Industry News

Thermo Fisher Scientific has launched its first GMP-manufactured Cas9 protein for clinical genome editing research.

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

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

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.

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

Tjoapack has doubled its packaging capacity with the completion of its Netherlands facility expansion.

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

FDA is reviving efforts to establish a Quality Management Maturity program.

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.

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

Democrats have proposed a measure to facilitate access to less costly comparator drugs needed in clinical trials, while another bill aims to increase transparency in the costs of clinical trials.

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.

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

NIH has announced four new grant awards to fund new tuberculosis research advancement centers.

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.

ATMPS Ltd has been granted a patent from the United States Patent and Trademark Office for the use of its Hataali blockchain technology used in personalized medicines.

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

Legislative proposals set the stage for debate on FDA policies and programs and whether to include some measures in legislation to reauthorize user fees.

Stanley Capital has announced the acquisition of MyMeds&Me by its portfolio company Drug Safety and Pharmacovigilance Services Solutions.

ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms.

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