Well, the world has a new wonder drug for preventing HIV AIDS. The FDA approving Gilead's injectable just a few days ago. And joining us right now exclusively to talk about this is Gilead Sciences chairman and CEO Daniel OD.Dan, welcome. Thank you very much for coming here. I I know that this is something you've been working on for a very long time.I think we've been talking about it for over a year at this point, but this is Gilead's focus to try and bring new drugs and hopefully eventually eradicate this ...

Core Insights - Teva Pharmaceutical Industries Ltd. announced the final analysis of the PEARL Phase 4 migraine prevention study, demonstrating that AJOVY (fremanezumab) showed sustained effectiveness over a two-year period in reducing migraine frequency, duration, and severity [1][3] Study Overview - The PEARL study was a 24-month real-world observational study involving 1,140 patients, predominantly female (87.25%), with 33.1% having episodic migraine (EM) and 66.9% chronic migraine (CM) [2][3] - The primary endpoint was a ≥50% reduction in Monthly Migraine Days (MMD) during the first 6 months of treatment, with secondary endpoints including mean change from baseline in MMD and treatment adherence [2] Effectiveness and Adherence - Over 66% of patients with EM and 51.6% with CM achieved the primary endpoint and benefitted from sustained migraine prevention for over 24 months [1][3] - Injection adherence rates remained high at approximately 90%, with over 75% (854 out of 1,129) of participants completing the study duration [1][3] Safety and Tolerability - The final analysis confirmed the favorable long-term safety and tolerability of fremanezumab, consistent with its known safety profile from previous studies [1][3] - The data supports the continued clinical use of fremanezumab for migraine prevention, particularly in populations with high disease impact [1][3] Clinical Implications - The findings underscore the importance of real-world studies in shaping clinical practice and highlight the critical role of CGRP-pathway therapies in improving patient outcomes, especially given that migraine is the second leading cause of disability worldwide [1][3]

Core Insights - Gilead Sciences, Inc. (GILD) received FDA approval for lenacapavir, branded as Yeztugo, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg [1][7][10] - Yeztugo is the first and only twice-yearly PrEP option available in the United States, representing a significant advancement in HIV prevention [1][10] - The approval was based on late-stage studies, PURPOSE 1 and PURPOSE 2, which demonstrated that ≥99.9% of participants who received Yeztugo remained HIV-negative [2][8] Company Performance - Year to date, GILD shares have increased by 18.6%, contrasting with a 4% decline in the industry [4] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as its other prevention drug, Truvada, faces generic competition [12] Competitive Landscape - Yeztugo's long-acting dosing aims to improve PrEP uptake by addressing adherence challenges and stigma associated with daily oral medications [7][10] - Gilead's flagship drug, Biktarvy, holds over 51% of the treatment market share in the United States, indicating strong market positioning [11] - The approval of Yeztugo is expected to catalyze uptake among historically underserved populations, providing a competitive advantage over daily oral pills [11][10] Regulatory and Market Developments - Yeztugo was granted Breakthrough Therapy Designation and has also received validation from the European Medicines Agency for marketing authorization [9] - The approval of long-acting injectable forms of PrEP, such as Yeztugo and ViiV Healthcare's Apretude, indicates a growing trend in HIV prevention strategies [13][14]

Lucid to partner with Hoag in its mission to eradicate esophageal cancer by expanding access to EsoGuard precancer testing across its extensive healthcare delivery networkNEW YORK, June 18, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that Hoag, a nationally-recognized regional healthcare delivery network, has launched a comprehensive, int ...

NORTH CHICAGO, Ill., June 18, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.1 The study met the primary endpoint of treatment discontinuation d ...

MSD Solutions Lab programs unite academic researchers and industry partners to drive innovationWASHINGTON, June 11, 2025 /PRNewswire/ -- The National Safety Council released findings from 2023-2024 MSD Solutions Lab Research to Solutions (R2S) and MSD Solutions Pilot Grant programs. Results showed practical applications and measurable progress toward reducing musculoskeletal disorders (MSDs), the most common workplace injury.Launched by the MSD Solutions Lab, a groundbreaking NSC initiative established in 2 ...

