Biopharma News

Gerresheimer has announced it will be expanding its ClearJect product line of pre-fillable syringes with a new 2.25-mL cyclic olefin polymer (COP) staked in needle (SIN) syringe.

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.

A global agreement with Polpharma Biologics gives Sandoz commercialization rights to a proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

BioCity has revealed it will be investing in Kinomica, an early-stage precision medicine biotech company that was spun out of Barts Cancer Institute, Queen Mary University of London.

LBB Specialties and Meggle Excipients & Technology will work to distribute excipient products to companies in the American pharmaceutical and nutraceutical industries.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

iBio granted a license to CC-Pharming for the commercialization of its iBio Rituximab drug for treatment of B cell non-Hodgkin lymphomas, chronic lymphocytic leukemia, and autoimmune diseases.

GSK will handle the development, regulatory, commercialization activities, and costs of the drug, while Ionis will obtain license fees and milestone payments of up to $262 million, including a $25 million license fee.

A ruling in Oklahoma that Johnson & Johnson’s marketing efforts created a public nuisance may establish a precedent of other jurisdictions.

The new vaccine will offer protection against the Nipah virus after a single dose.

The transaction is part of Bristol-Myers Squibb’s proposed acquisition of Celgene.

Innovate UK has awarded a grant worth thousands to the Atelerix Consortium for the collaborative work with the Cell and Gene Therapy Catapult and Rexgenero on development of cell stabilization technology.

ABPI has issued a statement of support in response to the United Kingdom’s Prime Minister’s recent order of urgent action to boost the numbers of children receiving vaccinations.

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

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.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

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.