The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Kite Pharma, Gilead Sciences’ cell-therapy subsidiary, and Gadeta, an Utrecht, Netherlands-based company developing cancer immunotherapies based on gamma delta T cell receptors (TCRs), have formed a pact to develop gamma delta TCR therapies in...
Novartis has formed a deal with MorphoSys AG, a Planegg, Germany-based developer of antibodies, and Galapagos NV, a Mechelen, Belgium-based clinical-stage pharmaceutical company, to develop and commercialize their joint investigational, fully...
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from AbbVie, Amgen, and UCB.
Editor's Note: This article was updated on a continuous basis for news announced from Wednesday July 11, 2018...
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Pfizer, and Astellas Pharma.
Editor's Note: This article was updated on a continuous basis for news announced from Wednesday July 11 to...
Moderna Therapeutics, a Cambridge, Massachusetts-based biotechnology company focusing on messenger RNA (mRNA) therapeutics, has opened a new manufacturing facility in Norwood, Massachusetts for clinical development of mRNA therapeutics.
The...
AbbVie has signed patent license agreements with Mylan over Mylan’s proposed biosimilar to AbbVie’s Humira (adalimumab). Humira is AbbVie’s top-selling drug with 2017 sales of $18.43 billion.
Under the agreements, AbbVie will grant Mylan a...
The US Food and Drug Administration (FDA) has issued draft guidance, Innovative Approaches for Nonprescription Drug Products, as part of the agency’s effort to increase access to nonprescription drugs to increase drug competition.
“While the FDA...
MedImmune, AstraZeneca’s global biologics research and development arm, has partnered with 4D Molecular Therapeutics (4DMT), a company specializing in gene-therapy vector discovery and product development, to develop and commercialize a gene...
Dr. Reddy’s Laboratories, a Hyderabad, India-headquartered pharmaceutical company, has announced its intent to appeal a preliminary injunction made by a federal US district court against further sales and commercialization of Dr. Reddy’s...
Novartis has signed an agreement with CELLforCURE, a contract development and manufacturing organization and part of the biopharmaceutical company, LFB, to produce chimeric antigen receptor T-cell (CAR-T) therapies at CELLforCURE’s bioproduction...
GlaxoSmithKline (GSK) has agreed to sell the rights to its investigational drug, tapinarof, to Dermavant Sciences, the dermatology subsidiary of Roivant Sciences, a Basel, Switzerland globally headquartered biopharmaceutical company, for £250...
The US Food and Drug Administration (FDA) has formed a new Drug Shortages Task Force that will be led by Keagan Lenihan, the FDA’s Associate Commissioner for Strategic Initiatives. The task force is being charged to delve into why some drug...
The US Food and Drug Administration (FDA) has announced a voluntary recall of several drug products containing the active ingredient, valsartan, which is used to treat high blood pressure and heart failure. Three companies are involved in the...
Valeant Pharmaceuticals International has completed the change of its company name to Bausch Health Companies, as previously announced in May 2018. The new name is taken from its subsidiary, Bausch + Lomb, an eye-care company, which Valeant...
Genmab A/S, a Copenhagen, Denmark-based biopharmaceutical company developing therapeutic anti-cancer antibodies, has formed a license pact with Immatics Biotechnologies GmbH, a Tuebingen, Germany-based clinical-stage biopharmaceutical company, to...
