News

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

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.

The US Food and Drug Administration?s website will no longer allow the public to electronically submit comments to its dockets.

The US Food and Drug Administration approved 69 new drug applications last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of Drug Industry Daily.

Pfizer and Hikal signed a contract manufacturing agreement in which Hikal will supply active pharmaceutical ingredients.

The US Food and Drug Administration?s Subcommittee on Science and Technology released a report in November 2007 announcing that the agency is underfunded and cannot fulfill its mission. The FDA Science Board Advisory Committee has now discussed the report and decided to open a public comment period based on the subcommitee?s findings.

Crucell and Sanofi Pasteur Sign Agreement, WuXi Pharma Names COO, More...

The US Food and Drug Administration released a draft plan for modifying its information technology infrastructure. The plan follows the renewal of the Prescription Drug User Fee Act (PDUFA IV).

Merck & Co. and Pfizer signed separate pacts for preclinical drug candidates to treat schizophrenia.

Richard Spoor, senior vice-president of global procurement at Merck & Co., Inc., discusses the company's strategy and progress made in its supply strategy that involves increased outsourcing and implementing lean-manufacturing principles in its manufacturing network. Pharmaceutical Technology's senior editor Patricia Van Arnum moderates.

The National Nanotechnology Initiative's new strategic plan affirms the federal government's support for research and development in nanotechnology, including for medical and healthcare applications.

President Bush signed HR 2764, making appropriations to the US Food and Drug Administration during FY 2008, which ends September 30, 2008.