PharmaFocus Today – Page 232 – media

Alkermes Spins Off Oncology Business with $275M to Focus on Neuroscience

Pictured: Cancer cell surrounded by cytokines/iStock, Marcin Klapczynski Alkermes on Wednesday announced that it has completed the spinoff of its oncology business to become a pure-play neuroscience company. Mural Oncology will begin trading on the Nasdaq starting Thursday, with Alkermes shareholders receiving a share of Mural for every 10 shares of Alkermes. Mural is launching with $275 million, which is expected to fund it through the fourth quarter of 2025, and an interleukin-2 cytokine as its most advanced asset. Nemvaleukin alfa is being studied as a monotherapy for advanced mucosal or cutaneous melanoma in Phase II and is in a Phase III study in combination with Keytruda for platinum-resistant epithelial ovarian cancer. The therapeutic is designed to avoid the hallmark toxicities of IL-2 immunotherapies. The studies are potentially registrational with readouts expected in early 2025. Additional assets include therapies targeting IL-18 and IL-12. Mural will nominate a development candidate for each program in ...
- Source: drugdu
- 126
- November 17, 2023
Ipsen, Genfit Build Case for Rare Liver Disease Drug with Phase III Data

By Tristan Manalac Pictured: Illustration of diseased liver/iStock, Mohammed Haneefa Nizamudeen Ipsen and partner Genfit on Monday posted promising data from the Phase III ELATIVE trial for their investigational dual peroxisome activated receptors agonist elafibranor, further building the candidate’s case for regulatory approval in primary biliary cholangitis. More than half of patients treated with elafibranor achieved the study’s primary endpoint of biochemical response, defined as having normal bilirubin concentrations alongside a substantial decrease in alkaline phosphatase levels, maintained below a particular threshold. Only 4% of placebo comparators met these biochemical response criteria. Elafibranor also normalized alkaline phosphatase levels in 15% of treated patients, compared to none in the placebo group. In terms of safety, ELATIVE found that elafibranor was well-tolerated with an adverse event profile that was similar to placebo. Common side effects included abdominal pain, diarrhea, nausea and vomiting. In a statement, Christelle Huguet, executive vice president and head ...
- Source: drugdu
- 203
- November 16, 2023
Jazz Inks $770M Deal with GSK Spinout Autifony, Nabs Two Neuro Assets

By Tyler Patchen Pictured: A neurosurgeon analyzes an MRI/iStock, gorodenkoff GSK spinout Autifony Therapeutics has entered into an exclusive global licensing deal potentially worth $770.5 million with Jazz Pharmaceuticals for two different ion channel targets associated with neurological disorders. Under the deal announced on Tuesday, the U.K.-based biotech Autifony will receive an undisclosed upfront payment from Jazz and is eligible to receive development, regulatory and commercial milestone payments as well as royalties on any future net sales. Autifony, which is focused on developing treatments for central nervous system disorders and other brain diseases, will spearhead the drug discovery and the preclinical development of the two ion channel targets. Prior to the completion of preclinical development, Jazz will take over clinical development and assume responsibility for manufacturing, regulatory actions and commercialization. “Jazz has an exceptional track record of rapidly advancing neuroscience development programs and effectively commercializing novel therapies that offer improvements ...
- Source: drugdu
- 115
- November 16, 2023
Olympus receives Class I recall label for another bronchoscope safety issue

Dive Brief Olympus Corporation has issued another corrective action for numerous models of bronchoscopes after reports of injuries where patients may have suffered burns to their airways or lungs. The corrective action came after four adverse event reports of “endobronchial combustion during therapeutic procedures with Olympus bronchoscopes,” an Olympus spokesperson said in an emailed statement. The Food and Drug Administration labeled the corrective action as a Class I recall, though Olympus said in a Nov. 9 press release that no devices need to be removed. The recall affects nearly 68,000 devices according to an FDA report entry. Dive Insight Bronchoscopes are used for endoscopic diagnosis and treatment in the airways to the lungs. In an Oct. 12 letter to customers, Olympus warned healthcare personnel about the risks of conducting high-frequency cauterization with Olympus bronchoscopes in an oxygenated environment, which may result in combustion during cauterization. The company said in a ...
- Source: drugdu
- 148
- November 16, 2023
IU researchers receive $5 million grant to improve care for adolescents with opioid use disorder

IU School of Medicine researchers are taking steps to improve the accessibility and quality of care for adolescents experiencing opioid use disorder (OUD) and other substance use disorders (SUDs), thanks to a new $5 million grant from the National Institute of Health’s Helping to End Addiction Long-Term (HEAL) Initiative. The grant will fund the new project “Workforce and System Change to Treat Adolescent Opioid Use Disorder within Integrated Pediatric Primary Care” led by faculty from the Department of Psychiatry and Department of Pediatrics. The $5 million will be awarded across 5 years, with formative work happening in the first year before transitioning into a clinical trial phase. “Addressing the growing risk of overdose deaths among adolescents has become a critical concern, and Indiana unfortunately has one of the ten highest rates of adolescent overdose deaths in the United States,” said Zachary Adams, PhD, associate professor of psychiatry at Indiana School ...
- Source: drugdu
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- November 16, 2023
It Will Take More Than Government Regulation of Pharmacy Benefit Managers to Lower Drug Costs

