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Tag: biotech


FDA, Regulations

FDA Advisory Panel to Meet on COVID Booster Shots

September 17, 2021

Via: Drugs.com

U.S. Food and Drug Administration advisors will meet Friday to consider whether it is safe and effective for Americans to receive a third “booster” dose of the Pfizer-BioNTech COVID-19 vaccine. The FDA posted the materials it intends to use in […]


Clinical Trials, Research and Development

Excision’s CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance

September 17, 2021

Via: FierceBiotech

A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application, according […]


News

After Clinical Setbacks, Theravance Axes 75% of Workforce and Refocuses on Respiratory Drugs

September 16, 2021

Via: Genetic Engineering and Biotechnology News

Intent on bouncing back from a pair of later-phase clinical trial failures, Theravance Biopharma said it will eliminate about 75% of its workforce—270 jobs—and slash its R&D budget next year through a restructuring that will refocus the company on respiratory […]


FDA, Regulations

Mobocertinib approved as first oral therapy for EGFR Exon20+ NSCLC

September 16, 2021

Via: European Pharmaceutical Review

Takeda have announced that the US Food and Drug Administration (FDA) has approved Exkivity™ (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion […]


Industry, Vaccines

As Pfizer’s booster AdComm nears, FDA staffers say COVID vaccines are already working as intended

September 15, 2021

Via: FiercePharma

Ahead of the FDA’s advisory meeting to review Pfizer’s COVID-19 booster application, agency staffers voiced skepticism about the need to quickly roll out follow-up shots. As it stands, authorized vaccines are doing their job, the staffers said. In briefing documents […]


Industry, Vaccines

COVID Vaccines for Kids Under 12 Could Come This Fall: Fauci

September 15, 2021

Via: Drugs.com

Many parents hoping for COVID-19 vaccines for their children younger than 12 may get their wish this fall, according to Dr. Anthony Fauci. The vaccines could be authorized by the U.S. Food and Drug Administration this fall for children ages […]


Industry, Vaccines

Moderna Highlights New Clinical Data on its COVID-19 Vaccine

September 15, 2021

Via: Drugs.com

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today highlighted a new analysis suggesting that the Moderna COVID-19 vaccine is highly effective against circulating variants of concern, including in a vaccine effectiveness study conducted […]


FDA, Pricing, Regulations

To lower drug prices, Senate leaders, FDA urge U.S. Patent and Trademark Office to alter patent processes

September 14, 2021

Via: FiercePharma

The Senate and the FDA are appealing to the U.S. Patent and Trademark Office (USPTO) to examine how it can limit the ability of pharmaceutical companies to leverage patent strategies to extend their drug monopolies. In separate letters last week […]


FDA, Regulations

FDA starts pilot after AstraZeneca, J&J make case for novel drug delivery excipients

September 14, 2021

Via: FiercePharma

Academic literature features a steady stream of papers on novel excipients with the potential to improve drug delivery but they rarely show up in newly approved drugs because companies shy away from the additional risk they entail. Recognizing that, the […]


Manufacturing, Research and Development

AGC Biologics Expands pDNA and mRNA Manufacturing Capacity

September 14, 2021

Via: Contract Pharma

AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), unveiled expansion plans for the company’s Heidelberg facility to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects. With this expansion, AGC Biologics is boosting its current […]


Cell and Gene Therapy, Industry

AbbVie bets big on a gene therapy for eye diseases

September 13, 2021

Via: Biopharma Dive

While estimates vary, AMD is thought to affect a large number of people. A study published in 2014, for instance, projected the patient population globally would hit 196 million in 2020 and grow to 288 million by 2040. Among those […]


Industry, Vaccines

Biden Bolsters Vaccine Production in Pandemic Preparedness Plan

September 10, 2021

Via: Biopharm International

As part of a broad initiative to prepare for and prevent future global disease outbreaks, White House officials recently announced a nearly $3 billion program to ramp up production of vaccines and their components to better serve patients in the […]