BioCentury | Jul 2, 2020
Product Development

First Phase III data for an IL-6 mAb in COVID-19 disappoint

A Phase III miss for IL-6 inhibitor Kevzara may not reflect a broader problem with the target or the strengthening theory that immune modulators are the best line of defense against severe forms of COVID-19....
BioCentury | Jul 1, 2020
Politics, Policy & Law

PhRMA sues Minnesota, says law requiring free insulin has ‘staggering’ implications

PhRMA has sued the state of Minnesota to block implementation of the Alec Smith Insulin Affordability Act, a law that requires manufacturers to provide insulin free to thousands of state residents. If allowed to stand,...
BioCentury | Jul 1, 2020
Regulation

June 30 Quick Takes: Another first for Ultragenyx; plus approvals for Genentech’s Phesgo, Keytruda, Bavencio and Ultomiris

Ultragenyx’s Dojolvi wins FDA approval for rare disease FDA approved Dojolvi triheptanoin (UX007) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat long-chain fatty acid oxidation disorders, making it the first drug approved for the indication. The...
BioCentury | Jun 30, 2020
Finance

Qiming-backed Gan & Lee hits ceiling to reach $5.2B market cap in first day on Shanghai

The latest in a string of Qiming portfolio companies to go public, Gan & Lee saw its stock gain the maximum allowed by the Shanghai exchange in its first day of trading to bring its...
BioCentury | Jun 23, 2020
Deals

Vaccines deal with Sanofi to propel Translate Bio’s mRNA therapeutics platform

An expanded deal with Sanofi for vaccines gives Translate Bio a vote of confidence for its mRNA platform, along with $425 million up front that will help the biotech evaluate new therapeutic targets for its...
BioCentury | Jun 23, 2020
Product Development

June 22 Quick Takes: Invitae acquiring ArcherDX; plus lymphoma approval for Karyopharm, Merck, Nabriva, Myovant, Assembly-AbbVie, Genentech and more

ArcherDX picks deal with Invitae over IPO  Genetic testing company Invitae (NYSE:NVTA) is acquiring ArcherDX Inc., adding a cancer diagnostics platform to its precision oncology business. ArcherDX’s shareholders will receive $325 million in cash plus...
BioCentury | Jun 20, 2020
Deals

Clinical scorecard for COVID-19: lessons from the first wave of controlled trials

Breaking through the noise of poor-quality clinical studies are the first clear signals of a treatment paradigm for COVID-19, indicating how and when to use the two major therapeutic approaches -- attacking the virus and...
BioCentury | Jun 20, 2020
Product Development

Regeneron’s commercial future

As its long-standing tie-up with Sanofi winds down, the main loss Regeneron faces is access to the pharma’s commercial footprint, as the biotech has yet to build one for itself. An analysis of Regeneron’s wholly...
BioCentury | Jun 19, 2020
Management Tracks

Dubovsky succeeds Fries as Novavax CMO; plus Carl June to head Ziopharm SAB, Dewpoint, FerGene, Cambrex, Adverum, Epsilen and more

Novavax Inc. (NASDAQ:NVAX), which expects Phase I data for its COVID-19 vaccine in July, hired Filip Dubovsky as SVP and CMO. He succeeds CMO Louis Fries, who has retired. Dubovsky was head of clinical engagement...
BioCentury | Jun 18, 2020
Product Development

Vaccines from CureVac, Imperial enter the clinic as PDS finds a partner for its product

CureVac and Imperial announced trial starts for their COVID-19 vaccines this week. A third vaccine, from PDS Biotech and Farmacore, is expected to start a Brazilian Phase I trial. The trial starts come as the...
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