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Today's Rundown

Featured Story

Lilly, swinging at the king, shows Dupixent rival works in phase 3, but wait for key figures goes on

Eli Lilly is gunning for Regeneron and Sanofi’s blockbuster Dupixent. Having paid $1.1 billion to enter the IL-13 space last year, Lilly has now revealed the success of its challenger in two pivotal trials—but is yet to share the numbers that will show whether lebrikizumab is a true contender for the throne.

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Top Stories

The 7-year itch? Boehringer culls $600M cancer pact with CureVac, heaping more woe to the biotech

Back in 2014, a German pharma and a then largely unknown fellow German biotech in CureVac penned a $600 million mRNA cancer pact. Buried in financials posted Monday morning, CureVac quietly reported that Boehringer Ingelheim has walked away from the deal, which was penned in 2014 and included $45 million upfront plus $556 million in biobucks.

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Investors are tripping on psychedelics startups despite a murky path to commercial success

Eighteen venture capital firms have poured more than $79 million into biopharma companies developing psychedelic compounds into therapies for depression, post-traumatic stress disorder, and more. Two IPOs in the field have outperformed expectations. But all that cash is flowing into an industry that’s facing its fair share of risks.

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Sponsored: Artificial Intelligence in Drug Discovery Requires Validated Data

Machine-learning-based techniques in drug and diagnostic discovery require copious amounts of biomedical data, and that data needs to be validated to ensure success.

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Zombie biotech Sesen Bio's resurrection plans limping again as FDA rejects bladder cancer drug

The stroke of 4 p.m. on a Friday is witching hour for biotechs, and it proved to be a scary night for Sesen Bio. The once zombie, now resurrected biotech was hoping for an approval for its bladder cancer asset Vicineum (oportuzumab monatox-qqrs), but data and manufacturing issues have scuppered those plans.

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FDA lifts clinical hold on Rocket gene therapy trial, creating launchpad for start of pediatric dosing

Rocket Pharmaceuticals’ gene therapy trial is back on track. With the FDA lifting the clinical hold after Rocket changed the study protocol, the biotech is now on course to start dosing children in the third quarter. 

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Beckley Psytech bags $80M to fuel psychedelics for depression, debilitating headaches

With the funding, Beckley Psytech will complete a phase 1b study of psilocybin in a rare, debilitating headache condition and start a phase 1 study of a new formulation of 5-MeO-DMT, a psychedelic found in the venom of the Sonoran Desert toad, before kicking off a phase 2 study in depression.

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Exelixis fuels $15M into the Invenra research engine, firing up a 20-target cancer collab

Exelixis and Invenra are expanding their oncology collaboration for the second time, with Exelixis doling out $15 million upfront this time. The partnership and licensing agreement comes with an additional 20 oncology targets.

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BrainQ reels in $40M to trial AI-powered electromagnetic field therapy device for stroke recovery

The new investment will help cover the costs of a clinical trial that BrainQ is planning to launch in several U.S. hospitals.

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After FibroGen's FDA rejection in anemia, Akebia CEO aims to seize first-in-class opening with vadadustat

In the race for novel oral drugs to treat anemia of chronic kidney disease, AstraZeneca and FibroGen’s roxadustat held the front-runner position for quite some time. But as that program has now stumbled, rival Akebia Therapeutics sees a first-in-class opportunity for its underdog vadadustat.

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Here are 3 major policy areas that health industry groups are closely watching in $3.5T infrastructure bill

As the Senate starts to develop the contents of a $3.5 trillion reconciliation package, industry groups are keeping a close eye on what healthcare policies could eventually be included and what could not.

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Resources

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eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

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Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

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