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Novo Nordisk posts ‘best-case scenario’ cardio outcomes data for star obesity drug Wegovy

Novo Nordisk has been riding the momentum of weight loss drug Wegovy ever since it stormed onto the market in 2021, creating widespread hype and even some supply shortfalls. But, now, a cardio outcomes trial could seriously change the game for the burgeoning medicine. In a large phase 3 trial, the drug cut the risk of major adverse cardiovascular events by 20% compared with placebo and standard of care, Novo said Tuesday. Specifically, investigators measured Wegovy’s 2.4-mg dose for its ability to cut the risk of a cardio death, heart attack or stroke. The trial enrolled 17,604 people and tested the drug for up to five years in people 45 and older who were overweight or obese and who had established cardiovascular disease. To be eligible for the trial, patients had to have had no history of diabetes. Based on the trial win, Novo Nordisk said it expects to seek ...
- Source: drugdu
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- August 10, 2023
J&J signs Stelara biosimilar settlement deal with Formycon and Fresenius

Johnson & Johnson (J&J) has reached a settlement with Formycon and Fresenius over their Stelara biosimilar FYB202, setting its US launch date to 15 April 2025. The companies confirmed that they are on track to submit the biosimilar’s biologics license application (BLA) later this year, based on the 7 August announcement. This marks the third settlement reached by J&J and pharma companies that are trying to market Stelara’s biosimilars this year so far. In May, J&J settled its patent lawsuit with Amgen, setting the biosimilar’s launch to no later than 1 January 2025. A month later, J&J reached a settlement with the producers Alvotech and Teva Pharmaceuticals, with a US licence entry date for their Stelara biosimilar AVT04 of no later than 21 February 2025. Also known as ustekinumab, Stelara was first approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to ...
- Source: drugdu
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- August 10, 2023
Merck and Ginkgo Bioworks enter biologic manufacturing collaboration worth up to $490m

Merck & Co – known as MSD outside the US and Canada – and Ginkgo Bioworks have announced a new biologic manufacturing collaboration worth up to $490m. The partnership will utilise Ginkgo’s capabilities in cell engineering, ultra high-throughput multiplexed screening, protein characterisation and process optimisation to improve production efficiency and increase yields. In exchange, Ginkgo could receive up to $490m in upfront research fees, research milestone fees, option licence payments and commercial milestone payments. Jason Kelly, chief executive officer and co-founder of Ginkgo, said: “We’re thrilled to leverage our platform to improve the production of biologics in collaboration with Merck. “In particular, we will utilise some of our unique capabilities, such as automated protocols to do predictive ultra high-throughput multiplexed screening, product characterisation and process optimisation.” Also commenting on the collaboration, Dr Michael Kress, senior vice president, development sciences and clinical supply at Merck Research Laboratories, said: “At Merck we ...
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- August 10, 2023
MSD and Astex announce expansion to oncology drug discovery collaboration

MSD – known as Merck & Co in the US and Canada – and Astex Pharmaceuticals have expanded their drug discovery collaboration, with the goal of identifying small-molecule candidates with activity towards a tumour suppressor protein. The partnership will see Astex apply its fragment-based drug discovery platform to develop therapeutics targeting forms of the p53 tumour suppressor protein. The candidates will then be handed off to MSD for further optimisation and preclinical development. MSD is granted an exclusive global licence to research, develop, and commercialise candidates arising under the collaboration. In exchange, Astex will receive an upfront payment of $35m and is eligible for milestone payments totalling approximately $500m per programme, as well as tiered royalties on sales. Harren Jhoti, president and chief executive officer of Astex, said: “Astex is applying its fragment-based drug discovery capability to design and generate small molecule modulators tailored to a wide range of potentially ...
- Source: drugdu
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- August 10, 2023
【EXPERT Q&A】Is it mandatory to conduct clinical trials for drug registration in India?

