Health News Highlights: Cancer Drug Trials, GenScript Scrutiny, and More
This summary covers recent health news highlights, including Gilead's Trodelvy failing in a bladder cancer trial, Pfizer's optimistic sales forecast for Lorbrena, U.S. lawmakers' concerns about GenScript's China links, FDA's cautious stance on MDMA for PTSD, and the EU's recommendation for Valneva's chikungunya vaccine.
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.
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.
Global pandemic treaty to be concluded by 2025, WHO says
Talks aimed at reaching a global agreement on how to better fight pandemics will be concluded by 2025 or earlier if possible, the World Health Organization said on Saturday. The WHO's 194 member states have been negotiating for two years an agreement that would, among other things, improve international coordination and collaboration before and during pandemics.
Delaware judge lets more than 70,000 Zantac lawsuits go forward
A Delaware judge has allowed more than 70,000 lawsuits over discontinued heartburn drug Zantac to go forward, ruling that expert witnesses can testify in court that the drug may cause cancer. The ruling on Friday by Judge Vivian Medinilla of the Delaware Superior Court in Wilmington is a setback for former Zantac makers GSK, Pfizer, Sanofi and Boehringer Ingelheim, which had argued that the expert witnesses' opinions lacked scientific support.
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.
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.
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