Tag: FDA

FDA, News, Regulations

FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

November 23, 2020

Via: BioSpace

The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week. Blueprint Medicines’ Pralsetinib for Non-Small Cell Lung Cancer Blueprint Medicines had a target […]

Industry, Vaccines

Pfizer and BioNTech request emergency authorization from FDA for Covid vaccine

November 20, 2020


Pfizer and BioNTech on Friday applied for an emergency use authorization from the Food and Drug Administration for their coronavirus vaccine. If Pfizer’s application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, […]

Cell and Gene Therapy, Industry, News

Catalent Appoints Open Innovation, Biologics, Cell and Gene Therapy VP

November 19, 2020

Via: Contract Pharma

Catalent has appointed Behzad Mahdavi, Ph.D., MBA, as Vice President of Open Innovation, Biologics, Cell and Gene Therapy. In this new role, Dr. Mahdavi will join a team of experts in Catalent’s Science and Technology Group that works with customers […]

FDA, Regulations

FDA said to plan early December advisory meetings to discuss Covid-19 vaccines ahead of potential authorization

November 18, 2020


The Food and Drug Administration has asked a group of advisors to set aside three days in early December for potential meetings to discuss Covid-19 vaccines — a key step in the agency’s authorization process, according to two people familiar […]

FDA, Mergers and Acquisitions, Regulations

As Urovant gears up for vibegron FDA decision, the biotech gets snapped up by Sumitovant Biopharma

November 13, 2020

Via: FierceBiotech

Urovant began life as an offshoot of Vivek Ramaswamy’s Roivant goliath, but is now firmly a part of the Sumitovant Biopharma family after the life science company bought up the rest of its shares in the biotech. This comes around […]

FDA, Regulations

FDA grants emergency authorisation to Lilly’s COVID-19 antibody

November 11, 2020

Via: Pharma Times

Bamlanivimab is now available under emergency use for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older who are at high risk of progressing to severe COVID-19 and/or hospitalisation. In a statement, Lilly […]

Industry, Vaccines

BIO Chairman: FDA Vaccine Reviews Too Complex and Costly for States to Replicate

November 10, 2020

Via: BioSpace

Several states have pledged to review COVID-19 vaccines themselves, after U.S. Food and Drug Administration (FDA) Emergency Use Authorizations EUA), to ensure safety and efficacy. A robust review, however, is unlikely. In reality, if state reviews go forward, they most […]

Clinical Trials, Research and Development

Antibody-Drug Combination Regresses Pancreatic Tumor in Mice

November 9, 2020

Via: Genetic Engineering and Biotechnology News

According to the National Cancer Institute, about 10% of patients with pancreatic cancer (PC) remain alive five years after diagnosis. Tumor size has a strong impact on survival rates. The larger the tumor, the less likely it is to be […]

Clinical Trials, FDA, Regulations, Research and Development

FDA authorizes first test that screens for Covid-neutralizing antibodies

November 6, 2020


The Food and Drug Administration announced on Friday that it has authorized the first serology test that screens for neutralizing antibodies caused by a previous coronavirus infection. Neutralizing antibodies prevent viruses from infecting cells, though questions remain about how long […]

FDA, Regulations

Biogen hits snag after Alzheimer’s drug fails to win support from FDA panel

November 6, 2020


A Food and Drug Administration panel on Friday unexpectedly declined to endorse Biogen’s experimental Alzheimer’s drug aducanumab in a setback for the pharmaceutical company. In an 8-1 vote, the panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that […]

FDA, Regulations

FDA Places New CMC Demands on bluebird’s Sickle Cell Treatment

November 5, 2020

Via: BioSpace

Shares of bluebird bio fell more than 17% in premarket trading after the company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration (FDA) for two more […]

FDA, Regulations

FDA Awards Fast Track Designation to Multiple Non-COVID-19 Candidates

November 4, 2020

Via: BioSpace

While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. Food and Drug Administration (FDA) has remained busy lining up potential approvals of medications for other diseases and illnesses. Many of these […]