PharmaFocus Today – Page 251 – media

FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The FDA has 49 committees and panels oriented around various therapeutic areas and modalities. As regulatory submissions increasingly include digital components, the agency wants to ensure it is adequately informed about these technologies. It’s adding a digital health advisory committee charged with providing that perspective. The FDA expects the new advisory committee will become fully operational in 2024. It will discuss technologies such as artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. In addition, topics covered by this new committee could include decentralized clinical trials, patient-generated health data, and cybersecurity. The committee will consist of a core nine voting members, including the chair. Members serve terms of up ...
- Source: drugdu
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- October 17, 2023
Opioid use disorder treatment lowers risk of overdose after surgery, study finds

Although people with opioid use disorder (OUD) are significantly more likely to overdose or have a complication after major surgery than those without the disorder, using medications for the treatment of OUD before surgery may eliminate that extra risk, suggests a large, first-of-its-kind study presented at the ANESTHESIOLOGY® 2023 annual meeting. Patients with OUD who didn’t use an OUD medication (such as buprenorphine or methadone) were over four times more likely to overdose after having surgery, yet those who used evidence-based OUD medication before surgery were essentially at no greater risk than those who didn’t have OUD, according to the study. Taken orally, OUD medications reduce withdrawal and cravings and prevent opioids from producing the feeling of euphoria that drives addiction. Anjali Dixit, M.D., MPH, pediatric anesthesiologist at Stanford University, California, said, “We know that OUD treatments are very effective in helping to prevent relapse, overdose and death in nonsurgical ...
- Source: drugdu
- 137
- October 17, 2023
Interest in RNA Editing Accelerates as Therapies Approach the Clinic

By Gerard Platenburg Pictured: RNA/iStock, Artur Plawgo Based on the significant progress made over the last few decades with RNA therapeutics, RNA editing is widely considered the next generation of promising medicines in this field. RNA therapies have made significant progress over the last few years, with an increasing number of FDA approvals beginning in 1998 with Vitravene for CMV retinitis, followed by Macugen for macular degeneration in 2004 and Spinraza for spinal muscular atrophy in 2016. There have also been multiple siRNA-based drugs, including Onpattro for polyneuropathy of hereditary transthyretin-mediated amyloidosis in 2018. And finally, in 2020, perhaps the most well-known products in the RNA space were introduced: the mRNA-based COVID-19 vaccines. All of these demonstrate the strength of RNA therapies and their potential impact on diseases with high unmet need. RNA therapeutics are indeed elegant approaches to altering RNA and thus protein expression, opening the potential to target ...
- Source: drugdu
- 137
- October 17, 2023
FDA Approves Pfizer’s Ulcerative Colitis Drug, $6.7B Arena Buy Pays Off

By Connor Lynch Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis The FDA has greenlit Pfizer’s ulcerative colitis drug etrasimod, marketed as Velsipity, based on Phase III results published in The Lancet, the company announced Friday. Pfizer’s Elevate UC Phase III registrational program, consisting of the Elevate UC 52 and Elevate UC 12 clinical trials, examined the safety and efficacy of a 2-mg daily dose of the oral medication for patients intolerant to or who had failed on trials of a conventional, biological, or Janus kinase inhibitor therapy. Both studies “achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of Velsipity,” Pfizer said in Friday’s announcement. In the Elevate 52 UC trial, 27% of patients achieved clinical remission, compared to 7% of patients receiving a placebo at week 12, and by week 52 it was 32% versus 7%. In the Elevate 12 UC ...
- Source: drugdu
- 108
- October 17, 2023
FDA Clears Pfizer’s Braftovi + Mektovi for Non-Small Cell Lung Cancer Treatment

Treatment indicated for patients with BRAF V600E-mutant metastatic form of disease. Image Credit: Adobe Stock Images/Tex vector Pfizer revealed that the FDA has approved Braftoni (encorafenib) + Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. Previously, the medication was approved for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. “Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, MD, PhD, chief oncology research and development officer, EVP, Pfizer. “Since its initial FDA approval in 2018, Braftovi + Mektovi combination therapy has helped thousands of people living with BRAF V600E- or V600K-mutant ...
- Source: drugdu
- 111
- October 17, 2023
Financial Pressures Drove Nearly 40% of Hospitals M&A Deals in Q3

