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AGC Biologics Completes PPQ Manufacturing Campaign with Provention Bio for Type 1 Diabetes Product Candidate, Teplizumab

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), achieved the on-schedule completion of a drug substance Process Performance Qualification (PPQ) campaign, focused on teplizumab (PRV-031) for partner Provention Bio, Inc., a biopharmaceutical company dedicated to...

Intravacc and Therapyx jointly develop the world’s first prophylactic gonorrhea vaccine

Intravacc, a global leader in translational research and development of viral and bacterial vaccines, has partnered with American, Buffalo, NY, based Therapyx, to further develop and optimize the world's first prophylactic vaccine against gonorrhea, NGoXIM. For this Therapyx received...

Trialbee Partners with Clinerion for Expanded Access to Global Real-World Data to Accelerate Patient Recruitment for Clinical Trials

Trialbee, a leading global technology provider for patient matching and engagement in clinical trials, announced a partnership with Clinerion, a worldwide leader in medical data informatics with a global research network comprised of 30.2 million patients online across 69...

Merck’s KEYTRUDA Receives Two New Approvals in Japan

Merck, known as MSD outside the United States and Canada, announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA monotherapy is now approved for the treatment of...

Imfinzi approved in Japan for the treatment of extensive-stage small cell lung cancer

AstraZeneca’s Imfinzi (durvalumab) has been approved in Japan for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with etoposide plus a choice of platinum chemotherapy (either carboplatin or cisplatin). SCLC is a highly aggressive,...

AstraZeneca Phase I clinical trial initiated for COVID-19 monoclonal antibody

The first participants have been dosed in a Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19. The trial, called NCT04507256, will evaluate the safety, tolerability and pharmacokinetics...

AbbVie, Harvard University Form Research Alliance to Address Emergent Viral Diseases

AbbVie and Harvard University announced a $30 million collaborative research alliance, launching a multi-pronged effort at Harvard Medical School (HMS) to study and develop novel therapies against emergent viral infections, with a focus on those caused by coronaviruses and...

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