BioCentury | May 30, 2020
Product Development

May 29 ASCO Quick Takes: Investors sour on Arvinas’ targeted degraders; plus MacroGenics, Karyopharm, Blueprint

Targeted degrader company Arvinas takes hit on updated proof of concept data  Arvinas Inc. (NASDAQ:ARVN) shed nearly $500 million in market cap Friday after updated Phase I/II data showed no new responses among 12 additional...
BioCentury | May 29, 2020
Management Tracks

Leaving Sanofi, Loew to guide Ipsen’s path forward for troubled musculoskeletal program

Incoming CEO David Loew will arrive as Ipsen tries to recover from setbacks that have hobbled development of palovarotene, one of its two candidates to treat rare disease FOP and the key to its billion-dollar...
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 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 2, 2020
Product Development

Good test hunting: FDA authorizations point to benchmarks for COVID-19 serology

The critical role of COVID-19 antibody testing in reopening society -- combined with controversy around the regulatory flexibility these tests have received and reports that some are performing poorly -- have put all eyes on...
BioCentury | Apr 29, 2020
Emerging Company Profile

Taysha: Applying AAV9 across the CNS

Taysha launched with a $30 million seed round and a team of former AveXis leaders ready to parlay their experience with Zolgensma into a broad pipeline of AAV9-based gene therapies for other CNS disorders. The...
BioCentury | Apr 29, 2020
Politics, Policy & Law

U.S. blueprint highlights sequential COVID-19 antibody testing as route to minimizing false positives

In its COVID-19 Testing Blueprint unveiled Monday, the Trump administration made its latest push to improve the accuracy of serological tests on the U.S. market, this time by doubling them up. But banking on sequential...
BioCentury | Apr 29, 2020
Politics, Policy & Law

Daily chart: White House, CDC and FDA thinking on sequential COVID-19 serological tests

In a COVID-19 Testing Blueprint released April 27, the White House, CDC and FDA illustrated how the accuracy of serological testing for COVID-19 antibodies could be increased by using two tests sequentially, instead of relying...
BioCentury | Apr 28, 2020
Product Development

Blueprint stumbles in GIST race, clearing path for Deciphera

A Phase III miss for Blueprint’s Ayvakit avapritinib in third- and fourth-line GIST likely means the biotech won’t see its NDA approved in the indication, positioning Deciphera to claim a larger share of late-stage settings....
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