Don Tracy, Associate Editor Proposed legislation aims to address pharmacy benefit manager tactics to reduce prescription drug prices. This year has seen a renewed push by Congress on efforts aimed at regulating the practices of pharmacy benefit managers (PBMs). Currently proposed legislation addresses issues such as the impact of PBMs on patient costs, perverse incentives favoring high-priced drugs, and a greater need for transparency. Currently, PBMs act as intermediaries, managing prescription drug claims and establishing formularies on behalf of insurers, contracting with networks of pharmacies, and negotiating rebates from drug manufacturers. As the authors of a commentary recently published by The New England Journal of Medicine (NEJM) note, PBMs have a significant impact on patient premiums and out-of-pocket costs for prescription medications. “PBMs help control costs by designing formularies that steer patients toward using lower-priced medications and by negotiating lower costs with drug manufacturers in exchange for offering preferred formulary ...
- Source: drugdu
- 194
- November 16, 2023
Ditch Paternalism & Focus On The ‘Accumulation of Marginal Gains’

Providers must abandon paternalism and treat patients like partners in the decision-making process when drawing up care plans, according to Chris Waugh, Sutter Health’s chief design and innovation officer. Instead of prescribing a major lifestyle overhaul without considering a patient’s unique life circumstances, providers should “recognize that it’s about the tiny things and the accumulation of marginal gains,” he said. By KATIE ADAMS Historically, healthcare providers have had a reputation of paternalism — as one might guess, this type of approach doesn’t support patient engagement or care plan adherence. Like many other innovators in the industry, Chris Waugh — Sutter Health’s chief design and innovation officer, believes providers need to abandon paternalism and pivot toward collaboration. They must start treating patients like partners in the decision-making process when drawing up care plans, he said during an interview last week at the Reuters Total Health conference in Chicago. “We’re often asking ...
- Source: drugdu
- 99
- November 16, 2023
Pfizer’s cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K. Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule (PSSM) capabilities at its site in Sandwich in Kent in the U.K., a company spokesperson confirmed over email. The spokesperson described the layoffs as a “one of the consequences” of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October. Under the current plan, the Sandwich site isn’t closing, and other functions will continue “with a different size,” the spokesperson added. Currently, around 940 people are employed at the facility. Local news outlet Kent Online earlier reported that Pfizer was proposing to discontinue all lab and manufacturing work at the Sandwich site.The site is the location where Pfizer scientists first discovered Viagra. During the pandemic, Pfizer invested 10 ...
- Source: drugdu
- 173
- November 16, 2023
Orphelia pushes boundaries with regulatory barriers for pediatric indications

Orphelia Pharma is taking action to drive regulatory agencies like the European Commission to adapt pharmaceutical legislations that would facilitate the development of rare disease pediatric drugs, like the company’s Kizfizo (Ped-TMZ). Kizfizo, a temozolomide biosimilar, is the first oral liquid suspension of temozolomide designed to act as a monotherapy or as a Kizfizo/DNA topoisomerase inhibitor combination treatment for the treatment of relapsed or refractory (r/r) neuroblastoma. Originally indicated exclusively for the treatment of glioblastoma in adults in the US, temozolomide has been used off label to treat r/r neuroblastoma patients for years. The drug is approved for treating GBM in adults and children in Europe. Use of temozolomide in this manner, especially in children, has its drawbacks because children end up being underdosed, executive chairman Giles Alberici told Pharmaceutical Technology. “You often open the capsules and put that in your water. And this is something that should not be ...
- Source: drugdu
- 93
- November 16, 2023
Sandoz opens new antibiotic and biosimilar facilities in Austria and Germany

Antimicrobial resistance is considered one of the top ten global public health threats Sandoz has announced the opening of two new European facilities in Austria and Germany to strengthen the development and supply of critical medicines in the EU and beyond. The two facilities include a new facility for the production of penicillin at Kundl, Austria, along with a new biosimilar development centre in Holzkirchen, Germany. Both facilities align with Sandoz’s commitment to ensuring sustainable access to quality antibiotics as well as spearheading the development of biosimilars. Antibiotics are used to treat or prevent some types of bacterial infections by killing or stopping them from spreading. Antimicrobial resistance has been declared one of the top ten global public health threats facing humanity by the World Health Organization. Currently, penicillin antibiotics are the leading category of antibiotics worldwide. Sandoz’s new penicillin production process aims to improve its ecological footprint and will ...
- Source: drugdu
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- November 16, 2023

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