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Tuesday, January 24, 2023 | 11am ET / 8am PT UGTs are the most common enzymes involved in metabolism after CYP enzymes, followed by numerous hydrolases, carbonyl reductases, aldehyde oxidase and other enzymes. Hear Dr. Brian Ogilvie discuss case studies and strategies to address non-CYP related metabolism questions in your drug’s safety assessment. Register now..
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Wednesday, January 25, 2023 | 1:00pm ET In this webinar, you’ll learn about a case study pursued in collaboration with Geneos Therapeutics and Personalis to utilize a tumor-informed ctDNA assay to retrospectively analyze clinical response to a class of personalized immunotherapies developed against tumor-specific neoantigens in advanced hepatocellular cancer (HCC) patients. Register now.
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| By Nick Paul Taylor Eli Lilly and Merck & Co. have identified PeptiDream’s peptides as a way to deliver therapeutic payloads to targets, leading them both to lay down more than $1 billion in milestones to work with the biotech. |
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By Nick Paul Taylor Unicycive Therapeutics has laid the groundwork for entering a market targeted by Sanofi and Takeda, posting pivotal bioequivalence data on a candidate designed to improve compliance with kidney disease treatment regimens. |
By Nick Paul Taylor Mayo Clinic has signed up to support development of InSitu Biologics’ prolonged-release drug delivery technology for anti-cancer therapeutics. The agreement gives Mayo a financial interest in InSitu Biologics and its platform technology. |
By Nick Paul Taylor Acasti Pharma has shared early clinical data on its betamethasone oral-mucosal metered spray, providing preliminary validation of its belief the delivery format can address an unmet need in a rare, childhood neurological disorder. |
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Thursday, February 2, 2023 | 11am ET/8am PT Regulators have made it abundantly clear - through recent guidance and inspection findings - that demonstrating sponsor oversight of an outsourced study is a critical requirement for TMF health and inspection-readiness. Join this webinar to discover how global biopharmaceutical company Chiesi and its CRO partners collaborate to ensure ongoing oversight compliance, in the face of increasing documentation requirements and trial complexity. Register now.
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By Annalee Armstrong A scathing congressional report has detailed communications described as "inappropriate" and "atypical" between Biogen and the FDA regarding the approval of Alzheimer’s disease drug Aduhelm plus the decision-making behind the pricing and marketing of the now-benched medicine. |
By Kevin Dunleavy Each year, many scientists and other experts working in the biopharma industry see years of their work culminate in FDA approvals. In 2022, however, fewer drugs were approved than was typical in recent years. Is this the result of the FDA becoming gun-shy after its much-criticized sanction of Biogen's Alzheimer's disease treatment, Aduhelm, in 2021? Or was 2022 just a cyclical blip on the approval landscape? |
Fierce podcastsDon't miss an episode |
| This week on “The Top Line,” we discuss the medtech industry’s highest paid CEOs. Plus, we cover Theranos' COO's prison sentence, highlights from the American Society of Hematology annual meeting and other top headlines from this week. |
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| WhitepaperHow can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
| WhitepaperClarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent |
| eBook Catalent’s Carla Vozone discusses the significant trends in the Orally Inhaled & Nasal Drug Delivery (OINDP) segment including large molecules and novel indications. Sponsored By: Catalent |
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| eBook Download now to learn about the benefits of transitioning from intravenous to subcutaneously administration, the advantages of using prefilled syringes, and explore challenges and solutions for transitioning from vials to prefilled syringes. Sponsored by: Catalent |
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