In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a period filled with patent cliffs and new government-mandated pricing pressure in the latter half of the decade. Bristol Myers will have a relatively stable business through 2025 as large legacy products, though declining, continue to generate sizable chunks of revenue. Still, the company’s focus will center on a growth portfolio that includes 11 key brands and about three dozen clinical candidates. Besides commercialization and R&D efforts, the company remains interested in dealmaking, Boerner said. “This, along with pipeline execution, can best position the company into the transition period,” the CEO told analysts Friday. Bristol Myers has “some clear strengths” compared with other companies that have successfully navigated similar periods of patent losses in the past, Boerner figures. The CEO touted the company’s “expanding growth portfolio across multiple ...
One day after Roche said it was starting to establish Vabysmo as the new standard of care in age-related macular degeneration (AMD) and diabetic macular edema (DME), Regeneron clapped back with the same claim about its new treatment—high-dose Eylea. “We continue to see physicians prescribe Eylea HD in both treatment experienced and treatment naïve settings as Eylea HD is increasingly recognized as the new standard of care,” Marion McCourt, Regeneron’s commercial chief, said as the company presented its fourth-quarter and 2023 earnings. Eylea HD is Regeneron’s response to Vabysmo, which hit the market in the first quarter of 2022 as a game-changing, longer-acting treatment. Vabysmo allowed many patients to reduce dosing from six times a year—with Regeneron’s original version of Eylea—to three times a year. Vabysmo has been an immediate hit as illustrated by Roche’s sales figures, which were presented on Thursday. In its first full year on the market, ...
On February 2, 2024, a batch of trivalent influenza vaccine Anflu® produced by SINOVAC arrived in Santiago, Chile. This is the first time that SINOVAC influenza vaccines have exported finished influenza vaccines prepared from the candidate strains recommended by the World Health Organization for influenza vaccines in the southern hemisphere to a country in the southern hemisphere. The vaccine will be distributed to private vaccination centers in Santiago and other major cities across the country for the local 2024 Southern Hemisphere Influenza Season vaccination campaign starting in March. Bárbara Ester Orellana Álvarez, SINOVAC’s Director of Registration in Chile, said the vaccine is now safely stored in cold storage under license from the Chilean Institute of Public Health (ISP). The timely arrival of this shipment demonstrates SINOVAC’s commitment to providing the Chilean people with vaccines of the highest quality and safety standards. “We are confident that this operation will contribute to ...
On February 1, 2024, Fapon, a global leading life science company, and Bio Farma, a state-owned pharmaceutical holding company in Indonesia specializing in vaccines, life science products, and other pharmaceuticals, signed a memorandum of understanding to formalize their commitment to strengthening medical innovations in Indonesia. In doing so, the memorandum will further solidify Fapon’s global ecosystem for diagnostics and medical treatment. Jielun ZHU, Chief Financial Officer and Chief Investment Officer of Fapon, I.G.N. Suharta Wijaya, Finance and Risk Management Director of Bio Farma and Sri Harsi Teteki, Medical, Institutional and Governance Relations Director of Bio Farma attended the official signing ceremony. The partnership between Fapon and Bio Farma focuses on developing biological medicines and technologies, medical devices, and IVD solutions with an emphasis on healthcare localization. The goal is to foster a synergistic collaboration between the two companies, drive medical innovation and technology transfer, and boost the development of healthcare ...
Drugdu.com expert’s response: Pharmaceutical intermediates are one or more chemical substances generated during the drug synthesis process, playing a crucial role in the production of the final Active Pharmaceutical Ingredient (API). The variety of pharmaceutical intermediates depends on the chemical structure and synthesis pathway of the target drug. Here are some common types of pharmaceutical intermediates: Benzene Ring Intermediates: Many drugs, especially anticancer and cardiovascular drugs, are based on the benzene ring structure. Heterocyclic Compounds: Such as pyridine, thiophene, imidazole, etc., commonly used in pharmaceutical manufacturing. Amino Acids and Peptides: They are the foundation of many bioactive molecules and drugs, like insulin. Carboxylic Acids and Their Derivatives: Often used in the synthesis of anti-inflammatory drugs and antibiotics. Esters and Ethers: Utilized in the synthesis of various drugs, including painkillers and sedatives. Sulfur Compounds and Thioethers: Play an important role in the synthesis of certain special drugs. Aldehydes and Ketones: Key intermediates ...
