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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 23, 2023 |
| By Annalee Armstrong Daiichi Sankyo and AstraZeneca finally have some clarity on the deaths that occurred in two phase 3 studies for their Enhertu follow up Dato-DXd. The gist of the safety update is that more patients in the lung cancer study experienced a key adverse event when taking Dato-DXd compared to breast cancer. |
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By Annalee Armstrong BioNTech’s new manufacturing process for CAR-T seems to have done the trick in boosting the potency of the solid tumor therapy BNT211, but that bit of extra juice seems to have upped the side effect profile as well. |
By Nick Paul Taylor Roche really was lining up a $7 billion challenge to Merck & Co. Months after a media report about a potential deal, the Swiss drugmaker has agreed to pay Roivant and Pfizer $7.1 billion upfront for regional rights to a bowel disease candidate that is on the cusp of phase 3. |
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 Annalee Armstrong,Max Bayer A nearly year-long clinical hold on Verve Therapeutics’ base editing therapy meant to treat a genetic form of high cholesterol has been lifted in the U.S., thanks to data from an ongoing human trial elsewhere in the world and some preclinical work that has allayed the FDA’s concerns. |
By James Waldron If it wasn’t enough for Cargo Therapeutics to raise $200 million and recruit a C-suite of biopharma veterans so far this year, the CAR-T-focused company is now eying up an IPO. |
By Annalee Armstrong MADRID—If Eli Lilly could simply offer an oral option in place of Faslodex for breast cancer, Jacob Van Naarden would be happy. Early evidence shows that the Indianapolis-based pharma’s oral SERD may be able to do that. |
By Annalee Armstrong Merck & Co. showcased early pharmacokinetic data from its KRAS G12C inhibitor MK-1084 at the European Society for Medical Oncology, suggesting the candidate may be able to find a way around some of the challenges that have troubled earlier entrants to the space. |
By Nick Paul Taylor Merck & Co. is pruning its pipeline of antibody-drug conjugates. Days after Merck paid $4 billion for three Daiichi Sankyo assets, Kelun-Biotech has revealed the Big Pharma has decided (PDF) to pass on two of its preclinical ADCs. |
By Annalee Armstrong Responses to Merus’ bispecific antibody in pancreatic and lung cancer are creeping higher with every data cut, giving CEO Bill Lundberg confidence that the dual American and Dutch biotech may someday be able to give a much-needed lifeline for one of the most difficult cancers out there. |
By Annalee Armstrong When patients reached Ambrx Biopharma’s phase 1/2 clinical trial for prostate cancer, they were nearing the end of their treatment journey. CEO Daniel O’Connor and Chief Clinical Officer Sandra Aung don’t take that lightly. |
By Gabrielle Masson GSK is the latest to partake in a string of recent antibody-drug conjugate deals, dishing out $85 million cash and up to $1.4 billion in biobucks for Hansoh Pharma’s gynecologic cancer asset. |
By Angus Liu As Novartis aims to move its radiotherapy Pluvicto into an earlier treatment setting in prostate cancer, it has posted a mixed bag of trial data that cast a cloud of uncertainty over its regulatory path forward. |
By Andrea Park Once again, Philips has been hit with an FDA Class I label for a correction to certain of its respiratory support devices. |
By Nick Paul Taylor Alright, alright, alright, Matthew McConaughey is lending his smooth Texan voice to a cancer awareness campaign. Working with Stand Up To Cancer (SU2C) and Visit Myrtle Beach, the Oscar-winning actor has created a public service announcement to raise awareness of the importance of funding cancer research. |
By Annalee Armstrong ESMO attendees arrived in Madrid to torrential downpours Thursday evening, a gloomy atmosphere that did not reflect the overall excitement of an industry conference that promised to showcase breakthroughs in breast, lung and prostate cancer. |
By Conor Hale Both companies have sought to build digital platforms with the ability to tap into patient communities and collect real-world information that could be useful to medical product designers and drug developers. |
Fierce podcastsDon’t miss an episode |
| In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients. |
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