News

Scientists at The Wistar Institute are taking further steps into understanding a gene regulator that can lead them closer to developing new cancer therapies.

A follow-on biologics approval pathway may be on the way. US Health and Human Services Secretary Mike Leavitt accepted Sen. Charles Schumer's (D-NY) suggestion that the Food and Drug Administration and Congress work together to formulate legislation for such a pathway.

Chesapeake to relocate and expand, AVI BioPharma appoints CEO, More...

Nektar Therapeutics eliminated approximately 150 positions as part of a restructuring program designed to help the company complete its transition from a drug-delivery service provider to a drug-development organization.

Contract manufacturers of active pharmaceutical ingredients and intermediates unveil expansion plans and strategies at this year's Informex.

A recent business outlook survey conducted by the Synthetic Organic Chemical Manufacturers Association reveals a generally favorable view of current and future business conditions for contract manufacturing of active pharmaceutical ingredients and intermediates.

The US Food and Drug Administration is requesting a 5.7% increase in its budget between the current fiscal year, FY 2008, and FY 2009, for a total $2.4 billion budget.

Amira and GSK Form Agreement, Xenome Appoints Ian Nisbet CEO, More...

Amgen will partner with R&D firm Takeda Pharmaceutical Company Ltd. toward the development and commercialization of 13 of Amgen?s molecules, with one included as an option.

The US Food and Drug Administration posted on its website a Jan. 24 Warning Letter to Novartis Vaccines and Diagnostics.

Brief pharmaceutical news items for February 2008.

A news roundup for February 2008.

The author suggests a route for nanotechnology's future in the pharmaceutical industry.

Can an overload of patent applications lead to the US' demise as a scientific leader?

An updated book summarizes recent research for formulators and drug-delivery specialists.

If at first the product fails, then inspect, inspect again

A wave of pharmaceutical expansions is expected in Europe this year, surprisingly by Indian companies.

Text sirtuins are the new kinases, according to a presentation given last month at the JP Healthcare Investors Conference in San Francisco by Sirtis CEO Christoph Westphal.

The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter use of "Mevacor" (lovastatin) 20 mg.

Members of Congress have strongly urged the US Food and Drug Administration to reconsider its proposed rule to amend regulations permitting companies to promptly update their drug and device labels with new safety information.

Codexis Opens Budapest Lab, Allos Names Bruce K. Bennett VP of Manufacturing, More...

Connecticut Attorney General Richard Blumenthal is investigating Schering-Plough (Kenilworth, NJ) and Merck & Co. (Whitehouse Station, NJ), according to a Reuters report.

A possible recession in the US and a global credit crunch are going to be major factors in the amount of money available as shareholders tighten their purse-strings.

Actavis Acquires Site From Pfizer, Cardiokine Names President and CEO, More...

Roche and Ventana Medical Systems signed a definitive merger agreement, thus ending negotiations that began in June 2007.

Based on its investigation into the safety of over-the-counter cough and cold drug products for children, the US Food and Drug Administration is recommending against such products for all children under two years of age.

Congressmen John Dingell and Bart Stupak have requested that the Government Accountability Office perform an updated assessment report in response to the US Food and Drug Administration?s potential development of a new class of behind-the-counter drugs.

The US Food and Drug Administration published a draft annex to its ICH Q8 Pharmaceutical Development guidance that clarifies that document?s key concepts.

Novo Nordisk Drops Inhaled Insulin Product, Neurocrine Appoints CEO and President, More...

Noven Pharmaceuticals received a warning letter from the US Food and Drug Administration stemming from an on-site inspection of the company?s manufacturing facility in Miami, Florida, concluded July 2007.