Doing his version of the Texas Two-Step, Texas Attorney General (AG) Ken Paxton is again shuffling Eli Lilly and Co. into a state courtroom – this time for allegedly overstepping the anti-kickback line.

The increasing recognition of its importance in national security, economic growth and health has seen biotech emerging as the latest frontier in geopolitical competition, with implications for companies ranging from startups to multinationals – and for global investment in the sector.

Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP).  In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, a disease that has yet to see a cure, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels.

With a packed pipeline of drug candidates targeting multiple markers of cancer, Bayer AG signed on for a new project, this time going after the KRAS pathway with a global deal that could bring Kumquat Biosciences Inc. up to $1.3 billion in payments.

Syntara Ltd.’s stock plummeted 52% on news that the FDA recommended an additional phase IIb trial following a type C meeting about the company’s clinical development plan for lysyl oxidase inhibitor amsulostat (SNT-5505, formerly PXS-5505) in myelofibrosis.

After about a two-week absence as the U.S. FDA’s CBER director, Vinay Prasad’s return overall prompted a mild reaction on Wall Street for some stocks tied to companies developing cell and gene therapies.

Billing it as a necessary reform to protect tax dollars from frivolous government spending, redundancy and waste, U.S. President Donald Trump issued a new executive order (EO) requiring his political appointees to sign off on grants and awards from agencies such as the NIH and to monitor those awards over time to ensure they’re being used properly.

Boehringer Ingelheim GmbH’s zongertinib enters the market as the first oral HER2-targeted therapy for patients with non-small-cell lung cancer, following an accelerated approval by the U.S. FDA. Branded Hernexeos, the drug is cleared for use in adults with unresectable disease or whose tumors have HER2 tyrosine kinase domain activating mutations and who have received prior systemic therapy.

Drug companies and organizations challenging the Medicare drug negotiations have yet to convince a U.S. court that the process, mandated by the 2022 Inflation Reduction Act, violates the Constitution. The most recent decisions came this week when the U.S. Court of Appeals for the Second Circuit ruled Aug. 7 against Boehringer Ingelheim GmbH and the Sixth Circuit ruled Aug. 6 against a challenge filed by the Dayton, Ohio, Chamber of Commerce, the U.S. Chamber, and the Ohio and Michigan Chambers.

Among the strong points of Nektar Therapeutics Inc.’s atopic dermatitis (AD) prospect, rezpegaldesleukin (rezpeg), an IL-2 pathway agonist and regulatory T-cell proliferator, is the drug’s faster onset of action – a feature that experts say may help differentiate the compound from competitors in the OX40 space.