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.

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.

Merck Sells Facility to Cherokee Pharmaceuticals, Inflazyme Announces Senior Management Resignations, More...

The $6.3 billion Indian pharmaceutical industry is at a crossroad. Aiming to be the international home for quality drugs, which could in itself propel India's market to $20 billion by 2015 according to recent estimates, the generic hothouse is clearly moving beyond its earlier low-cost mindset.

With 2007 projects wrapped up, or so we hope, forward-looking companies need to take their next step.

Fixing FDA lies in the hands of the government, but is the president-to-be paying attention?

Brief pharmaceutical news items for January 2008.

Process efficiency is measured not only by what is kept, but also by what is thrown away.

News, world briefs, facility roundup, events and other items for January 2008.