Stalicla announced the successful closing of a $17.4m Series B funding round as deal-making interest stirs in the central nervous system disorder space. “In the current environment, we see this [financing round] as a huge success, but we’re targeting a much larger round in Q3 2024 with the involvement of large venture capital funds,” says Stalicla CEO Lynn Durham in an exclusive interview with Pharmaceutical Technology. Stalicla aims to use the extra funds to launch a Phase III substance use disorder (SUD) study for its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform in 2025. The US National Institute on Drug Abuse and the National Institutes of Health are supporting Stalicla’s development of STP7.Stalicla acquired the therapy through an in-licensing agreement with Novartis in January 2023. In this deal, the Swiss company acquired the worldwide rights for studies using the STP7 platform for SUD, neurodevelopmental disorders, and other indications in ...
Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company’s two most advanced programs are depression drugs in mid-stage development. By FRANK VINLUAN Matching a drug to a patient’s biology is not a new idea, but it hasn’t caught on in neuropsychiatric disorders, which have high failure rates in drug studies. The technology of Alto Neuroscience brings precision medicine to psychiatric drug research and its IPO has raised $128.6 million to see if this approach can yield better clinical trial results. Alto priced its IPO late Thursday, offering more than 8 million shares for $16 apiece. The Los Altos, California-based company was able to raise more than planned. When Alto set preliminary financial terms earlier this week, it projected offering 6.7 million shares in the range of $14 and $16 each, which would have raised $100.5 million at ...
One day after Roche said it was starting to establish Vabysmo as the new standard of care in age-related macular degeneration (AMD) and diabetic macular edema (DME), Regeneron clapped back with the same claim about its new treatment—high-dose Eylea. “We continue to see physicians prescribe Eylea HD in both treatment experienced and treatment naïve settings as Eylea HD is increasingly recognized as the new standard of care,” Marion McCourt, Regeneron’s commercial chief, said as the company presented its fourth-quarter and 2023 earnings. Eylea HD is Regeneron’s response to Vabysmo, which hit the market in the first quarter of 2022 as a game-changing, longer-acting treatment. Vabysmo allowed many patients to reduce dosing from six times a year—with Regeneron’s original version of Eylea—to three times a year. Vabysmo has been an immediate hit as illustrated by Roche’s sales figures, which were presented on Thursday. In its first full year on the market, ...
More than two years after Aduhelm’s controversial and ill-fated FDA accelerated approval, Biogen is discontinuing the Alzheimer’s disease therapy after walking a rocky path. Wednesday, Biogen said it’s pulling all efforts from the first-of-its-kind anti-amyloid beta therapy to focus on Leqembi, its Eisai-partnered newer medicine, and its pipeline candidates. The newer drug, Leqembi, won a full FDA approval early last year, making the partners’ marketing efforts on the therapy much simpler than was the case with Aduhelm. Biogen is taking a $60 million charge and is discontinuing all development and sales of Aduhelm, the company said. It’s terminating the ENVISION clinical study, which sought to confirm the benefit of the medicine as required under its 2021 accelerated approval. The decision follows Biogen’s move to launch a strategic review in early 2023 under new CEO Chris Viehbacher, the former Sanofi chief who joined the Massachusetts drugmaker in November 2022. During that ...
Insulin prices have long been a pain point for diabetics. The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development. By FRANK VINLUAN Inflation remains a top consumer gripe, but the higher cost of milk and eggs is negligible when compared to insulin. Spending on insulin has tripled in the past decade, topping $22 billion in 2022, according to research from the American Diabetes Association. While some of that increase is due to a growing patient pool, it’s also due to rising prices. The inflation-adjusted cost of insulin increased 24% from 2017 to 2022. Lower-cost insulin is becoming available to more Americans with diabetes. Implementation of the Inflation Reduction Act last year was a catalyst. One of the federal law’s provisions set a $35 cap on the monthly out-of-pocket cost for insulin. Though the ...
With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP). Friday, the HELP Committee’s chairman, Sen. Bernie Sanders (I-Vt.), said J&J’s Joaquin Duato and Merck’s Robert Davis have “reconsidered their positions” and have agreed to join BMS’ CEO Chris Boerner at a committee hearing scheduled for February 8. Duato and Davis’ cooperation comes shortly Sanders said the HELP Committee would vote to subpoena the CEOs after they declined a previous invitation to talk drug pricing. That subpoena vote has now been called off, the Committee said in a press release Friday. Sanders’ HELP Committee has already been crusading against steep drug prices over the past year. The committee has already heard testimony from chief executives ...
Two cancer therapies have topped Clarivate Analytics’ Drugs to Watch in 2024, an annual report that identifies potential blockbusters and other medicines that could “transform treatment paradigms.” Clarivate predicts Johnson & Johnson’s combination treatment Akeega and Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan will generate $2.7 billion in sales each in 2029. On the list of 15 transformative medicines, these are the only ones expected to exceed $2 billion in sales by 2029. Clarivate’s report, which is in its 12th year, highlights drugs that have recently been approved or are expected to be approved in 2024. Its sales estimates cover the G7 countries—U.S., U.K., Japan, France, Italy, Germany and Canada. J&J was the only company with more than one drug on the list. Clarivate also spotlighted J&J’s Talvey, a first-in-class bispecific antibody to treat multiple myeloma. The analysts forecast Talvey’s sales will reach $850 million in 2029. The only other cancer ...
An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced by other factors, the FDA said. Consequently, the agency said it determined the reports did not demonstrate a clear relationship with GLP-1 drugs. This finding is preliminary. “However, because of the small number of suicidal thoughts or actions observed in both people ...
The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing. By FRANK VINLUAN An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced ...
AbbVie took the top two TV drug ad spending spots with its immunology duo Rinvoq and Skyrizi, respectively, in December as it looks to cement its place as the pharma with the deepest direct-to-consumer pockets. AbbVie spent nearly identical amounts on all DTCs for each drug: $39.8 million for Rinvoq across its five spots and $39.7 million for Skyrizi across seven spots. In November, the positions of the two drugs were swapped, with Skyrizi taking the top spot and Rinvoq coming in second. Coming in third place was rival Dupixent, marketed by Sanofi and Regeneron, with a much smaller $27.6 million spent across its ads for the blockbuster med. And Pfizer has suddenly started to spend big on its new RSV vaccine Abrysvo, coming in fourth place with a strong spend of $18 million last month, more than five times the $4 million it spent in November. In fifth place ...
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