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Review pricing/license options and place a preorder Download a free 30-page pre-publication overview (including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits) You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal.
Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “ Demystifying Complex Operations in Psychedelic Research ,” available on-demand now. Check out the full webinar !
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NeedyMeds , a non-profit organization known for providing patients with help in finding pharmaceutical company-sponsored prescription assistance programs and other drug savings options, hosted a webinar about drug importation last year called “ Drug Importation: The topic everyone’s talking about.” The featured speaker was, Shabbir J.
This webinar will highlight how top health systems are tackling these ubiquitous challenges and the steps they’ve taken to innovate across the care continuum. png Listing Introduction This webinar will be sponsored and moderated by Biofourmis. The bottom line is suffering. Click here to login.
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To access the webinar, please go to the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webinar will be available following the presentation. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. About Biogen. Source link:[link].
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Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies.
FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap. 11] Jeffrey N.
CSE: BHSC) (the “Company” or “BioHarvest”) invites its shareholders and the general public to join a Live Video Conference (“Webinar”) on Thursday, January 21st, 2021 at 2:00 PM Eastern Standard Time (11:00 AM Pacific Standard Time). . – January 20, 2021) – BioHarvest Sciences Inc.
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She serves as the Director of Business DevelopmentSearch and Evaluation at AstraZeneca, focusing on licensing and collaboration opportunities for drug candidates targeting respiratory and immunology indications.
However, it does not explicitly address how it might affect products like companion diagnostics (CDx, or IVDs intended to ensure safe use of specific therapeutics) or the regulatory landscape of non-licensed tests used in the course of clinical trials by drug developers.
Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below.
KOL Webinar Information
BioLineRx will host a KOL webinar today, December 16, 2020 at 8:00 a.m. Interested parties can register for the webinar here. Kenilworth, N.J. ,
Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. On June 26, 2025, the Food and Drug Administration eased some of the medicines' reporting requirements. Abecma and J&J’s Carvykti are used for multiple myeloma.
This webinar will give current and prospective investors a clear vision of the Company’s goals for 2021 and beyond. The meeting will consist of presentations from the Company’s management team, with additional commentary from board members and collaborators, and will include a question and answer session for analysts and attendees.
Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. and European drugmakers.
Webinar and conference call. A webinar and conference call for investors and analysts will begin at 2:00 pm UK time today, please join 10-15 minutes prior to the scheduled start time. Webinar ID: 995 4603 8702. The combination represents a significant step in AstraZeneca’s strategic and financial-growth plans.
The regulator is also working on an Innovative Device Access Pathway (IDAP) that mirrors the pathway already in place for drugs (the Innovative Licensing Access Pathway, or ILAP). Canada, Japan, Brazil and Australia. Read AgencyIQ’s complete history and analysis of the lead-up to the proposed medical device regulations here.]
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. To get an approved NDA or Biologics License Application (BLA) you must conduct all phases of clinical studies. A: Yes, the EUA is just temporary. Then you can submit an application for approval.
Published June 27, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that you may have missed. An oral solution of fenfluramine is already cleared in the U.S.
The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” The MHRA is holding a webinar on the new pathway from 11am to 12pm BST on September 14. market more quickly.
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and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.
Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. MHRA also offered an online webinar to learn more about the pathway and public involvement.
Published June 23, 2025 Delilah Alvarado Staff Reporter post share post print email license A micrograph image of influenza A virus. Influenza A virus" [Micrograph]. Retrieved from Flickr.
The following PDUFA dates were obtained from publicly available sources. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).
FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program. The following PDUFA dates were obtained from publicly available sources.
Prohaska, Kavita C. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. The following PDUFA dates were obtained from publicly available sources.
Published June 30, 2025 Jonathan Gardner Senior Reporter post share post print email license Moderna announced results from an influenza vaccine clinical trial on June 30, 2025.
Published July 2, 2025 By Kristin Jensen post share post print email license Endometriosis involves the outgrowth of womb lining tissue in the pelvis or abdomen. Organon acquired the drug in its purchase of Forendo Pharma in 2021.
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