Bio/Pharma News

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.

The agency approved Insmed’s Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease).

The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.

Kangstem Biotech has selected Orgenesis subsidiary, MaSTherCell, as its contract manufacturing partner for the European clinical trial of Furestem-AD.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

The divestiture of the European generic-drug business of Sanofi-Zentiva-to Advent International has been completed.

The company’s biosimiliar to Amgen’s Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The company plans to lay off approximately 400 employees to support the restructuring of its R&D organization.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.

The agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.

The company announced it is creating a new Primary Care global business unit and a China & Emerging Markets unit.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

The companies will develop therapies targeting the in-vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform.

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

The collaboration will explore the potential of Dyadic’s gene-expression platform to produce multiple biologic vaccines and drugs.

Emergent BioSolutions is set to acquire Adapt Pharma, a pharmaceutical company focused on addressing the opioid overdose and addiction crisis, in a deal worth up to $735 million.

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

The purchase of Novartis’ cystic fibrosis products TOBI Podhaler and TOBI solution is expected to strengthen Mylan’s global respiratory portfolio.

Skin-focused company LEO Pharma acquired Bayer’s prescription treatment portfolio.

The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.

Bristol-Myers Squibb appointed a new executive vice-president and chief commercial officer from within the company, effective immediately.

The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

The acquisition will support Novo Nordisk’s development of glucose-responsive insulins.

Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.

The acquisition will strengthen Astellas Pharma’s position in ophthalmology.

GSK will close the Sligo, Ireland skincare product manufacturing site by 2021.

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.

Pharmaceutical scientist association announces upcoming term’s board of directors.