Biopharma News

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.

Rentschler Biopharma and Vetter are unveiling a strategic collaboration called Xpert Alliance.

Symbiosis announced the successful completion of UK Research and Innovation project to enhance the manufacturing supply chain for ATMPs within the UK.

KeyPlants has shipped a first-of-its-kind vaccine manufacturing facility to Senegal in West Africa.

Sanofi and IGM Biosciences have announced a collaboration agreement for oncology, immunology, and inflammation targets.

Pfizer has issued a voluntary nationwide recall on lots of Accuretic tablets due to high levels of nitrosamine.

Novavax’ COVID-19 vaccine has been granted emergency use authorization for use in the adolescent population ages 12–18 in India.

Orion is planning to refocus its R&D efforts on the development of new proprietary products focused on cancer and pain.

FDA has approved Novartis’ targeted radioligand therapy Pluvicto for the treatment of progressive PSMA-positive metastatic castration-resistant prostate cancer.

EMA has recommended the approval of Roche’s Polivy plus R-CHP for the treatment of previously untreated diffuse large B-cell lymphoma in the EU.

Huma has acquired AstraZeneca’s digital health platform, and AstraZeneca has become a shareholder of Huma in a partnership to accelerate digital-first patient care.

Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.