GT Biopharma Promotes COO to Top Post, Effective Immediately
Mr. Cross has held the position of President and COO of GTBP since November 16, 2017. Source: BioSpace
Guangzhou Facility Warned for Deficient Procedures
The FDA sent a warning letter to Chinese manufacturer Guangzhou Baiyunshan for failing to follow proper cleaning, validation and storage procedures at its Guangzhou, Guangdong facility. Source: Drug Industry Daily
Medtech Petitions FDA for Permission to Change Dosage in ANDA for Generic Excedrin
Medtech petitioned the FDA to allow the company to submit an ANDA for generic Excedrin in which the proposed product is in a dosage form different from the reference drug.…
Cellectis’ T-Cell Gene Editing Technology Granted Patents
The U.S. Patent and Trademark Office issued two patents to French cell therapy group Cellectis for use of CRISPR technologies in T-cells. Source: Drug Industry Daily
FDA Finalizes Guidance on Co-Crystals in NDAs and ANDAs
The FDA finalized new guidance establishing co-crystals as a drug product intermediate. Source: Drug Industry Daily
Azar Defends FY 2019 Budget Request at Congressional Hearing
In his first appearance as HHS Secretary on Capitol Hill, Alex Azar fielded questions Wednesday about the Trump administration’s plans to address the opioid crisis and drug prices. Source: Drug…
FDA Declares Pfizer's Atopic Dermatitis Drug a Breakthrough
The Phase 3 program is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety global development program. Source: BioSpace
Merck Chemist Arrested for Stealing Deadly Chemical
A 60-year-old chemist has been charged with stealing 219.79 grams of potassium cyanide, a deadly poison, from a Merck facility in Pennsylvania. Source: BioSpace
Tetraphase's Lead Antibiotic Fails Another Late-Stage Study
The phase 3 IGNITE3 clinical trial enrolled 1,205 patients who were randomized 1:1 to receive IV eravacycline or ertapenem. Source: BioSpace
3 Biotechs Facing Stiff Headwinds in 2018
The stock market has been rocky recently, but overall the biotech market appears to have been comparatively stable. Source: BioSpace
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