Drugdu.com expert’s response: Based on the years of experience from Drugdu.com, the number and cases of clinical trials conducted in India are related to the current clinical situation and whether the original research drug is marketed locally. Specific issues require case-by-case analysis. In general, for drug registration in India, if it is a chemical drug or a formulation, and the original research drug is already marketed in India, it can be registered as a generic drug in India, and clinical trials can be waived. Some orphan drugs, especially those that face recruitment challenges in clinical trials and are already marketed in the regulatory markets of Europe and the US, can also apply for exemption from local clinical trials. However, for biologics such as vaccines, monoclonal antibodies, and blood products, conducting phase III (bridging) clinical trials locally is mandatory for registration in India. Taking phase III clinical trials as an example, ...
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- August 9, 2023
Clinical Trials drug registration
analysts

Dive Brief Analysts at Needham expect a U.S. Food and Drug Administration advisory panel to support the safety and efficacy of Medtronic’s renal denervation device at a meeting later this month. The meeting, which the FDA scheduled in June, will enable experts in circulatory system devices to discuss the evidence on Medtronic’s Symplicity Spyral and ReCor Medical’s rival renal denervation system. While the analysts expect Medtronic to face questions over the failure of its pivotal trial, they think the experts will vote in favor of the device, putting it on track to target a $1 billion-plus market. Dive Insight Medtronic’s multi-year effort to build confidence in renal denervation as a way to treat high blood pressure hit a snag late last year when a pivotal trial found it worked no better than drugs alone at reducing patients’ blood pressure at home. However, while the missed endpoint was an unwelcome development ...
- Source: drugdu
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- August 9, 2023
Out-of-pocket costs a barrier to treatment for opioid use disorder

Most individuals diagnosed with opioid use disorder are not on recommended medications and even fewer remain in care, according to a research letter published today in JAMA Internal Medicine by lead author Ashley Leech, PhD, assistant professor in the Department of Health Policy at Vanderbilt University Medical Center (VUMC). In 2021, there were more than 100,000 overdose deaths in the United States, with the highest rates among those ages 25-54. Just 22% of the 40,000 individuals with opioid use disorder studied by VUMC researchers continuously used buprenorphine for a full year. And among those who discontinued, many were on the medication for just over a month, which is markedly below recommended levels, the authors said. Stephen Patrick (MD, MPH, senior author, director Center for Child Health Policy at VUMC) said, “Treatment with medications like buprenorphine is safe and highly effective, reducing risk of countless adverse outcomes including overdose death. Nationwide, ...
- Source: drugdu
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- August 9, 2023
Potential treatment for inherited blindness wins FDA fast-track

The US Food and Drug Administration (FDA) is addressing inherited blindness in children after it granted HuidaGene Therapeutics a rare paediatric disease designation (RPDD) to expedite the development and review times of the company’s gene therapy candidate. China-headquartered HuidaGene’s HG004, which received an orphan drug designation in March, is a one-time gene replacement drug intended to treat patients who are affected by inherited retinal diseases (IRDs) caused by mutations in the RPE65 gene. The therapy delivers a functional version of the gene to the retinal pigment epithelium via an adeno-associated virus (AAV) vector. RPE65-induced IRDs include Leber’s congenital amaurosis (LCA), severe early childhood-onset retinal dystrophy (SECORD), early-onset severe retinal dystrophy (EOSRD), and retinitis pigmentosa (RP). The diseases are often present in toddlers and can cause night blindness and a loss of visual field and central vision. The impairment of vision at such an early age likely affects other areas of ...
- Source: drugdu
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- August 9, 2023
Biogen, Sage’s postpartum depression approval overshadowed by larger rejection

While an FDA approval is typically cause for celebration, Sage Therapeutics and Biogen have a tough road ahead to market their new postpartum depression (PPD) drug.Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage. But PPD represents just a fraction of the total market Biogen and Sage were hoping to tap into. Alongside Friday’s approval, the partners also received a rejection for Zurzuvae in adults with major depressive disorder (MDD). The FDA told the partners their application didn’t provide “substantial evidence of effectiveness” and that additional studies would be needed. Sage and Biogen said they are reviewing possible next steps. The dual approval and rejection was “more disappointing than good,” according to analysts ...
- Source: drugdu
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- August 9, 2023
Eli Lilly announces positive results for Retevmo in phase 3 lung cancer study

Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
- Source: drugdu
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- August 9, 2023

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