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Eisai, Biogen’s Alzheimer’s disease drug Leqembi passes muster at FDA adcomm

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen’s Leqembi is heading into the final stretch of its regulatory review on strong footing.During a Friday meeting, members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee took a careful look at the data behind the partners’ Alzheimer’s disease drug. Ultimately, the group voted 6 to 0 that the drug’s Clarity AD study verify its clinical benefit. In the discussion portion of the meeting, advisory committee members described the trial results as “robust,” “meaningful,” “consistent” and “significant.” Now, it’s up to the FDA to decide whether to follow the advisory committee’s guidance. The agency is expected to decide on the application by July 5. Before the Friday discussion, the FDA released its own briefing document that appeared to outline agency support for a full approval. During the meeting, the FDA’s acting director of the ...
- Source: drugdu
- 111
- June 13, 2023
Cosette acquires worldwide rights to Endoceutics’ Intraros prescription drug

Cosette Pharmaceuticals has acquired the worldwide rights to prescription drug, Intraros, from Endorecherche’s subsidiary Endoceutics. The transaction includes 108 issued and pending patents globally with the latest expiring this year including three Orange Book listed patents. The acquisition will expedite Cosette’s women’s health portfolio, with a commercial stage product that is patent protected. At present, Intrarosa is offered in almost all major markets, including the UK, the US, Canada, EU and Israel through local partners such as Tecnimede, Avia, Theramex, Lupin, Labatec, Dexcel, Lacer, Lee’s Pharma, and Valenta. It is expected to be launched in Asian market in 2025. Cosette Pharmaceuticals president and CEO Apurva Saraf said: “This transformative acquisition further strengthens Cosette’s commitment to women’s health with a patent protected, novel drug formulation. “In partnership with MSH Pharma, Cosette will leverage its unique commercial and manufacturing capabilities to ensure continued patient access to Intrarosa. We look forward to expanding ...
- Source: drugdu
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- June 13, 2023
Novartis reveals results from pivotal CML survey

International data questions the assumption that chronic myeloid leukaemia is now a ‘solved’ disease Novartis’ survey of unmet (SUN) needs in chronic myeloid leukaemia (CML) data has highlighted the requirement for an increased patient voice during treatment discussions. It concludes that such exchanges would balance quality of life, efficacy and tolerability across therapies. The data has emerged from research in Australia, Brazil, Canada, France, Germany, Italy, Japan, South Korea, Spain, the UK and US. The final analysis is expected to be published later this year. The results reveal necessity for greater communication and shared decision-making between patients and physicians, as well as more tolerable therapy options that do not sacrifice quality of life (QoL) for efficacy. The survey also underlines an opportunity for physicians, patients, and other stakeholders to collaborate and better meet expectations for CML. Across the 11 nations, similar themes emerged around treatment goals, joint decision-making and treatment ...
- Source: drugdu
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- June 13, 2023
Ipsen/Albireo Look to Add Rare Genetic Disease to Bylvay’s Label

In February 2023, the FDA accepted an sNDA submitted by Albireo, seeking to add the rare genetic disease Alagille syndrome to Bylvay (odevixibat)’s label. The target action date is June 15. Albireo entered into an agreement in January to be acquired by Ipsen Alagille syndrome is a heritable condition characterized by the lack of bile ducts that drain the liver, leading to the accumulation of bile, which ultimately causes organ damage. The disease can also affect the heart, skeleton, eyes, kidneys and central nervous system. Common symptoms include yellow skin or eyes, stunted growth and severe pruritus. Bylvay’s Alagille bid is supported by data from the Phase III ASSERT study, a double-blinded, randomized and placebo-controlled trial that enrolled more than 50 participants across 32 trial sites in North America, the Middle East, Europe and the Asia-Pacific region. In the study’s main analysis, Bylvay significantly reduced pruritus after 6 months of ...
- Source: drugdu
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- June 13, 2023
Ironwood Pushes Gut Drug to Pediatric Setting

By Tristan Manalac On June 14, the FDA is set to release its verdict on Ironwood Pharmaceuticals’ supplemental New Drug Application (sNDA), in which the company proposes to use Linzess (linaclotide) for the treatment of functional constipation in kids and teens aged 6–17 years. Ironwood is developing and commercializing Linzess in collaboration with AbbVie, following a 2015 agreement with Allergan. AbbVie acquired Allergan in 2019. Linzess is a guanylate cyclase-C (GC-C) agonist that works by binding to the GC-C receptor within the intestinal epithelium, which in turn increases fluid secretion, faster transit and lower pain-sensing in the intestine. The drug won the FDA’s approval in August 2012 to treat patients with chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. Linzess’s label bears a boxed warning for risk of serious dehydration when used in children under two years of age. Ironwood supported Linzess’ sNDA with data from a ...
- Source: drugdu
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- June 13, 2023
Medicinal cannabis is a ‘life-changing treatment’ for people with Tourette syndrome

