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Trial Investigating Peanut Allergy Immunotherapy Hits Final Milestone

A trial investigating desensitisation immunotherapy delivered as toothpaste for adults with peanut allergy reached a final milestone after Intrommune Therapeutics completed the last patient’s last visit. The Phase I OMEGA clinical trial (NCT04603300) is a multi-centre, randomised, placebo-controlled double-blind study involving splitting 32 participants with peanut allergy into two groups to receive either an escalating dose of the company’s candidate INT301 or placebo. The primary outcome is the safety of the drug compared to placebo. Safety is measured by the percentage of participants able to tolerate the highest dose and incidence of adverse reactions. Intrommune Therapeutics’ candidate utilises the company’s oral mucosal immunotherapy (OMIT) platform to deliver the therapy in fully functional toothpaste. OMIT’s simple administration allows for improved adherence, which is important for desensitising a patient to a specific allergy. Allergy immunotherapy requires consistent exposure. Peanut allergy is one of the most common allergies that ...
- Source: drugdu
- 125
- July 28, 2023
Octapharma Secures FDA Nod for Warfarin Reversal Agent Balfaxar

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. But using a blood thinner carries risks of its own as patients become prone to bleeding, particularly during urgent surgery or other invasive procedures. To combat the risk, Swiss plasma specialist Octapharma has developed a treatment that rapidly restores the blood’s ability to coagulate. On Wednesday, the FDA signed off on the company’s Balfaxar (prothrombin complex concentrate, human-lans). Already marketed as Octaplex in Europe and Canada, Balfaxar is for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists such as warfarin. Balfaxar, which is a lyophilized powder for reconstitution, is provided with sterile water for injection by way of a new transfer device called Nextaro. The drug earned approval based on a phase 3 trial that ...
- Source: drugdu
- 141
- July 28, 2023
Alkermes, Nearing Oncology Split, Posts Big Q2 Sales Gain After Winning J&J Arbitration Case

With winnings from its arbitration battle against Johnson & Johnson in hand—alongside a jump in its own product sales—Alkermes seems to be feeling itself heading into the second half of 2023. After the Dublin-based drugmaker won a high-stakes case versus J&J last month, the company bumped up its 2023 sales forecast by $425 million to between $1.55 billion and $1.68 billion. In revealing second-quarter results, the company provided some details behind the new guidance. Alkermes expects J&J’s royalties and interest on late payments for 2022 to come in at around $197 million, while 2023 royalties should land between $265 to $280 million, the company said in an investor presentation (PDF). Those payments relate to J&J’s schizophrenia drug Invega, which uses Alkermes’ NanoCrystal technology and delivered sales of $4.1 billion last year. With the arbitration win in tow, Alkermes generated $617 million this quarter, including $248 million of back royalties and interest from ...
- Source: drugdu
- 116
- July 28, 2023
GSK Tamps Down Short-Term Expectations for RSV Shot Arexvy, but Still Boosts 2023 Guidance

Expectations are sky high for GSK’s entry this fall into the new respiratory syncytial virus (RSV) vaccine market. The company forecasts peak sales of £3 billion ($3.9 billion) for its shot Arexvy, while Global Data sees the vaccine as the market leader through 2029. But with Arexvy set to launch in the United States later this year, GSK is tamping down the anticipation. On Wednesday, CEO Emma Walmsley said that Arexvy will not hit the ground running as quickly as GSK’s shingles shot Shingrix, which generated £784 million ($1.05 billion) in its first full year on the market (2018). “It won’t be the same rate of build as Shingrix was,” Walmsley said as GSK presented its second-quarter earnings (PDF). “But we do think it is a really key pillar.” The competitive landscape was more favorable for Shingrix to thrive early on, Walmely said. She also noted that the newly established market for ...
- Source: drugdu
- 116
- July 28, 2023
Magic Mushrooms Found to Reduce Anorexia Nervosa Psychopathology

Researchers at the University of California at San Diego have studied the effects of magic mushrooms as a therapeutic in treating anorexia nervosa. In their paper, “Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study,” published in Nature Medicine, the researchers detail the treatment results for an otherwise therapeutic-resistant disorder. A News and Views article has been published in the same journal issue discussing the work done by the team. Ten participants in partial remission from anorexia received psilocybin therapy. Safety, tolerability, primary outcomes, patient acceptability, and eating disorder specific psychopathology were assessed. Psilocybin therapy was found to be safe and well-tolerated. Participants reported positive changes three months after dosing, with some demonstrating clinically significant reductions in eating disorder psychopathology. Some participants had a robust positive response to just a single-dose treatment. No serious adverse events were reported. Anorexia nervosa (AN) is characterized by excessive preoccupation, fear ...
- Source: drugdu
- 146
- July 28, 2023
UnitedHealthcare Invests $11.1M To Address SDOH Needs

UnitedHealthcare awarded grants to 66 nonprofits across 12 states. The grants will support those struggling with social isolation, behavioral health, food insecurity and other social determinants of health. UnitedHealthcare is providing $11.1 million in grants to 66 nonprofits in 12 states, the health insurer announced Tuesday. The grants will support those battling food insecurity, social isolation, behavioral health issues and other social determinants of health. The grants are part of Empowering Health, a program launched in 2018 that aims to improve access to care and address social determinants of health. To date, UnitedHealthcare has invested a total of $62 million in 30 states and the District of Columbia through the program. The newest round of grants will go toward organizations in Colorado, Georgia, Kansas, Massachusetts, Michigan, Minnesota, Mississippi, New York, Pennsylvania, Rhode Island, Texas and Washington. Recipients include: Massachusetts-based Community Servings, which received $300,000 to create a program ...
- Source: drugdu
- 152
- July 28, 2023
Roche Snubs SQZ HPV 16 Programme, Leaving the Beleaguered Company in the Lurch

Atricky 2023 has become even harder for SQZ Biotechnologies after Roche decided not to pick up the company’s HPV 16 positive solid tumour programme. In 2018, the companies expanded their immune-oncology development deal in an agreement totalling a potential $1bn when milestone payments were accounted for. The deal included option rights for HPV 16 positive solid tumours under the SQZ-APC-HPV programme. SQZ’s technology harnesses tumour antigens by squeezing cells. The squeezing process induces presentation of antigens which allow an immune response. SQZ has had to weather a tricky year after culling 60% of its workforce in December 2022. The company reported a net loss of nearly $80m for 2022. However, SQZ is expecting data from an antigen presenting cell (APC) trial and an activating antigen carrier (AAC) trial in the second half of 2023 and Q4 of 2023 respectively. For now, the company said it ...
- Source: drugdu
- 113
- July 27, 2023
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
- 107
- 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
- 254
- 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
- 119
- July 27, 2023

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