News

Europe Phases Out COVID-19 Flexible Regulations

July 06, 2023

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.

COVID-19 Vaccine, Nuvaxovid, Gains EU Approval

July 06, 2023

Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.

Chime Biologics Forms mAb Development and Manufacturing Deal with Leads Biolabs and BeiGene

July 06, 2023

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

Meletios Therapeutics’ Efforts in Antiviral Field Gains Recognition from Bpifrance

July 06, 2023

Meletios Therapeutics has been awarded with funding worth €1.2 million (US$1.3 million) from Bpifrance’s Deeptech development program.

Syngene Adds Biologics Drug Substance Manufacturing Capacity with Facility Acquisition

July 06, 2023

Syngene has acquired a multi-modal biologics drug substance manufacturing facility in Bangalore, India, from Stelis Biopharma.

FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A

July 05, 2023

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

Frontrunner in Therapies for Complement-Mediated Diseases

July 02, 2023

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

Donaldson Company Acquires Univercells Technologies for €136 Million

June 30, 2023

Donaldson Company’s €136 million (US$148 million) acquisition of Univercells is designed to broaden its portfolio of biomanufacturing solutions.

FDA Approves UCB Generalized Myasthenia Gravis Treatment

June 30, 2023

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

Tower Cold Chain Expands to American Center of Excellence

June 29, 2023

Tower Cold Chain will soon open its new headquarters in Philadelphia.