Health Highlights: Breakthroughs, Setbacks, and Future Prospects

This health news summary spotlights major developments in cancer treatments, regulatory actions on biotechnology, and the global readiness for future pandemics. Highlights include Gilead's and Pfizer's cancer drug trials, concerns over MDMA for PTSD therapy, and the approval of Moderna's RSV vaccine. US and EU regulatory activities are also featured.

Following is a summary of current health news briefs.

Gilead's Trodelvy fails bladder cancer trial, modestly extends lung cancer survival

Gilead Sciences' Trodelvy failed to improve survival for patients with advanced bladder cancer and only modestly extended the lives of previously treated patients with late-stage lung cancer in a pair of clinical trials, raising questions about growth prospects for the medicine. Trodelvy has accelerated U.S. approval for treating advanced urothelial cancer, but Gilead on Thursday said a large trial failed to confirm that the drug improved survival.

Pfizer sees lung cancer drug topping $1 billion in sales following impressive 5-year data

Pfizer said it expects its cancer drug Lorbrena to top $1 billion in annual sales by 2030 on the strength of data presented on Friday showing most patients treated for a rare form of advanced lung cancer in a clinical trial were alive without the disease worsening after five years. Lorbrena, like Pfizer's Xalkori, is designed to treat cancer with a mutation of a specific gene called anaplastic lymphoma kinase, or ALK.

US lawmakers ask FBI for briefing on GenScript Biotech's links to China

The U.S. House of Representatives committee on China has asked the FBI and the intelligence community for a briefing on GenScript Biotechnology Co and three subsidiaries to determine if the Chinese Communist Party has influence over their operations. In a letter dated May 30 to the FBI and the U.S. office of the director of national intelligence, committee chair John Moolenaar and ranking member Raja Krishnamoorthi said GenScript's work with U.S. companies and the government raises concerns about the intellectual property of U.S. firms and could help improve China's biotech capabilities.

US FDA staff raises concerns over data from MDMA-based PTSD therapy

The U.S. health regulator's staff said on Friday data on the psychedelic drug MDMA for post-traumatic stress disorder was difficult to interpret, and raised new safety concerns ahead of a meeting of the agency's advisers. The comments set the stage for discussions over the therapy's benefits and risks by the U.S. Food and Drug Administration's advisory panel on Tuesday, as the agency reviews the therapeutic use of the drug for the first time.

EU regulator backs use of Pfizer's gene therapy for rare bleeding disorder

The European Medicines Agency (EMA) has recommended the use of Pfizer's gene therapy for a rare bleeding disorder called hemophilia B, which typically requires regular infusions of a blood-clotting protein, the regulator said on Friday. The regulator has recommended granting a 'conditional marketing authorization,' which is for the approval of a medicine addressing unmet medical needs of patients based on less comprehensive data than normally required.

Texas top court won't guarantee right to abortion in complicated pregnancies

Texas' highest court on Friday refused to ensure that doctors in the U.S. state are not prosecuted for abortions they believe are necessary in medically complicated pregnancies, rejecting a lawsuit by 22 patients and physicians. The Texas Supreme Court's decision follows an earlier ruling from the court denying a woman's request for an emergency abortion of a non-viable pregnancy. In both cases, plaintiffs said the medical exception to the state's near-total abortion ban was unclear, and left doctors unwilling to perform medically necessary abortions in the face of severe penalties including potentially life in prison.

EU regulator recommends use of Valneva's chikungunya vaccine

The European Medicines Agency (EMA) recommended Valneva's single-dose chikungunya vaccine for use on Friday, setting it up as the first preventive shot against the disease in Europe. EMA's recommendation for the French firm's vaccine Ixchiq comes as the mosquito-borne disease, for which no approved drugs exist, has been spreading due to climate change.

Novartis leukemia drug more effective than older treatments in trial

Swiss drugmaker Novartis said patients with a type of leukemia who took its Scemblix had a significantly better response and a lower dropout rate than those who received current standard-of-care drugs in a late-stage study with details presented on Friday. The company said in January that the oral drug met the main goals of the 405-patient trial.

World unprepared for another pandemic as WHO treaty talks push on

The world is unprepared for another health crisis like COVID-19, a leading global health expert has warned, as countries make a last push to agree a way forward for a pandemic treaty amid fears the political climate for agreement could sour. World Health Organization member states gathered in Geneva on Friday to work out how to continue negotiations about an accord after missing this month’s deadline.

US FDA approves Moderna's RSV vaccine with lower-than-expected efficacy in its label

The U.S. Food and Drug Administration approved Moderna's respiratory syncytial virus (RSV) vaccine, the company announced on Friday, giving it a shot at much-needed new revenue from a second product. Moderna's vaccine was approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older, but with a label indicating the shot was 79% effective at preventing at least two symptoms of RSV, such as cough and fever.