Fact Check: Moderna began clinical trials of COVID vaccine in 2020, not 2017
Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...
pharmaphorum2d
Managing the challenges and embracing the opportunities of EU-wide HTA
While the European Medicines Agency (EMA ... The Regulation on Health Technology Assessment (HTAR), passed in 2021 under the auspices of European Network for Health Technology Assessment (EUnetHTA ...
pharmaphorum2d
NICE says yes to BeiGene's Brukinsa after Scottish nay
The final appraisal document from health technology assessment (HTA ... after Brukinsa was approved by the Medicines and Healthcare products Regulatory Agency (MHRA). That approval also included ...
MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx® for Treatment of Venous Leg Ulcers
Phase III trial to assess the efficacy and safety of EscharEx® for debridement and facilitation of active wound closureInterim analysis planned ...
Le Lézard1d
Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment.Troriluzole demonstrated a 50-70% slowing of SCA disease progression on the ...
Le Lézard2d
KalVista Pharmaceuticals Presents New Sebetralstat Data at the Western Society of Allergy, Asthma & Immunology 2025 Annual Meeting
KalVista Pharmaceuticals, Inc. , today announced the presentation of novel data related to long-term prophylaxis and sebetralstat at the Western Society of Allergy, Asthma & Immunology (WSAAI) 2025 ...
centerforbiosimilars5d
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...
PipelineReview.com13h
BEYONTTRA™ (acoramidis), the First Near Complete TTR Stabilizer (≥90%), Approved by the European Commission to Treat ATTR-CM
PALO ALTO, CA, USA I February 11, 2025 I BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused ...
PipelineReview.com5d
Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa
SOUTH SAN FRANCISCO, CA, USA I 06, 2025 I Denali Therapeutics Inc. (NASDAQ: DNLI), today announced the primary analysis of the Phase 1/2 study in 47 ...
Aviation Week9h
EDA Explores Aircraft Battery Health Monitoring
EDA Explores Aircraft Battery Health Monitoring is published in Aerospace Daily & Defense Report, an Aviation Week ...
News Medical on MSN6d
New European scheme sets quality standards for breast cancer care
The first official version of the European quality assurance scheme for breast cancer services is now available on the European Commission web hub.