The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
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 complex generic drugs. Complex generics are drugs that, by nature...
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 collaboration will...
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) of the Lorillard Tobacco Company, as...
The US Food and Drug Administration (FDA) has issued a draft guidance to help companies developing drug products for rare diseases conduct more efficient pre-investigational new drug application (pre-IND) meetings. The draft guidance specifically...
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 Court of Appeals for the Federal...
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 Corporation (CVS), the largest retail pharmacy chain in the...
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 venture...
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),...
GlaxoSmithKline (GSK) is closing part of its cephalosporins antibiotics manufacturing plant in Ulverston, England and planning staff reductions of approximately 200 employees. This follows a strategic review from which GSK decided to keep its...
Bayer is planning staff reductions of approximately 227 employees at its biologics manufacturing plant in Berkeley, California, which recently began production of its newly approved hemophilia A therapy, Jivi (antihemophilic factor [recombinant])....
Janssen Pharmaceuticals, one of the pharmaceutical companies of Johnson & Johnson, has formed a license and collaboration deal with Arrowhead Pharmaceuticals, a Pasadena, California-based biotechnology company, to develop and commercialize...
GlaxoSmithKline (GSK) has signed a three-year clinical manufacturing agreement with Hitachi Chemical Advanced Therapeutics Solutions (HCATS), an Allendale, New Jersey-based contract development and manufacturing organization.
Under the agreement,...
Novo Nordisk is planning staff reductions of approximately 250 employees in the US as part of a reorganization resulting from an assessment of resource needs against its business priorities. Last month (September 2018), the company announced staff...
Merck & Co. and Dragonfly Therapeutics, a Waltham, Massachusetts-based company specializing in cancer immunotherapies, have partnered to discover, develop, and commercialize immunotherapies for patients with solid tumor cancers in a deal worth...
