Saturday, December 7, 2019

Saturday, December 7, 2019

Latest News

GILEAD SCIENCES: Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™

Gilead Sciences, Inc. (NASDAQ: GILD) announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food and Drug Administration (FDA) recommended approval of Descovy®(emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men by a vote of 16 to 2.

NORD: Funded By FDA, C-Path And NORD To Launch Rare Disease Data Analytics Platform

The collaborative project between the organizations will kick off at a launch meeting in September and will aim to reduce barriers for the development of new treatments and cures for rare diseases

THERMO FISHER SCIENTIFIC: New Expanded Analytical Instrument Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories

Thermo Scientific Medical Device portfolio provides an extensive range of chromatography and mass spectrometry instruments for performing laboratory developed tests

Despite Right to Try Act, ALS patients still desperately wait for fatal disease drug treatments

People afflicted with the deadly and crushing disease amyotrophic lateral sclerosis (ALS) are searching for some glimmer of hope in the shadow of promising drug treatments, however ALS patients do not currently have real access to these drugs, which are presently in trials.

NIIMBL: NIIMBL and FDA Sign New Agreement to Support Advanced Innovation in Biopharmaceutical Manufacturing

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware, on behalf of NIIMBL, has entered into a Collaborative Research and Development Agreement (CRADA) with the Food and Drug Administration (FDA).

FDA expanding its drug approval process by incorporating ‘real world’ data and evidence

The U.S. Food and Drug Administration is using some new tools in its drug approval process and at least one prominent industry leader is giving the government entity a thumb’s up.

SIMULATIONS PLUS: Enters into New Research Collaboration Agreement with the FDA

Center for Veterinary Medicine to apply GastroPlus® to assess product bioequivalence in canines

HALOZYME THERAPEUTICS, INC.: Halozyme Announces Janssen Submits BLA To FDA For Subcutaneous Formulation Of DARZALEX® Utilizing ENHANZE® Technology

Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that its collaborator Janssen Biotech, Inc. (Janssen) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma.

Former FDA head Scott Gottlieb appointed to Pfizer’s board of directors

Former Food and Drug Administration Commissioner Scott Gottlieb joined pharmaceutical corporation Pfizer’s board of directors on June 27, after stepping down from the FDA in April.

TSG CONSULTING: Urges Medical Device Manufacturers to Take Advantage of FDA's Pre-sub Meeting Program

With the majority of 510(k) submissions having major deficiencies or being rejected the first time, scientific and regulatory experts TSG Consulting recommend that manufacturers schedule a Pre-Submission (Pre-Sub) meeting with the FDA to improve the likelihood of the medical device being approved for sale in the US market.

NATIONAL INDUSTRIAL HEMP COUNCIL: Food and Drug Administration (FDA) to Speak at National Industrial Hemp Council (NIHC) 2019 Hemp Business Summit

The NIHC is pleased to announce Lowell Schiller as a keynote speaker at the National Industrial Hemp Council's 2019 Business Summit.

GILEAD SCIENCES, INC.: Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year

Gilead Sciences, Inc. (NASDAQ: GILD) announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib.

Doctors, not FDA, should be empowered to deal with opioid crisis, association says

The Food and Drug Administration recently unveiled a new draft guidance for tackling opioid addiction, and scheduled a public hearing for Sept. 17 to discuss the crisis.

‘This is nuts’: FDA program set to help doctors navigate bureaucracy

Health care experts are expressing doubts about the FDA’s new call center, Project Facilitate, which is designed to assist physicians treating cancer patients.

FDA Reporter