News

A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead's Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned.

PharmaMar has released the results of MI130004, a novel antibody drug conjucate created using a molecule of marine origin.

Roche will acquire oncology-focused healthcare technology and services company Flatiron Health for $1.9 billion to further its personalized oncological healthcare strategy.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

The company aims to add the additional analytical services in the European Union throughout 2018.

The new training center, the Jefferson Institute for Bioprocessing, will prepare engineering students and industry professionals for the field of biologics manufacturing.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.

The company has entered into an agreement with an undisclosed partner to support the development and manufacture of a new biomanufacturing cell line.

The company has expanded its single-use manufacturing capabilities at its facility in Fermoy, Ireland.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

Fluarix Tetra has been approved for use in children aged six months and above.

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

The companies will work together on developing regenerative medicine therapies for heart failure.

Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

Honeywell offers an augmented/virtual reality approach to train the industrial workforce.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.

A new report states that more research and clinical development must be done in the treatment of pain and addiction.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.