Pharmaceuticals, Biotechnology and Life Sciences
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The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA)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.
Schreiner MediPharm has launched a new tamper-evident security concept for luer-lock syringes: Cap-Lock features a combination of a cap adapter and label that firmly seals prefilled syringes and reliably indicates any first opening.
The Janssen has filed for a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of guselkumab brand Tremfya, for the treatment of adult patients with active psoriatic arthritis (PsA), and expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.
The addition of daratumumab – or in this particular study – Darzalex to bortezomib, lenalidomide and dexamethasone (VRd) induced higher response rates in newly diagnosed patients with multiple myeloma who were eligible for high-dose therapy and autologous stem cell transplantation (ASCT) compared with VRd alone.
Catalyst Pharmaceuticals, said Friday it will not conclude the offering of shares of its common stock announced on Wednesday, September…