Dive Brief Medical devices patients can use at home, such as infusion pumps and ventilators, are the top health technology hazard of 2024, a nonprofit patient safety organization said Wednesday. ECRI named at-home devices as the top hazard in response to examples of harms such as medication errors with the use of infusion pumps that suggest products “may be too complex for laypeople to use safely and effectively.” The group identified inadequate or onerous device cleaning instructions as the second biggest hazard of the year, reflecting evidence that reprocessing failures can spread infections. Dive Insight ECRI publishes a list of what it considers the top 10 health technology hazards each year. Devices given emergency authorization during the COVID-19 pandemic and cybersecurity threats topped its lists in 2021 and 2022, respectively, but the nonprofit has since focused on dangers related to at-home products. Last year, Philips’ recall of millions of respiratory ...
Dive Brief Edwards Lifesciences received approval from the Food and Drug Administration for its Evoque tricuspid valve replacement system, making it the first company to bring a transcatheter treatment for tricuspid regurgitation to the U.S. Tricuspid regurgitation is a condition where the valve between the two right heart chambers doesn’t close properly, allowing blood to leak backward. Edwards’ Evoque device is inserted through a minimally invasive surgery and is designed to replace the tricuspid valve. Competitor Abbott has submitted a device for FDA approval called TriClip, which clips together a portion of the leaflets of the tricuspid valve to prevent blood from leaking back. The FDA plans to hold an advisory panel on Feb. 13 to discuss the device. Dive Insight The approval for Evoque is a “meaningful milestone for [Edwards] as well as for the industry,” Shagun Singh, an RBC Capital Markets analyst, wrote in a research note. The ...
Davy James Vabysmo is the first bispecific antibody approved to treat ocular conditions such as diabetic macular edema and wet age-related macular degeneration. Findings from the global Phase III BALATON (NCT04740905) and COMINO (NCT04740931) trials show Roche’s Vabysmo (faricimab-svoa) produced sustained retinal drying and improved vision in patients with retinal vein occlusion (RVO).1 Vabysmo, the first bispecific antibody approved to treat ocular conditions, inhibits a pair of disease pathways involved in multiple vision-threatening retinal conditions by neutralizing angipoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).2 In February 2022, Vabysmo became the first and only FDA-approved injectable eye medicine for diabetic macular edema and wet age-related macular degeneration. “This is the first time that vision and anatomical improvements have been maintained for more than a year in global Phase III studies for both branch and central retinal vein occlusion,” Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global ...
Don Tracy, Associate Editor App aims to leverage digital technology to significantly reduce pharmacy costs. Veracity Benefits and Levrx Technology have announced a strategic partnership with the launch of the Veracity Rx app. The app was developed with the goal of leveraging advanced digital technology to significantly reduce pharmacy costs by 40%-60% below the national average. According to a joint press release, the app provides members with efficient access to their pharmacy benefits and offers personalized, real-time data and insights for saving on medications. “Our collaboration with Levrx Technology is instrumental in streamlining our mission to digitize and promote pharmacy programs that yield optimal health outcomes and deliver financial results,” said James Davie, chief revenue officer, Veracity Benefits, in the press release. “The VeracityRx App is a testament to our commitment to providing cutting-edge solutions that benefit both employers and employees.” According to the companies, the primary features of the ...
Pharmaceutical Executive Editorial Staff Darzalex Faspro has previously been approved by the FDA for eight indications in multiple myeloma. The FDA will evaluate Johnson & Johnson’s supplemental Biologics License Application (sBLA) for Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation therapy and in combination with lenalidomide (D-R) for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1 Darzalex Faspro, a CD38-directed antibody, has previously been approved by the FDA for eight indications in multiple myeloma, with three in the frontline treatment of newly diagnosed patients who are transplant eligible or ineligible. “We are committed to changing the course of multiple myeloma through building combination regimens such as D-VRd with complementary mechanisms of action. The Darzalex Faspro-based quadruplet therapy demonstrated a clinically significant reduction in the risk of progression or death for transplant-eligible, newly ...
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