’s hormone replacement therapies Premarin and Prempro to see if they satisfy its editorial standards.
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Posted in Industry Stories
“Pandemic flu vaccines on way after FDA approval” (USA Today)
“Lilly Unveils Blueprint for Speeding Innovative Medicines to Patients” (drugs.com)
“FDA Sends Warning Letters to Allergan and Bioniche” (drugs.com)
Posted in Industry Stories
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