BioPharma Today

Coming In Wednesday's "The Pink Sheet" DAILY - Vertex's Kalydeco Cystic Fibrosis Drug Speeds Through FDA

FDA announced the approval of Vertex’s Kalydeco for cystic fibrosis on Jan. 31, after just three months’ review and no advisory committee evaluation. It is thought to be the second-quickest FDA approval of a drug, trailing only Novartis’ leukemia drug Gleevec.

Accountable Care Organizations: What You Need to Know Now!

Regulatory and market pressures are driving health systems to improve healthcare quality and outcomes while reducing costs. This concept of quality and cost improvement is currently defined as accountable care, however it is manifesting in several different forms: the accountable care organization (ACO), the patient-centered medical home (PCMH), bundled payments and other models. Regardless of the outcome of the healthcare reform debate and the ultimate design of the ACOs, various core elements of accountable care are being explored and incorporated by health systems of all sizes and structures.

Coming In Wednesday's "The Pink Sheet" DAILY - Teva CEO To Step Down In May

Aveo/Astellas’ investigational tivozanib topped Onyx/Bayer’s Nexavar in advanced kidney cancer patients, 70% of whom were treatment naïve, in a head-to-head Phase III trial. The results strengthen Aveo’s plan to dominate the first-line spot in that indication but also reopen the question of how many added months of survival constitutes a true improvement.

How "Clean" Will PDFUA V Be? Rep. Pitts Outlines His Priorities

Article preview from "The Pink Sheet"- July 18, 2011

Pennsylvania Republican Joe Pitts, chairman of the House Energy and Commerce Health Subcommittee, has a straightforward approach to reauthorizing the Prescription Drug User Fee Act – get it done early.

FDA Pressed To Clarify Permissible Formulary, Clinical Guideline Communications

Article preview from "The Pink Sheet"- July 5, 2011

A coalition of seven pharmaceutical companies is asking FDA to issue clarifying regulations in four areas of off-label communications.

Latest News From "The Pink Sheet" DAILY - RXi Buys Apthera, Merck Serono Extends CNS Collaboration With Newron

Cure Rates Hold Up Across Genetic Status For Vertex's Telaprevir

Latest News From "The Pink Sheet" DAILY - Amyvid Complete Response Letter Could Force More Trials For the Alzheimer's Disease Diagnostic

Ariad Opts-in To Co-Promote mTOR With Merck

The biotech takes advantage of the Big Pharma's financial wherewithal and regulatory/market expertise to build out its own commercial infrastructure.   read more

Boehringer Ingelheim Has Two Years To Prepare CFC-Free Combivent

FDA rejects a petition the firm had submitted in 2006 asking the agency exempt the COPD drug from a ban on ozone-depleting substances.   read more

EU's Advisory Panel Clears BMS/Pfizer's Apixaban; Turns Down Vectibix Extension

Europe's scientific advisory committee, the CHMP, gives positive opinions on apixaban and Viropharma's Cinryze, but doesn't want Vectibix's indications extended.   read more

Amyvid Training Issues Lead To Complete Response Letter, Could Force More Trials

FDA says consistent training program needed for market implementation of amyloid diagnostic. Lilly says issues will be resolved promptly.   read more

Cadila Healthcare Chairman Pankaj Patel On The Potential For Consolidation In The Indian Industry: An Interview With PharmAsia News

Every player wants to continue to work rather than take a back seat. Unless that mindset comes to India, consolidation within Indian players is tough to find, says Patel.   read more

Financings Of The Fortnight: Exelixis Follows Horrible Year With Successful Stock Offering

News on recent financings by Aerie Pharmaceuticals, Nimbus Discovery, BioCryst and Omthera Pharmaceuticals.   read more

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Have you seen our M.E.N.A Coverage?

Check out these headlines covering the Middle East and North Africa (MENA) in "PharmAsia News".

Coming In Monday's "The Pink Sheet" DAILY - Cephalon Posts Strong Full-Year Earnings

Promedior Inc., a Malvern, Pa. start-up has launched a Phase Ib study of its lead compound PRM-151, a recombinant human protein with potential to stop and even reverse the uncontrolled scarring at the root of fibrotic diseases such as idiopathic pulmonary fibrosis, for which there curently are no appproved therapies.

Latest News From "The Pink Sheet" DAILY - FDA Faces $220 Million Budget Cut

FDA Budget Spared Deepest Cuts As House Republicans Seek To Slash Spending In FY'11