News

FDA announces FY 2013 user fee rates and EMA furthers relationship with Japan.

Abbott forms a partnership with the US Secretary of State's International Fund for Women and Girls to support grassroots organizations that are working to advance health, education, and economic opportunity for women in Burma.

Prominent scientists and political leaders at the International AIDS Conference in Washington, D.C., in late July were optimistic for the first time about bringing an end to the global AIDS pandemic.

Pharmaceutical industry leaders Pfizer, Novartis, Merck, and other companies released second-quarter 2012 results, emphasizing growth of new products and strength in emerging markets.

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.

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European Union customs in 2011.

The European Commission has issued a statement of objections against Lundbeck and several other pharmaceutical companies with the preliminary view that Lundbeck formed agreements with generic-drug companies to prevent the market entry of cheaper versions of its antidepressant, citalopram.

Amicus Therapeutics, GSK Expand Fabry Pact; US District Court Rules in Favor of Pfizer, Northwestern University in Lyrica Patent Case; and More.

A roundup of industry regulatory news.

MedImmune, the global biologics arm of AstraZeneca, announced that it is restructuring its infectious disease and vaccines R&D and operations. This will result in the closure of MedImmune's sites in Mountain View and Santa Clara, California.

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

The UK's Medicines and Healthcare products Regulatory Agency has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials.

The European Commission is looking to provide Sweden with EUR4.3 million to help 700 workers affected by AstraZeneca job cuts to find new work.

Bristol-Myers Squibb Begins Tender Offer to Acquire Amylin Pharmaceuticals; FDA Approves Gilead's Truvada for Reducing the Risk of Acquiring HIV; and More.

We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?

The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.

GlaxoSmithKline has announced that it will acquire Human Genome Sciences (HGS) for $14.25 per share in cash, or approximately $3.6 billion on an equity basis.

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.

FDA promotes supply chain pilot program. EMA opens pharmacovigilance legistation up for public consultation. USP Calls for Somatropin Cell-Based Bioidentity Method.

Global spending on medicines is estimated to reach nearly $1.2 trillion by 2016.

Amgen Completes Acquisition of KAI Pharmaceuticals; Renaissance Acquisition Holdings Acquires DPT Laboratories; and More.

Highlights of UN Conference on Sustainable Development, held in Rio de Janeiro, Brazil, last month and related industry initiatives.

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

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.

GSK Extends Deadline for Tender Offer to Acquire Human Genome Services; Sartorius Opens New Filter, Aseptic-Bag Production Facility in Puerto Rico; and More.

FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

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.

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

EMA and MHRA provide insight into increased GMP deficiencies.