Will we ever land the Alzheimer's moonshot? Genentech's crenezumab partners reflect on failure Dilution be damned: Scholar Rock raises $205M as 24-month data point to durability of SMA efficacy Back to SPAC: Zura Bio opts for blank-check route to fund Pfizer drug into phase 2 Sponsored: An Integrated Approach to Developing Next-Generation Genomic Medicines Trial site staff shortages, sluggish patient recruitment force Addex to scrap phase 3 Parkinson's study Cytokinetics' heart failure drug delayed as FDA seeks more time for review Pfizer chisels off stake in Akero with $25M equity investment to support NASH dreams Doubling up: Checkpoint on track to expand indications for cancer drug approval request Mind over matter: Scientists unlock regeneration mechanism for brain injury Screen addicts, rejoice: J&J Vision to roll out contact lenses designed for digital device fatigue FTC puts drugmaker and PBM rebates in the crosshairs over mounting insulin prices 'The Top Line' podcast: The top 10 list of pharma profits turns up some surprises, bluebird bio's gene therapies win over FDA's expert panel, plus this week's headlines Fierce Pharma Asia—Daiichi AML med's 2nd FDA shot?; BeiGene's Brukinsa delay; Kyowa Kirin mulls asset sale Chutes & Ladders—Despite gender parity strides, biotech's upper echelons still skew male, white Featured Story | By Annalee Armstrong In a moment of public reflection, the partners on Genentech's failed Alzheimer's disease therapy consider what happened, what they learned and what happens next. read more |
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Top Stories By Nick Paul Taylor Stuck in a hard place, Scholar Rock has raised $205 million while its stock is at an all-time low to secure the cash it needs to survive through to the delivery of phase 3 spinal muscular atrophy (SMA) data. The biotech disclosed the financing alongside 24-month data from its phase 2 trial of apitegromab in SMA. read more By James Waldron The SPAC route may have fallen from favor, but at least one biotech is still willing to give it a try. Zura Bio, whose lead asset is an autoimmune drug licensed from Pfizer, has announced plans to merge with blank check company JATT Acquisition Corp. to the tune of $189 million. read more Sponsored by: Danaher Corporation The life sciences companies at Danaher enable gene editing, gene therapy and mRNA medicines with integrated solutions that improve research, development and manufacturing. read more By Nick Paul Taylor Addex Therapeutics waited more than a decade for the chance to learn whether dipraglurant is effective in dyskinesia associated with Parkinson’s disease (PD-LID), suffering delay after delay after delay as it tried to get a late-phase trial started. After all that, the phase 2b/3 trial has crashed out before delivering data. read more By Annalee Armstrong The FDA needs more time to consider Cytokinetics’ omecamtiv mecarbil after getting a look at some additional data. read more By Annalee Armstrong Pfizer has dropped off a little bit of cash in the form of an equity investment for Akero Therapeutics, adding $25 million for the biotech to continue work on two midphase trials in the difficult liver disease nonalcoholic steatohepatitis. read more By James Waldron Interim phase 1 results have sustained Checkpoint Therapeutics’ hopes for a second indication for its lead anti-PD-L1 antibody. read more By Gabrielle Masson Scientists have discovered a new collaborative mechanism that unveils how neural stem cells sense injury and communicate for tissue repair, moving science closer to boosting neuron regeneration after brain damage. read more By Conor Hale Johnson & Johnson Vision announced its Acuvue Oasys Max 1-Day lenses have received regulatory green lights in the U.S., Canada and Europe. read more By Fraiser Kansteiner With FTC's latest enforcement policy statement, the regulator warns that it’s putting pharma companies and prescription intermediaries “on notice” that rebates and anti-competitive fees to exclude cheaper drug alternatives from prescription formularies could run afoul of competition and consumer protection laws. read more By Teresa Carey This week on "The Top Line," we discuss our special report on the top 10 most profitable pharma companies in 2021. We also talk about the two bluebird bio gene therapy candidates that won expert recommendations for FDA approvals. Plus, we're back in person (and on billboards) at BIO. read more By Angus Liu Daiichi Sankyo's once FDA-rejected leukemia med tees up new regulatory application. BeiGene's application for Brukinsa in chronic lymphocytic leukemia hit a three-month FDA delay. Kyowa Kirin is reportedly weighing the sale of some international assets. And more. read more By Fraiser Kansteiner The gender divide in biotech is starting to close, according to BIO's third annual diversity survey, but there's still much work to be done, especially at the top level of the industry. read more Resources Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. 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