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We explain what types of agency meetings can be sought in the EU, US, Japan, China, and Canada, and provide details to guide requesting and preparing for agency interactions. Learn more. 
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Today’s Big NewsAug 9, 2023 |
Regeneron adds Decibel to gene therapy playlist, turning up volume on long-running hearing loss collaboration
Nektar CEO slams Eli Lilly's 'egregious error,' laments lost time for rezpeg
Terns, trailing rivals, hits in phase 2 NASH trial but fails to quash differentiation doubts
Novartis' BTK inhibitor hits hives in phase 3, teeing up filings to counter Dupixent threat
Takeda, Denali drop Alzheimer's asset after phase 1 peak reveals 'narrow therapeutic window'
After a 'reset', Beam aims to dose first patient in sickle cell trial this year
Cash-strapped Salarius lays off more than 50% of staff as clinical ambitions prove too costly
Flagship's Alltrna collects $109M as it passes go to Stop Codon Disease
Palisade’s stock collapses as sole asset flunks phase 2 GI trial in post-surgery patients
RNA biotech ADARx hauls in $200M, almost doubling two previous raises combined
Cash-strapped Kiora sharpens focus on rare retinal diseases, looks to partner off other assets
New Epstein-Barr vaccine may thwart infection and later disease, too |
| By Annalee Armstrong Regeneron, listening to the call for more gene therapies, has added hearing loss specialist Decibel Therapeutics to its playlist in a deal valuing the biotech at $109 million at closing. |
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By Gabrielle Masson Nektar Therapeutics CEO Howard Robin is not backing down after the biotech accused Eli Lilly of botching the math behind the formerly partnered immunology asset rezpeg. |
By Nick Paul Taylor Terns Pharmaceuticals has confirmed what other biotechs have already shown: selective activation of thyroid receptor-beta appears to reduce liver fat in non-alcoholic steatohepatitis. But with Terns years behind its rivals, the phase 2a trial failed to clear up doubts about whether TERN-501 can stand out. |
By Nick Paul Taylor Novartis’ fight to hold onto the chronic hives market is on track. With rivals closing in on its blockbuster Xolair, the Swiss drugmaker has reported positive top-line results from a pair of phase 3 clinical trials that will support filings for approval next year. |
By James Waldron Takeda and Denali Therapeutics have made the joint decision to end work on their troubled Alzheimer’s disease therapy after a glimpse at early phase 1 data suggested it would get limited uptake by patients. |
By Max Bayer Beam Therapeutics hasn't yet dosed any patients for its gene-edited sickle cell disease cell therapy, but CEO John Evans says that could happen by the end of the year—if all goes well. |
By James Waldron Despite a string of recent good news on the clinical front, Salarius Pharmaceuticals is halving its workforce and bracing for the potential end of the company as remaining resources are eaten away. |
By Annalee Armstrong Alltrna has raised another $109 million in a series B as the Flagship Pioneering biotech turns its sights on Stop Codon Disease, a range of genetic diseases caused by premature termination codon mutation. |
By James Waldron Palisade Bio has ended development of its lead and only drug in one of two potential indications after it failed to reduce adhesions in patients undergoing bowel resection surgery, sending the biotech’s stock into freefall. |
By Max Bayer ADARx has raked in a $200 million series C, almost twice as much as the previous two joint series B rounds combined. The question now is how quickly can the biotech's RNA pipeline be expanded? |
By Gabrielle Masson Kiora Pharmaceuticals is narrowing its line of sight to only two assets that tackle rare retinal diseases, while two other programs will be handed off to prospective partners. |
By Helen Floersh Interest in developing a vaccine for Epstein-Barr virus, or EBV, has grown as the link between infection and later consequences like multiple sclerosis and cancer has become clear. A new vaccine that appears effective in mice could protect against both short- and long-term disease. |
By Angus Liu After overseeing the approval of KRAS inhibitor Krazati, Mirati Therapeutics CEO David Meek is stepping down. The change comes as Mirati prepares to start a pivotal trial for Krazati and Keytruda in PD-L1-high lung cancer patients. |
By Conor Hale Hand-held ultrasound developer Butterfly Network is clipping its wings with a plan to extend its cash runway, in part by reducing operating costs by an average of $2 million per month. |
By Fraiser Kansteiner In a large phase 3 trial, Wegovy cut the risk of major adverse cardiovascular events by 20% compared with placebo and standard of care, Novo said Tuesday. Specifically, investigators measured Wegovy's 2.4-mg dose for its ability to cut the risk of a cardio death, heart attack or stroke. |
By Anastassia Gliadkovskaya The program will be available to full-time, part-time and hourly employees. They and their partners will have free access to Maven's care team and advocates. |
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| This week on "The Top Line," we discuss how to support patients during the cancer drug shortage, plus this week's headlines. |
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