Fierce Biotech

People with a rare eye disease may soon get an alternative to surgery. All 12 members of an FDA advisory committee voted to recommend the approval of teprotumumab, a drug Horizon Therapeutics picked up in its buyout of River Vision two years ago. The agency is expected to make a decision by March 8.

The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients by the notoriously difficult-to-clean devices, and efforts earlier this year to urge the industry to move toward safer designs.

Caresyntax, a Boston-based startup looking to bring automation and artificial intelligence to the operating room, has garnered $45.6 million in new funding and picked up an OR-focused data firm to broaden its footprint.

Early data out of former Fierce 15 winner Gritstone Oncology have been heralded as a big win for the early-stage biotech by analysts.

Amid all the talk about aducanumab and whether it can be approved in Alzheimer’s disease next year in a classic phoenix from the flames tail, Biogen has served up another trial flop.

Anixa Biosciences has delayed a planned IND filing by 12 months to buy time to improve its CAR-T candidate. The delay will enable Anixa to perform additional genetic engineering intended to boost the efficacy of the treatment in ovarian cancer.

A thumping election win for the Conservative Party has positioned the U.K. to push ahead with plans to leave the EU. The new parliamentary arithmetic gives Boris Johnson the numbers to pass the withdrawal agreement and take the U.K. out of the EU, although what will happen after that remains a mystery.

Baylor researchers scoured all of the proteins present in 500 diverse cancers and made a surprising discovery: All of those cancers, it turns out, can be slotted into 10 subtypes, each of which is driven by a common set of proteins. The data may lead to new ideas for drug development in ovarian, breast, colon, renal and uterine cancers, they believe.

After being hit with an FDA rejection for Sarepta Therapeutics' second Duchenne muscular dystrophy drug back in the summer, it looked like a long road, tinged with more than a hint of political intrigue, for it to be approved.

A study of Foundation Medicine’s FoundationOne liquid biopsy test found it was able to predict the risk that a person’s breast cancer would return after being treated for early-stage triple-negative disease.

Pyxis brings on SpringWorks founder Sullivan; Insitro hires chief data officer Batzoglou; Frinzi to step down from J&J Vision.

Almirall is enlisting Iktos to speed up drug design for its discovery programs. Under the deal, the pair will use Iktos’ AI technology to design new compounds that tick multiple drug criteria boxes. Almirall is not disclosing the number of programs the duo is working on, nor is it sharing which disease areas they target.

Pfizer’s 2017 spin-out company SpringWorks has lost president and founder Lara Sullivan, M.D. who has moved over to Pyxis Oncology as its new chief and director.

In this week's EuroBiotech Report, Sanofi inks $2.5B Synthorx takeover and posts sutimlimab data, Roche shares bispecific results and more.

In our EuroBiotech roundup this week, Pfizer Ventures backs ImmunOs, Genmab shares cancer data and Newron delays readout. 

A synthetic form of the active ingredient in magic mushrooms has cleared an early-phase trial. The drug, Compass Pathways’ COMP360, came through the placebo-controlled phase 1 without setting off any safety alarms, setting the stage for further tests in treatment-resistant depression. 

Gilead’s Kite has filed for FDA approval of its second CAR-T cell therapy. Kite hopes to win approval for KTE-X19 in mantle cell lymphoma on the strength of midphase results linking it to a 67% complete response rate.

Pfizer’s Tikosyn (dofetilide) has been available since 1999 to treat patients with irregular heartbeats. Now, years after the drug has gone generic, scientists at Georgetown University have found a potential new use for it—treating pulmonary arterial hypertension.

A decade-long study found patients with early breast cancer may be spared radiation procedures that span the whole breast, and that shorter and less invasive courses of treatment aimed at portions of the breast may be just as effective.

Julie Grant came to life sciences because she was hospitalized a lot as a child. She is the fourth woman to join Canaan’s ranks of general partners. She joins Maha Ibrahim, who focuses on technology investments, and Nina Kjellson and Wende Hutton, who both focus on healthcare.