Search Results for “Roche” – Page 15 – 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
Bayer wins latest Roundup cancer trial, ending losing streak

Dec 23 (Reuters) – Bayer has won a trial in a lawsuit brought by a California man who said he developed cancer from exposure to its Roundup weedkiller, ending what had been a five-trial losing streak for the company in trials over similar claims. The verdict was handed down on Friday by a jury in San Benito County, California Superior Court, Bayer announced. The company said in a statement that the verdict was “consistent with the evidence in this case that Roundup does not cause cancer and is not responsible for the plaintiff’s illness.” Lawyers for plaintiff Bruce Jones did not immediately respond to requests for comment. Like most plaintiffs in Roundup lawsuits, Jones alleged that the product caused him to develop a form of cancer called non-Hodgkin lymphoma. Around 165,000 claims have been made against the company for personal injuries allegedly caused by Roundup, which Bayer acquired as part ...
- Source: drugdu
- 138
- December 28, 2023
M&A saw an uptick in 2023. Analysts expect the trend to continue

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024. Wielding plenty of firepower, drugmakers are more likely to make higher-value deals in the new year as they address growth challenges that loom later in the decade because of patent cliffs and the effects of the Inflation Reduction Act. “Executives will continue to deploy cash balances and seek out areas of innovation and clinical differentiation,” PricewaterhouseCoopers wrote in its Pharmaceutical and Life Sciences: U.S. Deals 2024 Outlook. “As regulators’ perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps.” Look no further ...
- Source: drugdu
- 229
- December 26, 2023
FDA Grants Priority Review to Genentech’s sBLA for Xolair to Treat Food Allergies

Pharmaceutical Executive Editorial Staff If approved by the FDA, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure, including peanut, milk, and egg allergies. The FDA has granted Priority Review to Genentech’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of allergic reactions, such as anaphylaxis, that may result from an accidental exposure to one or more foods in patients aged 1 year and older with a food allergy. If the FDA approves the application, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure. Roche said it expects the FDA to decide on the approval in the first quarter of 2024. “Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global ...
- Source: drugdu
- 103
- December 22, 2023
Genentech elevates interim CEO Ashley Magargee to full-time leadership position

Genentech’s brief leadership interregnum is coming to an end as the company’s interim chief executive, Ashley Magargee, prepares to take a permanent place on the throne. Magargee, who was tapped to temporarily steer the Roche subsidiary in November, will don the mantle of full-time CEO on Jan. 1, 2024, Genentech said Tuesday. Magargee, who most recently headed up Genentech’s commercial portfolio in addition to her interim CEO duties, is taking the place of Alexander Hardy. Hardy hit the exit back in November and now serves as CEO of BioMarin. Having served at Genentech since 2004, Magargee is no stranger to the South San Francisco-based drugmaker. In terms of her leadership pedigree, Magargee has operated in senior management positions at both Roche and Genentech across life cycle management, digital customer experience and market access, Genentech said in a release. Genentech and its Swiss parent Roche have been locked in a complicated ...
- Source: drugdu
- 89
- December 14, 2023
On Heels of ASH Data, Pfizer Eyes FDA Submission for New Hemophilia Drug

Pfizer already reported its experimental drug for hemophilia A and B met a pivotal study’s goals of reducing bleeding episodes. During the annual meeting of the American Society of Hematology, the company presented a full look at the results, which are expected to support regulatory submissions soon. By FRANK VINLUAN Patients with hemophilia A or B can manage the inherited bleeding disorders with regular infusions of the clotting proteins they lack. This treatment helps—until it doesn’t. One problem with these infused factor replacement therapies is patients can develop inhibitors, which are antibodies that render the clotting proteins ineffective. Experimental Pfizer drug marstacimab takes a different approach to both forms of hemophilia. Results from a pivotal study show the subcutaneously injected drug met the main goals of reducing bleeding episodes. The company also has some additional long-term data showing continuing improvement beyond the initial clinical trial evaluation period. The full Phase ...
- Source: drugdu
- 94
- December 12, 2023
EyePoint Pharma Stock Surges on Phase II Wet AMD-Therapy Results

