On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.

Last week, the Pharmaceutical Research and Manufacturers of America Foundation awarded Johns Hopkins University and the University of Washington each a $250,000 grant to establish a three-year graduate certificate program. The program is formally known as the PhRMA Foundation Center of Excellence for a Comparative-Effectiveness Research Educational Program. The funds are the foundation's first grants to educational institutions.

The United Kingdom's life-sciences industry this week welcomed a new, multimillion-pound strategy that aims to both support the industry and encourage innovation in the unsettled economic climate.

In an initiative that could signal a new era in private–public partnerships, AstraZeneca will make 22 compounds available for free to medical researchers next year for projects funded by the United Kingdom's Medical Research Council.

Cultivating a productive investment environment will require partnerships with a range of stakeholders.

Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination.

As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.

Contract organizations must have highly organized teams and plans to accommodate today's audits.

Political leaders need to consider the impact of the biopharmaceutical industry on the economy.

Employee training-at all levels-is crucial for moving forward with a successful risk- and quality-based manufacturing strategy.

BioMarin Announces FDA Approval of Expanded Biologics Manufacturing Facility; Par Pharmaceuticals Makes Executive Appointments; and More.

Where does the time go? It is very hard for me to believe that I am already writing for the final issue of the year, looking back over 2011 and planning for 2012.

Elan and the University of Cambridge have launched a center for innovation and drug discovery that will focus on translational research into therapies for Alzheimer's and Parkinson's diseases. The Cambridge–Elan Center will be located at the University of Cambridge, and the agreement between the two will last for 10 years. Its goal is to discover novel compounds that can alter the behavior of proteins associated with neurodegenerative disorders and be developed into new treatments.

EMA Hosts Subgroup Analysis Workshop.

On Nov. 21, 2011, Gilead Sciences agreed to acquire Pharmasset for $137 per share in cash, or a total of approximately $11 billion. Pharmasset's board of directors unanimously approved the transaction, which is expected to close during the first quarter of 2012.

The justice department announced that Merck has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx.

Despite the fact that Europe's population is ageing rapidly, the region is astonishingly still underprepared for dealing with the health-related effect of this demographic trend.

The breast cancer indication for Avastin has been revoked after FDA Commissioner Margaret A. Hamburg concluded that the drug has not been shown to be safe and effective for this use.

On Nov. 19, 2011, Ben Venue Laboratories voluntarily and temporarily suspended the manufacture and distribution of products made at its Bedford, Ohio, facility. These products include Doxil (doxorubicin HCl liposome injection), which the company produces for Johnson & Johnson. The company's clients include Pfizer, Hospira, and Teva.

The European Commission has unveiled a comprehensive action plan against antimicrobial resistance that includes provisions to promote R&D as well as the possibility of establishing fast-track procedures for marketing authorizations.

FDA Holds Special Press Briefing Regarding Revocation of Genentech's Avastin.

On Nov. 17, 2011, a bill that would increase penalties for those convicted of trafficking in counterfeit drugs was introduced in the House of Representatives. The Counterfeit Drug Penalty Enhancement Act of 2011, cosponsored by four US Senators and two US Representatives.

The Society of Chemical Manufacturers and Affiliates issued a statement to the US Senate Committee on Environment and Public Works supporting the evaluation of national chemical-control laws but specifically opposing the Safe Chemicals Act, which was introduced earlier this year by Sen. Frank Lautenberg (D-NJ).

Pfizer, MIT Break Ground on New Research Units in Massachusetts; PhRMA Names Richard I. Smith Executive Vice-President of Policy and Research; and More.

World Diabetes Day on Nov. 14, 2011, saw the release of the International Diabetic Federation's (IDF) fifth edition of the Diabetes Atlas, which produced some staggering statistics for future escalation of the disease.

Ablynx, Merck Sorono Expand Osteoarthritis Partnership; Genzyme Makes Senior Appointments to Multiple Sclerosis, Rare Diseases Businesses; and More.

AstraZeneca, Bayer, Sanofi, Tibotec, TB Alliance, and the World Health Organization agreed to share information on tuberculosis compounds within their respective drug pipelines, according to the Critical Path to TB Drug Regimens. The purpose of the agreement is to promote information sharing around scientific and clinical studies so that partners can identify opportunities to test compounds in combination.

At a press conference held Nov. 10, 2011, FDA Commissioner Margaret Hamburg said the agency had approved 35 novel medicines in fiscal year 2011. Among the approved products were two drugs for late-stage metastatic melanoma and the first drug to treat Hodgkins lymphoma in 30 years.