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Clinical Trials, Research and Development

Biotech IPOs: Intra-Cellular Therapies, 10x Genomics and Spero Therapeutics

September 11, 2020

Via: BioSpace

New York-based Intra-Cellular Therapies announced the pricing of its underwritten IPO of 4,750,000 shares at $24 per share, in hopes of raising about $106.5 million. On September 9, the company announced positive topline results from its Phase III Study 402 […]


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 […]


Clinical Trials, Research and Development

BriaCell Awarded Research Grant from Wiseman Cancer Research Foundation

September 4, 2020

Via: BioSpace

BriaCell Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is announcing that it has received a research grant from the Wiseman Cancer Research Foundation, a 501c(3) nonprofit organization based […]


FDA, Manufacturing, Regulations, Research and Development

FDA scolds Mylan for ‘repeated’ manufacturing problems

September 4, 2020

Via: Biopharma Dive

Before legal troubles and a challenging generics market wiped out much of its value, Mylan was an industry titan with a glowing manufacturing record to match. “There was a time, of course, that the very thought of Mylan receiving an […]


Clinical Trials, Manufacturing, Research and Development

CNS Pharmaceuticals Announces US Drug Manufacturing Milestones

September 3, 2020

Via: BioSpace

CNS PHARMACEUTICALS AG, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today provides an update on progress for the U.S. manufacturing […]


Clinical Trials, Research and Development

Alzheimer’s Immune Response Interactions Revealed

September 3, 2020

Via: Genetic Engineering and Biotechnology News

Alzheimer’s disease is a progressive form of dementia. When toxic proteins like beta-amyloid and tau accumulate in the brain, they form plaques and tangles. Researchers have been focusing on how brain plaque contributes to Alzheimer’s disease and what role they […]


Cell and Gene Therapy, Clinical Trials, Industry, Research and Development

City of Hope Scientists Use Two Powerful Immunotherapies to Eradicate Solid Tumors

September 2, 2020

Via: BioSpace

City of Hope scientists have combined two potent immunotherapies — an oncolytic virus and chimeric antigen receptor (CAR) T cell therapy — to target and eradicate solid tumors that are otherwise difficult to treat with CAR T therapy alone, according […]


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 […]