BioCentury | Nov 27, 2020
Deals

With $1.5B Sage deal, Biogen bolsters Phase III pipeline ahead of aducanumab decision

Biogen is paying Sage $1.5 billion up front to gain rights to two late-stage CNS products to bolster the company’s pipeline as it approaches one of the biggest binary decisions in recent industry...
BioCentury | Nov 21, 2020
Finance

Mei readies Antengene to take its next steps to becoming a global biotech

Fresh off its $360 million IPO on the Hong Kong stock exchange, Shanghai’s Antengene is looking to take the next step in its evolution by building out its pipeline and launching its first drug....
BioCentury | Nov 14, 2020
Politics, Policy & Law

Candidates for next FDA commissioner

Four former FDA officials and an oncologist are on a list of candidates President-elect Joe Biden’s team is considering as FDA commissioner, individuals who are advising the transition team told BioCentury....
BioCentury | Nov 14, 2020
Deals

Innovation in a hurry: China biotechs see a fast track to global stage – survey

The Chinese biopharma landscape in five years will see a majority of the money magnet companies commanding innovation, with first-in-class targets filling their pipelines and innovative biologics outpacing...
BioCentury | Nov 7, 2020
Politics, Policy & Law

CIRM refuels with $5.5B and a chance to improve its track record

While a narrow win on California’s Prop. 14 has replenished CIRM’s coffers with $5.5 billion, the stem cell institute will likely have to improve its track record to justify the taxpayer outlay. ...
BioCentury | Nov 5, 2020
Product Development

FDA signals relatively clear path ahead for Alzheimer’s therapy aducanumab

FDA appears to be leaning toward approval of the first theoretically disease-modifying therapy for Alzheimer’s disease, or any neurodegenerative disorder, based on two incomplete Phase III trials, one...
BioCentury | Nov 5, 2020
Politics, Policy & Law

HHS proposes regulation sunset rule that could create uncertainty for industry, paralyze FDA

A proposed rule released Wednesday seeks to make regulations from FDA and other HHS agencies automatically sunset 10 years after they have  gone into effect unless the agencies undertake a cumbersome, time-consuming process to renew...
BioCentury | Nov 4, 2020
Politics, Policy & Law

China’s Hatch-Waxman Act: Not there yet

On Oct. 17, China amended its patent law and introduced patent linkage and patent term extension to strengthen protection of pharmaceutical inventions. Unfortunately, the long-awaited changes are unlikely...
BioCentury | Oct 28, 2020
Product Development

Angelman trial pause for antisense oligo comes with efficacy data that lift Ultragenyx shares

GeneTx and Ultragenyx will look to adjust dosing and administration in their Phase I/II trial of GTX-102 to treat Angelman syndrome after patients experienced a serious adverse event thought...
BioCentury | Oct 27, 2020
Product Development

SMA data validate growth factor-targeting platform for Scholar Rock as stock price doubles

Scholar Rock’s interim Phase II data for SRK-015 in spinal muscular atrophy is breathing new life into the theory that blocking myostatin can improve muscle growth and function. It also provides validation...
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