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TOP STORIES
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
When Doug Ingram became Sarepta Therapeutics’ CEO in 2017, he didn’t have a connection to muscular dystrophy, but he has developed a fierce passion for the therapeutic area. He will step aside from his role to dedicate more time to his family.
The Denton site is part of a network of manufacturing plants Novartis is building across the U.S. to make cancer drugs that must be shipped to patients quickly.
After its next-generation obesity asset CagriSema lost a head-to-head matchup with Eli Lilly’s Zepbound, Novo Nordisk is throwing more money into the obesity space, striking a deal with Vivtex to advance novel weight loss pills.
In his State of the Union address on Tuesday evening, President Donald Trump urged Republican leaders to pass legislation cementing his new drug pricing initiatives as he touted his efforts to lower healthcare costs for Americans.
The rescheduling of the Advisory Committee on Immunization Practices comes amid fresh leadership upheaval at the CDC as NIH director Jay Bhattacharya replaces Jim O’Neill as acting head of the agency.
Solstice Oncology will gain an exclusive worldwide license to Harbour BioMed’s porustobrt, an anti-CTLA-4 antibody currently being studied for melanoma, colorectal cancer and other malignancies in China.
A trial of a MacroGenics’ drug temporarily paused enrollment after several safety events, including a fatality. The deceased patient had developed a severe case of neutropenia and concurrent septic shock.
Slate Medicines will move forward with a migraine drug from a Chinese biotech, while Alveus Therapeutics will advance a dual GLP-1/GIPR fusion protein for weight loss.
Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another leadership change shakes up CDC; and Gilead acquires CAR T partner Arcellx for nearly $8 billion.
IPO
LB Pharma needed $350 million to advance a promising schizophrenia candidate at a time when the biotech markets were locked up tight. Fortunately, it wasn’t CEO Heather Turner’s first rodeo.
FDA
Regulators overseeing rare disease treatments need better tools to weigh competing risks in real time. Sarepta Therapeutics’ Elevidys is a prime example of why.
PRESS RELEASES
Financing was led by new investor and top-tier healthcare fund Nantahala Capital and longtime Envoy Medical shareholder, billionaire Glen Taylor Closing of $30 million in gross proceeds in upsized offering, with up to an additional $48 Million upon exercise of milestone warrants, provides potential funding through commercialization Company hosting Fireside Chat with Dr. Theodore McRackan, on February 25th at 10 a.m. ET, to discuss his initial experiences as clinical trial’s leading implanter
Naturally-Derived 5 mg Psilocybin Capsules Mark the Company’s Second Drug in Market Under Australia’s Authorised Prescriber Scheme
Leadership Enhancements Position Company for Upcoming Regulatory Engagement and Clinical Milestones New Appointments Reinforce Operational Readiness Across Finance, Regulatory Affairs and Program Leadership
MARKET RESEARCH REPORTS