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
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
