The FDA’s approval of Agios Therapeutics Inc.’s Pyrukynd (mitapivat) for treating hemolytic anemia marks a turnaround from nearly a year ago. That’s when Agios sold its commercial, clinical and research-stage oncology portfolio to privately held Servier Pharmaceuticals LLC to concentrate on rare diseases. Read More
Glaxosmithkline plc has voluntarily paused a late-stage trial of its potential respiratory syncytial virus (RSV) maternal vaccine candidate in pregnant women following a safety warning. In a brief statement, the London-based firm said it also paused recruitment in two other trials investigating the drug in pregnant women. Read More
Phase III data are due any day from Ascendis Pharma A/S, and Wall Street’s thoughts have turned to hypoparathyroidism (HPT), an indication fraught with questions in recent years. Read More
Researchers at Inserm have developed a method to direct pre-existing antibodies toward new targets. Their bimodular fusion proteins could be a broadly useful method for expanding access to antibody therapy. In a study that appeared in the Feb. 11, 2022, issue of Science Advances, the teams showed that antibodies to Epstein-Barr virus (EBV), which are present in 95% of the global population, could be redirected to a target cell of their choosing by fusing an EBV antigen to a cellular targeting ligand. Read More
After a landmark clinical trial of the first POLQ inhibitor in cancer last year, a recently formed U.K. biotech is gearing up to bring a potential rival to the clinic in the coming months. Varsity Pharmaceuticals Ltd., of Cambridge, is planning to begin a phase I trial of novobiocin, a drug previously used as an antibiotic, which has also been found to inhibit the polymerase theta inhibitor (POLQ) pathway. Read More
LONDON – Two years into the pandemic and the number of new drugs approved by the EMA fell from 97 approvals in 2020 to 92 in 2021. But both years are still well up on pre-COVID-19 times in 2019 when 66 products got the nod, according to the EMA’s annual human medicines report. Read More
Livzon Pharmaceutical Group Inc.’s key interim data from the phase III trials of its recombinant SARS-CoV-2 fusion protein vaccine, V-01, has shown efficacy against the omicron variant. The phase III trial aims to evaluate the efficacy, safety and immunogenicity of V-01 as a booster in adults older than 18 after they have received two doses of inactivated vaccines. Read More
In the latest chapter in an ongoing contract dispute between AOP Orphan Pharmaceuticals GmbH and Pharmaessentia Corp., the German Federal Court of Justice this week set aside the €143 million (US$162.8 million) in damages awarded to AOP, citing procedural flaws in quantifying the product supply and damages. Read More
As part of its ongoing effort to speed drug pricing competition in the U.S. through the development of generics, the FDA is releasing another batch of draft and revised draft product-specific guidances on the design of bioequivalence studies to support abbreviated new drug applications. Among the 30 new draft guidances is one specific to remdesivir, which was approved in October 2020 as a COVID-19 treatment. Read More
With the study of long COVID-19 continuing to evolve, the BioWorld team is taking a closer look at the condition – a complex syndrome affecting more than 100 million people globally –
and what's being done about it. In this episode, BioWorld Senior Science Editor Anette Breindl and Staff Writer Lee Landenberger, fresh off writing a pair of detailed stories about these issues, join us to talk about how consensus around what long COVID is has emerged.
Biopharmas raising money in public or private financings, including: Acerus, Bioasis Technologies, Blue Water Vaccines, Genesis Unicorn Capital, Tryp. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, AN2, Astrazeneca, Beigene, BMS, Cstone, Epygenix, Immune-Onc, Kato, Lupin, Moderna, Poxel, Sanofi, Valbiotis, Zai Lab. Read More
