Rein Therapeutics Receives FDA Fast Track Designation For LTI-03 In IPF

Rein Therapeutics (NASDAQ: RNTX) said it has expanded its Phase 2 RENEW trial of inhaled peptide LTI-03 for idiopathic pulmonary fibrosis into the United Kingdom, with the first U.K. patient randomized. The company reported 16 patients enrolled to date. Trial sites are enrolling in the U.S., Australia, and the U.K., with two additional countries expected to add sites soon.

The FDA approved AstraZeneca's camizestrant (Etcamah) for advanced breast cancer, triggered by a blood test detecting ESR1 mutations. The drug, used with CDK4/6 inhibitors, showed 16-month median progression-free survival in trials. The approval is conditional, pending confirmatory studies on overall survival benefits. The FDA also authorized the Guardant360 CDx test for detecting ESR1 mutations. The drug carries warnings for heart rhythm issues and fetal harm.

Apple has filed a lawsuit in the Johannesburg High Court against a local company, alleging the sale of counterfeit iPhones and packaging. The products were seized at OR Tambo International Airport in March. Apple seeks a court declaration that the products are counterfeit and an injunction to prevent further trading.

The Seattle Times and Newsday sued OpenAI and Microsoft, alleging unauthorized use of paywalled content to train AI models like ChatGPT and Copilot. The publishers demand destruction of the datasets and compensation. OpenAI claims fair use, while Microsoft offers to discuss solutions. The case follows similar lawsuits, including one by the New York Times, with the DOJ intervening, citing potential impacts on journalism and national security.

Tesla launched its Cybercab robotaxis in Austin, Texas, despite lacking traditional controls. The NHTSA opened an audit to assess compliance with federal safety standards. Experts debate regulatory hurdles and Tesla's potential to push boundaries. Tesla claims its Full Self-Driving software is safer than human drivers, but critics question its reliability. The company may self-certify the Cybercab, bypassing exemption limits.

AstraZeneca's breast cancer drug, camizestrant (brand name Etcamah), received FDA approval for use in metastatic breast cancer patients with a specific genetic mutation. The drug is expected to generate over $5 billion in annual sales, according to the company, but analysts predict lower figures. The FDA's approval follows an earlier advisory panel vote against the medicine.