Commentaries

兑现中国知识产权改进承诺的时机已至

Publisher's note: the English language version of this article may be found here . 两年前的今天, 2017年10月8日, 中共中央和国务院的最高机构制定了知识产权改革的路线, 下决心推动中国进入全球医药创新的生态系统。 可惜这一宏伟规划尚未付诸实施。 当中美谈判代表本周在华盛顿举行新一轮贸易谈判之时, 中国有机会将这一承诺变为现实。 中国实施其在2017年作出的改进知识产权保护的规划将为提升中美互信取得突破, 同时激励中国的新药研发企业为中国乃至全球的患者创造新药。 美好愿景  2017年的两办意见宣布改进中国药品审查和注册制度、 鼓励创新、 应对公共卫生挑战, 为行业带来了希望的春风。 中共中央办公厅、 国务院办公厅印发的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》 (两办意见) 包含36项改革措施, 并要求政府有关部门认真贯彻落实。 两办意见特别列出了药品知识产权保护的四项改进措施: 措施15:建立上市药品目录集(在制药行业称为“橙皮书”),载入新药专利保护和试验数据保护等信息。...

Time to fulfill China’s promise of IP reform

Two years ago, on Oct. 8, 2017, the top bodies of the Chinese Communist Party and the Chinese government created a pathway to IP reform that promised to propel the nation into the global innovation...

Biopharma, patients should demand changes to CFIUS regulation

In a misguided effort to protect U.S. national security, the Treasury Department has proposed barriers to Chinese investments in U.S. biopharma companies that would slow the development of new medicines, constrain funding for emerging companies...

Foreign investment in U.S. biotech will become harder, and stay harder

It would be easy to brush aside the government’s increased scrutiny of foreign investments in U.S. companies in the interest of national security as either a temporary symptom of the trade war or a policy...

Letter to the Editor: Business Roundtable vs. the social contract

In a Sept. 13 Editor’s Comment in BioCentury, our Washington Editor Steve Usdin writes about the importance of the biopharmaceutical industry renewing its commitments to the social contract under which corporations do business and reap...

Another chance to renew the social contract

The Business Roundtable, a club of CEOs of many of the largest U.S. corporations, has given biopharma companies a new impetus for telling the public how they plan to live up to their social commitments....

China’s biosimilars in fast lane

Though coming from behind, China is cracking the seal on its biosimilar market and may even be poised to over-take the U.S. and Europe in less than a decade. On February 22, 2019, China’s National...

Moving Beyond a Buzzword: How small- to mid-sized biotechs can adopt patient centricity in oncology trials

A major benefit of integrating the patient voice into clinical trials is the ability to speed enrollment, yet few companies take advantage of this due to the perception that it is too costly and time-consuming....

Fearmongering about China diminishes American life sciences competitiveness

No country has ever spied its way into technological superiority. The Soviet Union tried mightily and failed miserably. This lesson is relevant at a time when members of Congress are making unsubstantiated allegations about Chinese...

No more crickets: The biopharma industry must speak out against the Trump administration’s fetal tissue ban

When President Donald Trump considered a range of options about regulating the use of fetal tissue in medical research, he made a simple political calculation. A ban would solidify support from religious anti-abortion advocates, while...

There are opportunities to eradicate opioid misuse: Investors and innovators should seize them

Eradicating opioid misuse and addiction will take an integrated, holistic approach involving prevention, treatment, and recovery. Crucially, it will also take the help of investors and innovators in biotechnology who understand the challenges and opportunities...

Making Orphan drug prices work for society

The Orphan Drug Act worked too well. It didn’t just stimulate development of therapies for rare diseases, it reoriented huge swaths of the industry to the pursuit, all attracted by the high prices and product...

The time is now: novel partnerships and funding models for accelerating science to the marketplace

We are in a golden age of biopharmaceutical development, enabled by the convergence of technology and science. But much of the gold is left unmined because mechanisms are not deployed to develop all compounds that...

Gottlieb: How a cultural shift is transforming FDA’s drug reviews

A decade ago, the FDA secured new tools, resources, and authorities to implement a watershed change in how the agency approached the drug review process. The novel framework turned on a more active approach to...

For patients’ sake, collaborate already

Cancer immunotherapy companies must stop squandering the most precious stakeholder, patients, and collaborate now on platform trials to test new combination regimens. A straightforward platform trial design that tests different combo partners with PD-1/PD-L1 agents...