News

On Feb. 21, 2012, FDA announced steps the agency plans to take to increase the declining supply of certain cancer drugs. These steps came in response to President Obama?s Oct. 31, 2011 Executive Order.

Eli Lilly plans to invest EUR 330 million ($443.2 million) at its Kinsale location in Ireland to create a new biopharmaceutical commercialization and manufacturing facility. The investment will lead to 200 new jobs, as well as an additional 300 construction roles during the building process.

Merck KGaA announced measures intended to reduce costs and increase efficiency to ensure the long-term success of its business model. The measures are part of a comprehensive transformation program that will be implemented in two phases. In the first two years, Merck plans to implement a new leadership organization, implement efficiency measures, and develop a long-term growth strategy. In the second phase, the company will explore new areas for growth. Cost savings from the first-phase efficiency measures are expected to fuel second-phase growth.

The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country's first plant to manufacture APIs for antiretroviral (ARV) medicines.

President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion

FDA has released a draft guidance for API manufacturers titled Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.

On Feb. 1, 2012, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V.

GlaxoSmithKline (GSK) released its fourth quarter and full year 2011 earnings report on Feb. 7, 2012. In the report, the company tracks its R&D performance, and calculated the return on R&D to be 12%, up from 11% in 2010, and closing in on the company’s goal of a 14% return.

After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases (NTDs) by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization (WHO), and several other global health entities.

The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The consent decree was filed against Ranbaxy Laboratories Ltd., an Indian corporation, and its subsidiary Ranbaxy Inc., headquartered in Princeton, New Jersey. The decree was filed on Jan. 25, 2012, and is subject to court approval.

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced that it will transition the management of its benefit?risk action team (BRAT) to the Centre for Innovation in Regulatory Science (CIRS), according to a press release. CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters. This transition is being made to further the program?s technical development and broaden input from the scientific community.

Pfizer announced a decrease in fourth-quarter revenues, but a slight increase in full-year 2011 revenues in its financial report issued on Jan. 31, 2012. Ian Read, chairman and CEO, stated in a company release, ?Overall, 2011 was a year of setting new direction and focus for Pfizer. I am pleased with our 2011 financial performance, which was achieved in the face of a challenging global market and product losses of exclusivity of approximately $5 billion.?

The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.

On Jan. 11, 2012, AstraZeneca and IMS Health announced a three-year collaboration to use real-world healthcare data from Europe to guide AstraZeneca?s discovery and clinical development programs.

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and programs for human generic drugs and biosimilar biological products.

Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention.

The US Pharmacopeia (USP) announced in a press release a draft standard contained in the proposed USP General Chapter <1083> Good Distribution Practices?Supply Chain Integrity.

Bristol-Myers Squibb (BMS) has signed an agreement to acquire the clinical-stage biotechnology company Inhibitex in a deal worth approximately $2.5 billion.

Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.

FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.

The National Institutes of Health (NIH) announced in a press release the establishment of the National Center for Advancing Translational Sciences (NCATS), a center dedicated to the translation of scientific discoveries into new drugs, diagnostics, and devices.

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, narcotic pain medicines used by cancer patients to manage pain.

On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland.

Pfizer and GlaxoSmithKline (GSK) entered into separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis and is one of the leading causes of death in children under the age of five in developing countries.

On Dec. 22, 2011, Baxter International and Momenta Pharmaceuticals entered into a global collaboration to develop and commercialize follow-on biologic products. Baxter will contribute its clinical-development and biologic-manufacturing expertise, experience with sterile injectables, and global commercial capabilities to the collaboration. Momenta will bring its expertise in high-resolution analytics, characterization, and product and process development to the joint effort.

In a Warning Letter, FDA cited ?significant violations? of CGMP regulations, including several repeat observations, at three Novartis facilities. The violations included failure to prevent microbiological contamination of sterile drug products, failure to investigate out-of-specification batches, failure to clean and maintain equipment, and failure to ensure drugs? identity, strength, quality, and purity.

The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer. The initiative will begin in January 2012, according to a jointly issued press release on Dec. 9, 2011, and will enable the two authorities to rely on each other's inspections outcomes instead of conducting inspections in duplicate