Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test. Read More
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. Read More
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. Read More
Little more than two months after inking a $2 billion-plus commercialization deal with Swiss oncology specialist Helsinn Group around the fibroblast growth factor receptor (FGFR) inhibitor infigratinib, Bridgebio Pharma Inc.'s subsidiary, QED Therapeutics Inc., has won accelerated FDA approval for the therapy, to be marketed as Truseltiq. Approval for the oral medicine covers the treatment of patients with previously treated locally advanced chemotherapy-resistant bile duct cancer (cholangiocarcinoma) harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test. Read More
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc. Read More
Bristol Myers Squibb Co. said the FDA has approved Zeposia (ozanimod) as the first and only oral sphingosine 1-phosphate (S1P) 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. Read More
The Biden administration released its full budget proposal for fiscal year 2022, increasing the FDA’s budget authority to nearly $3.6 billion, up 10% over 2021. The Alliance for a Stronger FDA said that though analysis is needed to parse out the details, the proposal will be supported. Read More
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. Read More
New hires and promotions in the biopharma industry, including: 180 Life Sciences, Erasca, Herophilus, Mynd, Neubase, Orum, Reflexion, Relief, Tranquis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Chiasma, Cstone, Eqrx, Omeros, Tetra, Turning Point, Zai Lab. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beroni, Cyclerion, Disc, Hunterian, Roche, Sapience, Synbal, Tetra. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Amgen, Astrazeneca, Biohaven, BMS, Calliditas, Diurnal, Eton, Fennec, Humanigen, Iterum, Lantheus, Novo, PCI, Provention, Ryvu, Verrica. Read More