Australian researchers have published the first robust clinical study proving that medicinal cannabis effectively treats the debilitating effects of Tourette syndrome. The findings—which show a statistically and clinically significant reduction in motor and vocal tics in just six weeks—are published in the journal NEJM Evidence. The clinical trial was led by neuropsychiatrist Dr. Philip Mosley, a Research Fellow at the Wesley Research Institute and QIMR Berghofer Medical Research Institute. The University of Sydney’s Lambert Initiative for Cannabinoid Therapeutics, with Wesley Research Institute, assisted with study design and execution, and analyzed blood levels of cannabinoids among participants. The analysis found a significant association between levels of cannabis in the bloodstream and the response to active treatment. THC (tetrahydrocannabinol) is the active hallucinogenic compound in cannabis that produces a “high” effect, while CBD (cannabidiol) is a non-psychoactive compound. Both are used medicinally in Australia. Study co-author Professor Iain McGregor, the Academic Director ...
- Source: drugdu
- 133
- June 12, 2023
Women feel the pain of losses more than men when faced with risky choices, according to new research

Women are less willing to take risks than men because they are more sensitive to the pain of any losses they might incur than any gains they might make, new research from the University of Bath School of Management shows. Published in the British Psychological Society’s British Journal of Psychology, the study—”Gender differences in optimism, loss aversion and attitudes toward risk”—also finds that men are ‘significantly’ more optimistic than women, making them more willing to take risks. Researcher Dr. Chris Dawson, associate professor in business economics at the University of Bath School of Management, said the findings were significant and could help explain sex-specific outcomes in different employment sectors, and in financial markets. “It is widely acknowledged that men, across many domains, take more risks than women. These differences in how the sexes view risk can have significant effects,” Dr. Dawson says. “For instance, differences between the sexes in risk ...
- Source: drugdu
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- June 12, 2023
Purolite to build $190M resin plant in Pennsylvania, plans 170 hires

Purolite, a subsidiary of Ecolab that produces purification resins for drug manufacturing, earmarked at least $190 million to build a production plant that will employ 170 workers.The facility, which will produce a variety of products for the healthcare and drug manufacturing industries, will be located in Landenberg, Pennsylvania, according to a June 6 press release from Gov. Josh Shapiro’s office. Resins are used to purify process streams during drug manufacturing and are considered critical to final product quality although they are not part of the finished product. The facility is expected to be completed by the first half of 2025. It will represent the first site in Purolite’s U.S. biologics division. “Purolite’s new facility will help bring security of supply to our global pharmaceutical and biotech customers, enabling lifesaving drugs to reach patients fast,” Hayley Crowe, Purolite’s senior vice president and general manager, said in the release. Purolite received a ...
- Source: drugdu
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- June 12, 2023
After recent troubles, Catalent expands its biologics services platform

Global CDMO giant Catalent, which has been struggling through difficult financial times, added more biologic processes to its OneBio platform, which features capabilities for antibody and recombinant proteins, cell and gene therapies, and messenger RNA.The rollout of the added services is part of the company’s participation at the BIO International Convention taking place in Boston this week, Catalent said in a June 5 press release. The additions come in the wake of the CDMO delaying the release of its earnings report multiple times after admitting in April that it was struggling with “productivity issues” and high costs at three major production sites—including two of its largest. The locations at issue include Catalent’s gene therapy manufacturing site in Harmans, Maryland, as well as its drug product and drug substance plants in Bloomington, Indiana, and Brussels, Belgium. Catalent’s problems may have caused life sciences conglomerate Danaher to shelve plans in April to ...
- Source: drugdu
- 111
- June 12, 2023
European Commission grants two new marketing authorisations for UCB’s Bimzelx

The European Commission (EC) has granted UCB’s Bimzelx (bimekizumab) two new approvals, with the inflammatory disease drug now authorised to treat certain adults with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The marketing authorisations, which follow a pair of recommendations from the European Medicines Agency’s human medicines committee earlier this year, make Bimzelx the first and only IL-17A and IL-17F inhibitor approved in the EU for these two indications. The authorisation for PsA – a type of arthritis that affects some patients with psoriasis – specifically applies to those with active disease who have had an inadequate response or have been intolerant to one or more disease-modifying antirheumatic drugs. The approval was supported by results from two phase 3 trials in which Bimzelx showed improvements over placebo in joint and skin symptoms across biologic naïve and TNF inhibitor-inadequate responder populations. “The approval of [Bimzelx] in PsA provides rheumatologists and dermatologists ...
- Source: drugdu
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- June 12, 2023

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