PharmaFocus Today – Page 197 – media

Regeneron fends off Viatris’ Eylea biosimilar with patent win

Armed with a new victory over Viatris in a patent dispute, Regeneron can knock off one contender in the Eylea biosimilar race. A West Virginia judge ruled that Viatris’ proposed biosimilar violates a Regeneron patent that covers ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist suitable for intravitreal administration to the eye. That patent is expected to expire in June 2027. Viatris, a generic and biosimilar specialist created by Pfizer through the combination of its Upjohn business with Mylan back in 2020, was the first to file for a coveted Eylea biosimilar in 2021. Regeneron struck back with its suit in 2022, arguing that the proposed copycat steps on 24 of its patents. The complaint was later trimmed to three, according to Bloomberg. Viatris has since offloaded its biosimilars unit to Biocon Biologics in a $3.33 billion cash-and-stock deal. Amgen tried to get into the litigation ...
- Source: drugdu
- 165
- January 3, 2024
‘Disappointed’ IQVIA hit by judge’s decision to uphold FTC’s block of its DeepIntent buyout

A U.S. judge has upheld the Federal Trade Commission’s (FTC) decision to block IQVIA’s long-running attempt to buy the owner of pharma digital ad specialist DeepIntent. The long-running saga centers on IQVIA, the leading biopharma data provider, and its attempt to snap up Propel Media for its DeepIntent business. IQVIA tried to buy Propel back in 2022 (financials details remain unknown), but the FTC last year put a block on the deal, arguing that it would inevitably give IQVIA a market-leading position in advertising for healthcare products, namely prescription drugs, to doctors and other healthcare professionals. According to the official complaint filed by the FTC in 2023, the merger would result in a “heightened motivation” for IQVIA to withhold critical information, hindering competition among rival companies and potential new entrants. Additionally, the complaint asserts that the merger would lead to decreased market competitiveness. The company is one of the world’s ...
- Source: drugdu
- 89
- January 3, 2024
FDA clears neurovascular aspiration, access catheters from Perfuze

BY SEAN WHOOLEY The Millipede catheter. [Image courtesy of Perfuze] Perfuze announced today that the FDA cleared its Millipede 070 aspiration catheter and second-generation Millipede 088 access catheter. Galway, Ireland-based Perfuze developed Millipede 070 to address critical unmet needs in ischemic stroke treatment. It aims to remove clots rapidly and safely through a novel, unique catheter. Millipede 070 has a unique design with a rib-and-recess surface architecture to improve navigability and reduce tip stiffness while maintaining durability. The design features superior deliverability and high procedural efficiency, enabling a more refined approach for restoring blood flow to the brain during endovascular thrombectomy procedures. The company currently has enrollment underway for its MARRS pivotal clinical study to support future regulatory submissions. “Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their opportunity to completely restore blood flow to the brain on their first attempt,” said Wayne Allen, CEO. “The ...
- Source: drugdu
- 173
- January 2, 2024
One VC Firm’s 5 Healthcare Predictions for 2024

Executives at LRVHealth expect to see a continued focus on generative AI, increased enrollment in Medicare Advantage and more in 2024. By MARISSA PLESCIA The healthcare landscape in 2024 presents some interesting challenges and opportunities, whether it’s in regards to generative AI or value-based care, according to executives at LRVHealth, a healthcare venture capital firm. These executives shared five predictions for 2024 with MedCity News: 1. Generative AI will become a reality: Generative AI will become more than “just hopes, dreams and pilot programs” in 2024, according to Keith Figlioli, managing partner at LRVHealth. The healthcare industry will start to actually put AI into practice next year. However, there will be some challenges, as well. 2. “We’ll see at least one event around bias or misuse of generative AI in clinical delivery,” Figlioli said. “Most healthcare companies aren’t applying generative AI to personal health information (PHI), but this event will ...
- Source: drugdu
- 210
- January 2, 2024
Super Factory with International Standards for AIM Bio’ Vaccines Ready for Launch

AIM Bio is gearing up for the imminent launch of its blockbuster products, the 13-valent Pneumococcal Conjugate Vaccine and the 23-valent Pneumococcal Polysaccharide Vaccine. The production lines are ready and preparations are underway for WHO-PQ certification. These super vaccine factories have been designed and constructed according to WHO-PQ standards, fully preparing for the global market, showcasing Emergent’s forward-looking layout and arrangements in the international market. In Emergent’s super vaccine factories, the vaccine production process is monitored in real-time, and batches of vaccine products undergo online review and release. The entire production process is traceable with data records, minimizing human intervention, ensuring the repeatability and consistency of vaccine production, reducing the risk of human error, and lowering the risks of contamination and cross-contamination. The digitization and intelligence have reached a globally leading level. Represented by the workshop for the 13-valent Pneumococcal Conjugate Vaccine in Ningbo, these super vaccine factories designed and ...
- Source: drugdu
- 112
- January 2, 2024
China’s First Domestic Oral Trivalent Reassortant Rotavirus Attenuated Live Vaccine Approved for Market

