FDA Issues Form 483 to Sun Pharma for Mfg Violations
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The US Food and Drug Administration (FDA) has issued a Form 483 with four observations to Sun Pharmaceutical Industries following a pre-approval inspection of the company’s facility in Halol, Gujarat,…

Valisure Submits Citizen Petition to FDA For DMF Impurity in Valsartan
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New Haven, Connecticut-based Valisure, an online pharmacy, has submitted a citizen petition to the US Food and Drug Administration (FDA) to request that the FDA take certain actions following the…

Track-and-Trace Provider Kit Check Selected for FDA Pilot Program
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Kit Check, a provider of automated medication management solutions for hospitals, has announced it has been accepted into a pilot program by the US Food and Drug Administration Act for…

Gilead, Nurix in $2.3-Bn Pact for Protein-Degradation Drugs for Cancer
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Gilead and Nurix Therapeutics, a drug-discovery company specializing in the body’s natural process to control protein levels, have entered into a global collaboration to discover, develop and commercialize targeted protein…

BMS to Divest Celgene’s Blockbuster Drug Otezla in $74-Bn Pending Merger
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Bristol-Myers Squibb (BMS) has provided an update on the approval process and timeline for its pending $74-billion acquisition of Celgene. To allow the transaction to close on a timely basis…

AbbVie To Acquire Allergan for $63 Billion
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AbbVie and Allergan have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash-and-stock transaction for a transaction equity value of approximately $63 billion, based…

Lonza, Piramal, LSNE, Tergus Pharma Expand; Aptar Makes Two Acquisitions
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The latest news from CDMOs, CMOs, and suppliers featuring news from Lonza, Piramal Pharma Solutions, Tergus Pharma, LSNE, Aptar, and Rentschler Fill Solutions. Chemicals/Chemical API Manufacturing Lonza To Expand HPAPI…

Sanofi Teams Up With Google To Create New Virtual Innovation Lab
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Sanofi has teamed up with Google to create a new virtual Innovation Lab, where the two companies will apply Google’s technology and analytics with Sanofi’s data to change how Sanofi…

Momenta, Sandoz Settle Generic Lovenox Suit with Amphastar
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Momenta Pharmaceuticals, a biopharmaceutical company developing therapeutics for rare immune-mediated diseases and biosimilars, and Sandoz AG, the generics arm of Novartis, have settled litigation with Amphastar Pharmaceuticals, a specialty and…

Dr. Reddy’s Divests Rights to Two Neurology Products to Upsher-Smith
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Dr. Reddy’s Laboratories, a Hyderabad, India-based pharmaceutical company, has entered into a definitive asset purchase agreement with Upsher-Smith Laboratories, a generics and brands pharmaceutical company, in which Dr. Reddy’s would…