BioPharma Today

Pfizer Restructures for a More Flexible Future

Article preview from "IN VIVO" - October 28, 2008

Read about a move that could position Pfizer for more drastic measures down the road, the pharma giant has reorganized its development and commercial operations into several business units designed to foster autonomy and financial responsibility in the areas of specialty medicine, primary care, and emerging markets. These units join Pfizer's oncology and mature products businesses.

FDA Action On Off-Label Tysabri May Signal Policy Shift On Compassionate Use

Article preview from "The Pink Sheet" - October 28, 2008

Find out why the FDA appears to be setting new policy on when drugs should be available for compassionate use...

Regulatory Risk and Business Development: Type 2 Diabetes Falls Out of Favor

Article preview from "The RPM Report" October 28, 2008

If you think this is a bad time to try to get a loan, try selling a type 2 diabetes research project to a Big Pharma company...

WellPoint Seeks More Quality Of Life, Cost Data In Formulary Submissions

Full article reprinted from "The Pink Sheet"- October 28, 2008

Read about why WellPoint's updated formulary submission guidelines aim to give drug companies more detailed advice on submitting information on a drug's cost-effectiveness and its impact on pharmacy and medical budgets...

Eli Lilly In Asia Expansion Overdrive

Article preview from "PharmAsia News"- October 28, 2008

Find out why Eli Lilly opened a brand new Asian office and unveiled a major expansion at a second office in as many days as part of a company-wide shift to a new collaborative research and development model...

Pharmaceutical/Biotechnology Deal Statistics Quarterly, Q2 2008. A look at financing, M&A, and alliance activity, April-June 2008

Article preview from "IN VIVO" October 21, 2008

Read about the Highlights from the Q2 2008 review of pharmaceutical and biotechnology dealmaking: Despite the dearth in biopharmaceutical financings in the quarter (total money raised was just $2 billion) acquisitions thrived with total M&A volume of $11.8 billion. And biopharma alliance activity reached $2.7 billion in potential deal value during 2008's second quarter with only a handful more deals than the first quarter, but a 43% increase in dollar volume.

FDA’s DTC Web Site For Consumers Sparks Congressional Investigations

Article preview reprinted from "The Pink Sheet" October 21, 2008

Read about why The pharmaceutical industry's effort to limit federal oversight of its advertising practices has become more difficult with revelations that an FDA Web site aimed at educating consumers was designed by a PR firm that has done work on drug product launches...

Drug Controller General Of India Surinder Singh On India’s Regulatory Overhaul: An Interview With PharmAsia News

Article preview reprinted from "PharmAsia News" October 21, 2008   

Read about how Surinder Singh took the mantle of the Drug Controller General of India a few months ago. From being a microbiologist to handling the most important regulatory position in the Indian drug industry, Singh is already confronted with a host of challenges. Overhauling the regulatory system, dealing with vexatious registration issues and advocating for Indian drug industry on global forums, Singh has been working on an extremely tight schedule. Singh took time off from his busy routine and sat down with PharmAsia News' India bureau to discuss India's impending regulatory overhaul...

UnitedHealth Plans “Series” Of Part D Formulary Restrictions In 2009

Full article reprinted from "The Pink Sheet" October 21, 2008

Find out why national stand-alone Medicare drug plans co-sponsored by UnitedHealth and AARP will impose new formulary restrictions in major drug categories including cholesterol treatments, proton pump inhibitors and osteoporosis therapies in 2009 to help control costs...

Proper Venue Sought for Resolving Global Pharma Supply Chain Crisis

Article preview reprinted from "The Gold Sheet" October 21, 2008

Find out who can coordinate a global response to the pharma supply chain crisis. Industry and regulators debate whether ICH, which smoothed over GMP differences among developed nations, is the right institution for today’s problems, which emanate from non-ICH countries...