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Wednesday, February 15, 2023 | 1pm ET / 10am PT Biosimilars continue to gain global acceptance and momentum, with 2023 set to be a landmark year. However, the complex and ever-changing regulatory environment is still a challenge. Join industry experts for an important discussion on biosimilar regulatory trends and key insights for navigating the biosimilar regulatory landscape. Register now.
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| By Nick Paul Taylor Eisai’s full-throttle development of a subcutaneous sibling to recently approved Alzheimer’s disease drug Leqembi could bear fruit in the coming quarters, with the Biogen-partnered drugmaker aiming to file for approval in the next year or so. |
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By Nick Paul Taylor Recurv Pharma has netted $24 million to take a new spin on an old idea through to phase 2a. With TVM Capital Life Science in its corner, the biotech is positioned to deliver clinical proof-of-concept data on its nano-emulsion taxane formulation. |
By Nick Paul Taylor Orexo has filed for FDA approval of a nasal high-dose naloxone formulation based on its amorphOX drug delivery technology, putting it on track to bring the opioid overdose rescue formulation to market in the first half of 2024. |
By Nick Paul Taylor Revive Therapeutics has added a MDMA microneedle patch to its portfolio of projects, partnering with PharmaTher to prepare a candidate for clinical development in multiple indications. |
By Kevin Dunleavy Regeneron anticipates an August launch for its new longer-lasting version of Eylea as it tries to fend off Roche's Vabysmo. Eylea delivered an 8% increase in sales last year, despite a 3% drop in the fourth quarter. |
By Annalee Armstrong A day after imposing a second round of layoffs, Inovio revealed a small data set for its Ebola vaccine booster, which the company hopes could someday also boost its fortunes. |
By Ben Adams,Zoey Becker,Kevin Dunleavy For the third year in a row, Evaluate Vantage’s most hotly tipped drug approval when it comes to future sales potential is an Alzheimer’s therapy, but there is far more caution in this year’s list than we have seen before. |
By Conor Hale,Andrea Park In 2021, light at the end of the COVID tunnel spurred an explosion of medtech deals. But in 2022, that exuberance waned. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss what we can expect from the obesity market in 2023. We also recap the drugs approved last year. |
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Tuesday, Feb 28, 2023 | 11:00am ET The heavy lifting for the pharmaceutical industry to comply with the November 2023 DSCSA go-live date is still ongoing. One item now finalized is to ensure that the required data exchange through the supply chain is only done with trusted, authorized, and registered trading partners. Join us for this discussion to stay up-to-date on this important legislation and be prepared for compliance. Register now.
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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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| May 1-3, 2023 | Jersey City, NJ |
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