FDA approves Sandoz’s denosumab biosimilars

March 6, 2024
Medical Communications FDA, Jubbonti, Musculo-skeletal disorder, Sandoz, Wyost, denosumab

Sandoz has announced that the US Food and Drug Administration (FDA) has approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), which are …

Regenxbio announces initial efficacy data from phase 1/2 AFFINITY DUCHENNE trial

March 6, 2024
Research and Development Duchenne Muscular Dystrophy, Musculo-skeletal disorder, Regenxbio, clinical trial

Regenxbio has announced additional interim safety data from its phase 1/2 AFFINITY DUCHENNE trial of RGX-202 in patients with Duchenne …

GSK’s Jemperli recommended by NICE for endometrial cancer treatment

March 5, 2024
Medical Communications GSK, Jemperli, NICE, Oncology, endometrial cancer

GSK has announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Jemperli (dostarlimab) …

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Novartis shares new data for Zolgensma in children with SMA

March 5, 2024
Musculo-skeletal disorder, Novartis, Zolgensma, sma, spinal muscular atrophy

Novartis has announced new data to continue the support of the clinical benefits of Zolgensma (onasmenogene abeparvovec), for the treatment …

FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment

March 4, 2024
Medical Communications FDA, Johnson & Johnson, NSCLC, Oncology, Rybrevant

Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Rybrevant (amibantamab-vmjw) following a priority …

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EMA validates two applications for datopotamab deruxtecan for cancer treatments

March 4, 2024
Medical Communications CHMP, Daiichi Sankyo, EMA, Oncology, datopotamab deruxtecan

AstraZeneca has announced that the European Medicines Agency (EMA) has validated to marketing authorisation applications (MAAs) for AstraZeneca and Daiichi …

Cardiff Oncology doses first patient in colorectal cancer trial

March 1, 2024
Research and Development Cardiff Oncology, Oncology, clinical trial, colorectal cancer

Cardiff Oncology has announced that it has dosed the first patient in its randomised first-line phase 2 trial, CRDF-004, for …

Viracta Therapeutics completes enrolment for T-cell lymphoma cohort in NAVAL-1 trial

March 1, 2024
Medical Communications Oncology, Viracta Therapeutics, lymphoma

Viracta Therapeutics has announced that it has completed stage 2 enrolment into the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) …

AstraZeneca’s Voydeya recommended for approval in EU by CHMP

February 29, 2024
Medical Communications AstraZeneca, CHMP, EMA, Haematology, Voydeya

AstraZeneca has announced that Voydeya (danicopan) has been recommended for marketing authorisation in the European Union (EU) by the Committee …

Spero Therapeutics’ bacterial infection treatment gains FDA IND clearance

February 29, 2024
Medical Communications FDA, Infections and infestations, Spero Therapeutics, bacterial infections, investigational new drug

Spero Therapeutics has announced that it has gained US Food and Drug Administration (FDA) clearance for the investigational new drug …

Viatris and Idorsia enter research and development collaboration

February 28, 2024
Research and Development Idorsia, Pharmacy, Viatris, acute myocardial infarction, systemic lupus erythematosus

Viatris and Idorsia have announced that they have entered into agreements for a significant global research and development collaboration. Under …

Amneal and Zambon Biotech enter agreement for Parkinson’s treatment

February 28, 2024
Research and Development Amneal pharmaceuticals, Neurology, Parkinson's disease, Zambon Biotech, licensing agreement

Amneal Pharmaceuticals has announced that it has entered into an exclusive licensing agreement with Zambon Biotech for IPX204 in the …

GSK shares positive results from phase 3 trial for gonorrhoea treatment

February 27, 2024
Research and Development GSK, Infections and infestations, antibiotic, clinical trial, gonorrhoea

GSK has announced positive headline results from its phase 3 EAGLE-1 trial for gepotidacin, its potential first-in-class oral antibiotic with …

Amgen opens new biomanufacturing facility in Ohio, US

February 27, 2024
Manufacturing and Production Amgen, Biomanufacturing, Manufacturing Facility, Ohio, Pharmacy, US

Amgen has announced that it has opened a new manufacturing site in Central Ohio, US. This will be the latest …

Roche shares data from phase 3 trial of Xolair as allergy treatment

February 26, 2024
Research and Development Allergic Disorders, Roche, Xolair, allergy, clinical trial, food allergy

Roche has announced data from stage 1 of the National Institutes of Health (NIH)-sponsored phase 3 OUtMATCH trial, which assessed …

Boehringer Ingelheim announces results from phase 2 trial for liver disease treatment

February 26, 2024
Research and Development Boehringer Ingelheim, Hepatology, clinical trial, liver disease, survodutide

Boehringer Ingelheim has announced results from the phase 2 trial of survodutide for the treatment of liver disease due to …

AbbVie and Tentarix collaborate on oncology and immunology treatments

February 23, 2024
Research and Development AbbVie, Oncology, collaboration, immunology

AbbVie and Tentarix Biotherapeutics have announced that they have entered a multi-year collaboration focused on the discovery and development of …

Almirall licenses Novo Nordisk’s anti-IL-21 monoclonal antibody for dermatology treatment

February 23, 2024
Research and Development Almirall, Dermatology, Novo Nordisk, dermatology, monoclonal antibody

Almirall has announced that it has entered into an exclusive license agreement with Novo Nordisk for the rights to its …

FDA accepts BLA for Regeneron’s linvoseltamab for Priority Review

February 22, 2024
Medical Communications FDA, Oncology, Regeneron, bla, priority review

Regeneron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for …

BioAscent opens new protein production facility

February 22, 2024
Manufacturing and Production BioAscent, Pharmacy, facility, protein production

BioAscent has announced that it has opened its new state-of-the-art protein production facility in an event chaired by Professor Michael …

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