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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
- 128
- 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
- 112
- 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
- 117
- 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
- 111
- 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
- 106
- 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
- 141
- 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
- 153
- July 21, 2023
Study Shows How NSAIDs Exacerbate C. Difficile Infections

Why do nonsteroidal anti-inflammatory drugs (NSAIDs) exacerbate gastrointestinal infections by Clostridioides difficile, the leading cause of antibiotic-associated diarrhea worldwide? In a new paper published in Science Advances, researchers at Children’s Hospital of Philadelphia (CHOP) have begun to answer that question, showing that NSAIDs disrupt the mitochondria of cells lining the colon, sensitizing them to damage by pathogenic toxins. Clostridioides difficile, often referred to as C. difficile or C. diff, is a bacterium that leads to a wide range of symptoms, from mild diarrhea to complex infection and death. The factors that influence this wide spectrum of clinical outcomes remain largely unclear, but emerging evidence suggests that factors like diet and pharmaceutical drugs influence both susceptibility to infection and disease progression. However, researchers still know very little about how these factors impact the course of C. difficile infection. Prior studies have shown that NSAIDs like indomethacin, aspirin, and ...
- Source: drugdu
- 140
- July 21, 2023
Phase III Data Show Keytruda’s Promise in Earlier-Stage Cervical Cancer

Pictured: Merck Research Laboratories headquarters in Silicon Valley/iStock, Michael Vi Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) aced one of its primary efficacy metrics in the Phase III KEYNOTE-A18 study, the company announced Wednesday. Though its news release was sparse with specific data from the study, Merck said that an independent Data Monitoring Committee found that Keytruda with chemoradiotherapy led to a significant and clinically meaningful improvement in progression-free survival (PFS), as compared with chemoradiotherapy alone. “[T]hese results reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes,” Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, said in a statement. KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized and double-blinded trial enrolling 980 patients with newly diagnosed, locally advanced cervical cancer. To be eligible, patients must also be classified as high-risk, defined as having stage 1B2 to 2B and lymph ...
- Source: drugdu
- 108
- July 21, 2023
J&J, Astellas Join Pharma Lawsuits Over Medicare Drug Price Negotiations

Pictured: Gavel on desk/Courtesy, iStock Astellas and Johnson & Johnson have filed lawsuits against the Medicare program, challenging the constitutionality of the Inflation Reduction Act’s drug pricing provisions. These legal actions add to a growing wave of litigation from drugmakers seeking to block the implementation of the Medicare Drug Price Negotiation Program. The IRA, designed to address rising healthcare costs and make medications more affordable for Americans, has faced significant opposition from the pharmaceutical industry. Friday, Astellas filed a lawsuit challenging the program, arguing that it violates the Fifth Amendment by unlawfully depriving them of their intellectual property rights. The pharma claimed that the IRA’s provisions, which allow Medicare to negotiate drug prices directly with manufacturers, amount to an unconstitutional confiscation of their patented drugs. Tuesday, J&J also filed a lawsuit against the Biden administration over the Medicare Drug Price Negotiation Program. The company asserted in its filing that the program is ...
- Source: drugdu
- 104
- July 21, 2023

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