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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Enhertu granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer

27 April 2022 - Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a significant improvement in both progression-free ...

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PBS brings hope to cancer patients

25 April 2022 - Late-stage breast cancer patients, many of them young women, will have access to a life-extending medication ...

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With $35 million in funding, Waltz Health aims to lower drug prices working with – not against – the system

26 April 2022 - After a 30 year career as an executive at some of the country’s largest pharmacy benefit ...

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Just one in five new cancer treatments available to Irish patients

26 April 2022 - Delays in reimbursing new treatments may affect course of illnesses, study says. ...

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Amarin partner HLS Therapeutics completes reimbursement negotiations with Pan-Canadian Pharmaceutical Alliance for Vascepa (icosapent ethyl)

26 April 2022 - Amarin Corporation announced today its partner HLS Therapeutics has completed negotiations with Canada’s pan-Canadian Pharmaceutical Alliance for ...

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Prothena receives FDA fast track designation for PRX012, a next generation anti-amyloid beta antibody under investigation for the treatment of Alzheimer’s disease

26 April 2022 - PRX012 is a potential best in class, subcutaneous anti-amyloid beta antibody therapy currently in a Phase ...

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Intra-Cellular Therapies announces FDA approval of new dosage strengths for Caplyta (lumateperone) for specific patient populations

25 April 2022 - Caplyta label now includes dosage recommendations for specific patient populations; those with moderate or severe hepatic ...

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VBL Therapeutics receives FDA fast track designation for ofra-vec for the treatment of platinum-resistant ovarian cancer

26 April 2022 - OVAL Phase 3 top-line progression-free survival primary outcome data for ofra-vec expected in 2H 2022; with ...

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Treadwell Therapeutics announces fast track designation granted by the FDA to CFI-400945 for the treatment of acute myeloid leukaemia

26 April 2022 - Treadwell Therapeutics announced today that the U.S. FDA has granted fast track designation to CFI-400945, a first ...

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HAS decides in favour of reimbursement of Paxlovid

25 April 2022 - After authorising early access to Paxlovid for the treatment of COVID-19 on January 22, HAS assessed ...

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Health economic assessment of Leqvio in the treatment of high LDL cholesterol and mixed lipid disorders

26 April 2022 - The Swedish Dental and Pharmaceutical Benefits Agency has undertaken a health economic assessment of Leqvio (inclisiran) for ...

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Pharming receives Promising Innovative Medicine designation for leniolisib from UK MHRA

26 April 2022 - A Promising Innovative Medicine designation is an early indication that leniolisib is a candidate for the ...

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Insights from the March 2022 PBAC meeting (part 1)

26 April 2022 - Yesterday, we noted a recommendation rate of 78% which the highest value we have recorded since ...

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Swissmedic has accepted the new oral edarvarone formulation for the treatment of ALS

25 April 2022 - Mitsubishi Tanabe Pharma announced that Swissmedic has accepted the filing for an investigational oral suspension formalation ...

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ObsEva announces confirmation of positive CHMP opinion for linzagolix, an oral GnRH antagonist, for the treatment of uterine fibroids

25 April 2022 - ObsEva today announced that the CHMP of the EMA has confirmed its previously adopted positive opinion, ...

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