Biopharma News

Lonza has formed a long-term, strategic collaboration with a global biopharma company for bioconjugation.

The gene therapy increases the ability of retina cells to make a soluble form of CD59, a protein that shields the retina from damage, to prevent additional damage and to preserve vision.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

MHRA has granted a temporary authorization for emergency use to Pfizer and BioNTech for the mRNA vaccine against COVID-19.

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

The new powerful, precise, and compact instrument can be retrofitted for point-of-care clinical testing at urgent care facilities, hospitals, or physicians’ offices.

The expansion of the companies’ partnership will integrate lead optimization efforts to advance cancer immune therapy drug discovery.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.

The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.

The agreement follows a recent announcement that Sartorius plans to invest $100 million in Songdo, South Korea’s bio cluster.

The agreement will allow Roche to use CEVEC’s proprietary ELEVECTA technology, which is designed to enable fully scalable, high-performance AAV vector production in suspension bioprocesses.

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.

The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.

An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.

Researchers concluded that the nasal spray should catch and coat the virus inside the nose, preventing it from spreading throughout the body, and it is then removed by nose-blowing or swallowing.

Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.

Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.

PhoreMost and Oxford Biomedica have entered into a discovery collaboration for the development of next-generation chimeric antigen receptor T-cell therapies.

Apeiron Biologics has selected Domainex to advance the development of inhibitors for the E3 ubiquitin ligase Cbl-b.

FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

Interim efficacy data suggests the Pfizer/BioNTech mRNA-based vaccine has an efficacy rate above 90%.

Lonza has inaugurated its first ADC payload manufacturing suite at the Visp, Switzerland site.

ProteoNic has licensed its protein expression technology, 2G UNic, to Gilead Sciences.