| 02.11.22 | Cassava clears one hurdle as FDA declines Alzheimer's petition; Giroir returns to biotech with molnupiravir discoverer

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Today's Rundown

Cassava scores a win as FDA declines to intervene in petition to stop its Alzheimer's drug trials Ex-FDA interim chief Giroir rejoins biotech world with eyes on $50M fundraising for new infectious disease company ProQR shares plummet as eye disease treatment flops phase 2/3 pediatric trial Hunting for cutting-edge biotech, Fujifilm sets up early-stage VC fund With approval in sight, ObsEva sells regional rights to women’s health drug for tiny upfront Curevo will go head-to-head against GSK's Shingrix thanks to new $60M financing Lilly back in COVID-19 antibody game with $720 million deal with U.S. for omicron-busting hopeful AHIP presses for clarification on effect of CMS' Aduhelm decision on Medicare Advantage plans Ipsen telegraphs $400M deal for consumer healthcare split Eli Lilly talks up ‘long-term’ game plan for tirzepatide launch, but don’t expect major sales early on Vivocore combines InterVivo, Transpharmation to form neuroscience CRO with an interest in psilocybin Illumina CEO: Here's why speeding Grail's cancer test to patients requires 'every part of our company' Fierce Pharma Asia—Lilly, Innovent’s PD-1 saga; Biogen, Eisai’s Aduhelm rebuttal; Surprise FDA foreign inspections? Chutes & Ladders—Editas fires chief medical officer without explanation

Featured Story

Cassava scores a win as FDA declines to intervene in petition to stop its Alzheimer's drug trials

By Annalee Armstrong

Cassava Sciences has chalked up one win in an ongoing battle over the integrity of its clinical trials for Alzheimer’s disease. The FDA is declining to intervene in a citizen petition's plea to halt ongoing clinical trials of the company's drug, simufilam, saying the petition was not the appropriate venue for such a complaint.

This week's sponsor is PARAXEL Biotech.

Ex-FDA interim chief Giroir rejoins biotech world with eyes on $50M fundraising for new infectious disease company

By Kyle LaHucik

Former FDA Acting Commissioner and Admiral Brett Giroir, M.D., is back in the private sector and jumping into securing a series A for his latest biotech. Altesa BioSciences, which broke cover Thursday, builds upon the work of the Emory scientists behind Merck's COVID-19 antiviral molnupiravir and a billion-dollar HIV treatment.

ProQR shares plummet as eye disease treatment flops phase 2/3 pediatric trial

By maxleiva

ProQR’s treatment for a congenital eye disease in children failed to improve vision and mobility, a tough pill to swallow that Wall Street spat back up.

Hunting for cutting-edge biotech, Fujifilm sets up early-stage VC fund

By Nick Paul Taylor

Fujifilm is pushing deeper into early-stage biotech venture capital, providing fresh funding for a new VC unit and rolling its existing investments in areas such as regenerative medicine and cell therapies up into the group.

With approval in sight, ObsEva sells regional rights to women’s health drug for tiny upfront

By Nick Paul Taylor

ObsEva has found a taker for its near-approval uterine fibroid treatment linzagolix. With the oral GnRH antagonist on the cusp of approval on both sides of the Atlantic, ObsEva has sold rights to the drug in Europe and certain other territories to Theramex.

Curevo will go head-to-head against GSK's Shingrix thanks to new $60M financing

By Max Bayer

Curevo Vaccine is hoping $60 million in financing will help the small biotech literally go head-to-head against GlaxoSmithKline's market-dominating shingles vaccine Shingrix.

Lilly back in COVID-19 antibody game with $720 million deal with U.S. for omicron-busting hopeful

By Kevin Dunleavy

The U.S. has agreed to a $720 million deal for bebtelovimab, the company announced on Thursday. Contingent upon an FDA nod, the company will supply 600,000 courses of the treatment for high-risk patients with mild-to-moderate COVID-19.

AHIP presses for clarification on effect of CMS' Aduhelm decision on Medicare Advantage plans

By Robert King

AHIP commented it strongly supports CMS' decision to narrowly cover the Alzheimer's Disease drug Aduhelm, but it wants more clarification for how the decision will affect Medicare Advantage plans.

Ipsen telegraphs $400M deal for consumer healthcare split

By Fraiser Kansteiner

With the blessing of its board of directors, Ipsen entered exclusive talks with French pharmaceutical compatriot Mayoly Spindler to divest its global consumer health franchise, the company said Friday. Ipsen is in line to receive about €350 million ($398 million) for its CHC unit.

Eli Lilly talks up ‘long-term’ game plan for tirzepatide launch, but don’t expect major sales early on

By Ben Adams

Eli Lilly is taking the long view when it comes to the potential launch of its megablockbuster hopeful tirzepatide, and it's focusing on access programs to ensure patients can get their hands on the diabetes drug without being out-of-pocket.

Vivocore combines InterVivo, Transpharmation to form neuroscience CRO with an interest in psilocybin

By Gareth Macdonald

InterVivo Solutions and Transpharmation have merged to form a neuroscience-focused preclinical services CRO.

Illumina CEO: Here's why speeding Grail's cancer test to patients requires 'every part of our company'

By Conor Hale

The sequencing company’s $1.2 billion in sales marked a new quarterly high, but bigger spends on R&D and administrative expenses pushed net income down 56%. CEO Francis deSouza tells us that spending is key to innovation at Illumina—and he details the ways it will need to help Grail get its blood test to as many patients as possible.

Fierce Pharma Asia—Lilly, Innovent’s PD-1 saga; Biogen, Eisai’s Aduhelm rebuttal; Surprise FDA foreign inspections?

By Angus Liu

Eli Lilly and Innovent Biologics' PD-1 application hit a tough FDA review. Biogen and Eisai launched a formal attack on Medicare's proposed Aduhlem coverage policy. GAO advised the FDA to start running unannounced foreign inspections. And more.

Chutes & Ladders—Editas fires chief medical officer without explanation

By Kyle LaHucik

Editas fired its chief medical officer 15 months into the role. Bayer poached GlaxoSmithKline's oncology leader. Boundless Bio snagged an Ionis executive director.