 Actavis Buys Warner Chilcott for $8.5 BillionFollowing weeks of speculation, Actavis said Monday it will acquire Warner Chilcott in an all-stock transaction valued at $8.5 billion. Read More
Japanese API Maker Warned for Broad Lack of Quality ControlAsada Milling, a Japanese maker of active pharmaceutical ingredients (API), has been warned by the FDA for a general lack of quality control — and cleanliness — at its facility located in Gunma, Japan. Read More
Judge: Actavis’ Lialda ANDA Infringes Shire’s ‘720 PatentA federal judge handed Shire a victory May 9, ruling that Actavis’ generic version of Lialda, indicated for ulcerative colitis, infringed the company’s ‘720 patent. Read More
FDA, USP Enlist Industry’s Help in Improving OTC Drug QualityFDA and U.S. Pharmacopeial Convention (USP) officials say proactive industry participation — mainly by offering up drug samples and technical information — is vital to improving the quality of OTC finished drugs, the subject of recent high-profile recalls. Read More
Biotest Recalls Biologic Drug Due to ParticlesJust two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles. Read More
Ranbaxy and Justice Settle Manufacturing Compliance CaseGeneric drugmaker Ranbaxy announced May 13 it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York. Read More
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Lawmakers Lambaste Drugmakers for ‘Egregious’ PricesLawmakers outraged by what they call extraordinary drug price increases have asked the Government Accountability Office to see if the increases are justified and directed the Federal Trade Commission (FTC) to investigate a drug firm’s potential anti-competitive conduct for one product. Read More
CBER Guidance Addresses Trial Design for IGIV ProductsA statistical demonstration of a serious infection rate of less than 1 per person-year is adequate to provide substantial evidence of efficacy in clinical trials of investigational human immune globulin intravenous (IGIV) products, CBER says. Read More
FDA Launches Fellowship ProgramIn an effort to attract more scientific talent to the FDA, the agency is launching a two-year fellowship program designed to train scientists and engineers on the scientific foundations of its regulatory actions. Read More
DME Firm Owner Flees Country Following Fraud ConvictionThe owner of two south Florida durable medical equipment (DME) companies has fled the country after receiving a 130-month prison sentence for defrauding Medicare. Read More
St. Jude Gets FDA Approval of Wireless TransmitterThe FDA has approved St. Jude Medical's Merlin@home transmitter, a radio-frequency wireless technology that remotely monitors patients' implanted cardiac devices. Read More
SyntheMed Gets Canadian Approval for Adhesion TreatmentSyntheMed received Health Canada approval for the use of Repel-CV to reduce adhesions in pediatric patients who undergo open-heart surgery. Read More
Japanese API Maker Warned for Broad Lack of Quality ControlAsada Milling, a Japanese maker of active pharmaceutical ingredients (API), has been warned by the FDA for a general lack of quality control — and cleanliness — at its facility located in Gunma, Japan. Read More
Judge: Actavis’ Lialda ANDA Infringes Shire’s ‘720 PatentA federal judge handed Shire a victory May 9, ruling that Actavis’ generic version of Lialda, indicated for ulcerative colitis, infringed the company’s ‘720 patent. Read More
FDA, USP Enlist Industry’s Help in Improving OTC Drug QualityFDA and U.S. Pharmacopeial Convention (USP) officials say proactive industry participation — mainly by offering up drug samples and technical information — is vital to improving the quality of OTC finished drugs, the subject of recent high-profile recalls. Read More
Biotest Recalls Biologic Drug Due to ParticlesJust two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles. Read More
Ranbaxy and Justice Settle Manufacturing Compliance CaseGeneric drugmaker Ranbaxy announced May 13 it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York. Read More
Conducting Bulletproof CAPA Investigations — ADVANCED
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