Hospital M&A activity has been returning to pre-pandemic levels this year, according to a new report. There were 18 M&A transactions in Q3, compared to seven in Q3 2021 and 10 in Q3 of last year. The reason why M&A activity is regaining its momentum is because hospitals are seeking partnerships to grow and protect their long-term financial sustainability — the report found financial distress was the driving factor behind nearly 40% of deals announced during Q3. By KATIE ADAMS Hospitals and health systems have undergone extreme financial pressure in the past couple years, and this issue is being reflected in the sector’s M&A activity, according to a new report from Kaufman Hall. The report pointed out that hospitals’ median operating margins were in the red for all of 2022. Things have gotten better this year, and 2023 will likely end as a much more stable year for hospital finance ...
- Source: drugdu
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- October 17, 2023
Akero’s Three-Step Plan to Win Back Investors

By Jia Jie Chen Pictured: Stocks trending down/iStock, lerbank Shares of Akero Therapeutics crashed this week after the biotech released data from a late-stage trial of its lead candidate, efruxifermin, in nonalcoholic steatohepatitis. Although the Phase IIb study met multiple secondary endpoints, the effect on the primary endpoint was not considered statistically significant. The SYMMETRY trial compared 182 patients with compensated cirrhosis—also known as F4 fibrosis—who were treated with efruxifermin (EFX) with a placebo control group. The data showed that 22% of patients treated weekly with 28 mg of efruxifermin (EFX) saw at least a one-stage improvement in liver fibrosis with no non-alcoholic steatohepatitis (NASH) worsening, while 24% of those treated with 50 mgs of EFX achieved this result; this compared to 14% of patients in the placebo arm who experienced similar improvement. The differences between the placebo group and both experimental arms were not statistically significant, with p-values at ...
- Source: drugdu
- 118
- October 16, 2023
Ozempic’s Pros, Cons and Correct Use Cases

By George Kramb Pictured: Man preparing Ozempic injection/iStock, imyskin Thanks to TikTok, Ozempic has emerged as this year’s go-to weight loss drug. The current debate revolves around a need to understand Ozempic’s true benefits, unmarred by the overshadowing emphasis on weight loss. Ozempic is not a weight loss drug. It is an injectable prescription medicine used “along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes,” according to its label. As such, it is crucial to recognize its multifaceted nature and the responsible approach it demands. Ozempic’s role in the evolving world of healthcare—and inadvertently weight loss—involves both medical benefits and societal perceptions. The Authentic Benefits of Ozempic Amidst the clamor surrounding Ozempic’s media coverage, it’s imperative to redirect the focus to its true advantages when employed for its designated purposes. Ozempic’s primary function lies in regulating blood sugar levels, offering crucial assistance to ...
- Source: drugdu
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- October 16, 2023
Newly discovered synthetic adjuvant materials could make vaccines more accessible, sustainable

New raw vaccine materials that could make vaccines more accessible, sustainable, and ethical have been discovered. Adjuvants are vaccine ingredients that boost a person’s immune response to a vaccine, providing greater protection against disease. One of the most prevalent adjuvant materials used in vaccines is squalene, which is typically sourced from shark livers. Researchers at the University of Nottingham collaborated with the Access to Advanced Health Institute (AAHI) to identify synthetic alternatives to squalene that ensure sustainable, reliable, and ethical sourcing of adjuvant raw materials for vaccines moving forward. New synthetic adjuvant materials were developed from commercially available methacrylate monomers, ensuring that a reliable supply of the material is continually available. The combination of these adjuvant materials are scalable through catalytic chain transfer polymerization, a process that allows high levels of control over the molecular weight of the product polymer. Controlling the molecular weight is key to the use of ...
- Source: drugdu
- 116
- October 16, 2023
How Nemours Children’s Is Working to Solve the ‘Horrendous’ Youth Mental Health Crisis

If you think the state of young people’s mental health in the U.S. hasn’t reached a crisis point yet, you are sorely mistaken, Lawrence Moss said Monday during an interview at HLTH. He is the CEO of Nemours Children’s Health, a pediatric health system with more than 95 locations in four states. Moss gave some sobering statistics on the youth mental health crisis, saying that nearly a quarter of children in the U.S. have a diagnosable mental health disease and that youth suicide rates have quadrupled over the past few years. “When you talk about child health right now, it’s more about behavioral health than physical health. We don’t typically like to think of it that way, but that’s the reality. If you can only do one thing for the health of children in this country, it would be in the behavioral health sphere,” he declared. One of the most ...
- Source: drugdu
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- October 16, 2023

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