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Over our many years of preparing & filing FDA submissions, we have often encountered sponsors who cannot file a New Drug Application or Biologic License Application within expected timeframes; mostly due to a failure to start & complete prerequisite activities before the targeted filing date. Download our checklist to learn how to keep your NDA submission on track.
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Today’s Big NewsOct 27, 2023 |
| By Max Bayer AbbVie CEO Rich Gonzalez says the company was aware of the potential for an ADC transaction with Daiichi that Merck ultimately pounced on, electing to prioritize internal work instead. |
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By Nick Paul Taylor Sanofi has reported setbacks to a trio of candidates bought in by its business development team, halting (PDF) work or posting negative data on assets picked up from Denali Therapeutics, Kymab and Principia Biopharma. |
By Annalee Armstrong A historic moment in pharmaceuticals will happen next week: an FDA advisory committee is set to review the first-ever CRISPR gene editing-based therapy, Vertex Pharmaceuticals and CRISPR Therapeutics’ exa-cel for sickle cell disease. |
Sponsored by WCG The FDA and EMA recommend EACs and DMCs be independent from sponsors and CROs. Our industry expert shares how and when to select the right EAC providers and more to de-risk your clinical trials. |
By Nick Paul Taylor PTC Therapeutics is keeping its regulatory teams busy. In its third-quarter results, the biotech reported pushback against its plans to seek approval for two molecules based on existing data—and saw its share price fall more than 20% in the wake of the update. |
By Annalee Armstrong Medicenna Therapeutics is letting its Nasdag listing lapse after determining the effort to stay on the New York stock exchange was not worth it. The company is also executing a management shakeup as it retreats to Canada. |
By Max Bayer,Gabrielle Masson Johnson & Johnson’s year of transition and restructuring is not slowing down, this time marked by the departure of a longtime key executive. |
By Helen Floersh The small molecule, which indirectly targets the tough-to-drug MYC gene, worked even better when combined with PARP 1/2 inhibitor talazoparib. |
By Ayla Ellison,Kevin Dunleavy In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body. |
By Andrea Park For the second time in the last year, the U.S. International Trade Commission has determined that Apple violated a competitor’s patents in a health-tracking feature of its popular Apple Watch, setting up the devices for a potential ban in the U.S. |
By Fraiser Kansteiner Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. Now, the Swiss pharma giant wants a peek at Takeda’s business records to find out whether its confidential information has been used improperly. |
By Paige Minemyer Despite reporting slightly worse physical and mental health, Americans are feeling more optimistic about their vitality, according to a new analysis from the Cigna Group, which concludes that employers can play a key role in addressing these challenges. |
By Angus Liu In a busy week for the antibody-drug conjugate (ADC) field, Merck signed a three-drug deal with Daiichi Sankyo but abandoned two preclinical assets from Kelun-Biotech. Meanwhile, AstraZeneca and Daiichi's TROP2 ADC disappointed in a lung cancer trial. And GSK in-licensed an ADC from China's Hansoh Pharma. |
Fierce podcastsDon’t miss an episode |
| | In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body. |
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You don’t have to choose between oversized and clean-and-reuse systems. There’s a system that’s fit-for-purpose — which scales all the way up to 200 L and beyond. See how.
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