Biogen cuts price for Alzheimer’s drug Aduhelm by half

20 December 2021 - The drug has sold poorly since its approval in June due to concerns about its safety, effectiveness ...

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Amylyx Pharmaceuticals announces FDA acceptance and priority review of new drug application for AMX0035 for the treatment of ALS

29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for ...

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Janssen submits biologics license application to U.S. FDA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma

29 December 2021 - Janssen  announced today the submission of a biologics license application to the U.S. FDA seeking approval ...

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PBS listing for Braftovi and cetuximab for metastatic bowel cancer patients with BRAFV600 mutation

30 December 2021 - Pierre Fabre Australia today announced that Braftovi (encorafenib) in combination with cetuximab will be listed on the ...

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Valemetostat new drug application submitted in Japan for treatment of patients with adult T-cell leukaemia/lymphoma

28 December 2021 - Submission of orphan drug designated valemetostat based on pivotal phase 2 trial in patients with relapsed/refractory adult T-cell ...

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Swiss regulator approves Roche-Regeneron COVID-19 drug

27 December 2021 - The Swiss medicines agency, Swissmedic, has given the green light to the monoclonal antibody cocktail Ronapreve developed ...

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Janssen COVID-19 booster shot approved in Switzerland

28 December 2021 - Medicines regulator Swissmedic has approved the booster of the single-dose vaccine from Johnson & Johnson. ...

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LEO Pharma announces FDA approval of Adbry (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate to severe atopic dermatitis

28 December 2021 - Adbry is the first biologic launched by LEO Pharma in the United States and is expected to ...

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ICER to assess treatments for Alzheimer’s disease

22 December 2021 - Report will be subject of CTAF meeting in July 2022; draft scoping document open to public ...

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COVID-19 vaccine weekly safety report (23 December 2021)

23 December 2021 - To 19 December 2021, the TGA has received 415 reports which have been assessed as likely to ...

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Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen

28 December 2021 - Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression ...

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Vivoryon Therapeutics receives FDA fast track designation for varoglutamstat in early Alzheimer’s disease

22 December 2021 - 21 – Vivoryon Therapeutics today announced that the U.S. FDA has granted fast track designation for varoglutamstat ...

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Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-001 in development for the treatment of AML

27 December 2021 - Celularity today announced the U.S. FDA has granted fast track designation for its non-genetically modified cryopreserved human ...

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FDA approves add-on therapy to lower cholesterol among certain high-risk adults

22 December 2021 - FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with diet and maximally ...

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Ligand’s Partner CStone Pharmaceuticals receives approval in China for sugemalimab (Cejemly) for the first-line treatment of advanced non-small-cell lung cancer in combination with chemotherapy

22 December 2021 - Sugemalimab was discovered using the OmniAb platform. ...

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Public Summary Documents – September 2021 PBAC meeting

24 December 2021 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the September 2021 PBAC ...

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