All News

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

After reviewing the ?shortcomings in quality assurance? that were recently identified at Ben Venue Laboratories?s Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta, Liminity and Vistide. EMA?s Committee for Medicinal Products for Human Use has been reviewing medicines manufactured at Ben Venue since early November 2011, after a joint GMP inspection by FDA and the UK and French medicines regulatory agencies highlighted several problems in the company?s quality-management system, particularly in relation to the sterile filling process and possible particle contamination during manufacturing.

AstraZeneca entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately owned generic-drug manufacturing company based in Guangdong province, China, for an undisclosed amount. Guangdong BeiKang Pharmaceutical?s portfolio includes injectable medicines used to treat infections. Upon completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines. The deal is contingent upon approval from the Ministry of Commerce in China and is expected to close in the first quarter of 2012.

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.

Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung?s latest effort to strengthen its position in biosimilars.

The United Kingdom?s (UK) 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.

On Dec. 1, 2011, the Pharmaceutical Research and Manufacturers of America (PhRMA) Foundation awarded Johns Hopkins University and the University of Washington each a $250,000 grant to establish a three-year graduate certificate program.

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 (UK) Medical Research Council (MRC).

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

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.

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. Gilead will finance the transaction with cash, bank debt, and senior unsecured notes.

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.

AstraZeneca, Bayer, Sanofi, Tibotec, TB Alliance, and the World Health Organization agreed to share information on tuberculosis (TB) compounds within their respective drug pipelines, according to the Critical Path to TB Drug Regimens (CPTR). 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. Under the agreement, if two or more organizations choose to work together to further develop a regimen, they will enter into a separate arrangement that defines the rights and responsibilities of each party

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. Since Annex 16 was introduced in 2001, a number of positive and negative trends have occurred in the pharmaceutical industry. In particular, confusion has arisen over the role of the qualified person (QP), and harmonization of requirements has been lost between member states. The EMA cites several commonly asked questions within the concept paper:

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. Other approvals included drugs to treat late-stage prostate cancer, thyroid cancer, metastatic breast cancer, and late-stage lung cancer.

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 on Nov. 10, 2011. 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.

Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, EMA for the first time brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop. According to a press statement, the workshop was designed to enable EMA and attendees to review regulatory and scientific challenges in developing medicines for eye disorders.

GlaxoSmithKline (GSK) 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, according to a press statement. The final amount and terms of the settlement are expected to be finalized in 2012. GSK says that the payments will be funded through existing cash resources.

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.

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.

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 the following steps to prevent and reduce drug shortages

On Oct. 26, 2011, FDA dedicated $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). 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.

The European Commission has launched an antitrust investigation to examine whether contracts between Johnson & Johnson (J&J) and Novartis were designed to delay the market entry of generic versions of Fentanyl in the Netherlands. Fentanyl, developed by J&J, is a strong painkiller for chronic pain.

Last week, Abbott unveiled a plan to separate into two publicly traded companies, one focusing on diversified medical products and the other on research-based pharmaceuticals.

Merck, Sharpe, and Dohme (MSD) and Singapore?s Economic Development Board jointly announced plans for significant investments by MSD to improve its existing manufacturing facilities in Singapore, as well as for new manufacturing, marketing, and research activities.