Biopharma News

The divestiture is in line with Bayer’s strategy to focus on its life sciences business.

Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.

A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).

Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%

Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.

The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.

The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.

Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.

Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.

Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.

Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. 

Gilead Sciences gains rights to clinical and preclinical programs in Galapagos’ portfolio through a 10-year global research and development collaboration.

Boehringer Ingelheim will combine assets from its cancer immunology portfolio with the KISIMA immunization platform from AMAL Therapeutics.

Oncology drug discovery and development company, ADC Therapeutics, has closed its Series E financing expansion, in which it raised $103 million.

Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.

Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

The companies will join forces to develop new immuno-oncology therapies in a deal worth up to $470 million.

The companies will work to develop a liver tissue model for screening the toxicity of drugs.

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.

In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

Be The Match BioTherapies and TrakCel have announced a collaboration to provide integrated solutions for companies developing cell and gene therapies.