In its $2 billion acquisition of Bellus Health Inc., GSK plc is getting camlipixant, which is being developed to treat refractory chronic cough. Bellus shares will be acquired for $14.75 each in cash. The company’s stock (NASDAQ:BLU) had nearly doubled at midday as shares were going for about $14.40 each. The deal is expected to close no later than the third quarter of 2023. The selective P2X3 receptor antagonist is currently in phase I and phase III studies. In December 2021, Bellus produced positive data from the SOOTHE phase IIb study, which met its primary endpoint for 50-mg and 200-mg twice-daily doses. Based on that data, Bellus began the pivotal CALM phase III study in the fourth quarter of 2022.
Gamida’s gamble on Omisirge pays off as FDA approves blood cancer cell therapy
Providing a much-needed lift to struggling Gamida Cell Ltd., the FDA has approved the firm’s advanced cell therapy Omisirge (omidubicel-onlv) to reduce the risk of infection in patients with hematologic malignancies aged 12 years and older who are scheduled to have umbilical cord blood transplantation. Omisirge works by speeding up the recovery of neutrophils in the body, and it is the first allogeneic (donor) stem cell transplant therapy to be approved on the basis of a global, randomized phase III clinical study. The company’s shares (NASDAQ:GMDA) jumped 38% to close at $1.12 on April 17, shortly after the approval was announced. They continued to rise by 56%, as of midday on April 18.
Universal RAS inhibitor from Immuneering yields positive phase I data in solid tumors
Immuneering Corp. disclosed positive pharmacokinetic (PK), pharmacodynamic, and safety data from the phase I trial testing the RAS inhibitor IMM-1-104 at the American Association for Cancer Research annual meeting. The experiment is an open-label study meant to evaluate the safety, tolerability, PK and preliminary efficacy of IMM-1-104 in patients with advanced RAS-mutant solid tumors. Cambridge, Mass.-based Immuneering is using a Bayesian mTPI-2 escalation design, which includes a dose-escalation phase and a dose-evaluation portion to establish the right amount of drug that will be deployed in phase II. Dual MEK blocker IMM-1-04 is the first candidate to attack RAS universally, Immuneering noted. The firm also disclosed a $30 million financing. Shares (NASDAQ:IMRX) were trading midday at $12.86, up 67 cents.
Life sciences funding ‘unclear’ amid bank blowups
The implosion of Silicon Valley Bank and of the investment bank Credit Suisse has left the current funding backdrop for life sciences “completely unclear,” according to Jim Wilkinson, chief financial officer of Oxford Science Enterprises (OSE). “I had a cup of coffee yesterday with Credit Suisse, and with Morgan Stanley, and I talked to one of our co-investors who has accessed some cash for us. They all gave me completely different stories,” Wilkinson said. OSE has preferential right of access to all the science generated by the £800 million per annum invested in research at Oxford University, but it needs co-investors to help scale the companies it forms around this IP engine.
Pharma groups urge Japan’s MHLW to reform drug pricing policies
Pharma groups are calling on Japan’s Ministry of Health, Labour and Welfare (MHLW) to reconsider its current drug pricing policies that include annual price cuts on innovative drugs. “Japan has long been a global leader in life sciences and is a critically important partner in developing new medicines for patients around the world,” said the Japan Pharmaceutical Manufacturers Association, the Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations in a joint statement. But over the years, changes to pricing rules coupled with annual price cuts on drugs have put Japan’s biopharma industry at a competitive disadvantage.
SNBL acquires Satsuma to launch nasal powder for migraine
Shin Nippon Biomedical Laboratories Ltd. (SNBL) agreed to acquire Satsuma Pharmaceuticals Inc. as part of a deal worth as much as $220 million that includes rights to the STS-101 migraine drug. Shin Nippon will pay 91 cents in cash per share, as well as a non-tradeable contingent value right worth up to $5.77 per share based on the potential sale, license, or other grant of rights of Satsuma’s migraine drug STS-101. Satsuma’s shares (NASDAQ:STSA) rose by 65% April 17, the day the acquisition was announced, to close at $1.08. STS-101 is a dihydroergotamine nasal powder that is designed for the acute treatment of migraine.
Doudna, Banfield lead $70M research initiative on CRISPR-based microbiome engineering
A research initiative led by Jennifer Doudna and Jill Banfield of the Innovative Genomics Institute (IGI) at the University of California (UC), Berkeley, has landed $70 million in funding from the Audacious Project to bring the power and precision of CRISPR-based genome editing to the gut microbiome of humans and animals, in an ambitious attempt to engineer complex microbial communities to achieve outcomes that can benefit human health and the environment. The work will involve several dozen scientists at the IGI and at partner institutions UC San Francisco and UC Davis. The end goal is to develop the biological know-how and the technologies to modulate the gut microbiome of infants to tackle inflammatory conditions, such as childhood asthma, and of cattle to reduce methane emissions. The gene editing tools the consortium will develop will be broadly applicable to other settings, Banfield told BioWorld.
Left behind in the US: COVID-19 monovalent mRNA vaccines
The latest U.S. FDA emergency use authorizations (EUAs) to fall by the wayside as COVID-19 continues to evolve are the ones for the original Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines. Today, on April 18, the FDA ended the EUAs for the monovalent vaccines, which targeted only the original SARS-CoV-2 virus. In their place, the agency said it is simplifying vaccine administration by amending the EUAs for the companies’ bivalent vaccines, comprised of both the original and omicron BA.4/BA.5 strains, so they will now be used as both boosters and for primary vaccination in all individuals 6 months and older.
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