Biopharma News

FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).

AbbVie will grant Pfizer license to launch a biosimilar to AbbVie’s Humira worldwide.

GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.

The acquisition will give Genentech full rights to Jecure’s preclinical portfolio of NLRP3 inhibitors.

The vaccine producer announced an expansion to its Holly Springs, NC, manufacturing facility where it will increase production of its cell-based quadrivalent influenza vaccine.

AstraZeneca is set to divest United States rights to Synagis (palivizumab) to Swedish Orphan Biovitrum (Sobi), a biopharmaceutical company focused on rare diseases, for $1.5 billion.

The companies will develop AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease in a collaboration worth $170 million.

The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.

AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.

The multi-year collaboration will incorporate NextCure's proprietary FIND-IO platform, a technology designed to identify novel cell-surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites.

The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).

Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.

The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).

AbbVie will assume full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF).

AstraZeneca and Innate Pharma further expand oncology collaboration with a new multi-term agreement.

The companies will work together to advance a number of Morphic's oral integrin therapeutics for fibrosis-related indications in a deal with $100 million.

The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

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.

Insmed’s Arikayce (amikacin liposome inhalation suspension) is the first drug approved under the agency’s Limited Population Pathway for Antibacterial and Antifungal Drugs, established to support development of antibiotics for unmet medical needs.

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.

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

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

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 sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.