China
China recently made strategic moves to allow direct foreign investments into cell and gene therapy development, as well as into hospitals in certain cities and regions across the country. Foreign firms are generally optimistic despite some challenges.
With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."
The US FDA Commissioner pushed for rebalancing the US’s pharmaceutical supply chains while also stressing that US-China commerce has a role that would be risky to compromise.
With BIOSECURE's legislative progress on pause until after the election, a Pink Sheet infographic looks back on the Capitol Hill progress to date and looks ahead to the potential impact if it is enacted, using Evaluate Pharma data to highlight the likely holes in pharma’s supply chain.
A senior McKinsey executive discusses trends in the CDMO sector amid geopolitical tensions, the spurt in customer queries at Indian firms and also facets of the deals scenario.
With the BIOSECURE Act halfway to congressional approval, stakeholders are pushing for a financial boost to ensure the US gains the business Chinese companies will lose, but that may be a big lift.
If the US Congress continues to target trials at Chinese military hospitals, the impact could be relatively small, while a broader focus could upend multinational development programs.
China’s top drug regulator is implementing a pilot program offering shorter review times for IND applications to improve the quality and efficiency of clinical studies and stimulate the country’s innovative drug sector.
Shanghai issues a new set of policies and financial incentives designed to support and speed up regulatory and commercial activities in the biopharma sector, in a comprehensive stimulus package for companies based in the major Chinese city.
HPV vaccine shipments to China are expected to fall after a government crackdown on bribery and corruption caused scientific communication with health care providers to decline. Gardasil also may be hurt by budgetary pressures on distribution of the government-reimbursed vaccine.
The latest FDA guidance will have profound impact to Chinese biotech sector at a time when going global and a US approval is vital to its very survival.
China’s National Healthcare Security Administration (NHSA) seems determined to require pharma firms to comply with the agency’s request to cap the prices of innovative drugs, according to a senior official directly involved in annual price negotiations.
With the sheen of inevitability now scuffed off the BIOSECURE Act, diplomatic efforts to reduce US dependence on Chinese APIs are increasing in prominence. And the power of the legislation itself could be determined by litigation about a video app.
Antibody-drug conjugates, GLP-1 receptor agonists and cell/gene therapies propelled a big increase in clinical trial registrations in China last year, but why do sponsors sometimes remain reluctant to actually start studies?
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Faster, more powerful and able to handle voices and visual images, newly released AI platform GPT-4o could potentially accelerate many tasks currently handled by pharma firms' medical affairs professionals, who are exploring ways to keep themselves relevant while embracing the unprecedented technology, DIA China hears.
Next Generation Gene Therapeutics is fast-tracking clinical trials in the US for its gene therapy candidates for Bietti's crystalline dystrophy and classic phenylketonuria, supported by China data, the Chinese venture's CEO says in an interview.
Apparently months after his actual detention, news has finally surfaced that a key researcher behind China's rapid development of a homegrown COVID-19 vaccine is said to have "severely violated" Communist Party rules and regulations and is the subject of a probe for possible corruption.
Former and incumbent regulatory officials from China and the European Union highlighted the need for supportive regulatory policies for the innovative drug sector at the recent DIA China annual meeting.
US FDA Principal Deputy Commissioner Namandjé Bumpus recently attended a biotech-themed roundtable with the Senate Select Committee on Intelligence and national security officials as Congress’ pulls the FDA into its worries about Chinese influence of the pharma industry.