PharmaFocus Today – Page 319 – media

New ultra-flexible neural implant records single-neuron activity in deep-brain regions

A new ultra-small and ultra-flexible electronic neural implant, delivered via blood vessels, can record single-neuron activity deep within the brains of rats, according to new study. “This technology could enable long-term, minimally invasive bioelectronic interfaces with deep-brain regions, writes Brian Timko in a related Perspective. Brain-machine interfaces (BMIs) enable direct electrical communication between the brain and external electronic systems. They allow brain activity to directly control devices such as prostheses or modulate nerve or muscle function, which can help individuals with paralysis or neurological disorders regain function. However, most conventional BMIs are limited to measuring neural activity at the brain’s surface. Recording single-neuron activity from deep brain regions often requires invasive intracranial surgery to implant probes, which can result in infection, inflammation, and damage to brain tissues. An alternative approach to implanting bioprobes into deep-brain regions is via the brain’s vascular network. Here, Anqi Zhang and colleagues present ultra-flexible micro-endovascular ...
- Source: drugdu
- 114
- July 22, 2023
Novartis acquires DTx Pharma in deal worth up to $1bn

Novartis has announced its acquisition of DTx Pharma, a preclinical stage biotech focused on developing siRNA therapies for neuroscience indications, in a deal worth up to $1bn. The transaction gives Novartis access to DTx’s fatty acid ligand-conjugated oligonucleotide (FALCON) platform as well as its lead preclinical therapy for Charcot-Marie-Tooth disease type 1A (CMT1A). Approximately 150,000 people in the US and Europe are affected by CMT1A, a slow-progressing and degenerative disease of the peripheral nervous system. There are currently no approved treatments to address the underlying genetic cause of the condition: the over-expression of PMP22, a protein that causes the myelin sheath that supports and insulates nerves in the peripheral nervous system to function abnormally. DTx-1252, which was recently granted Orphan Drug Designation by the US Food and Drug Administration, decreases the expression of this protein. “The FALCON platform facilitates this targeted approach by conjugating siRNAs to naturally occurring fatty acids ...
- Source: drugdu
- 147
- July 22, 2023
AstraZeneca/Sanofi’s RSV antibody receives FDA approval for use in infants

AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, the companies announced. The US Food and Drug Administration’s (FDA) decision makes the long-acting antibody the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease. The approval, which also applies to children aged up to 24 months who remain vulnerable to severe RSV disease through their second RSV season, was based on results from the Beyfortus clinical development programme spanning three pivotal late-stage clinical trials and follows a unanimous vote by the Antimicrobial Drugs Advisory Committee on the favourable benefit-risk profile of the drug. Across all clinical endpoints, a single dose of Beyfortus ...
- Source: drugdu
- 130
- July 22, 2023
Sandoz doubles down on biosimilars with $90M Slovenia site where it plans to hire 200

Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest.The Novartis generics unit is plugging $90 million into a new biosimilar technical development center in Ljubljana, Slovenia, where the company aims to hire 200 new staffers. The new site, which Sandoz says will become “key” to its biosimilar development, will feature end-to-end drug substance and drug product development, the company said in a press release Thursday. This isn’t Sandoz’s first foray into the Balkan country. The announcement follows the company’s recent plan to invest a whopping $400 million in a new manufacturing plant there in Lendava. What’s more, Sandoz has already set up prior complex generic development capabilities in Ljubljana. Nearby, the company is also expanding its biosimilar development firepower in Holzkirchen, Germany. The latest move comes shortly after Sandoz unveiled its Act4Biosimilars action plan in June, under which it’s angling to triple global biosim ...
- Source: drugdu
- 142
- July 22, 2023
WHO director-general calls out critics of planned pandemic accords

At the World Health Organization’s (WHO) sixth meeting of the Intergovernmental Negotiating Body in Geneva, the WHO director-general Dr Tedros Adhanom Ghebreyesus has called out critics of the organisation’s planned pandemic accords at the opening remarks of Intergovernmental Negotiating Body’s sixth meeting. “20 years ago, the tobacco industry tried to undermine negotiations on the WHO Framework Convention on Tobacco Control. The same thing is happening now. Groups with vested interests are claiming falsely that the accord is a power grab by WHO, and that it will stymie innovation and research,” he said in his opening remarks on 19 July. The “Pandemic prevention, preparedness and response accord” is an agreement between the WHO member states to “draft and negotiate a convention, agreement or other international instrument under the Constitution of the World Health Organization to strengthen pandemic prevention, preparedness and response”. Member states began developing the pandemic accords in February 2022 ...
- Source: drugdu
- 118
- July 22, 2023
Bodybuilding supplement may help stave off progression of Alzheimer’s

