BioCentury | Jun 5, 2020
Finance

With $85M series B, Athira seeks to recover neuronal health in Alzheimer’s patients

Athira’s crossover-laden $85 million series B round will fund the start of a pivotal trial this year of an Alzheimer’s disease therapy that the company thinks could not only slow disease progression, but also improve...
BioCentury | Jun 2, 2020
Regulation

June 1 Quick Takes: CHMP recommendations, plus FDA action on AbbVie-Neurocrine, Shionogi, AZ, Lilly, Genentech

CHMP backs Ebola vaccine, targeted cancer therapies  EMA’s CHMP recommended approval of a two-component Ebola vaccine -- Zabdeno and Mvabea -- from Johnson & Johnson (NYSE:JNJ) Friday. The agency also backed two targeted cancer therapies:...
BioCentury | May 23, 2020
Product Development

Hot topics at ASCO 2020

Center stage at this year’s virtual ASCO meeting are a series of hot topics that demonstrate the transformative potential of a single data readout or regulatory update. Areas to watch include next-generation checkpoint targets, where...
BioCentury | May 15, 2020
Regulation

Fourth-line GIST showdown ends in an FDA win for Deciphera, a rejection for Blueprint

FDA approved Qinlock repretinib from Deciphera as fourth-line treatment for advanced gastrointestinal stromal tumors (GIST), marking the first approved therapy for the indication. Also on Friday, competitor Blueprint said FDA issued a complete response letter...
BioCentury | May 13, 2020
Product Development

Gilead secures global access to remdesivir via generic manufacturing deals

The first manufacturing deals for Gilead’s remdesivir, plus a series of grants for institutions across Europe to develop COVID-19 diagnostics and therapeutics, highlight the importance of global collaboration to tackle the pandemic. Gilead Sciences Inc....
BioCentury | May 8, 2020
Regulation

$8B Loxo deal yields first drug with approval of Lilly’s targeted lung cancer therapy

FDA’s approval of Retevmo selpercatinib from Eli Lilly is the second approval for a genetically defined subset of non-small cell lung cancer patients this week. The selective RET inhibitor is the first product of the...
BioCentury | May 7, 2020
Finance

May 6 Quick Takes: Grail raises year’s largest venture round; plus fresh funds for Insmed, Kura, TG, BerGenBio, Limbix and Kineta

New round pushes Grail’s venture tally over $1.9B Grail Inc. raised $390 million in a series D round, marking the year's largest venture round to date. New backers, including Public Sector Pension Investment Board and...
BioCentury | May 6, 2020
Regulation

FDA approval of Novartis’ capmatinib heralds arrival of new targeted lung cancer therapies

FDA’s approval of the c-MET inhibitor Tabrecta capmatinib from Novartis is the first for a series of targeted non-small cell lung cancer therapies expected to reach the market this year. It’s also the first approval...
BioCentury | May 1, 2020
Product Development

April 30 Quick Takes: Pfizer to co-develop Valneva’s Lyme disease vaccine; plus Aravive-WuXi Biologics, Siga-BARDA, Pear, Capricor

Valneva gets $130M up front in Lyme disease vaccine deal  Pfizer Inc. (NYSE:PFE) will collaborate with Valneva SE (Euronext:VLA) to develop VLA15, the biotech’s vaccine candidate for Lyme disease. In a deal announced Thursday, Valneva...
BioCentury | Apr 30, 2020
Product Development

U.K.’s ACCORD platform trial to feed therapies into COVID-19 master protocols

The U.K. has launched the ACCORD platform trial to quickly test potential COVID-19 treatments that could be fast-tracked into larger master protocol trials. The Accelerating COVID-19 Research & Development platform (ACCORD) study is a nationwide...
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