Catalent To Acquire BMS’ Solid Dosage and Sterile Mfg Facility in Italy
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Bristol-Myers Squibb (BMS) and Catalent have announced that Catalent has agreed to purchase BMS’ oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy. The 19,300-square-meter Anagni…

Amgen, Allergan Get FDA OK for Biosimilar of Roche’s Herceptin
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The US Food and Drug Administration (FDA) has approved Amgen’s and Allergan’s biosimilar of Roche’s Herceptin (trastuzumab). Their biosimilar, Kanjinti (trastuzumab-anns), was approved for the treatment of HER2-overexpressing adjuvant and…

Vertex Makes Two Gene-Editing Deals, Worth Up to $1 Billion Each
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Vertex Pharmaceuticals has made two deals, worth up to $1 billion each, to enhance its gene-editing capabilities in drug development. The company is expanding its collaboration with CRISPR Therapeutics, a…

Pharma Companies Sue HHS Over Rule Requiring Drug Pricing in TV Ads
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Amgen, along with Merck and Co., Eli Lilly and Company, and the Association of National Advertisers, have filed suit against the US Department of Health and Human Services’ (HHS) regarding…

Pfizer to Acquire Array BioPharma for $11.4 Billion
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Pfizer has entered into a merger agreement with Array BioPharma, a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of small-molecule medicines for cancer and other diseases, for…

Johnson & Johnson’s Janssen, Genmab Sign Antibody Pact
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Genmab, a biotechnology company specializing in antibody therapeutics for the treatment of cancer, has entered into a worldwide license and option agreement with Janssen Biotech, part of Johnson & Johnson,…

BI Opens New $135-Million Manufacturing Facility for Respimat Inhaler
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Boehringer Ingelheim (BI) has opened a new production plant in Sant Cugat del Valles, Spain, to produce and package Respimat, an inhalation device for patients with asthma and chronic obstructive…

Teva Expands Recall of Bulk Losartan Tablets
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In another recall of “sartan”-containing products, Teva Pharmaceuticals USA has expanded its voluntary recall to the consumer level in the US of losartan potassium tablets, used in antihypertensive drugs. The…

Merck & Co., Walmart, IBM Selected for FDA Blockchain Pilot Program for Drug Supply Chains
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Merck and Co. has been selected by the US Food and Drug Administration (FDA), along with Walmart, IBM, and KPMG, to participate in a pilot program in support of the…

Aurobindo’s Formulation Manufacturing Facility Cited by FDA
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Aurobindo Pharma, a manufacturer of generic pharmaceuticals and a contract manufacturer, has received a Form 483 with 10 observations, following an inspection by the US Food and Drug Administration (FDA)…