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.

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.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification.

GlaxoSmithKline has come to a tentative agreement with the US government to conclude ongoing investigations relating to sales and marketing practices. The settlement is still subject to negotiation, but GSK expects to pay around $3 billion, which is covered by existing legal provisions. The final amount and terms of the settlement are expected to be finalized in 2012.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other private and public organizations.

In response to the increase in drug shortages over the past three years, President Obama issued an executive order on Oct. 31, 2011 that directs FDA to take several steps to prevent and reduce drug shortages.

Pfizer Completes Acquisition of Icagen; 3M Drug Delivery Systems Names James Ingebrand Vice-President and General Manager; and More.

The Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on the consolidation of United Kingdom (UK) medicines legislation on Oct. 26, 2011. Seeking to greatly simplify and elucidate the law regulating medicines in the UK, the MHRA invited interested parties to contribute to legislation development.

On Oct. 26, 2011, FDA dedicated $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation. The centers, which will be located at the University of Maryland and at Georgetown University, will focus on the scientific knowledge and training needed to modernize and improve the ways the agency reviews and evaluates drugs and medical devices.

Careful mixing during a product's distillation can help avert trouble from a strong concoction.