by Rush University Medical Center Graphical abstract. Credit: Cell Reports (2023). DOI: 10.1016/j.celrep.2023.112717 RUSH researchers recently discovered that a muscle-building supplement called beta-hydroxy beta-methylbutyrate, also called HMB, may help protect memory, reduce plaques and ultimately help prevent the progression of Alzheimer’s disease. Results from the study were published in Cell Reports. HMB is not a prescription drug or a steroid, but an over-the-counter supplement that is available in sports and fitness stores. Bodybuilders regularly use HMB to increase exercise-induced gains in muscle size and strength while improving exercise performance. HMB is considered safe even after long-term use, with no known side effects. “This may be one of the safest and the easiest approaches to halt disease progression and protect memory in Alzheimer’s disease patients,” said Kalipada Pahan, Ph.D., the Floyd A. Davis, MD, Professor of Neurology and professor of neurological sciences, biochemistry and pharmacology at RUSH Medical College. Reduces plaques ...
- Source: drugdu
- 127
- July 22, 2023
Sanofi Puts Up $125M to Partner on Oral Drug That Could Be Dupixent’s Successor

Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable. If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent. By FRANK VINLUAN Photo: Nathan Laine/Bloomberg, via Getty Images Sanofi is a dominating presence in inflammation and immunology with Dupixent, a blockbuster drug whose sales continue to grow in multiple approved indications. That product is an antibody administered by injection, so several companies are vying to compete by developing oral alternatives. Now Sanofi is joining them. The Paris-based pharmaceutical giant has struck up a partnership with Recludix Pharma. The deal focuses on the biotech’s preclinical oral small molecules, which have potential applications in a range of immunological and inflammatory diseases. Sanofi has committed to $125 million in near-term payments to Recludix to begin the alliance. San ...
- Source: drugdu
- 116
- July 22, 2023
Shifting tides for weight loss drugs

By Katie Palmer and Lizzy Lawrence As GLP-1 drugs grow in popularity, businesses are adapting to handle the influx of interest. At Noom, which grew up as a behavior-based coaching tool for weight loss, that has meant the launch of a new service to prescribe weight loss medications — and on Wednesday, a new CEO to head up the company. Geoff Cook, who previously led online dating company the Meet Group, will replace founder Saeju Jeong, who will now be executive chairman. Meanwhile, TikTok is cracking down on some users who post frequently about the weight loss drugs. The social media platform has played a large role in the demand for GLP-1s, but earlier this month, TikTok banned dozens of accounts, many of which make money via partnerships with weight loss-focused telehealth companies. “My hunch is TikTok may be worried about this potential avalanche of concern coming from both irresponsible ...
- Source: drugdu
- 112
- July 22, 2023
How doctors are learning to work with GPT-4

By Katie Palmer and Lizzy Lawrence Last week at Beth Israel Deaconess Medical Center, medical residents got a chance to test GPT-4 on a patient case, a workshop the hospital’s training physicians hope can help prepare the next generation of medical minds for the technology. “It’s going to be utterly, utterly transformative, and medical education is not ready,” said Adam Rodman, a clinical reasoning researcher who co-directs the iMED initiative at Beth Israel. “And the people who have realized what a big deal it is are all kind of freaking out.” Read the on-the-ground dispatch from Katie and STAT’s Brittany Trang. Inside the lab, researchers are highlighting the kind of problems those residents could run into using the tool. A recent preprint shows that GPT-4 displays subtle, but systemic racial and gender bias when it’s put to a number of clinical tasks. Read more from Katie. Reference: https://www.statnews.com/
- Source: drugdu
- 145
- July 22, 2023
J&J Flags Potential Interference Between Heart Pump and TAVR Stents in Recall

Dive Brief Abiomed’s Impella heart pumps can potentially interact with transcatheter aortic valve replacement (TAVR) stents, causing damage to the heart pump’s motor, the Food and Drug Administration said in a recall posted Friday. The company, which was acquired by Johnson & Johnson in December, began the recall of its Impella heart pumps in June, warning that the problem could result in low flow from the damaged pump or that the fractured material could block blood flow. Abiomed is not pulling the device from the market, but cautioned physicians to place it carefully in patients. Dive Insight The FDA marked the recall as Class I, its highest risk category. It did not specify whether any injuries or deaths had been reported. The recall includes Abiomed’s Impella CP with SmartAssist, Impella 5.5, Impella 5.0, Impella 2.5 and Impella LD pumps, totaling 9,252 units. ...
- Source: drugdu
- 159
- July 21, 2023

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