PharmaFocus Today – Page 315 – media

FDA Clears Tarsus’ Xdemvy as First Treatment for Common Eyelid Disease

Patients with the eyelid disease Demodex blepharitis can now see a cure in Tarsus Pharmaceuticals’ Xdemvy, the first FDA-approved treatment for an ailment that affects some 25 million Americans. The eye drops directly target Demodex mites, an ectoparasite infestation that causes the disease. Tarsus expects Xdemvy, an eye drop formulation of pet flea and tick treatment lotilaner, to be available by the end of August. The company has already started marketing for the often-misdiagnosed disease with a campaign called “Don’t Freak Out. Get Checked Out,” which launched in May. And last year, the company started a marketing campaign called “Look at the Lids,” which encourages eye doctors to screen for the condition. In two trials involving more than 833 patients, investigators testing the drug noted improvement in collarettes, which is the accumulation of the mite’s waste and eggs. Before Xdemvy, the 1 in every 12 U.S. adults who suffer ...
- Source: drugdu
- 111
- July 27, 2023
FibroGen CEO Conterno, Who Scrapped Post-Lilly Plans Over Roxadustat Hype, Resigns After Launch Setbacks

Hopes around FibroGen’s anemia drug roxadustat were high in early 2020 when Enrique Conterno arrived as the company’s new CEO. He’d just come off a 27-year-run at Eli Lilly and was, according to an analyst interview at the time, “most impressed” by the commercial opportunity for roxadustat.But the last few years have not been kind to FibroGen and AstraZeneca’s drug, with an FDA rejection, commercial disappointments and a clinical trial flop considerably blunting the oral anemia med’s trajectory. It’s against that backdrop—plus a major layoff round—that Conterno, who’s been chief at FibroGen since January 2020, is now hitting the exit. Conterno has resigned from the FibroGen CEO post for “personal reasons,” the company said Tuesday. As FibroGen looks for a permanent successor, the company’s chief commercial officer Thane Wettig will don the mantle of interim chief executive officer. To support Wettig, Conterno plans to stick around as a special advisor to ...
- Source: drugdu
- 260
- July 27, 2023
Biogen, working through a ‘transition,’ plots 1,000 more layoffs by 2025

In reporting its first-quarter earnings, Biogen said it would halt the development of at least four investigational drugs to allow the company to focus on more lucrative opportunities.On Tuesday, Biogen revealed what those opportunities—and its other cost-cutting measures—would entail, saying (PDF) it would reduce its headcount by 1,000 by 2025. With the company starting 2023 with 8,725 employees, that’s an 11.5% reduction of the workforce. At the start of 2022, Biogen employed (PDF) 9,610 people, according to an SEC filing. The numbers show that Biogen has already been working to downsize in the wake of the disastrous Aduhelm launch for Alzheimer’s disease. The latest measures will save Biogen $1 billion in operating expenses by 2025, the company estimates, with roughly $300 million of that earmarked for re-investment as Biogen launches key products, including newer Alzheimer’s disease drug Leqembi, which gained a full approval from the FDA earlier this month. Biogen’s shift comes ...
- Source: drugdu
- 124
- July 27, 2023
BD Gains FDA Clearance to Relaunch Alaris Infusion Pump After Recalls

Dive Brief The Food and Drug Administration has granted Becton Dickinson 510(k) clearance for its updated Alaris infusion pump, paving the way for the company to begin distributing the system again and to remediate or replace all older versions of the device in the field, BD said Friday. The FDA’s green light comes two years after the company filed a new submission for modifications to the pump, which delivers medications and other fluids intravenously to patients, following a series of recalls due to system malfunctions. A large installed base of Alaris systems remains in hospitals. BD said it will address all recall requirements still open to bring those devices into compliance with the FDA clearance, including hardware, software and cybersecurity updates. Dive Insight Widely used in healthcare, infusion pumps from a number of manufacturers have been among the devices that frequently appear on the ...
- Source: drugdu
- 266
- July 27, 2023
Study Sheds Light on the Susceptibility of Chinese Men to 60 Diseases Related to Alcohol Consumption

Recently, a study conducted by researchers from Peking University and Oxford Population Health shed light on the susceptibility of Chinese men to 60 diseases related to alcohol consumption. The study, titled “Alcohol consumption and risks of more than 200 diseases in Chinese men,” was published in the prestigious journal Nature Medicine. Alcohol consumption poses a significant global health threat, with previous research highlighting its strong association with diseases such as liver cirrhosis, stroke, and various types of cancer. However, there has been a lack of systematic investigation into the overall medical impact of drinking within a specific population, which prompted the researchers to undertake this study. To conduct their research, the team utilized data from the China Kadoorie Biobank (CKB), a comprehensive database comprising information from over 512,000 adults recruited across China between 2004 and 2008. The database not only contained crucial health information but also included ...
- Source: drugdu
- 130
- July 27, 2023
Elevar Touts First-line Potential of Rivoceranib in Phase III Liver Cancer Trial

