A pair of weight-loss drugs — semaglutide and tirzapatide — could reshape the way we view and treat obesity, according to a Moody’s report dated May 18. The ratings firm notes that Novo Nordisk could benefit from a first-mover advantage in the obesity market as it now has two novel weight loss drugs on the…
Astellas’ Veozah wins regulatory nod as non-hormonal menopause treatment
Tokyo-based Astellas Pharma has won FDA approval for Veozah (fezolinetant) 45 mg to treat moderate to severe vasomotor symptoms associated with menopause. The non-hormonal menopause treatment represents the first neurokinin 3 receptor antagonist to win FDA backing for vasomotor symptoms, which afflict 60-80% of women during menopause. The approval was based on the BRIGHT SKY…
CRB installs new senior director of sustainability
The life sciences and food and beverage consulting firm CRB has named Mike Dieterich as its senior director of sustainability. Dieterich has more than 17 years of experience working in energy and sustainability. He’s led sustainability initiatives at companies such as AstraZeneca where he served as director, U.S. sustainability from January 2018 to April 2023.…
5 core trends in drug recalls: An analysis of 2022 and Q1 2023
Drug recalls surged in 2022, with defective pharmaceutical units reaching a five-year high, according to the Sedgwick 2023 State of the Nation Recall Index. Also in 2022, sterility was the top cause of recalls for the first time in more than six years. January 2023 saw a significant increase in the number of drug recalls…
Exploring the potential of Web3-based carbon tracking in pharma
Carbon tracking is a challenge in many industries, including the pharma sector. Companies are looking to manage their carbon emissions more effectively and meet their environmental, social and governance (ESG) goals, noted Maxence Cacheux, Zblocks co-founder and chief revenue officer. “They need to measure their internal carbon emissions (Scope 1), indirect emissions from the energy…
Vicks Nyquil FDA compliance issues explained
Procter & Gamble (NYSE:PG) recently received a warning letter from FDA for failing to meet the agency’s requirements in the drug listing. The warning related to Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion (National Drug Code (NDC): 58933-541), a powdered medicine intended to be dissolved in hot water before use. The FDA’s…
California partners with manufacturer to make affordable generic insulin
The state of California has established a $50 million collaboration over a decade with the generic drug manufacturer Civica. The goal of the collaboration is to create affordable state-branded generic insulin. Qualified individuals may obtain a 10-mL vial of generic insulin for $30 or less. California plans to provide a pack containing five prefilled 3…
FDA releases guidance on pharmaceutical supply chain security
The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S. So far this year, the agency has released more than…
PRISM.science debuts new adverse-event monitoring tool
PRISM.science, a biomedical database company, has launched a new product called AE Alert. The adverse event detection product provides comprehensive global literature surveillance to monitor adverse events related to prescription drugs. This product is designed to address the limitations of conventional pharmacovigilance literature surveillance by aggregating content in real-time. The company says AE Alert has…
FDA issues warning letters to several companies
In the first half of February, the FDA posted to its website several warning letters to companies and facilities for violations of cGMP regulations. The agency’s Center for Drug Evaluation and Research and Division of Pharmaceutical Quality Operations divisions sent warning letters to two hand sanitizer companies, a Turkish drug manufacturer, a Palm Beach Fertility…