BioPharma Today

China's Heart Disease Problem, Healthcare Reform - Latest From PharmAsia News

Wendy Diller — Thu, 11 Mar 2010 10:33:43 PST

Heart Ailments Rising In China -- China's Minister Of Health Calls For More Regional Support For Healthcare Reform -- Japan, U.S. Regulators Begin Collaborative Review Pilot With Femoral Stents

Coming in Friday's "The Pink Sheet" DAILY - AstraZeneca Forms Branded Generics Alliance With India's Torrent Pharmaceuticals

Wendy Diller — Thu, 11 Mar 2010 10:12:36 PST

AstraZeneca forms branded generics alliance with Torrent Pharmaceuticals - Advance Life Sciences has reached an agreement with FDA on approval path for Restanza - FDA has not found a clear connection between bisphosphonates and risk of bone fractures below the hip but is continuing to review data - Rep. Maurice Hinchey is proposing legislation to give FDA authority to curtail direct to consumer advertising

Latest News From "The Pink Sheet" DAILY - FDA Tells Congress It Needs More Authority Over Drug Safety

Wendy Diller — Thu, 11 Mar 2010 06:59:29 PST

FDA's Sharfstein tells Congress agency needs more authority over drug safety - Insurers push for enhanced medical cost controls in health reform legislation - Allergan's off-label suit against FDA will continue despite Botox approval for spasticity - Rival Medivation has a "Plan B" for prostate cancer trials if Sanofi-Aventis' cabazitaxel becomes new standard of care - FDA's drug and tobacco centers to hold joint meeting - German Health Minister to impose rebates on patented drugs to lower drug prices

Editors' Picks from the World Press

Wendy Diller — Thu, 11 Mar 2010 06:44:16 PST

Pipeline/RD News Ischemix begins Phase IIa trial of drug for tissue damage Business Finance Cel-Sci receives Byron's marketing fee for cancer drug candidate Takeda pays Affymax $5 million for anemia drug's milestone AstraZeneca partners with Torrent to launch branded generics...

Coming In Thursday's "The Pink Sheet" DAILY - Insurers On Health Reform

Wendy Diller — Wed, 10 Mar 2010 10:07:17 PST

Insurers will offer proposals to modify health reform legislation to address rising medical costs, AHIP’s Ignagni tells March 10 policy forum in response to HHS Secretary Sebelius’ call to come back to the table.

PhRMA Open To User Fees To Support Oversight Of Internet Drug Promotion

Josh — Wed, 10 Mar 2010 10:04:32 PST

Article Reprinted from "The Pink Sheet" Daily- March 9,2010 The pharmaceutical industry is seeking a path to participation in social media and the Internet without running afoul of FDA's promotional no-no's and appears willing to help pay for it. Read more...

Latest News From "The Pink Sheet" DAILY - Abbott Buys Facet For $720 Million

Wendy Diller — Wed, 10 Mar 2010 06:12:01 PST

Facet Says Yes To Abbott's $720 Million Buyout Offer

Coming In Wednesday's "The Pink Sheet" DAILY - FDA Reorganizes Office Of New Drugs

Wendy Diller — Tue, 09 Mar 2010 10:38:51 PST

Drug product reviews will be reassigned as FDA reorganizes its Office of New Drugs.

OrbiMed, Japan's NHI Price Listing, Avandia, Perrigo - Latest From PharmAsia News

Wendy Diller — Tue, 09 Mar 2010 09:04:47 PST

OrbiMed Leads Series A Financing In Its Second China Start-up -- Japan Sets New Reimbursement Prices For NHI-qualified Drugs; Cuts Average 5.75 Percent -- Korea FDA Sends Precautionary Notice To Doctors For Rosiglitazone -- Perrigo Will Acquire Orion Labs To Reach Australian Market

ANDA User Fees: Industry Takes Holistic Approach, Wants Whole New Office

Josh — Mon, 08 Mar 2010 08:57:13 PST

Article reprinted from The Pink Sheet- March 8, 2010 The generics industry is pushing FDA to create a commissioner-level office dedicated to handling issues related to ANDAs during negotiations over the creation a user fee program for generic drugs. Read more...

Direct from India: PharmAsia News Discusses Ranbaxy, Biocon on CNBC

Josh — Fri, 05 Mar 2010 10:50:15 PST

In this CNBC interview, PharmAsia News India Bureau Chief Vikas Dandekar discusses the latest developments at Strides Arcolab, Ranbaxy and Biocon.

Coming In Monday's "The Pink Sheet" DAILY - Favorable Data For BMS/Pfizer's Apixaban

Wendy Diller — Fri, 05 Mar 2010 10:18:40 PST

Although approval is considered fairly likely due to unmet medical need, a March FDA advisory committee review of InterMune’s pirfenidone for idiopathic pulmonary fibrosis likely will focus on what would constitute a clinically meaningful outcome in trials with a primary endpoint of forced vital capacity - Bristol-Myers Squibb/Pfizer's experimental anticoagulant apixaban, proved superior to standard of care in the second of three trials testing the oral factor Xa inhibitor in knee and hip replacement surgery patients.

Latest News from "The Pink Sheet" DAILY - Spotlight On Bristol-Myers At Investor Meeting

Wendy Diller — Fri, 05 Mar 2010 06:59:18 PST

At Investor Meeting, Spotlight is on Bristol-Myers CEO-Designate Lamberto Andreotti --and Pipeline -Two Deals Bolster Watson's Position In Branded Women's Health Products - House Ways & Means Chair Levin Is R&D Tax Credit Advocate; Stark Retains Health Panel Leadership

Editors' Picks from the World Press

Wendy Diller — Fri, 05 Mar 2010 06:48:20 PST

Pipeline/RD News BioVex begins Phase I trial of genital herpes vaccine in U.K. Study: Vaccine triggers immune response against mesothelioma Anti-clotting treatment apixaban works better than Lovenox in study Business Finance Bristol-Myers details strategy to offset future Plavix losses Aurobindo...