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FDA, News, Regulations

Trump health officials prepare to distribute coronavirus vaccine within 24 hours of OK from FDA

September 16, 2020

Via: CNBC

The U.S. government plans to transport a coronavirus vaccine to distribution sites across the U.S. within 24 hours after the Food and Drug Administration grants an emergency authorization or approval, senior administration officials said Wednesday. The government will use medical […]


Industry, Vaccines

Automation a Key Focus for Moderna’s COVID-19 Vaccine Contractor

September 15, 2020

Via: Genetic Engineering and Biotechnology News

Moderna hired Lonza to make its COVID-19 vaccine in May. Initially, the CDMO will manufacture the vaccine active ingredient—an mRNA molecule in lipid nanoparticles—at plants in the United States and Switzerland. However, the firms plan to establish additional production suites […]


Manufacturing, Research and Development

Sensors Take on Undersampling in Biomanfacturing

September 15, 2020

Via: Genetic Engineering and Biotechnology News

When asked about the biggest challenge in today’s bioprocessing, Sandy Williams, PhD, a biomedical engineering expert at Scientific Bioprocessing (SBI) in Pittsburgh who focuses on regenerative medicine, says, “The biggest concern we have heard from the industry is that bioprocessing […]


Industry, News, Pharma

Timber Pharmaceuticals Receives Notice of Allowance from U.S. Patent and Trademark Office for BPX-01 and BPX-04

September 15, 2020

Via: BioSpace

Timber Pharmaceuticals, Inc. (“Timber” or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases, today announced that it has received a formal notice of allowance from the U.S. Patent […]


Clinical Trials, Research and Development

Which immune response could cause a vaccine against COVID-19?

September 14, 2020

Via: World Pharma News

Immune reactions caused by vaccination can help protect the organism, or sometimes may aggravate the condition. It is especially important now when multiple vaccines against COVID-19 are being developed. The top immunologists analyse types of immune response to predict what […]


FDA, Regulations

FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision

September 10, 2020

Via: CNBC

The head of the Food and Drug Administration on Thursday said he has “no intention” of overruling career scientists at the agency on an approval of a coronavirus vaccine even though he has the authority. FDA Commissioner Stephen Hahn said […]


Clinical Trials, Research and Development

Corvus Pharmaceuticals Provides Update on Clinical Trial of CPI-006 for Patients with COVID-19

September 10, 2020

Via: BioSpace

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced updated data from its ongoing Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19. The results demonstrated that all evaluable […]


FDA, News, Pricing, Regulations

Democratic senators grill U.S. health officials on Trump interference in coronavirus vaccine process

September 9, 2020

Via: CNBC

Democratic senators on Wednesday grilled U.S. health officials about whether President Donald Trump is interfering in the development of potential coronavirus vaccines. National Institutes of Health Director Dr. Francis Collins and U.S. Surgeon General Dr. Jerome Adams testified before the […]


Cell and Gene Therapy, Industry

Improving Cell Therapy’s Supply Chain

September 8, 2020

Via: Genetic Engineering and Biotechnology News

Several elements of making cell therapies create significant obstacles in getting these treatments to more patients. “A main challenge for cell therapies—autologous or allogeneic—is cryopreservation in the supply chain,” says Simona Guidi, business development director at Rigenerand. “Products have a […]


FDA, Industry, Regulations, Vaccines

FDA Action Alert: Possible COVID-19 Action and Mallinckrodt’s Terlipressin

September 8, 2020

Via: BioSpace

It’s entirely possible that what we will be seeing most from the U.S. Food and Drug Administration (FDA) for the month of September is related to treatments and vaccines for COVID-19. In general, the vaccines probably will not have actionable […]


Cell and Gene Therapy, Industry

Gene therapy: Novel targets for congenital blindness

September 2, 2020

Via: ScienceDaily

As many as 40,000 people in Germany suffer from retinitis pigmentosa. This hereditary disorder is characterized by loss of photoreceptors in the retina, and can be caused by mutations in many different genes. Depending on the nature of the underlying […]


Clinical Trials, Research and Development

Virtualizing clinical trials to bring trials closer to patients

September 1, 2020

Via: Pharma IQ

The patient experience is an important consideration in trial design. Historically, the clinical trial process runs from the top-down and is heavily controlled by clinical settings and subject to strict validation rules for data gathering and analysis. However, the data […]