On December 28, the first domestically developed oral trivalent reassortant rotavirus attenuated live vaccine (Vero cells) produced by China National Pharmaceutical Group Corporation (Sinopharm) Lanzhou Institute of Biological Products received the approval and issuance certificate from the China Food and Drug Inspection Research Institute. The vaccine has been sent to various regions across the country and is about to commence vaccination. Rotavirus is a major cause of severe acute diarrhea in infants and young children, with almost every child under the age of 5 being infected at least once. If not intervened in a timely manner, it may lead to systemic damage affecting respiratory, circulatory, and central nervous systems, and in severe cases, dehydration, shock, and even death. Both the World Health Organization (WHO) position papers and the ‘Expert Consensus on Immunization Prevention of Rotavirus Gastroenteritis in Children’ released in China in 2020 clearly state that vaccination with rotavirus vaccines ...
- Source: drugdu
- 114
- January 2, 2024
Amgen swings into golf sponsorship, rebadging ex-Horizon deals under its branding

Amgen is getting into golf. Having acquired a clutch of sporting sponsorships in the Horizon Therapeutics acquisition, the big biotech has decided to keep the marketing relationship with the Irish Open and other deals going under its own brand. Dublin-headquartered Horizon, which was led by a man once described as “an avid golfer”, was a regular sponsor of sporting events, particularly golf in Ireland. In 2022, the company inked a six-year deal worth $15.5 million to be the title sponsor of the Irish Open. The deal was part of a roster of sponsorships that continued to grow even as Amgen worked to close its $27.8 billion takeover of the company. Now, Amgen has confirmed the commitment to Irish golf will outlive Horizon. Starting next year, the formerly Horizon-sponsored tournament will be rebranded as the Amgen Irish Open. The professional Irish golfers Shane Lowry, Pádraig Harrington, Séamus Power and Brendan Lawlor ...
- Source: drugdu
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- January 2, 2024
Recursion counts the costs of 2023 in…coffee?

Many biopharmas like to take a moment at the end of the year to reflect. Often, these reflections take the form of investments made or received, research undertaken, or drugs approved. For AI biotech Recursion Pharmaceuticals, however, (and this also strikes true for biopharma journalists), the focus of the past 12 months was: Coffee consumption. Posting on X (formerly Twitter), the biotech wrote: “At Recursion, our daily grind goes beyond experiments and algorithms—it’s fueled by a serious love for coffee. We’re big fans of data, so we crunched the numbers to find out how much java powered our teams.” Those numbers are, even for an editor, impressive. The team has a whole drank 5,523,490 mg of caffeine via 58,142 cups of coffee. Dark roast was the roast of choice, with 830 lbs consumed over the year, compared to 385 lbs for light roast, and 391 lbs for decaf. It was ...
- Source: drugdu
- 150
- January 2, 2024
Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager

Shanghai and Suzhou, TOKYO, December 28, 2023 – Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., “Elpiscience”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced a research collaboration and license agreement for novel bi-specific macrophage engagers, ES019 and another program. The two companies will collaboratively conduct early-stage research for these two programs. Elpiscience will also grant Astellas the right to add up to two additional programs to be included in the collaboration. If Astellas exercises its option, Elpiscience will grant Astellas the exclusive right to further research, develop, manufacture and commercialize the products for each program. Elpiscience is a privately held, clinical-stage biopharmaceutical company dedicated to developing next-generation immuno-oncology therapies for cancer patients worldwide. Their Bispecific Macrophage Engager Platform (BiME®) is anti-tumor associated antigen (TAA) and anti-signal-regulatory protein α (SIRPα) bispecific antibody-based platform to activate Tumor Associated Macrophage (TAM) phagocytosis killing towards ...
- Source: drugdu
- 143
- January 2, 2024
Innovent and Xuanzhu Enter into Clinical Trial Collaboration Investigating Combination Therapy of Sintilimab (PD-1 inhibitor) and A Novel ADC Candidate for Advanced Solid Tumors in China

ROCKVILLE, Md. and SUZHOU, China, Dec 28, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and Xuanzhu Biopharma, today announce that they entered into a clinical trial collaboration and supply agreement for the combination therapies of sintilimab injection (brand name: TYVYT®) with KM-501, a novel HER-2 bispecific ADC, as potential treatment options for advanced solid tumors in China. Under the agreement, Innovent will supply sintilimab for the collaborated clinical trial. Xuanzhu Biopharma will conduct a Phase 1b clinical study to evaluate the anti-tumor activity and safety of the combination therapy of sintilimab with KM-501 in Chinese patients with advanced solid tumors. TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company in China. It has been approved and included in ...
- Source: drugdu
- 140
- January 2, 2024

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