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Biogen Idec to Acquire Stromedix; Mylan, Pfizer Announce Epinephrine Autoinjector Settlement Agreement; and More.
Bedford Laboratories has announced a nationwide voluntary recall for the following three lots of Cytarabine for injection, USP: Cytarabine (cytarabine) for Injection (for treating leukemia), USP 1 g per vial, NDC #55390-133-01 lot 2066986 (expiration (exp.) date Mar. 31, 2014), lot 2111675 (exp. date: Apr. 30, 2014), lot 2131148 (exp. date: May 31, 2014). The voluntary market recall is being conducted due to a postrelease investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots. To date, there have been no reports of any adverse events for the lots being recalled, according to the company. Initial recall notification of the Cytarabine for Injection lots listed above were sent to impacted wholesalers and distributors by overnight courier and arranged for return of all recalled product. Hospitals, emergency rooms, clinics, physician offices, and other healthcare facilities and providers should not use the product lots listed above for patient care and should immediately quarantine any product for return. Read More
Biogen Idec has agreed to acquire Stromedix, a biotechnology company focused on therapies for fibrosis and organ failure. Under the terms of the agreement, Biogen Idec will make an upfront cash payment of $75 million and additional contingent value payments of up to $487.5 million based on the achievement of certain development and approval milestones across multiple indications. Stromedix’s lead candidate, STX-100, for treating fibrotic disease, is a humanized monoclonal antibody that selectively disrupts the TGF–beta pathway. Read More
The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the license of levothyroxine 100-microgram (mcg) tablets (levothyroxine sodium), manufactured by Teva, for treating hypothyroidism. This follows manufacturing difficulties and concerns that the product might not be interchangeable with other available levothyroxine 100-mcg tablets. This may lead to a loss of control of hypothyroidism when switching between products. Only levothyroxine 100-mcg tablets supplied in the Teva and Numark brands are affected. As this medicine is a generic drug, alternative products are available and most patients are unlikely to notice any change if they are switched from the Teva product to another levothyroxine product. Teva levothyroxine 100-mcg tablets will cease to be available in the UK within the next few weeks as stocks are exhausted. The decision to suspend follows a review by the Commission on Human Medicines (CHM), the MHRA’s independent advisory body, of manufacturing issues and sporadic reports of loss of control of hypothyroidism when switching between products. As a precautionary measure, while investigations are pending, Teva has voluntarily ceased manufacture and distribution in line with the CHM recommendation. The CHM review concluded that it may not be possible to switch use of the Teva product with other levothyroxine products, and that no further supplies of the product should be released for marketing until the aforementioned issues are resolved. Read More
Merck & Co. has formed a joint venture (JV) with Supera Farma Laboratorios, a Brazilian pharmaceutical company co-owned by Cristália and Eurofarma. The new JV will market, distribute, and sell a portfolio of pharmaceutical and branded generic-drug products from Merck, Cristália, and Eurofarma solely in the Brazilian retail sector. Read More
Mylan and Pfizer have announced that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Intelliject and Sanofi that will resolve pending patent litigation related to Intelliject’s 505(b)(2) new drug application for its epinephrine autoinjector known as e-cue, which will be manufactured and marketed by Sanofi. According to the terms of the settlement, Intelliject and Sanofi may launch e-cue no earlier than Nov. 15, 2012, subject to receipt of final approval from FDA. Read More
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More