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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
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- 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
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- 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
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- 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
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- 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
Lilly Notches Second Cholesterol Win with RNA Silencer

By Tristan Manalac Data from an early-stage study showed that Eli Lilly’s investigational RNA silencing therapeutic lepodisiran can induce sharp and durable reductions in serum lipoprotein(a) levels, the company revealed in a read-out presented over the weekend at the 2023 Scientific Sessions of the American Heart Association. These findings come nearly three months after the Indianapolis-based pharma notched another Phase I victory, this time for its oral drug candidate muvalaplin, which strongly decreased lipoprotein(a) levels in healthy participants within 24 hours. Lipoprotein(a), also known as Lp(a), is a form of cholesterol that can cause plaques to form in arteries and block blood flow and is often tied to the risk of developing cardiovascular diseases. The first-in-human trial of lepodisiran enrolled 48 patients who were given ascending doses of the investigational therapy—from 4 mg up to 608 mg—or a placebo. At the highest dose level, lepodisiran was able to elicit a ...
- Source: drugdu
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- November 15, 2023
Collections, Aggressive Tactics, and Consequences

Don Tracy, Associate Editor The growing issue of medical debt has caused stakeholders to reevaluate tactics as the cost of pharmaceutical healthcare continues to rise. In modern times, hospitals have continuously employed aggressive tactics to collect debts from patients, especially those in low-income situations. A recent study published by The New England Journal of Medicine (NEJM) notes that these tactics include wage garnishments, selling debts to third party buyers, reporting of delinquent debts to credit bureaus, lawsuits, seizures of bank accounts, property liens, foreclosures, refusals of care, and even arrests. Politicians on both sides of the spectrum have criticized these tactics, citing the lack of charity care. Since the 1980s, hospitals have shifted away from this in favor of incessant debt collection tactics, according to the investigators. In a recent episode of the An Arm and a Leg podcast, Luke Messac, MD, PhD, discussed his experience in this area. In ...
- Source: drugdu
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- November 15, 2023

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