The alleged activities of two Chinese hackers outlined in a federal indictment unsealed Tuesday offer “concrete examples of two concerning trends,” U.S. Assistant Attorney General John Demers said, as U.S.-China relations further soured with the news of the charges.

Before the lessons of COVID-19 fade into yesterday’s news, Congress should start preparing for the next pandemic, Sen. Lamar Alexander (R-Tenn.) is advising. As the chair of the Senate Health, Education, Labor and Pensions Committee, the senator issued a white paper Tuesday identifying areas that must be addressed.

HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma.

Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.

HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s (NMPA) nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM.

In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses.

Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals.

DUBLIN – Kurma Partners closed its third biotech fund, Kurma Biofund III, at €160 million (US$174 million), €10 million ahead of its initial target. The Paris-based fund will allocate the bulk of the capital to therapeutics firms, but it is also open to opportunistic investments in med tech, particularly in digital health applications and in biotech-med tech convergence, partner Peter Neubeck told BioWorld.

Saudi Arabia, which last year made its first appearance on the U.S. Trade Representative’s (USTR) Priority Watch List, is back on the list this year and is being singled out for an out-of-cycle review due to what the USTR calls its “unfair commercial use” and “unauthorized disclosure” of proprietary data submitted for drug approvals.

Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.