Nearly two years after Gilead Sciences Inc. spent $4.9 billion to buy Forty Seven Inc. and its lead candidate, magrolimab, the FDA clamped a partial clinical hold on five of Gilead’s clinical trials combining the therapy with azacitidine. The cause, according to Gilead’s management, is “an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms.” The company said it has not identified a clear trend in the adverse reactions or new safety signals.
Pfizer Inc. CEO Albert Bourla has been talking for the past few weeks about creating a vaccine to control the omicron variant. Now the company, with partner Biontech SE, has initiated a clinical study of its new candidate by testing it in healthy adults. Bourla has said the company can adapt its vaccine to new variants in under three months and could have one ready to go in March if necessary.
Sierra Oncology Inc. plans an NDA in the second quarter of this year for momelotinib (MMB), thanks to data from the phase III Momentum study with the drug in myelofibrosis (MF) patients who are symptomatic and anemic after treatment with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. MMB inhibits JAK1/2 and ACVR1/ALK2. Shares of San Mateo, Calif.-based Sierra (NASDAQ:SRRA) closed Jan. 25 at $22.68, up $7.17, or 46%.
The amount of clinical data reported in January so far is currently 30% below the amount reported during the same month last year, which was the slowest month of 2021.
LONDON – A pledge to “bottle” improvements made in setting up and running clinical trials during the pandemic has materialized in the formation of Protas Ltd., a nonprofit promising to stage large-scale phase III clinical trials in common diseases for less than one tenth the current cost. Protas will design and run randomized phase III studies of new and repurposed drugs in conditions including depression, dementia, heart, lung and respiratory conditions, arthritis and cancer.
In late February 2021, Oncopeptides AB scored a big win on the FDA’s accelerated approval for the first cancer peptide-drug conjugate, Pepaxto (melphalan flufenamide), in multiple myeloma. Less than eight months later, it was shutting down commercial operations and heading back to the drawing board after safety issues emerging in the confirmatory Ocean study prompted the Stockholm-based firm to pull Pepaxto from the market, just ahead of what was likely to be a negative FDA advisory panel vote.
Each year, more than 250,000 Americans undergo sinus surgery to treat a range of nose and sinus complaints. Full recovery can take several weeks, during which patients typically use opioids to treat their postoperative pain. Given the risk of opioid addiction, Tivic Health Systems Inc. is testing a bioelectronic device that offers an alternative to potent narcotics following sinus surgery.
When, late last year, Daiichi Sankyo Co. Ltd. won breakthrough status from the FDA for HER3-targeting lung cancer prospect patritumab deruxtecan, Wall Street began taking stock of other candidates in the space. “The winning strategy to therapeutically target HER3 remains to be seen,” noted a recent paper in Clinical Cancer Research, “but HER3 is a promising drug target, and the era of drugging the ‘undruggables’ has already started.”
UCB SA anticipates submitting regulatory applications in the third quarter for IL-17-targeting bimekizumab in psoriatic arthritis and ankylosing spondylitis, after chalking up second successful phase III trials in both indications. Meanwhile, the high commercial hopes for the would-be blockbuster remain at least temporarily deferred as pandemic-related travel restrictions have delayed FDA action on the BLA for plaque psoriasis.
PARIS – Robocath SAS has concluded an initial clinical study in Europe to demonstrate the safety and efficacy of robotic coronary angioplasty performed using its R-One platform. Sixty-two patients from six European hospitals participated in the R-Evolution clinical study. The study was aimed at assessing the safety and efficacy of the R-One robotic assistance platform.
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