Pharmaceuticals, Biotechnology and Life Sciences
GW Pharmaceuticals paved a way to launch Epidyolex in Europe, for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.
Faron Pharma posted operating loss of €6.3 million for the six months ended 30 June 2019, cutting it from the same period last year, of €14.0 million.
Roche will present a number of studies across its comprehensive oncology portfolio, covering a broad range of cancers including bladder, lung and breast will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain.
Amryt said that Scheme has been sanctioned by the High Court of Justice in England and Wales and the Scheme Court Order is expected to be filed with the Registrar of Companies on 24 September 2019, at which point the Scheme will become effective.
The U.S. Food and Drug Administration approved on Friday Novo Nordisk’s Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.
The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing.
The National Institutes of Health awarded six research grants for studies to develop a learning health care system for the treatment of early psychosis, as part of a broad research initiative called Early Psychosis Intervention Network (EPINET), which aims to develop models for the effective delivery of coordinated specialty care (CSC) services for early psychosis.
NICE has recommended the use of Takhzyro subcutaneous injection as an option for preventing recurrent attacks of hereditary angioedema (HAE) in people aged 12 and older, within their final appraisal document (FAD), Takeda UK said in a press release Wednesday.
Glenmark Pharmaceuticals won Orphan Drug Designation from USFDA to its bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies.
Mereo Biopharma has reported £16.2m net loss after tax for the six-month period for 2019, the company said in a press release announcing conference call.