Riskified (RSKD) FY Conference June 10, 2025 02:00 PM ET Speaker0 Well, you guys for showing up today. We have the pleasure of having Ito Gao from Riskified. And then for maybe those who don't know Riskified well, can Ito, could you maybe provide just a brief overview of what Riskified does? Speaker1 Sure. So we started by helping merchants manage ecommerce risk, looking at incoming transactions and understanding if they're fraudulent or not. And over the years, we've expanded to also helping them manage th ...

Group 1: FDA Approval and Product Launch - Merck announced FDA approval for its long-acting monoclonal antibody, clesrovimab, branded as Enflonsia, for the prevention of RSV in newborns and infants [1][7] - The approval was based on data from the pivotal phase IIb/III CLEVER study, which demonstrated a significant reduction in RSV disease and hospitalization in healthy infants [2][7] - Merck plans to launch Enflonsia in the U.S. ahead of the 2025-26 RSV season, with pricing set at $556 per dose and ordering expected to start next month [3][7] Group 2: Market Competition - Enflonsia will face competition from AstraZeneca/Sanofi's RSV antibody Beyfortus, which was also approved in 2023 and achieved blockbuster status in its first full-year sales [6][7] - Sanofi announced plans to increase the supply of Beyfortus, including shipping the antibody early in the third quarter of 2025 [7] - While multiple RSV vaccines are approved for use in the U.S., only Pfizer's Abrysvo is approved for immunizing infants, contrasting with Enflonsia and Beyfortus, which can be administered directly [8] Group 3: Stock Performance - Year to date, Merck's shares have declined by 20%, while the industry has seen a modest decline of 1% [4]

Financial Data and Key Metrics Changes - The company is executing a Fit for Growth program aimed at optimizing its cost structure, with a target of achieving $800 million in net cost savings by the end of the year [44] - The company has successfully executed activities necessary to yield $1 billion in growth and $800 million in net savings [44] Business Line Data and Key Metrics Changes - The company has shifted its focus from primarily neuroscience to include immunology and nephrology, with significant investments in four ongoing product launches [4][9] - The company has nine programs in phase three or phase three ready, indicating a robust pipeline for future growth [7] Market Data and Key Metrics Changes - The U.S. launch of Skyclaris is in a steady growth phase, while initial launches in Europe are progressing similarly [48] - The company has received approval in Brazil for Skyclaris, which is expected to be an important market [49] Company Strategy and Development Direction - The company is focused on redeploying capital from its MS business to support new growth opportunities in nephrology and immunology [5] - The company is actively pursuing business development opportunities, including the acquisition of Hai Bio, to enhance its pipeline [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the foundational position of the company for future capital deployment and growth opportunities [6] - The company is monitoring potential changes in drug pricing policies and tariffs, which could impact negotiations in the EU [14][15] Other Important Information - The company is excited about the potential of its pipeline assets, particularly in rare diseases and kidney diseases, as highlighted in an upcoming investor presentation [40][41] - The company is leveraging AI technology to identify patients for its therapies, indicating a focus on innovative approaches in patient engagement [49] Q&A Session Summary Question: How is the firm balanced now in terms of various disease areas? - The company is leveraging existing expertise in rare diseases while expanding into nephrology and immunology through strategic acquisitions [10] Question: What is the comfort level among PCP providers with the use of blood-based biomarker tests for Alzheimer's? - PCP providers are already using blood-based biomarkers alongside PET scans, indicating a growing acceptance of these tests [26] Question: What are the expectations for the upcoming readouts from the company's trials? - The company anticipates steady progression in growth and is optimistic about the potential for inflection points with new diagnostic tests and treatment methods [27]

SAN JOSE, Calif., June 10, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that its CEO, Dr. Amit Kumar, was interviewed by the New York Post to discuss Anixa's breast cancer vaccine, and the breast cancer vaccine was featured on Fox News' "Fox & Friends." Both the New York Post and Fox News highlighted the potential of Anixa's vaccine to change the paradigm for breast cancer tr ...