Amy Ritter, PhD

In the wake of the meningitis outbreak caused by contaminated compounded medications produced by the New England Compounding Center (NECC).

Boehringer Ingelheim has agreed to pay $95 million to settle allegations that it improperly promoted four of its drugs.

Watson Pharmaceuticals has received clearance from the Federal Trade Commission for its acquisition of generic drug manufacturer, Actavis.

Novasep announced that it will be investing EUR 30 million ($39 million) to build what will be the world's largest chromatography plant for the production of large volumes of commercial APIs.

In an op-ed in the New York Times, a trio of physicians from the Memorial Sloan Kettering Cancer Center in New York announced their decision to remove an expensive new cancer treatment from the hospital formulary.

he Nobel Prize for Physiology and Medicine was shared by two researchers: Sir John B. Gurdon of the Gurdon Institute, Cambridge, United Kingdom; and Shinya Yamanaka of Kyoto University, Kyoto, Japan and the Gladstone Institutes, San Francisco, CA, “for the discovery that mature cells can be reprogrammed to become pluripotent.”

FDA announced that it is working closely with the Centers for Disease Control (CDC) to identify the source of an outbreak of meningitis among patients who had received an epidural steroid injection.

Laboratories that offer stem-cell treatments have come under close scrutiny by FDA. A recent court ruling clarified that stem-cell products that have been more than minimally manipulated can be regulated as drugs, and FDA can require both an IND and manufacture under GMP for such products. Texas-based Celltex Therapeutics, a company that isolates and expands adipose-derived mesenchymal stem cells, ran into trouble with FDA earlier this year over its stem-cell products.

PharmTech spoke with industry experts about the challenges of implementing disposable chromatography systems.

The President's Council of Advisors on Science and Technology (PCAST) released a report containing recommendations for boosting innovation in drug discovery and development.

In a bit of good news for pharma, Moody’s Investors Service has upgraded its outlook for the global pharmaceutical industry to stable.

ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.

Ten biopharmaceutical companies announced the formation of a nonprofit organization called TransCelerate BioPharma, the mission of which is to accelerate the development of new medicines by identifying and solving common drug development challenges.

As the saying goes, an ounce of prevention is worth a pound of cure. The US Department of Health and Human Services (HHS) has taken that advice to heart.

A federal appeals court has ruled that the National Institutes of Health (NIH) can continue to fund embryonic stem cell research, upholding a July 2011 ruling that found that such research does not violate the Dickey-Wicker Amendment prohibiting federal funding for research in which a human embryo is destroyed.

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

In the September PharmTech issue, researchers from MIT’s Center for Biomedical Innovation (CBI) describe the interim results from recent research into 34 commercial-scale biopharmaceutical products at 11 international sites.

South Carolina-based Altec Medical pleaded guilty to one count of conspiring to defraud FDA and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.

On the heels of last week’s study showing that generic pharmaceuticals saved US consumers around a trillion dollars over 10 years, the Generic Pharmaceutical Association (GPhA) took the opportunity to advocate for the strategy known as pay-to-delay.

Elan Corporation announced plans to spin off its discovery unit and Neotope Biosciences division to create an independent entity focused on R&D.

Improving lives for less-that’s the tagline from the press release from the Generic Pharmaceutical Association (GPhA) describing the results of an IMS study of the savings produced by generic medicines.

Gilead Sciences announced that it is entering into agreements with Indian generic drug manufacturers to enhance access in developing countries to its anti-HIV medicine, emtricitabine.

The US District Court for the District of Columbia has ruled that FDA has the authority to regulate stem-cell treatments as drugs.

Merck Serono will be closing down operations in Geneva as part of its restructuring activities, which includes a spin off of the its Parkinson's disease R&D portfolio to a new company named Prexton Therapeutics.

New drug approvals sometimes come in class-specific clusters, as drug makers competing for the same indication race to get to market first. In the US, the year 2011 was notable for approvals of drugs to treat hepatitis C. Merck’s protease inhibitor, Victrelis (boceprevir), was the first in its class to be approved in May 2011, followed later that month by Incivek (telaprevir) from Vertex Pharmaceuticals.

Sandoz announced it has completed the acquisition of Fougera Pharmaceuticals, a maker of generic dermatology products, for $1.5 billion.

Par Pharmaceuticals, a maker of generic drugs, has entered into an agreement to be acquired by the private investment firm, TPG, for $1.9 billion.

On July 9, 2012, FDA approved a risk evaluation and mitigation strategy for extended-release and long-acting opioid medications.

This week, KV Pharmaceuticals filed a lawsuit against FDA to force the agency to stop compounded versions of their synthetic progesterone drug, Makena (hydroxyprogesterone caproate), from being produced.

GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability resulting from unlawful promotion of certain drugs, failure to report safety data, and alleged false price reporting practices.