Welcome to the sixth issue of PhaMed TransBrief, your go-to source for the latest news and insights in the pharmaceutical industry.
We hope you enjoy this issue of PhaMed TransBrief! (Read Time: 4 min.)
PhaMed Top Stories
New AMR certification launched for antibiotic manufacturers
A new certification has been launched to promote responsible antibiotic manufacturing and combat antimicrobial resistance. The certification, developed by the UK standards body BSI In verifies that waste streams containing antibiotic-active pharmaceutical ingredients and drug products are appropriately controlled during manufacturing.
After the initial evaluation, antibiotic manufacturers globally will be eligible for certification. Pfizer, Roche, Sandoz, and Teva are among the first market achievers to participate in a pilot program supporting antibiotic waste control measures. The World Health Organization estimates bacterial AMR caused 4.95 million deaths in 2019.
Abu Dhabi Department of Health links with Mass General Brigham to advance genomics research
Department of Health Abu Dhabi has partnered with Mass General Brigham‘s International Center for Genetic Disease to advance genomics research, develop therapies, and improve healthcare outcomes 🌍🔬. Joint labs and genetic screening programs will address global genetic diseases and reinforce Abu Dhabi as a leading healthcare and life sciences destination 🏥💉.
Pharma Game Changers
AstraZeneca turns to cows to cut U.S. carbon footprint
AstraZeneca 🏭 will use biogas made from cow manure and food waste 🍴 to cut emissions in its U.S. sites. The deal with Vanguard Renewables 💰 will produce as much energy 💡 as heating 17,800 homes 🏠 a year. The company aims to reduce emissions 🌍 by 98% 📉 by 2026.
Abbott’s $1.9B electrophysiology unit threatened by pulsed field ablation: analysts
field ablation devices from Boston Scientific, Johnson & Johnson, and Medtronic threaten Abbott’s $1.9 billion electrophysiology business. Abbott is cautious about PFA and plans to release a later-generation device. Analysts predict potential losses for Abbott as PFA takes over 90% of electrophysiology sales by 2025. 💼💉💰
Pfizer and GSK to battle for share of new RSV vaccine market
GSK and Fizer have FDA-approved RSV vaccines. 💉 GSK’s Arexvy is the first in the EU, but Pfizer’s Abrysvo targets multiple patient segments and is under review as a maternal vaccine. 💊 Moderna‘s mRNA-1345 is also expected to enter the market and may be better at targeting new viral strains. 🌡️
Korea’s Samsung Biologics and Pfizer partner for long-term manufacturing of biosimilars portfolio
🚀 Samsung Biologics and Pfizer are partnering to improve biopharmaceutical manufacturing and deliver life-saving treatments worldwide. Samsung Biologics will provide additional capacity through their Plant 4 facility, supporting oncology, inflammation, and immunology therapeutic areas. 💊💉🌍
Novo Nordisk says in talks to acquire French device-maker Biocorp for $165M
💬 Novo Nordisk is in talks to buy French medical device company Biocorp. The offer would value the company at 154 million euros 💰. They have been collaborating on a smart pen cap since 2021. 🤝
PhaMed Researches
China translates blood’s hidden gem Neutrophil into new-generation anticancer therapy
🔬 Researchers from The Chinese University of Hong Kong have found that neutrophils, a type of immune cell, play a role in lung cancer. Using gene editing technology, the team enhanced the anticancer capacity of neutrophils and tested their potential on lung cancer models.
The study has led to the first patented invention using gene engineering to mass-produce anticancer neutrophils from human blood, revealing the possibility of developing neutrophils into a novel immunotherapy for solid cancers. 💪
PhaMed Clinical Trials
Study of 2seventy Bio’s AML cell therapy paused after patient death
Seattle Children’s Hospital has stopped testing an experimental cancer cell therapy from 2Seventy Bio after a participant died during the early-stage clinical trial. The company has paused the PLAT-08 trial while investigating the cause of death and its potential link to the treatment made from patient T cells. 2Seventy’s chief medical officer said patient safety is their top priority, and they are assessing data and potential next steps with the FDA.
FDA Approvals & Recalls
✔ Novel Drugs Approvals:
Columvi (glofitamab-gxbm) Injection
Company: Genentech.
Date of Approval: June 15, 2023
Treatment for: Diffuse Large B-Cell LymphomaCompany: Bausch & Lomb Inc.
❌The FDA recalls:
Company: The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories
Date of Recall: 06/14/2023
Product Description: Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg
Recall Reason: Packaging may contain incorrect product due to labeling mix-up
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