China NMPA Nods IASO Bio's IND Application For IASO-782

IASO Biotechnology (IASO Bio) has disclosed that the National Medical Products Administration (NMPA) has granted approval for the investigational new drug (IND) application for IASO-782 Injection, a fully human monoclonal antibody targeting human...

US FDA Nods BioMarin's Brineura For Children Under 3 years

BioMarin Pharmaceutical Inc. declared that the FDA has given the green light to the company's sBLA for Brineura to help delay the loss of walking ability in children with CLN2 disease, also known as TPP1 deficiency. Before, Brineura was approved...

UK MHRA Nods Pfizer/BioNTech's Covid-19 Vaccine for Adults, Children

UK MHRA has provided the approval to a modified Pfizer/BioNTech Covid-19 vaccine (Comirnaty) designed for the JN.1 Covid-19 subvariant. The vaccine stimulates the immune system to generate antibodies and blood cells to combat Covid-19...

Reunion Neuroscience Commences Patient dosing in phase 2 Trial of RE104

Neuroscience Inc., a company focused on advancing in neuroscience, revealed that the initial patient has received medication in the RECONNECT phase 2 trial of RE104 for postpartum depression (PPD) treatment. RE104 was created with the intention of...

Carbogen Amcis Concludes FDA Inspections at Two Manufacturing Sites

CARBOGEN AMCIS, a top pharmaceutical process development and API manufacturing company in Switzerland, has passed FDA inspections at its Neuland and Aarau locations. The FDA performed standard inspections in Neuland for five days from June 17-21...

Dren Bio and Novartis Partner to Develop Novel Targeted Myeloid Engagers

Dren Bio, Inc, a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune, and other serious diseases, announced that it has entered into a strategic collaboration...

Novo Nordisk's Wegovy Receives UK Nod for Reducing Heart Risks

Wegovy, a weight-loss drug by Novo Nordisk, has been sanctioned approval by the UK regulator to help overweight and obese adults lower their risk of serious heart problems or strokes. The UK's Medicines and Healthcare products Regulatory Agency...

Budget 2024: Govt Plans to fully Exempt 3 cancer drugs from customs duty

The government suggested completely waiving custom duties for three cancer drugs. Finance Minister Nirmala Sitharaman suggested exempting three additional medicines from customs duties in order to help cancer patients, during the...

ViroCell Biologics Inks Pact with NCI Designated Cancer Center

ViroCell Biologics, a company focused on cell and gene therapy contract development and manufacturing, has signed a five-year agreement with a leading U.S. cancer center for GMP viral vector manufacturing for clinical trials. The cancer center...

Grunenthal Acquires Valinor Pharma For USD 250 Million

The acquisition of Valinor Pharma, LLC (Valinor) and its product Movantik (naloxegol) was announced by Grünenthal, a top company in pain management and related illnesses, with a total cost of around $250 million including royalty obligations...

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