BioPharma Today

Flu Vaccine Licensure Depends On Adjuvant; Fall Vaccination Campaign Likely

Article preview from "The Pink Sheet" July 14, 2009

Efforts are under way to expedite H1N1 vaccine development for a potential voluntary vaccine campaign in the fall, but how registration of the vaccine is handled by FDA depends on whether or not an adjuvant is used. Read on...

Follow-on Biologics Go Back To The Future: Senate Cmte. Endorses 12 Years of Brand Exclusivity

Full article reprinted from "The Pink Sheet" DAILY July 14, 2009

Senate proponents of shorter exclusivity for brand biologics now face a difficult choice: Do they pitch a floor fight on follow-on biologics after being defeated in the Health Committee? Read on...

Waking Up to REMS (Part 1): Don’t Believe the Lack of Hype

Full article reprinted from The RPM Report July 14, 2009

FDA’s top management can’t be accused of overstating the importance of the agency’s new drug safety tools. But sponsors need to wake up to the reality: the REMS are a critical fact of drug development and marketing. Read on...

Why Doesn't Pharma Get Smaller?

Article preview from IN VIVO July 14, 2009

Pharmas continue to diversify into lower margin businesses because CEOs and boards are betting on different requirements from a new system of health care delivery. They also figure their jobs will be safer. The choices: Is the likeliest avenue to growth through successful R&D, or through positioning appropriate for future health care delivery and payment systems? Read on...

The Asia Corner - From the Editors of PharmAsia News

The Asia Corner - From the Editors of PharmAsia News July 14, 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...

The Asia Corner - From the Editors of PharmAsia News July 14, 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...

The Health Care Reform Corner – From the editors of "The Pink Sheet"

The Health Care Reform Corner – From the editors of "The Pink Sheet"

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" DAILY highlight some of the major developments chronicled in those publications.

Read today's features...

How Big Of A Pharma Opportunity Is Russia? Local Manufacturing May Help Buoy Sales

Despite the recent collapse of Russia’s economy, Nycomed reckons it can capture €900 million ($1.25 billion) in sales from the region by 2013—in part through investing in local manufacturing.

Hamburg's FDA Reorganization Merges Budget And Policy Functions

FDA Commissioner Margaret Hamburg is reorganizing her direct staff reports to streamline the development and tracking of the agency's budget.

Can a Hippo Save the IPO Market for Life Sciences?

Full article reprinted from Start-Up July 7, 2009

A group of private enterprises are working to revive the moribund IPO market for venture-backed start-ups. Read more...

Vanda’s Atypical Approval: Is it Time to Rethink Attitudes Toward FDA?

Article preview from The RPM Report July 7, 2009

The atypical antipsychotic iloperidone appeared doomed after a “not approvable” letter and its sponsor faced liquidation. Talk about the comeback story of the year: FDA approved the drug May 6 and Vanda is back in business. Here’s the back story on one drug development miracle. Read on...