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Tuesday, October 1, 2024 | 11am ET / 8am PT The clinical trial landscape continues to evolve at a rapid pace. In this webinar, learn how new biomarker detection technologies drive key breakthroughs. With early detection, biomarker testing research can advance disease understanding and management in many care areas. Register now to join us.
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Today’s Big NewsSep 27, 2024 |
| By Fraiser Kansteiner Bristol Myers Squibb’s $14 billion deal for Karuna Therapeutics has borne fruit with the approval of a promising new schizophrenia drug. |
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By Nick Paul Taylor Cassava Sciences has agreed to pay $40 million to resolve an investigation into claims it made misleading statements about phase 2b data on its Alzheimer’s disease drug candidate. |
By Kevin Dunleavy Regeneron and Sanofi have announced that the FDA has expanded the label of megablockbuster Dupixent to treat COPD. With the nod, Dupixent becomes the first biologic treatment for COPD patients in the U.S. |
By Conor Hale Mendaera’s approach combines real-time imaging with robotic guidance for percutaneous procedures spanning biopsy, vascular access, pain management and more. |
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Tuesday, October 8, 2024 |10am ET / 7am PT In this webinar, you'll learn how companies can navigate the challenges of global expansion after their first regulatory approval. Discover how to make data-driven market entry decisions, launch efficiently, stay adaptable, and leverage commercial partners through case studies and real-life examples. Sign up to join us!
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By Fraiser Kansteiner Following the FDA's green light for a combo regimen of Sanofi’s Sarclisa in patients with newly diagnosed multiple myeloma last week, J&J has wasted little time hitting back with new data on its own cancer quartet leveraging the company’s subcutaneous oncology stalwart Darzalex Faspro. |
By Angus Liu The days of broad approvals for PD-1 inhibitors in stomach and esophageal cancers appear to be numbered. A group of external advisers to the FDA voted that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer and first-line esophageal cancer were not favorable in patients who have PD-L1-negative tumors. |
By Ben Adams After nabbing a new FDA license for Rexulti in Alzheimer’s agitation last year, the drug’s marketing duo Lundbeck and Otsuka are diving into the deep end to spread awareness about the disease. |
By Darren Incorvaia,Zoey Becker As the biotech approaches $1 billion in sales, Acadia CEO Steve Davis is stepping down and being succeeded by Catherine Owen Adams. Adams most recently led a $20 billion business as senior vice president and general manager, U.S., at Bristol Myers Squibb. |
By Fraiser Kansteiner Travere is pausing enrollment in its Harmony study evaluating pegtibatinase in classic homocystinuria to make improvements on manufacturing scale-up for commercial production and to fully enroll the phase 3 trial. |
By Nick Paul Taylor Biomea Fusion has escaped from the full clinical hold imposed by the FDA. After reviewing the data, the regulator has cleared Biomea to study its diabetes drug candidate under a revised protocol intended to mitigate liver toxicity concerns. |
Fierce podcastsDon’t miss an episode |
| | In this week's "The Top Line," Fierce journalists discuss key issues from promising but debated lung cancer data at recent conferences. |
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The effect of small strands of siRNAs on gene expression has had a
tremendous impact on basic and applied pharmaceutical research.
Download the QPS white paper to learn about siRNA identification,
profiling, and quantitation from the technical experts at QPS.
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| WhitepaperUnlock the Future of Biotherapeutics with Catalent Biologics! Sponsored by: Catalent Biologics |
| WhitepaperFinding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner. Sponsored by: IQVIA |
| WhitepaperUnique Solutions for Drug Discovery and Development Sponsored by: Cell Signaling Technology |
| WhitepaperWhen the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions. Sponsored by: WCG |
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| WhitepaperFacing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market. Sponsored by: Veranova |
| WhitepaperWe interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned. Sponsored by: Blue Matter Consulting |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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