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Updated: 8 hours 21 min ago

Horizon’s eye drug teprotumumab wins FDA panel backing in unanimous vote

Fri, 12/13/2019 - 13:58
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.

FDA clears Boston Scientific’s disposable duodenoscope, the world’s first

Fri, 12/13/2019 - 12:51
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.

OR data automator caresyntax nets $45M and a new acquisition

Fri, 12/13/2019 - 07:37
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.

Gritstone posts 'one of the most potent immunogenic-responses for a neoantigen vaccine'

Fri, 12/13/2019 - 06:28
Early data out of former Fierce 15 winner Gritstone Oncology have been heralded as a big win for the early-stage biotech by analysts.

Biogen chalks up another failure, but investors' eyes remain firmly on Alzheimer's

Fri, 12/13/2019 - 05:42
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 delays CAR-T trial in bid to boost efficacy

Fri, 12/13/2019 - 05:37
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.

Tory landslide election victory sets U.K. on path to Brexit

Fri, 12/13/2019 - 05:08
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.

New cancer drug targets emerge from massive protein analysis

Fri, 12/13/2019 - 04:26
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.

Analysts ponder what Sarepta's whirlwind approval means for Biogen—are all bets off?

Fri, 12/13/2019 - 01:04
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.

SABCS: Foundation's blood test predicts early relapses in triple-negative breast cancer

Thu, 12/12/2019 - 16:00
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.

Chutes & Ladders—Pyxis signs on Pfizer spinoff founder Sullivan

Thu, 12/12/2019 - 15:20
Pyxis brings on SpringWorks founder Sullivan; Insitro hires chief data officer Batzoglou; Frinzi to step down from J&J Vision.

Almirall taps Iktos for AI drug discovery work

Thu, 12/12/2019 - 07:42
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.

Pyxis Oncology nabs Pfizer spin-off founder as new CEO

Thu, 12/12/2019 - 07:13
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.

EuroBiotech Report—Sanofi inks Synthorx deal, Roche data, Leo's Dupixent rival and Ipsen

Thu, 12/12/2019 - 06:58
In this week's EuroBiotech Report, Sanofi inks $2.5B Synthorx takeover and posts sutimlimab data, Roche shares bispecific results and more.

EuroBiotech: More Articles of Note

Thu, 12/12/2019 - 06:43
In our EuroBiotech roundup this week, Pfizer Ventures backs ImmunOs, Genmab shares cancer data and Newron delays readout. 

Compass guides magic mushroom drug through early safety test

Thu, 12/12/2019 - 05:58
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 files for FDA approval of second CAR-T therapy

Thu, 12/12/2019 - 05:14
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.

Repurposing Pfizer's heart rhythm drug Tikosyn to treat PAH

Thu, 12/12/2019 - 04:16
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.

SABCS: 10-year study shows targeted radiation can be as effective as whole-breast doses against cancer

Wed, 12/11/2019 - 14:10
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.

Canaan Partners promotes Julie Grant to general partner

Wed, 12/11/2019 - 13:18
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.