News

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The breast cancer indication for Avastin has been revoked after FDA Commissioner Margaret A. Hamburg concluded that the drug has not been shown to be safe and effective for this use.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

The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation.

GlaxoSmithKline is looking to advance the commercialization of scientific innovation in Canada with its launch of the GSK Canada Life Sciences Innovation Fund, which was announced at a GSK-hosted event in Toronto last week. The $50-million national fund will identify strategic investment opportunities in Canada's life-sciences industry, including academic and health institutions, translational research centers and start-up companies.

ICH Steering Committee Approves Revised Guideline for Genotoxicity Testing and Data Interpretation for Medicines.

Merck & Co. highlighted the key developments in its late-stage pipeline and its near-term plans for regulatory filings. The company has 19 candidates in Phase III clinical trials and plans to submit eight new US regulatory filings in 2012–2013, including five new drug candidates.

We have changed the brand of our stoppers for a product that we freeze-dry in vials. Since the change, we have observed a significant increase in rejects for collapsed cakes. Why are the cakes collapsing? What can we do to prevent this problem?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the November 2011 edition from Sartorius Stedim Biotech and Thermo Fisher Scientific.

Implementing a zero-waste strategy is not merely an option, it can be seen as a crucial business imperative.

Until now, the industry has adhered to the tradition of producing three batches of product to validate its manufacturing processes. But FDA?s new process-validation guidance does not prescribe any number of batches that is necessary for compliance.

Procter & Gamble and Teva Pharmaceutical Industries Enter into Consumer Healthcare Partnership; USP Makes Several Executive Appointments; and More.

Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, the European Medicines Agency has recently, and for the first time, brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop.

Eli Lilly and Amylin Pharmaceuticals have mutually agreed to end a 10-year alliance relating to the diabetes medication exenatide.

The Society of Chemical Manufacturers and Affiliates issued a statement to support a recently introduced bill that it says will allow the federal government to more effectively deal with market-access barriers.