Commentaries

Biden time: 75 days to shape the coming 750 days

There is no time to celebrate or mourn the elections. The United States and the world are on the edge of a precipice and must act quickly to avoid disaster. It is reasonable to assume that...

中国版的Hatch-Waxman法案:同志仍需努力

Publisher's note: the English language version of this article may be found here. 今年10月17日,中国发布了第四次专利法修正案,其中引入了专利链接和专利期限延长两项制度,用以加强对药物发明的专利保护。可惜这些业界期盼已久的改革并不能为面对仿制药挑战的创新药企提供太多喘息的机会。 当这个新法在2021年6月生效时...

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...

Protecting biomedical innovation as a national security asset

In recent years, it has become fashionable to focus on the high price of new treatments for certain cancers and rare diseases. Many observers ask why it is that U.S. citizens should subsidize the rest...

Getting FDA back on track

Regardless of the outcome of the elections, FDA is likely to have a new commissioner next year, one who will step into a leadership vacuum that is exhausting the agency’s supply of credibility and...

Reversing the impact of COVID-19 on oncology clinical trials

The COVID-19 pandemic has harmed thousands of cancer patients by delaying or postponing clinical trials for new anticancer agents in various indications. These patients, whose lives depend on finding new...

‘Flipting’ the switch: a technological prescription for lower drug costs

It is time to do away with the middlemen that drive up drug costs for patients through their complex system of kickbacks. This week’s House committee hearings on drug pricing are a sign the...

Vaccine hesitancy: why American values matter

More than a third of Americans tell polls they would not take a vaccine to prevent COVID-19, the most devastating disease in 100 years. Vaccine hesitancy is even higher among Black people — hard-hit in...

FDA’s credibility on the line, plus biotech’s venture wave and a Back to School preview: a BioCentury podcast

With FDA’s independence in question, how the agency handles emergency use authorization of COVID-19 vaccines is becoming ever-more pressing. On the latest edition of the BioCentury This Week podcast,...

FDA should maintain ‘social distance’ from the White House

One of the most important public health tools to emerge this year is the concept of social distance. Its benefits aren’t limited to outdoor dining or supermarket checkout lines; they extend to interactions...

21st century pandemic, prehistoric clinical trials

The U.S. is trying to fight a 21st century pandemic with prehistoric clinical trials -- and achieving the kind of efficiency you might expect. In the last six months, tens of thousand of patients have...

China offers forward-thinking biotechs much more than an opportunity to get delayed clinical trials back on track

Weiji (危机), the Chinese term for crisis, combines the characters for “danger” and “opportunity,” an apt description of the challenge posed by COVID-19. While most of the world struggles with pandemic containment and ‘re-opening,’ China,...

Juneteenth and our path forward: Letter from BioCentury’s Co-Founders

Editor’s Note: BioCentury’s co-founders, Chairman Karen Bernstein, Ph.D., and President & CEO David Flores, have written to the company’s employees about BioCentury’s response to racism and racial inequities in healthcare. It is published in its...

Beyond molecules and microbes: biopharma's responsibility to racial justice in and outside its own walls

The killing of George Floyd has made it clear that life sciences leaders cannot focus exclusively on molecules or microbes, that their missions include helping to heal social as well as physical pathologies. The uncomfortable...

Industry is a white knight right now. Don’t throw it away

Biopharma is having a moment. All eyes are on drug, diagnostic and vaccine developers to get us out of this crisis and back to work. Now, companies -- individually and collectively -- must make good...