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Category: News


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 […]


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 […]


Industry, News, Vaccines

Immune-Boosting Components Double the Effectiveness of Melanoma Vaccine Candidate in Phase II Trial

November 18, 2020

Via: Genetic Engineering and Biotechnology News

A vaccine created to prevent the recurrence of the deadly skin cancer melanoma is about twice as effective when patients also receive two components that boost the number and effectiveness of immune system dendritic cells (DCs), according to the results […]


FDA, News, Regulations

FDA staff resist executive order amid fears Trump could reshape agency: report

November 3, 2020

Via: FierceBiotech

FDA officials are pushing back against an executive order that will make it easier for President Donald Trump to fire federal employees, according to a report in Politico. Patrizia Cavazzoni, the acting head of the FDA’s drug center, is reportedly […]


News

Samsung Biologics Establishes Partnership with China Biotech GeneQuantum Healthcare to Collaborate on ADC Development

November 2, 2020

Via: BioSpace

Samsung Biologics (207940.KS) has entered into a strategic partnership with GeneQuantum Healthcare, a China biotech company, to jointly develop an antibody drug conjugate (ADC) for the treatment of non-small-cell lung carcinoma (NSCLC), triple-negative breast cancer (TNBC), and other solid tumors. […]


Clinical Trials, News, Research and Development

Bacterial Toxin Found to Stimulate Tissue Regeneration

October 14, 2020

Via: Genetic Engineering and Biotechnology News

Staphylococcus aureus bacteria can be either a harmless resident of human skin, with one in four people harboring Staphylococcus aureus bacteria on their skin and mucous membranes of the upper respiratory tract, or a major pathogen wreaking havoc on our […]


FDA, News, Regulations

FDA expands probe into safety of AstraZeneca’s COVID-19 vaccine

October 1, 2020

Via: FierceBiotech

The FDA has expanded its investigation into AstraZeneca’s COVID-19 vaccine to include data from clinical trials of prophylactics based on the same viral vector platform, Reuters reports. AstraZeneca quickly gained regulatory clearance to resume dosing in the U.K. part of […]


Industry, News, Vaccines

Trump, Biden spar over COVID-19 vaccines at debate. Will it help public trust in the process?

September 30, 2020

Via: FiercePharma

With tens of millions of Americans tuned in to Tuesday’s presidential debate, the race for a COVID-19 vaccine took center stage in a big way. President Donald Trump said we’re “weeks away” from a working shot, while Democratic nominee Joe […]


Cell and Gene Therapy, Industry, News

Targeting DNA Repair Shows Potential in Advanced Cancer Therapy

September 30, 2020

Via: Genetic Engineering and Biotechnology News

Scientists in the U.K. report that a new precision drug that stops cancer from repairing its DNA has shown promise in an early-stage clinical trial, highlighting the potential of a new class of drugs known as ATR inhibitors. The drug […]


Cell and Gene Therapy, Industry, News

Culprit Behind Immunotherapy Resistance in Some Lymphomas Revealed

September 17, 2020

Via: Genetic Engineering and Biotechnology News

Cancer treatments can be unsuccessful due to malignant cells surviving radiation, chemotherapy, or by evading apoptosis. Now researchers from the University of Tsukuba in Japan, demonstrate how the protein Livin—an apoptosis inhibitor—allows some lymphomas to resist therapy, and how targeting […]


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, 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 […]