BioPharma Today

Coming in Wednesday's "The Pink Sheet" DAILY

After a snow delay, ChemGenex will have more time to prepare for what may be a challenging review of Omapro (omacetaxine mepesuccinate) for chronic myeloid leukemia by FDA's Oncologic Drugs Advisory Committee.

Chugai, Achillion, China's ADR Reporting Problem - Latest From PharmAsia News

China Grapples To Get A Handle On Reporting Mechanisms For Adverse Drug Reactions

02/09/10 11:33 GMT

"The Pink Sheet" Outlines Key Factors In The Fate Of Amgen's Osteoporosis Drug Denosumab.

 

Analysts at "The Pink Sheet," have recently delivered penetrating analysis of an important new drug. "The Pink Sheet" reports on critical elements in this process, from the inside debate among approval committee memebers to the unusual makeup of the committees and their reputations for rigorouse standards.

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What’s in Your Pipeline? The Feds Want to Know

The Agency for Health Care Research & Quality (the US government's de facto comparative effectiveness research center) is slowly but surely funneling out its portion of the $1.1 billion in stimulus money set aside for comparative effectiveness research last year.

Latest News from "The Pink Sheet" DAILY

Wellbutrin XL Generic From IntelGenx/Cary Pharma Delayed By Manufacturing, Food Effect Concerns

"Complete response" letter from FDA should be addressed by the end of the year, firms state.   read more

Editors' Picks from the World Press

Pipeline/RD News

• Dynavax will initiate 2,000-patient study of Heplisav

Business Finance

• Failed reform would slightly benefit health care firms, analysts say
• Analysis: Shareholder activists' influence on biotechs yields mixed results
• Teva, Active extend collaboration for multiple sclerosis drug
• Novavax, Rovi end partnership talks for flu vaccines

Government Legal News

• Anthera, FDA agree on trial design for heart drug varespladib
• FDA reviewers voice concern about pixantrone's efficacy
• FDA staff questions clinical significance of ChemGenex drug

Coming in Tuesday's "The Pink Sheet" DAILY

Canadian specialty pharma IntelGenx received a "complete response" letter from FDA for its antidepressant candidate CPI-300, a high-strength formulation of bupropion, the active ingredient in GlaxoSmithKline's venerable mood disorder therapy Wellbutrin XL. The hang-up appears to be more about IntelGenx's late-in-the-game switch of contract manufacturing organizations than the bioequivalence issues that have dogged Teva's generic version of the drug.

FDA's Oncologic Drugs Advisory Committee on Feb. 10 is to review Cell Therapeutics' Pixuvri (pixantrone) injection for treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma who have received two or more prior lines of therapy.

Latest News From "The Pink Sheet" DAILY

Gene Patents Would Be Limited Under HHS Advisory Committee Proposal

The committee recommends that anyone who uses a gene patent for research or to make or sell a genetic test should not be liable for infringement. read_more_>

Ranbaxy, Pfizer, Essential Drugs List, Dainippon Sumitomo - Latest From PharmAsia News

Corrective Actions "Inadequate," U.S. FDA Warns Ranbaxy; Threatens Seizure And Injunction

02/05/10 13:14 GMT

Coming in Monday's "The Pink Sheet" DAILY

An HHS advisory committee is proposing restrictions on gene patenting and licensing that could make it difficult for biotech companies to enforce certain patents and engage in technology transfer with universities.

Latest News from "The Pink Sheet" DAILY

GSK Argues Its Strategy Is Delivering As Still More Cuts Are Made, Including in R&D

CEO Witty suggests group has emerged from worst of patent storm with an upbeat forecast for 2010 and promises of further cost-cutting.   read more

Editors' Picks from the World Press

Pipeline/RD News

• Discovery ties immunoglobulin subtype to H1N1 flu
• Lancet retracts study linking autism to MMR vaccine
• 2 compounds could lead to additional drugs against HIV
• Optimer's fidaxomicin is as effective as Vancocin in late-stage study

Business Finance

• Drugmakers fight Obama's proposal to tax foreign profit
• Genzyme taps former Eli Lilly exec as manufacturing president
• Ore Pharmaceuticals relocates to Massachusetts
• BioMarin will pay $18 million to acquire Lead Therapeutics

Government Legal News

• Ranbaxy fails to address FDA's questions on manufacturing
• FDA clears Woodcock of conflict-of-interest allegation
• FDA program aims to block entry of tainted food, drugs

Coming in Friday's "The Pink Sheet" DAILY

GlaxoSmithKline CEO Andrew Witty delivers upbeat forecast in announcing the company's fourth quarter earnings. He cites sustained R&D productivity and the opportunity for 6 NME/vaccine launches in the next 18 months.
 
FDA’s advertising citation for Lilly’s Adcirca (tadalafil) highlights the dangers of using anecdotal evidence for promotions. The DDMAC letter matches patient testimonial’s against clinical trial data and finds the discrepancies overstate the efficacy of the pulmonary arterial hypertension therapy.

Astellas, Takeda, CSL - Latest From PharmAsia News

Did The World Health Organization Overreact To The Threat Of A/H1N1?

02/04/10 7:09 GMT

Latest News from "The Pink Sheet" DAILY

Prescription Drug Spending Rose 5.2% To $246.3 Billion In 2009, CMS Estimates

Editors' Picks from the World Press

Pipeline/RD News

• Japanese researchers identify 25 potential targets for leukemia drugs

Coming in Thursday's "The Pink Sheet" DAILY

Ironwood prices its IPO at $11.25 a share, well below its expected range, but still pulls in $188 million. Is it enough to inspire a new biotech IPO wave?

Humira, Astellas-Maxygen, Green Cross - Latest From PharmAsia News

Patent Granted And Revoked: Indian Patent Office Flip-Flop On Humira Worries Patent Experts

02/03/10 10:05 GMT

Latest News From "The Pink Sheet" DAILY

Biotech Building Blocks On Trial: ACLU, Myriad Battle Over BRCA Cancer Gene Patents

ACLU argues that isolated DNA molecules are like a carburetor taken from an engine, the same inside as outside the body; Myriad says they are new compositions of matter.   read more

Coming in Wednesday's "The Pink Sheet" DAILY

FDA will be hard-pressed to meet a March 29 PDUFA date for Theratechnologies’ Egrifta (tesamorelin) following cancellation of a Feb. 24 advisory committee review of the drug to treat patients with excess visceral abdominal fat in HIV-associated lipodystrophy.

Daiichi Sankyo, Pfizer, WHO Report - Latest From PharmAsia News

Daiichi Sankyo Lifts FY2009 Profit Forecasts, Submits NDA For Flu Inhaler Laninamivir

02/02/10 11:51 GMT

After Buying Vetnex, Pfizer Invests $40 Million To Set Up Discovery Research Center For Animal Health Drugs In India

02/02/10 8:55 GMT

WHO Report Evaluates Ways To Fund Drug R&D For Developing Countries; Critics Say It Fails To Address Access To Medicines

02/02/10 5:00 GMT

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