Shire Opens $1-Billion Plasma Manufacturing Plant
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Shire has opened its more-than-$1-billion plasma manufacturing plant near Covington, Georgia. The more than one-million-square-foot facility will add approximately 30% capacity to Shire’s internal plasma manufacturing network once fully operational.…

Lonza, Noramco, Schott, Almac, and PCI Pharma Services Expand
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A roundup of the latest expansions and investments from suppliers, contract development and manufacturing organizations and contract manufacturing organizations, featuring news from Lonza, Noramco, Schott, Almac, and PCI Pharma Services.…

FDA Issues Draft Guidances for Complex Generic Drugs
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As part of the US Food and Drug Administration’s (FDA) efforts to promote drug competition and patient access, the agency has issued two draft guidances to advance the development of…

Roche, Ionis To Develop Eye Disease Candidate in $760-Million Deal
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Roche has partnered with Ionis Pharmaceuticals, a Carlsbad, California-based pharmaceutical company, to develop Ionis’ antisense drug candidate for treating complement-mediated diseases, in a deal worth up to $760 million. The…

Perrigo CEO Steps Down; New CEO Named
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In keeping with a previously announced decision to divest its prescription (Rx) drug business and focus on consumer healthcare, Perrigo has appointed Murray S. Kessler, formerly Chief Executive Officer (CEO)…

FDA Issues Draft Guidance to Support Development of Rare-Disease Drugs
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The US Food and Drug Administration (FDA) has issued a draft guidance to help companies developing drug products for rare diseases conduct more efficient pre-investigational new drug application (pre-IND) meetings.…

Teva Loses Court Ruling to Allow Generics of Top-Selling Drug Copaxone
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A federal appeals court has ruled four patents by Teva Pharmaceutical Industries’ invalid for its top-selling drug Copaxone (glatiramer acetate), a multiple sclerosis drug and Teva’s top-selling product. The US…

US Gov’t OKs $69-Billion Merger of CVS, Aetna with Conditions
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In a deal that would mark a new business model for healthcare delivery,  the US Department of Justice (DOJ) has granted conditional approval for the $69-billion merger of CVS Health…

Dr. Reddy’s Sells API Manufacturing Business to Therapiva in India
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Dr. Reddy’s Laboratories has agreed to sell its active pharmaceutical ingredient (API) manufacturing business unit in Hyderabad, India to Therapiva, a Hyderabad, India-based emerging generics pharmaceutical company and Neopharma joint…

AbbVie, Novartis Sign Deal for Biosimilar Launch of AbbVie’s Humira
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AbbVie and Sandoz, Novartis’ generics arm, have signed a resolution of all intellectual property (IP)-related litigation concerning Sandoz’s Hyrimoz (adalimumab), a proposed biosimilar to AbbVie’s anti-inflammatory drug, Humira (adalimumab), AbbVie’s…