BioCentury | Sep 17, 2020
Product Development

Sept. 16 Quick Takes: AAT deficiency data lift Arrowhead; plus Metacrine’s IPO, Seer spinout and PDUFA dates for Niemann-Pick, burn therapies

Arrowhead gains on AAT deficiency dataArrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) gained nearly $1.4 billion in market cap Wednesday after sharing interim data from four alpha-antitrypsin (AAT) deficiency patients treated with ARO-AAT in the Phase II AROAAT2002...
BioCentury | Jul 27, 2020
Deals

With deal to promote CanSino’s vaccine, Pfizer validates Chinese company’s R&D, manufacturing

A deal with Pfizer under which the MNC will promote CanSino’s meningococcal vaccine provides a desired validation for CanSino and China’s newer vaccine companies. Pfizer Inc. (NYSE:PFE) will exclusively promote the vaccine from CanSino Biologics...
BioCentury | Jul 11, 2020
Politics, Policy & Law

China moves to deliver patent law reform

More than 18 months after the National People’s Congress discussed an initial set of reforms to China’s Patent Law, a new draft amendment to the law has been released that includes pharmaceutical provisions and adds...
BioCentury | May 23, 2020
Politics, Policy & Law

Delayed expectations for China’s patent reform

Four months after China signed a “Phase One” trade deal with the U.S., patent law amendments may not be among the priorities of the National People’s Congress, leaving it unclear when expected pharmaceutical patent protections...
BioCentury | Mar 27, 2020
Deals

Takeda pursuing exosome therapies through Evox deal

Takeda is betting on Evox’s exosome drug delivery technology via a partnership to develop five protein replacement and mRNA therapies for rare diseases. Evox Therapeutics Ltd., an Oxford, U.K.-based biotech, is eligible to receive up...
BioCentury | Dec 14, 2019
Politics & Policy

Trade deal could advance Beijing’s plans to improve pharma IP protections

A long-awaited U.S.-China trade agreement could help China make progress on an initiative to improve patent protections for pharmaceuticals, which have seen little improvement since early plans were released in 2017. The Office of the...
BioCentury | Nov 15, 2019
Company News

Sarepta partners with StrideBio to enable viral gene therapy re-dosing

To enable repeat dosing of adeno-associated virus gene therapies, Sarepta is partnering with StrideBio to use the latter’s capsid technology in up to eight CNS and neuromuscular programs. The immunogenicity of viral antigens limits the...
BioCentury | Nov 15, 2019
Politics & Policy

China’s CDE clarifies implementation of legislative reforms speeding drug approval

China’s Center for Drug Evaluation (CDE) has released draft regulations implementing recent legal reforms including guidelines for conditional approval and working procedures for breakthrough designation and priority review that could speed approval of new therapies....
BioCentury | Oct 24, 2019
Politics & Policy

Berkeley-Tsinghua transnational IP meeting highlights progress, risks for U.S. and China

Participants at a Berkeley conference Tuesday outlined both encouraging and concerning signals for transnational IP litigation in the U.S. and China. While available data suggest domestic and foreign parties have received equitable treatment in each...
BioCentury | Aug 30, 2019
Politics & Policy

Where innovators see room for improvement in China's Drug Administration Law

The innovative drug industry sees room for improvement and clarification in China's Drug Administration Law, which excluded IP reforms such as patent linkage and data exclusivity. China's National People's Congress (NPC) passed the revised Drug...
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