Bristol Myers strikes up Roche rivalry with $4.1B Turning Point buy Good news or bad news? FDA delays decision for Amylyx's ALS drug—and shares rise Prettying itself up for partners, Athersys lays off 70% of staff and most of C-suite After phase 3 fail, Biogen posts 12-month data cut to make case for ALS prospect In a rare rebuke, FDA refuses to fully review Aeglea's rare disease drug application After deeming success unlikely, Merck KGaA cuts lung cancer trial to consider future of ATR inhibitor Qiming Venture Partners boasts $260M oversubscribed fund, taps biotech leader to impart further wisdom Ashish Jha: COVID-19 vaccines for kids 5 and under could start as soon as June 21 'The Top Line' podcast: COVID therapies dominate 2021's top-selling drugs, raising the curtain on ASCO 2022, plus this week's headlines Pulse oximeters are notoriously inaccurate for darker skin tones—and that may have led to COVID treatment delays, study finds Medicare hospital trust fund to run out of money in 2028, trustees say ASCO: J&J, AbbVie go back to Imbruvica's roots in lymphoma. Will lack of survival win matter? Chutes & Ladders—Former AbbVie R&D chief Severino tapped to lead Flagship-launched Tessera Fierce Pharma Asia—Takeda CEO on drug pricing; Biogen, Samsung's US biosimilar launch; Astellas' antibody pact Featured Story | By Annalee Armstrong Eyeing a rivalry with Roche and a new cancer asset slated to hit the markets next year, Bristol Myers Squibb is picking up Turning Point Therapeutics in a $4.1 billion deal. read more |
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Top Stories By Annalee Armstrong This could be good news, or bad news. Amylyx Pharmaceuticals has received notice from the FDA that the decision date for its amyotrophic lateral sclerosis drug has been extended. read more By Nick Paul Taylor Athersys has reached straight for the big ax in an attempt to chop down on costs. Weeks after the failure of a stem cell trial tanked its stock, the biotech outlined plans to reduce headcount by 70% and remove most of its C-suite to cut costs and “become more attractive to both financial and strategic partners.” read more By Nick Paul Taylor Biogen is back with a fresh cut of data on its antisense amyotrophic lateral sclerosis candidate, pooling the results of a failed phase 3 and an open-label extension in an attempt to find a way forward for the Ionis Pharmaceuticals-partnered prospect. read more By Annalee Armstrong The FDA has no plans to make a decision on whether Aeglea BioTherapeutics’ rare disease drug is approvable, at least not until the company turns over clinical data that demonstrate a treatment effect. read more By Annalee Armstrong Merck KGaA's North American healthcare business, EMD Serono, is discontinuing a clinical trial for a med once considered a star in its oncology program, but an interim analysis has the company changing tactics. read more By Gabrielle Masson Qiming Ventures Partner appears to be living up to its name—which translates to enlightened in Chinese—closing out an oversubscribed $260 million financing round and adding former Atara Biotherapeutics CEO and president to its panel of partners that leads the company. read more By Robert King The White House announced the rollout of COVID-19 vaccinations for kids under 5 could start as early as June 21, with primary care doctors playing a big role. read more By Teresa Carey This week on "The Top Line," we discuss our special report on the top 20 drugs by 2021 sales, and it is no surprise that products that fight COVID-19 dominated the biopharma landscape. We also talk about this weekend’s ASCO meeting and the week's other big headlines. Plus, we have bloopers! read more By Andrea Park Pulse oximeters are among the many medical technologies that are less effective in patients with darker skin tones. A new study indicates that disparity may have led to delays in crucial treatment for COVID-19. read more By Robert King The latest Medicare Trustees report projects the Hospital Insurance Trust Fund will run out of money in 2028, two years later compared to last year's report. read more By Angus Liu Back in 2013, AbbVie and Johnson & Johnson’s Imbruvica got its very first FDA go-ahead, which was for previously treated mantle cell lymphoma. Now, the company is trumpeting a trial win in newly diagnosed patients despite not showing a life-extension advantage. read more By Max Bayer Severino jumps from AbbVie to well-funded Flagship Pioneering spinout building new gene writing tech. Pfizer finds replacement for R&D vax chief Jansen. Shionogi builds out leadership team of U.S. outpost. read more By Angus Liu Takeda's CEO warned that a “perfect storm scenario” could bring down drug prices and hurt biopharma investment. Biogen and Samsung Bioepis have launched the partnership's first U.S. biosimilar. Astellas inked an antibody discovery pact with GO Therapeutics. And more. read more Resources Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Sponsored By: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Catalent In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes. 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