Pictured: Illustration of a liver with tumors/iStock, libre de droit A pre-specified primary analysis of the Phase III CARES 310 trial showed that Elevar Therapeutics’ cancer candidate rivoceranib, when combined with fellow investigational drug camrelizumab, significantly improved survival in patients with unresectable hepatocellular carcinoma, the company announced Monday. Patients who received the drug combination saw a 48% reduction in the risk of death or disease progression, an effect that was significantly better as compared with Bayer’s Nexavar (sorafenib), the standard first-line treatment for unresectable hepatocellular carcinoma (uHCC). At the interim analysis, overall survival was also significantly longer in the rivoceranib-camrelizumab group versus Nexavar. Results of CARES 310 showed that “camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” Elevar CEO Saeho Chong said in a statement. The study’s findings were published Monday in the medical journal The Lancet. CARES 310 is a randomized, ...
- Source: drugdu
- 137
- July 27, 2023
Biogen to Cut 1,000 Jobs as Part of $1B Cost Savings Plan

Pictured: Biogen/The Boston Globe via Getty, John Tlumacki With full FDA approval and CMS coverage for Leqembi in hand, Biogen is ramping up its launch efforts for the Alzheimer’s drug and executing a massive cost reduction program. The biotech company announced second-quarter earnings and its new cost-savings plan on Tuesday. The “Fit for Growth” program is expected to generate around $1 billion in operating expense savings by 2025, which includes a headcount reduction of approximately 1,000 jobs, or about 11% of Biogen’s workforce. Around $300 million will be reinvested into product launches and R&D programs for a net savings of $700 million. The staff reduction will be completed by 2025. The company had more than 8,700 employees in 2022, according to Statista. Biogen CFO Michael McDonnell told investors on Tuesday’s earnings call that a “substantial portion” of the $700 million in net operating expense savings are expected to come from cutting ...
- Source: drugdu
- 148
- July 27, 2023
One Simple Brain Hack Might Boost Learning and Improve Mental Health

New research from Duke found that people who imagined being a thief scouting a virtual art museum in preparation for a heist were better at remembering the paintings they saw, compared to people who played the same computer game while imagining that they were executing the heist in-the-moment. These subtle differences in motivation—urgent, immediate goal-seeking versus curious exploration for a future goal—have big potential for framing real-world challenges such as encouraging people to get a vaccine, prompting climate change action, and even treating psychiatric disorders. The findings appeared online July 25 in the Proceedings of the National Academy of Sciences. Alyssa Sinclair, Ph.D. ’23, a postdoctoral researcher working in the lab of Duke Institute for Brain Sciences director Alison Adcock, Ph.D., M.D., recruited 420 adults to pretend to be art thieves for a day. The participants were then randomly assigned to one of two groups and received ...
- Source: drugdu
- 112
- July 27, 2023
Astellas Strikes Another Deal to Expand in Cancer, Partnering With PeptiDream

Photo: Kiyoshi Ota/Bloomberg, via Getty Images Astellas Pharma is far from alone in viewing cancer as a major growth area, but the Japanese drugmaker has specifically identified a type of therapy called targeted protein degradation as one of the key areas for increasing revenue. It just struck its second deal in the past two months to help it execute on that strategy and perhaps stand apart from others pursuing the same type of drugs. Under a partnership announced Tuesday, Astellas will work with PeptiDream to discover new protein degraders using the technology of that company. Specific targets were not disclosed, but they will be selected by Astellas. The deal also grants Tokyo-based Astellas the option to select up to three additional targets for inclusion in the collaboration. Astellas will pay PeptiDream 3 billion yen (about $21 million) up front. PeptiDream, based in Kawasaki, Japan, is eligible to receive up to ...
- Source: drugdu
- 123
- July 27, 2023
Kodiak Sciences Scraps Late-Stage Vision Loss Biologic

Pictured: Person undergoing an eye exam/iStock, Jacob Wackerhausen Kodiak Sciences shares fell over 50% on Monday after the company announced that its late-stage biologic failed to sufficiently improve the vision of patients with diabetes macular edema and that it would not be pursuing this program any further. The California-based company was testing tarcocimab tedromer, a novel antibody-polymer conjugate developed by the company for the treatment of vision loss. Kodiak had three Phase III trials: DAYLIGHT, GLEAM, and GLIMMER. The DAYLIGHT trial investigated the safety and efficacy of tarcocimab tedromer in a high-intensity dosing regimen for patients with wet age-related amcular degeneration (AMD). Not only was the drug “safe and well tolerated,” but it met the clinical target of “non-inferior visual acuity gains” relative to aflibercept, sold commercially as Eylea and Zaltrap. But the next two Phase III trials, GLEAM and GLIMMER, were far less promising. These were identical studies investigating ...
- Source: drugdu
- 131
- July 26, 2023

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