The second oral CGRP antagonist to win FDA approval for acute migraine care is now the first to add preventive treatment to its label, marking a valuable win for Biohaven Pharmaceutical Holding Co. Ltd. and its oral dissolving tablet, Nurtec (rimegepant). The U.S. approval, for preventive treatment of episodic migraine, officially blesses a use for the medicine already adopted by many doctors, Piper Sandler analyst Christopher Raymond wrote, while opening up a potentially rich new stream of revenue for Biohaven. Company shares (NASDAQ:BHVN) rose 3.2% by midday.

Cstone and Eqrx’s sugemalimab hits primary endpoint in lung cancer study

In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy. The clinical trial hit its primary endpoint of prolonged progression-free survival. The data couples with positive data from 2020 from the same study but in stage IV NSCLC showing sugemalimab plus standard-of-care chemotherapy prolonged progression-free survival. Sugemalimab was discovered by Cstone and is being tested in several other studies, including the indications lymphoma, gastric and esophageal cancer.

BMS adds ulcerative colitis to Zeposia’s U.S. label

Bristol Meyers Squibb Co. said the FDA has approved Zeposia (ozanimod) as the first and only oral sphingosine 1-phosphate receptor modulator for the treatment of ulcerative colitis (UC). The medicine, first FDA-approved in March 2020 for certain adults with multiple sclerosis, can now be used to treat patients with moderately to severely active UC. A marketing application to similarly expand the label in Europe is under review, with a regulatory decision expected in the second half of this year.

India does away with bridging trials for global vaccine candidates

HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. "The Central Government has proactively eased entry of vaccines approved by U.S. FDA, EMA, U.K.'s MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India in April,” said Vinod Kumar Paul, a member of government think tank NITI Aayog. “These vaccines will not need to undergo prior bridging trials. The provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries. No application of any foreign manufacturer for approval is pending with the drugs controller.” That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.

In CAR T therapy, China excels in speed but quality remains a concern

China is making strides in cell and gene therapy, notably so with a 61% surge in the number of clinical trials in six years, a new report by Ernst & Young showed. While analysts noted the increasing innovation efforts and cross-border collaborations, concerns remain if quality will be compromised by speed.

Holiday notice

BioWorld's offices will be closed in observance of Memorial Day in the U.S. No issue will be published Monday, May 31.

Also in the news

Affamed, Annovis, Antengene, Astrazeneca, Beroni, Betterlife, Biohaven, Bristol Myers Squibb, Calliditas, Centessa, Chiasma, Context, Cstone, Cyclerion, Disc Medicine, Diurnal, Eton, Fennec, Humanigen, Hunterian Medicine, Iterum, Lantheus, Lidds, Novo Nordisk, Omeros, Ose Immunotherapeutics, PCI, Provention, Ryvu, Sapience, Synbal, Tella, Tetra, Verrica, Zai Lab