| Today's Big NewsSep 30, 2022 |
| By Max Bayer Nearly six months after slashing more than a third of its workforce, Solid Biosciences is hoping to get on firmer footing through addition, not subtraction. The company is acquiring fellow gene therapy developer AavantiBio and raking in $75 million in new financing. |
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By Nick Paul Taylor Zealand Pharma’s phase 3 short bowel syndrome study has hit its primary endpoint, delivering data that could equip it to seek approval for a challenger to Takeda’s Gattex. |
Sponsored By THREAD One aspect of study design to consider when building better research experiences for patients is a genuinely patient-centered eCOA (electronic clinical outcome assessment) program. Here are some tips for ensuring that your eCOA is built with the needs of patients in mind and able to deliver the kind of engagement necessary for successful trials. |
Sponsored By Agilex Biolabs Australia’s largest and most technologically advanced provider of regulated bioanalysis and toxicology studies increases capacity by 500% with addition of new in-vivo facility in Brisbane |
By Nick Paul Taylor Kinarus Therapeutics is the latest company to swing and miss at the hospitalized COVID-19 opportunity. After seeing a who’s who of biopharma companies fail, the Swiss biotech has pulled the plug on a phase 2 clinical trial in response to the lackluster efficacy data reviewed at an interim analysis. |
By James Waldron Having overcome FDA trial issues last year, Rocket Pharmaceuticals expects the latest early-stage data for its heart disease drug to give the gene therapy a long-awaited boost into phase 2 trials. |
By Gabrielle Masson As the cell and gene field builds off a quarter of great scientific progress, the industry may be teetering on the brink of transforming medicine as we know it. |
By Zoey Becker After a long and winding road filled with AdComms, the FDA has finally approved Amylyx's ALS drug, Relyvrio. In an interview with Fierce Pharma, the company's co-founders say there is more research to be done and more drugs to be made to meet the unmet needs of ALS patients. |
By Max Bayer Merck's Keytruda has dazzled since first nabbing approval in 2014, earning billions of dollars in revenue and expanding its reach to more than a dozen cancers. But as the drug's patent expiration nears, can Merck manufacture a second clinical lightning strike? |
By Helen Floersh Pinning down backup genes along with the metabolic pathways they’re regulating, has historically required tedious screenings that gave limited information about how different genes interact. Now, a team of researchers has used machine learning to streamline the process and add context that could make precision medicines more precise. |
By Conor Hale The agency’s latest approval for Acuvue Abiliti adds to its number of potential users by allowing the lenses to be offered with stronger vision correction prescriptions. |
By Teresa Carey This week on "The Top Line," we talk with many of the Fierce 15 honorees to find out what makes them unique. We also share highlights from the Fierce Biotech Summit on gene editing innovations and battling biotech's bear market. |
By Gabrielle Masson,Max Bayer Moderna promotes Andres to new future-looking strategy role. Troubled CytoDyn unveils new president amid pipeline pivot. GSK set to bring on Burberry CFO for same role after Mackay retires. |
By Angus Liu Eisai and Biogen's lecanemab clinched a surprise phase 3 Alzheimer's win. Astellas got a less-than-ideal temporary injunction against a Pfizer generic to Lexiscan. Novartis sold a Sandoz Chinese plant to a local CDMO. And more. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we talk with many of the Fierce 15 honorees to find out what makes them unique. We also share highlights from the Fierce Biotech Summit on gene editing innovations and battling biotech's bear market. |
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