BioPharma Today

REMS Pivotal To Embeda, Remoxy Approvals; FDA Wants Class-Wide Plan

Article preview from "The Pink Sheet" November 25, 2008

Find out why Opioid drug sponsors may be asked to adhere to a single, class-wide Risk Evaluation and Mitigation Strategy, should FDA determine that it has the authority under the FDA Amendments Act of 2008 to require such action.

FDA Offers More Flexibility on Residual Solvents in Generic Drug Applications

Article preview from "The Gold Sheet" November 25, 2008

Read about how the FDA’s Office of Generic Drugs has taken a more flexible approach in implementing the U.S. Pharmacopeia’s General Chapter <467> on residual solvents.

GSK Forms Joint Venture With Shenzhen Neptunus Interlong Bio-Technique For Flu Vaccine

Full article reprinted from "PharmAsia News" November 25, 2008

Find out why GlaxoSmithKline announced Nov. 21 a joint venture with Shenzhen Neptunus Interlong Bio-Technique to develop flu vaccines aimed at strains specific to China, Hong Kong and Macau...

Surprise! Drug Approvals Increase in 2008

Full article reprinted from "The RPM Report" November 25, 2008

Read about Missed user fee deadlines. Multiple cycle reviews. A regulatory posture defined by the phrase “Safety First.” Complex new legislation. Understaffed, overworked review divisions. A hostile Congress eager to second-guess any and every decision. Divergent viewpoints built into the review process. Demands for more advisory committees with fewer conflicts of interest.

No wonder it is harder than ever to get drugs through FDA. Maybe not...

Who Should Be The Next FDA Commissioner? David Kessler Weighs In

Article preview from "The Pink Sheet" November 25, 2008

Find out why the Former FDA Commissioner David Kessler has a few ideas about the kind of person President-elect Barack Obama should pick to succeed Andrew von Eschenbach at FDA after he takes office Jan. 20.

Validating the Validating Deal

Full arcticle preview "Start-Up" November 19, 2008

Find out why With M&A exits on the minds of venture investors and management alike, the idea that a strategic alliance on an important project or platform application might dilute downstream acquisition value is a serious consideration for biotech firms.

Insurers View JUPITER With Caution; Can Benefit Be Achieved With Generics?

Full article Reprinted from "The Pink Sheet" November 19,2008

Read about how insurers begin to review the details of AstraZeneca's headline-making outcomes study on Crestor - the JUPITER trial - a key question is whether the benefit found can also be extrapolated to less expensive statins, including generics...

PSA: What We Have Here Is A Failure to Innovate

Article preview from "IN VIVO" November 19, 2008

Read about how the Discussion at FDC-Windhover's annual Pharmaceutical Strategic Alliances gathering in New York reflected the urgent need for the industry to adopt new models in order to spur innovation—in R&D, finance, business development, and commercial operations...

FDA Raising Approval Bar For NSAID/PPI Combos; Endpoints Under Review

Article preview from "The Pink Sheet" November 19, 2008

Find out why the FDA is considering changes to the approval process for NSAID and proton pump inhibitor combination products that may result in the agency prohibiting the use of endoscopic gastric ulcer reduction to support a gastroprotective marketing claim.

BIO Says Tax Revisions Would Relax Tight Money For Biotechs

Article preview from "The Pink Sheet" DAILY November 19, 2008

Find out why Tax law changes that enable biotechnology companies to invest in job-producing research should be part of an economic stimulus package...