FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Eisai statement on the Centers for Medicare and Medicaid Services’ National coverage determination with coverage with evidence development for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease

8 April 2022 - Eisai stands with people living with Alzheimer’s disease and their families, health care professionals and other ...

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TGA approved Yuflyma

8 April 2022 - The TGA has approved yet another adalimumab biosimilar. ...

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TGA provisionally approves Pfizer’s COVID-19 vaccine (Comirnaty), for use as a booster for individual aged 12–15 years old

8 April 2022 - The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, Comirnaty, for use as a ...

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What is the solution to America’s deepening access to medicines crisis?

7 April 2022 - Last week, a bill to limit the cost of insulin in the US passed the House of ...

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CMS finalises Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease

7 April 2022 - Today, the CMS released a national policy for coverage of aducanumab (Aduhelm) and any future monoclonal antibodies ...

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CADTH launches consultations on proposals to enhance drug review processes

4 April 2022 - CADTH has launched consultations on a proposed process for non-sponsored reimbursement reviews and a streamlined process ...

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Clayton Pharmaceuticals and VistaPharm receive FDA approval for sucralfate oral suspension

7 April 2022 - Approval validates the use of novel pathway for bioequivalence of complex generic drug products, which increases ...

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Concerns two different flu vaccines create two tier system for 65 and overs

8 April 2022 - PHARMAC is being accused of kicking an own goal on flu jabs, after those aged 65 ...

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BeiGene’s Brukinsa quickly passes HIRA’s reimbursement review

7 April 2022 - BeiGene’s Brukinsa (zanubrutinib), a next-generation BTK inhibitor, passed the Health Insurance Review and Assessment Service’s Cancer ...

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ICER publishes white paper evaluating reforms to orphan drug development, pricing and coverage

7 April 2022 - The white paper presents an analysis of the potential risks and benefits of reforms seeking to ...

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NICE says new triple negative advanced breast cancer drug too expensive for NHS use

7 April 2022 - NICE has today issued draft guidance which does not recommend sacituzumab govitecan for treating locally advanced or ...

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A radical treatment for insulin pricing

6 April 2022 - A private, non-profit company recently announced that it intends to bypass the traditional supply chain and sell ...

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TGA receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (Xevudy) for the BA.2 omicron sublineage

7 April 2022 - The TGA has received an application from GSK for a higher (1,000 mg) dose of its ...

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Hundreds of people with some forms of urothelial cancer to receive new treatment

7 April 2022 - Over 800 people with locally advanced or metastatic urothelial cancer are set to benefit from a new ...

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Innovent announces the approval of Pemazyre (pemigatinib) by the NMPA for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy

6 April 2022 - Innovent Biologics announced that the National Medical Products Administration has approved Pemazyre (pemigatinib) for the treatment of ...

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