Only about 5% of rare diseases have an approved therapy, and this is unlikely to change without novel development processes.

Only about 5% of rare diseases have an approved therapy, and this is unlikely to change without novel development processes.

• U.S. outbound investment rules — Proposed COINS restrictions would bar U.S. equity investing, joint ventures, co-development, and co-commercialization with many China biotech companies while ...

Gilead is adding to its flegdling oral autoimmune pipeline through a deal with a $1.3 billion upfront payment for a Phase I ...

A proposed outbound investment rule released by the U.S. Treasury Department Thursday would leave U.S. drugmakers free to ...

KRAS drives most pancreatic ductal adenocarcinomas, but KRAS status alone does not reveal which nutrients a tumor relies on ...

China’s proposed controls on specific biotechnology exports are unlikely, in themselves, to disrupt the trajectory of ...

One combined protocol can de-risk FDA acceptance of foreign data, capture the U.S. safety and PK evidence regulators want, ...

FDA’s accelerated approval of GSK’s Jemperli gives some patients with locally advanced rectal cancer a treatment that could ...

The Roche-Hansoh collaboration announced Monday is part of the Chinese pharma’s strategy to move beyond asset licensing to co ...

For pure gene silencing, siRNA offers better durability, deeper knockdown and cleaner safety, while ASOs still matter ...

• China regulation and export risk — Order 818 has sharply narrowed the IIT pathway and a proposed export-control regime ...