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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
- 197
- 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
- 102
- 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
- 175
- 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
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- 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
Takeda’s enzyme replacement therapy approved by FDA for rare blood clotting disorder

Takeda’s Adzynma (ADAMTS13, recombinant-krhn) has been approved by the US Food and Drug Administration (FDA) as the first therapeutic option for congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare inherited blood clotting disorder. Estimated to affect fewer than 1,000 people in the US, cTTP is caused by a deficiency in the ADAMTS13 enzyme that regulates blood clotting. Patients with cTTP can experience severe bleeding episodes, strokes and damage to vital organs, and mortality rates are high if left untreated. “Without treatment, cTTP is ultimately fatal,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He continued: “[The] approval reflects important progress in the development of much-needed treatment options for patients affected by this life-threatening disorder.” Until now, cTTP treatment has typically involved plasma therapy, which Takeda has previously described as “insufficient in restoring ADAMTS13, time-consuming and costly”. Adzynma, which has been authorised for use as a preventative ...
- Source: drugdu
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- November 16, 2023
Henry Schein says customer data breached in cyber incident

Dive Brief Henry Schein, a medical and dental supplies company, is still recovering from a cybersecurity incident last month that took some of its systems offline. In a letter to its customers, the company disclosed on Monday that a data breach occurred, but “we do not have all the details of what data may have been compromised.” Customer bank accounts and credit card numbers may have been affected. Henry Shein also issued a letter to its suppliers, writing that the company is “aware that the bank account information for a limited number of suppliers was misused.” CEO Stanley Bergman told investors on a Monday earnings call that the company is working to bring its e-commerce platform back online this week, and that the incident primarily affected its dental and medical distribution operations in North America and Europe. Dive Insight Henry Schein lowered its sales expectations for its 2023 fiscal year, ...
- Source: drugdu
- 101
- November 15, 2023
Major trial finds apixaban reduces stroke risk in patients with device-detected atrial fibrillation

The widely available blood thinner apixaban substantially reduced stroke in at-risk patients with a type of atrial fibrillation only detectable by a pacemaker or other implanted cardiac electronic device, a global study has found. The oral anticoagulant medication, which helps to prevent dangerous blood clots by thinning the blood, reduced the risk of stroke and blood clotting by 37% and reduced fatal or disabling stroke by 49% in individuals with device-detected atrial fibrillation, also known as sub-clinical atrial fibrillation (SCAF). This condition is not easily detectable through standard tests like electrocardiograms, unlike clinical atrial fibrillation. The study was published on Nov. 12 in the New England Journal of Medicine (NEJM) and simultaneously presented at the American Heart Association Scientific Sessions by lead researcher Jeff Healey, a senior scientist at the Population Health Research Institute (PHRI), a joint research institute of McMaster University and Hamilton Health Sciences. Healey and a global ...
- Source: drugdu
- 111
- November 15, 2023
Novartis Enters into Deal with Legend Biotech for $100 Million Upfront

By Tyler Patchen Legend Biotech has secured an exclusive global license deal with Novartis giving the Swiss pharma access to Legend’s CAR-T cell therapies. The deal announced on Monday will give Novartis access to CAR-Ts that target the delta-like ligand protein (DLL3) candidate LB2102, which Legend has been investigating to treat adults with certain small cell lung cancers. Novartis will pay Legend $100 million upfront, and the New Jersey–based biotech “will be eligible to receive up to $1.01 billion in clinical, regulatory and commercial milestone payments and tiered royalties,” according to the company’s announcement. The deal has Legend taking the lead on the Phase I trials for LB2102 in the U.S., while Novartis will handle all other development. No hard date has been given as to when the deal will close. For its part, Novartis will receive exclusive worldwide rights to develop, produce and eventually commercialize the therapies. The company ...
- Source: drugdu
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- November 15, 2023

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