BioPharmaceutical

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."

Already one of the world’s largest pharmaceutical markets, China has tremendous growth potential, but significant policy and market changes are rocking the basis of competition. Multinational biopharma corporations cannot succeed in this new environment unless they fundamentally reinvent their business models to adapt to sweeping change.

The CEO of South Korean biotech shares how his company was able to reach a partnership with Rani so quickly and why it is confident in its GLP-1/GLP-2 dual agonist for obesity and diabetes, despite recent disappointing clinical results for its sole rival.

The CEO of South Korean biotech shares how his company was able to reach a partnership with Rani so quickly and why it is confident in its GLP-1/GLP-2 dual agonist for obesity and diabetes, despite recent disappointing clinical results for its sole rival.

Already one of the world’s largest pharmaceutical markets, China has tremendous growth potential, but significant policy and market changes are rocking the basis of competition. Multinational biopharma corporations cannot succeed in this new environment unless they fundamentally reinvent their business models to adapt to sweeping change.

Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

Steffen Wagner has taken over as Stada’s head of Germany, adding to his existing responsibilities in Europe, after Eelco Ockers stepped down from the role. Ockers’ departure comes as German generics giant Stada restructures its business to bring its branded and consumer health interests into closer alignment as part of a more streamlined model.

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."

Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.

Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.

Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.

After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.

The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.  

Latvia’s Olainfarm has set out details of a five-year strategy called ‘Forward 2020-2025’ that it anticipates will “make internal processes more effective for sustainable growth.” While laying out its forecast for 2021, the company said that it has planned “significant investments for research and development, as well as the acquisition of products and modernization and digitalization.”

Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.

Biocon has made two key appointments to the management team of Biocon Biologics following a recent change in CEO for the biosimilars business.

Nichi-Iko says that remediation activities at its Toyama plant in the wake of a suspension over GMP violations mean that there may be delays to supply.

The Medicines Patent Pool has entered into a partnership with three companies for glecaprevir/pibrentasvir, a WHO-recommended treatment for people living with hepatitis C. The companies join previous generic licensee Mylan and originator AbbVie.