| | Webinar: Removing Antibody Drug Discovery's DNA Bottleneck Tuesday, September 14 | 2pm ET / 11am PT GPCRs have proven to be one of the most challenging targets for antibody drug development. In this webinar, we describe the use of next-generation DNA synthesis tools to overcome the DNA bottleneck in antibody-based GPCR drug discovery. Learn More. |
Teva's pursuit of J&J boosted by FDA acceptance of filing for approval of long-acting schizophrenia drug Impel gets FDA nod to challenge Bausch for migraine market Intarcia faces FDA refusal to approve as push to get diabetes delivery system to market enters endgame Sunovion cashes in sublingual Parkinson's drug, selling EU rights to Bial Meet Neffy, the friendly epinephrine nasal spray from ARS Pharma awaiting FDA approval Featured Story | By Nick Paul Taylor Teva has taken a step toward winning approval for a long-acting injectable to challenge Johnson & Johnson for the schizophrenia market. The FDA has accepted a filing for approval, giving Teva a shot at mounting a push to claim more than 10% of the market starting next year. read more |
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Top Stories By Nick Paul Taylor The long wait for a new formulation of migraine drug dihydroergotamine is over. Having rejected three filings from MAP Pharmaceuticals and Allergan in years gone by, the FDA gave the green light to Impel NeuroPharma late last week. read more By Nick Paul Taylor Intarcia Therapeutics has hit another roadblock at the FDA in its effort to win approval for a GLP-1 delivery system. After issuing two complete response letters and denying three dispute resolution requests, the FDA now plans to refuse to approve Intarcia’s filing for approval in Type 2 diabetes. read more By Nick Paul Taylor Sunovion Pharmaceuticals has found a taker for the European rights to sublingual Parkinson’s disease drug Kynmobi. Bial is on the other side of the deal, putting together an undisclosed financial package to secure rights for a treatment it plans to submit for approval by the end of the year. read more By Beth Snyder Bulik Friendly epinephrine? Meet Neffy, ARS Pharmaceuticals’ nasal spray epinephrine to treat severe allergic reactions to food, medicines and insect bites. Neffy, now awaiting FDA approval, aims to flip the script on past epinephrine autoinjector marketing that focused on fear around the severe reactions called anaphylaxis. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: XIFIN inc. Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Sponsored by: EVERSANA Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how. Sponsored by: Thermo Fisher Scientific Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications. Sponsored by: Blue Matter This white paper provides a concise overview of the trends currently shaping the market access environment in Europe, as well as the implications for biopharma companies. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Discover the current state of patient-focused dose design through clinical evidence, real-world case studies and patient preference-driven drug design solutions that can help develop better treatments and successful real-world outcomes. Sponsored by: Catalent This eBook features insights from experts in the industry on patient-centric drug development challenges and strategies on advancing drug design and development effectively. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Announcing the 9th International mRNA Health Conference November 09-10, 2021 | Mercure MOA Berlin & Online The MedTech Conference 2021 September 27 - 30, 2021 Let A Digital Sherpa Uncomplicate The Path for Patients Wednesday, September 15 | 1 PM ET Virtual U.S. Healthcare Compliance Certificate Program October 11 – 14, 2021 Promotional Review Committee Compliance & Best Practices September 13-15, 2021 | New Brunswick, NJ Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Digital Pharma East September 28-30, 2021 | Pennsylvania Convention Center, Philadelphia | October 5-8, 2021 | Virtual Event Fierce Pharma Marketing Awards September 29, 2021 | Philadelphia, PA Pharma PR & Communications Summit Jersey City, NJ | October 4-5, 2021 TMF Summit October 25-27, 2021 | New Orleans, LA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event | 