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Also, Roche's Avastin trial does not meet endpoint; Innate Pharma names regulatory VP; more...
Arena Pharmaceuticals (San Diego, CA) announced a plan to reduce its US workforce by approximately 31%, or roughly 130 employees, by June 22, 2009. The company will focus its resources on the expected filing of a new drug application for lorcaserin, its drug candidate for weight management currently in a Phase III clinical trial.
CIGNA (Bloomfield, CT) reached an agreement with Merck & Co. (Whitehouse Station, NJ), that will provide performance-based pricing for two diabetes drugs. CIGNA will provide its customers with increased discounts on Merck’s oral antidiabetes medications Januvia (sitagliptin) and Janumet (sitagliptin/metformin HCl). These drugs are used in conjunction with diet and exercise to improve glycemic control in adults with Type 2 diabetes. CIGNA will review available A1C lab values for people taking any oral antidiabetic medications, and, if at the end of the year, A1C values have improved, the discounts Merck offers on Januvia and Janumet will increase, according to a company press release.
Lonza (Basel) announced the successful startup of its high-titer 2000-L microbial manufacturing train in Hopkinton, Massachussetts. The facility’s 2000-L fermentation train is complemented by a highly flexible purification area capable of accommodating complex, high-titer and throughput-optimized purification processes.
Patheon (Research Triangle Park, NC), a provider of drug development and manufacturing services, signed agreements to commercialize two OROS-technology controlled-release products at its Cincinnati facility. OROS is a drug-delivery technology, developed by Patheon, used to achieve the controlled release of active drug substances. The first product will launch in late 2009, and the second is planned to launch in the third quarter of 2010.
Contract research organization PPD (Wilmington, NC) recently opened an office in Tokyo, which expands its Phase II-IV clinical development services. PPD will provide clinical management services from this location.
Roche (Basel) announced the results of its Avastin (bevacizumab) early-stage colon cancer trial did not meet the primary endpoint of lowering the risk of the cancer returning. The study was the first Phase III trial evaluating the use of Avastin plus chemotherapy (FOLFOX) for the treatment of colon cancer immediately following surgery (adjuvant therapy) compared with chemotherapy alone. Roche and Genentech said they remain committed to Avastin adjuvant programs, according to a company press release.
Roche Madison Inc. (Madison, WI), part of the global RNA Therapeutics group within Roche, opened its new facility with chemistry and biology laboratories at the University of Wisconsin Research Park in Madison. The group's research focuses on the discovery and development of nucleic-acid based technologies, including a proprietary RNAi (ribonucleic acid interference) delivery platform. The site currently has a 45-member staff and plans to hire additional staff during the next year.
Symyx Technologies (Sunnyvale, CA), a provider of formulation services, launched the Symyx Contract Development and Manufacturing Organization (CDMO). The Symyx CDMO offers biopharmaceutical formulation development, and preclinical and CGMP fill/finish manufacturing services.
On Apr. 28, 2009, the US Senate confirmed former Kansas governor Kathleen Sebelius as head of the Department of Health and Human Services in a 65-31 vote. Sebelius was sworn in late Tuesday and was briefed on the public health emergency involving swine flu. Read PharmTech’s past news story and blog post about Sebelius' appointment.
On Apr. 27, 2009, the US Food and Drug Administration issued emergency use authorizations (EUAs) to make available to medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. These EUAs apply to the use of certain Relenza (zanamivir, GlaxoSmithKline, London) and Tamiflu (oseltamivir phosphate, Roche, Basel) antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test. FDA issued the authorization in response to requests from the US Centers for Disease Control and Prevention. The EUA authority allows FDA to authorize the use of unapproved or uncleared medical products or uses of approved medical products following a declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency. Read a PharmTech blog post about swine flu treatment.
The US Food and Drug Administration issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks. The products involved in the labeling revision include acetaminophen, and a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs), which include aspirin, ibuprofen, naproxen, and ketoprofen. The revised labeling rule also applies to products that contain one of these ingredients in combination with other ingredients. Under the final rule, manufacturers must prominently display the active ingredients on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.
Biocodex (Gentilly, France), a privately held pharmaceutical company, appointed Marc H. Rohman vice-president and managing director of Biocodex, Inc. (San Bruno, CA), the company’s US subsidiary. Rohman said the future plans for Biocodex, Inc. include strategic alliances that will result in new product acquisition and/or product copromotion, according to a company press release.
Geron (Menlo Park, CA), a biopharmaceutical company, appointed Stephen M. Kelsey executive vice-president and chief medical officer, oncology. Additionally, Hassan Movahhed was appointed vice-president of clinical operations, oncology. Kelsey will manage the operational and strategic activities of the company’s oncology programs and will report to CEO Thomas B. Okarma. Hassan will be responsible for all oncology clinical operations and will report to Kelsey.
Biopharmaceutical company GTx (Memphis, TN) appointed Michael K. Brawer executive director of medical affairs and clinical development. Brawer will focus on educating the medical community about disease states of interest to GTx and will also participate in the development and execution of clinical research.
HUNT Biosciences (Levanger, Norway), a provider of biomarker discovery and validation services, appointed former GE Healthcare director Per Foss as its new CEO. The company is the commercial arm of the HUNT Study and associated biobank, which for the past 25 years has gathered blood samples from the general population of the Nord-Trondelag region of Norway together with detailed phenotype and environmental data.
Biopharmaceutical company Innate Pharma (Marseilles, France) appointed Marcel Rozencweig senior vice-president in charge of clinical and regulatory strategy. During his tenure in his previous position at Bristol-Myers Squibb (BMS, New York), a total of 17 marketing applications were successfully filed by BMS in the area of cancer, HIV and infectious diseases.
Pacific Biometrics (Seattle, WA), a provider of laboratory and contract research services, appointed Amar A. Sethi vice-president of science and technology, effective July 15, 2009. Sethi will report directly to Ron Helm, the company’s CEO.