By Connor Lynch Pictured: A patient being examined by an eye doctor EyePoint Pharmaceuticals marked a major win Monday, with Phase II results of its anti-VEGF therapy for wet age-related macular degeneration showing comparable results to Regeneron’s Eylea on a less-frequent dosing regimen. Share prices jumped over 200% in premarket trading on the news that EYP-1901 had hit all primary and secondary endpoints in the DAVIO 2 trial. The trial was investigating EyePoint’s EYP-1901 therapy, an “investigational sustained delivery maintenance treatment” for wet age-related macular degeneration (AMD) that combines vorolanib, a selective tyrosine kinase inhibitor, with “bioerodible Durasert E,” an injectable drug delivery system. The study tested two doses of the therapy, both 2 mg and 3 mg in 160 patients, finding both met all of the primary and secondary endpoints. That included the primary endpoint of “statistical non-inferiority change in best corrected visual acuity,” compared to the control of ...
- Source: drugdu
- 115
- December 6, 2023
Lilly’s Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing

As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. On Friday, Dec.1, the FDA granted accelerated approval to Lilly’s Jaypirca for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. Jaypirca, which is itself a BTK inhibitor, is now allowed following treatment with a BTK inhibitor and a BCL-2 inhibitor. The ability to help patients who have failed on a BTK inhibitor makes Jaypirca unique. The Lilly med is a non-covalent BTK inhibitor that binds to BTK by a mechanism different from existing covalent agents, namely AbbVie/J&J’s Imbruvica, AZ’s Calquence and BeiGene’s Brukinsa. “Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be ...
- Source: drugdu
- 98
- December 6, 2023
Eli Lilly and PRISM BioLab enter drug discovery collaboration worth over $660m

Eli Lilly has entered into a licence and collaboration agreement with PRISM BioLab aimed at discovering oral inhibitors of a protein-protein interaction (PPI) target, with the deal worth over $660m. The partnership centres around PRISM’s proprietary PepMetics technology, which the Japanese biotech says has the potential to “expand the field of drug discovery by turning previously undruggable PPIs into targets readily druggable with small molecules and by generating oral small molecule alternatives for injectable biologics”. Despite PPI dysfunction being implicated in a broad range of diseases, including cancer, fibrosis and autoimmune disorders, only a small proportion of PPIs are targeted by approved drugs. Lilly, which will select the first PPI target, has the option to add another two to the collaboration and will be responsible for the clinical development and commercialisation of any resulting products. In exchange, PRISM will receive undisclosed upfront payments from Lilly and will be eligible to ...
- Source: drugdu
- 104
- December 5, 2023
AbbVie diversifies oncology portfolio with $10.1 bn ImmunoGen acquisition

In a bid to expand its oncology pipeline AbbVie has announced it will acquire ImmunoGen under a definitive agreement. The proposed $10.1bn acquisition will see AbbVie purchase ImmunoGen’s outstanding shares at $31.26 per share. The acquisition is expected to be completed in mid-2024. On an investor call following the announcement this morning (30 November), AbbVie’s executive vice president and chief financial officer Scott Reents, said the funding of the transaction will be driven by a combination of cash and debt. The exact split of cash and debt has not been indicated, but Reents anticipates that AbbVie will spend at least $2bn in cash in the acquisition. Through the transaction, AbbVie will gain an asset in Elahere (mirvetuximab soravtansine-gynx), ImmunoGen’s lead antibody-drug candidate (ADC), which received an accelerated approval to treat folate receptor alpha (FRα)-positive, platinum resistant ovarian, fallopian tube, or primary peritoneal cancer, in November 2022. As per AbbVie’s executive ...
- Source: drugdu
- 100
- December 2, 2023

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