BioPharma Today

Breaking Today....

Labopharm receives notice of ANDA submission with paragraph IV certification for generic of Ryzolt(TM)
PR Newswire

Pfizer Receives Approval From Australian Competition And Consumer Commission (ACCC) For Pending Acquisition Of Wyeth
Business Wire

Dr Reddy's voluntarily recalls 4 drugs from U.S.
Reuters

Headlines From "The Pink Sheet" DAILY

SEC Investigates Elan Over Disclosures of Clinical Trial Data and Side Effect Reports

At issue: July 2008 reports of PML cases linked to Tysabri and key trial data for its Alzheimer's medication; Wyeth also gets a subpoena.   read more

 

Public Plan's CBO Score Makes It Reconciliation-Friendly

As public option goes down in Senate Finance Committee, CBO score breathes life into the proposal if Democrats use budget reconciliation maneuver to pass health reform.   read more

 

Senate Finance Defeats Public Plan Tied To Medicare Rates; Debate Will Move To House-Senate Conference

Public option amendments voted down by the Senate Finance Committee, but debate over the public plan and linking it to Medicare rates is kicked further down the road to conference process.   read more

 

For Sale: Repros Suffers An FDA Clinical Hold And Potential NASDAQ Delisting

FDA asks Repros to determine whether a lower dose of Proellex will lessen liver toxicity risks, but the company is strapped for cash.   read more

 

GSK Cervarix PDUFA Delay: Broad Label and Postmarket Plan Will Take Time

GlaxoSmithKline announced another delay Sept. 29 on the extended regulatory road for the HPV vaccine in the U.S.: but it may reflect good news. GSK needs a label that differentiates Cervarix from Gardasil. A quick review after the Sept. 9 advisory committee might have precluded the label it needs.   read more

 

Taking a BiTE Out of Cancer: An Interview With Micromet CEO Christian Itin

After securing $80.5 million in financing in August and renegotiating a partnership with MedImmune, Micromet is on course to take its first BiTE antibody into pivotal trials in 2010.   read more

 

FDA Advisory Committee To Review Human Genome Sciences' Anthrax Treatment

The U.S. government already has a stockpile of Human Genome Sciences' ABthrax (raxibacumab) for emergency use.   read more

 

Players That Evolve In Tandem With China's Health System Reforms Will Survive and Prosper, Says Pfizer Executive

Pfizer and French micro-credit group are exploring new approaches to help poor in China access medical care and medicines; Pfizer also testing micro-finance programs in India to help build rural health clinics.   read more

 

The Pink Sheet" DAILY is the leading on-line news and analysis service for the pharmaceutical industry. For information about a subscription or to sign up for a free trial, click here.

Pharma News From Around The Web

Pipeline/RD News

• Late-stage trial on Dynavax's hepatitis B vaccine begins
• Sanofi, Novo to present data on diabetes drugs amid cancer fears

Business Finance

• Dr. Reddy's voluntarily recalls 4 drugs from U.S. market
• Boehringer pays $8 million in milestone fees to Vitae
• Sanofi Pasteur delivers H1N1 vaccines earlier than expected
• Dishman likely to benefit from Abbott-Solvay merger

Government Legal News

• EU might investigate drugmakers on slow launch of generics
• Taro sues Sun regarding information in tender offer
• SEC investigates Elan on reporting of Tysabri-related brain infection
• Hawaii refuses to implement law allowing drug imports

The Health Care Reform Corner

The Health Care Reform Corner – From the editors of "The Pink Sheet" 9/29/2009

What are policymakers and stakeholders in Washington saying and doing about health care reform? In this periodic BioPharma Today feature, the editors of "The Pink Sheet"and "The Pink Sheet" DAILYhighlight some of the major developments chronicled in those publications.

Read today's features....

The Asia Corner - From the Editors of PharmAsia News The Asia Corner

From the Editors of PharmAsia News September 22, 2009

In this BioPharma Today feature, the editors of PharmAsia News take a closer look each week at the most important biopharma developments from China, India, Japan, and the Pacific Rim.

Read today's features...

Looking Forward to Pharma's Decade of Predictive Efficacy

Article preview from Start-Up 9-01-09

Drug developers can now tap into an array of new preclinical technologies including some that give them the ability to interrogate compounds in a broad biological context-a systems biology approach. In this issue, we profile four start-ups with technologies designed to predict drugs' efficacy: Champions Biotechnology, Cytox, Immuneering and Rhenovia. Read more...

Start-Up Previews

Full article reprinted from IN VIVO 9-01-09

A preview of the emerging health care companies profiled in the current issue of Start-Up. This month's profile group, "Looking Forward to Pharma's Decade of Predictive Efficacy," features profiles of Champions Biotechnology, Cytox, Immuneering and Rhenovia. Plus these Start-Ups Across Health Care: Freedom Meditech, MedShape Solutions, Molteni Therapeutics and TARIS Biomedical. Read On...

Pfizer Expects Speedy Integration Of Wyeth, R&D Head Mackay Says

Full articles reprinted from "The Pink Sheet" 9/29/2009

Pfizer's integration of Wyeth will progress much faster than previous integrations, with "significant announcements" expected within 30 to 60 days after the deal closes, Global R&D Head Martin Mackay said Sept. 22 during Windhover's Pharmaceutical Strategic Alliance Conference in New York City. Read on...

Post-Market Requirements Could Broaden Label For Allos' Newly Approved PTCL Drug Folotyn

Article preview from "The Pink Sheet" DAILY 9/29/2009


Two of the four post-market studies Allos is required to conduct as part of Folotyn 's Sept. 24 accelerated approval could broaden the label of the oncologic, newly cleared for treatment of relapsed or refractory peripheral T-cell lymphoma. Read on...

Headlines on PharmAsia News

Astellas/Boehringer Get Flomax Market Exclusivity Extension Through Pediatric Study

 

U.S.-based Huya Bioscience Signs Drug Development Pact With China's Guangzhou Institutes Of Biomedicine

 

Global CRO PPD Expands Asian Presence With New Singapore Facility

 

Japan Rolls Out Three-Tiered Review System For Medical Devices

 

PharmAsia News delivers highly specialized industry insight on the rapidly expanding Asian marketplace, including analysis of regulatory and commercial developments from bureaus across Asia, exclusive interviews, special guest columns, continuously updated newsfeeds and editor's picks from Asia. For subscription information or to request a free trial, click here.