Highlights from the May 25-28 CHMP meeting

29 May 2020 - Eight new medicines recommended for approval. ...

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Zealand Pharma announces FDA acceptance of new drug application for the dasiglucagon HypoPal rescue pen for treatment of severe hypoglycemia

22 May 2020 - PDUFA target action date scheduled for 27 March 2021. ...

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U.S. FDA approves Takeda’s Alunbrig (brigatinib) as a first-line treatment option for patients diagnosed with rare and serious form of lung cance

22 May 2020 - Long-term results from the Phase 3 ALTA 1L trial established Alunbrig as a superior first-line treatment compared ...

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Intercept provides regulatory update

22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept ...

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U.S. FDA approves Evofem Biosciences' Phexxi (lactic acid, citric acid and potassium bitartrate), the first and only non-hormonal prescription gel for the prevention of pregnancy

22 May 2020 - A new class of female-controlled birth control for use in-the-moment. ...

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Orphazyme’s arimoclomol receives US fast track designation in amyotrophic lateral sclerosis

22 May 2020 - Orphazyme announces that the Company has received fast track designation from the US FDA for the development ...

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Passage Bio receives rare paediatric disease designation for PBGM01 for patients with GM1 gangliosidosis

21 May 2020 - PBGM01 to enter the clinic in fourth quarter of 2020. ...

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Sunovion announces U.S. FDA approval of Kynmobi (apomorphine hydrochloride) sublingual film for the treatment of Parkinson’s disease OFF episodes

21 May 2020 - First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes. ...

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EMA validates Bristol Myers Squibb’s applications for idecabtagene vicleucel and CC-486

22 May 2020 - Applications based on positive results from pivotal KarMMa study in relapsed and refractory multiple myeloma and QUAZAR-AML-001 ...

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Improved deal means new treatment for a type of advanced breast cancer can be recommended by NICE

22 May 2020 - Draft guidance published today by NICE recommends atezolizumab for treating people with a type of breast cancer, ...

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European Medicines Agency accepts Astellas’ marketing authorisation application for roxadustat

21 May 2020 - Submission for the treatment of anaemia in adult patients with chronic kidney disease. ...

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Incyte and MorphoSys announce the validation of the European marketing authorisation application for tafasitamab

20 May 2020 - The application seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with ...

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EMA extends virtual-only meeting policy through August

20 May 2020 - The EMA has  announced it is extending its decision to hold all upcoming meetings virtually through ...

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CADTH posts final recommendation for Entyvio

21 May 2020 - CADTH has completed its consideration of subcutaneous vedolizumab for the treatment of adult patients with moderately to ...

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Medicines with one seller and many buyers: strategies to increase the power of the payer

20 May 2020 - Andrew Rintoul and colleagues argue that collaboration and transparency increase the market power of buyers who ...

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New rule makes it harder for patients to lower their out-of-pocket costs

20 May 2020 - In the midst of increased financial insecurity for Americans due to the COVID-19 pandemic, it is ...

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