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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CMS takes action to lower out of pocket Medicare Part D prescription drug costs

6 January 2022 - Today, the Centers for Medicare & Medicaid Services issued a proposed rule that would make updates to ...

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FDA shortens interval for booster dose of Moderna COVID-19 Vaccine to five months

7 January 2022 - Today, the U.S. FDA amended the emergency use authorisation for the Moderna COVID-19 Vaccine to shorten the ...

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AbbVie submits applications for upadacitinib (Rinvoq) in non-radiographic axial spondyloarthritis to U.S. FDA and EMA

7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...

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NICE recommends MSD’s Keytruda in combination with chemotherapy for routine treatment of lung cancer

7 January 2022 - With over 48,000 new cases diagnosed per year, lung cancer is the third most common cancer ...

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Dynacure receives fast track designation for DYN101, an investigational antisense oligonucleotide for the treatment of myotubular and centronuclear myopathies

6 January 2022 - Dynacure today announced that the U.S. FDA has granted fast track designation for its lead product ...

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Keytruda (pembrolizumab) plus Lenvima (lenvatinib) approved in Japan for patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy

27 December 2021 - First approval in Japan for the Keytruda plus Lenvima combination. ...

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Otsuka and Lundbeck announce FDA approval of supplemental new drug application for Rexulti (brexpiprazole) to treat schizophrenia in paediatric patients ages 13-17

6 January 2022 - Otsuka and Lundbeck announce the U.S. FDA has approved the supplemental new drug application of Rexulti ...

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ICER publishes evidence report on tirzepatide for type 2 diabetes

6 January 2022 - Tirzepatide has a novel dual GIP and GLP-1 receptor agonist mechanism of action and is seen as ...

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Updated agenda for the March 2022 PBAC meeting

5 January 2022 - The agenda for the March 2022 PBAC meeting has been updated.  ...

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U.S. FDA approves Immix Biopharma rare paediatric disease designation for IMX-110 as a treatment for life-threatening paediatric cancer

3 January 2021 - Immix Biopharma announced today that the U.S. FDA has granted rare paediatric disease designation for IMX-110 for ...

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Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS

4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...

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FDA grants breakthrough therapy designation for Cullinan Oncology’s CLN-081 in patients with locally advanced or metastatic EGFR mutated non-small-cell lung cancer

4 January 2022 - Cullinan Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for CLN-081 for ...

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TGA grants provisional determination to AstraZeneca for COVID-19 prophylaxis and treatment, tixagevimab and cilgavimab (Evusheld)

4 January 2022 - On 4 January 2022, the TGA granted a further provisional determination to AstraZeneca in relation to ...

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AbbVie announces U.S. FDA granted breakthrough therapy designation to telisotuzumab vedotin for previously treated non-small-cell lung cancer

4 January 2022 - There are currently no approved cancer therapies specifically for patients with c-Met overexpressing non-small-cell lung cancer. ...

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Zogenix submits type II variation application to the EMA to expand the use of Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome

20 December 2021 - Zogenix today announced that it has submitted its type II variation market authorisation application to the EMA ...

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