| Today's Big NewsSep 29, 2022 |
Biohaven's Nurtec-less pipeline takes another gut punch, fails ALS trial Aligos demands jury trial to settle Janssen theft allegations, files fraud counterclaims Troubled CytoDyn ditches COVID-19 indication, enters tricky NASH landscape with new leader at helm Novo enters NLRP3 arena, paying Ventus $70M for NASH hopeful Galecto links blood cancer prospect to reduced fibrosis in early data drop Good Idera: Pharma buys rare-disease-focused Aceragen in all-stock deal to keep money flowing With cash dwindling, Axcella shares look at blinded NASH data |
| By Max Bayer Biohaven failed its second clinical trial since the company sold off its migraine franchise to Pfizer back in May. The company's ALS treatment verdiperstat didn't improve symptoms over placebo. |
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By Gabrielle Masson Aligos Therapeutics has responded to Janssen Biopharma’s lawsuit that alleges theft, throwing back their own claims of unfair competition and promissory fraud, as well as demanding a jury trial to settle the matter. |
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By Gabrielle Masson Like many biotechs amid the prolonged bear market, CytoDyn is axing some of its lead programs and trimming down its pipeline. The company's job may be harder than most, however, as it faces an ongoing clinical hold and has decided to focus its efforts on the tricky indication of nonalcoholic steatohepatitis (NASH). |
By James Waldron Novo Nordisk is the latest Big Pharma to get in on the NLRP3 action, paying $70 million upfront for the exclusive license for Ventus Therapeutics’ VENT-01 program in peripherally restricted NLRP3 inhibitors targeting nonalcoholic steatohepatitis, chronic kidney disease and other cardiometabolic conditions. |
By Nick Paul Taylor Galecto has linked its myelofibrosis candidate GB2064 to reduced collagen fibrosis in a small clinical trial, offering early validation of the ability of the LOXL2 inhibitor to act on a variable that affects outcomes. |
By James Waldron With cash expected to run out within a year, Idera Pharmaceuticals was on the lookout for a fresh strategy. And it seems to have found one in the acquisition of Aceragen and the biotech’s pipeline of late-stage rare disease therapies. |
By Nick Paul Taylor Axcella Therapeutics has presented a glimpse at data from its ongoing, blinded phase 2b nonalcoholic steatohepatitis (NASH) trial, linking the high dose of its orally active mixture of amino acids to improved liver stiffness at week 24. |
By Angus Liu An FDA approval now looks all but certain for Eisai and Biogen's lecanemab. But before lecanemab can clear the name of the amyloid beta theory after the fallout from Biogen's Aduhelm launch and before the drug can realize its megablockbuster sales potential down the road, there’s one major hurdle to cross—reimbursement. |
By Conor Hale After more than 430 emergency green lights for COVID-19 tests since the start of the pandemic, the FDA is beginning to wind down its expedited review programs for coronavirus diagnostics, instead urging developers to follow its traditional regulatory paths to market. |
By Fraiser Kansteiner The FDA has scolded a Chinese drugmaker in the wake of an inspection in the spring. In its warning letter, the regulator laid out a laundry list of complaints tied to lapses in Zhejiang Tianyu Pharmaceutica's API production. |
By Dave Muoio Three in 10 hospitals adopted "distinctly" more generous charity care policies while about 8% became more restrictive from 2019 to 2021, researchers found. Still, vague language among many policies as well as merger and acquisition trends raised concerns. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we'll discuss how two Big Pharma companies, GSK and Takeda, made moves this week to bolster their environmental sustainability efforts. We'll discuss their strategies and what we can expect for the future. |
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