Biopharma News

Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.

The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.

Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.

Takeda’s TAKHZYRO prefilled syringe is now available for patients with hereditary angioedema aged 12 years and older in the United States.

AmoyDX has entered a Master Collaboration Agreement with AstraZeneca for multiple companion diagnostics programs in China, EU, and Japan.

High Purity New England has launched its third facility, focused on single-use assemblies.

GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9 billion.

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

Achilles Therapeutics has announced that it will expand its clinical manufacturing capabilities in the UK and enter a partnership agreement for expansion in the US.

VectorBuilder will expand with the construction of new $500 million Gene Delivery Research and Manufacturing Campus in Guangzhou, China.

Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine for treatment of COVID-19.

Opus enters a strategic collaboration with Resilience for AAV-based gene therapy development and manufacturing for inherited retinal diseases.

Orchard Therapeutics announces reimbursement agreement, which will make Libmeldy available for all eligible MLD patients in Italy.

Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.

Ymmunobio AG has signed a patent purchase agreement with LeukoCom GmbH to expand its development of cancer therapies.

Pfizer plans to acquire ReViral and its respiratory syncytial virus therapeutic candidates to strengthen Pfizer’s capabilities in infectious disease research.

Lonza and Asher Biotherapeutics have entered a manufacturing agreement for a cis-targeted IL-2 fusion protein, AB359.

IAVI and Moderna have announced a new collaboration to employ mRNA technology to meet the challenge of a range of global health issues.

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

UK’s MHRA has issued a positive opinion for the Early Access to Medicines Scheme for radioligand therapy in patients with advanced prostate cancer.

INCOG Biopharma has completed the construction of its cleanroom production area, marking a milestone in the completion of an overall $100 million investment in a new facility.

Catalent has acquired the Vaccine Manufacturing Innovation Centre in Harwell, Oxford to expand its biologics capabilities across the UK and Europe.

FDA has accepted Dupixent for Priority Review in patients aged 12 years and older with eosinophilic esophagitis.

Merck has expanded its manufacturing facility in Elkton, Va. to further increase its HPV vaccine supply.

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.

Sterling Pharma Solutions has unveiled a £1 million expansion project to increase its capabilities and laboratories capacity at its Deeside, UK site.

UK government has awarded chemical producer Croda a £15.9 million grant to increase the UK’s capacity to manufacture key vaccine ingredients.