Health News Roundup: U.S. FDA declines to approve Supernus' drug-device combination for Parkinson's disease; Novo Nordisk parent refiles US application on Catalent deal and more
Long-term data of the drug reinforced the findings that were seen in previous short-term studies, the company said. Geneos cancer vaccine shrinks liver tumors in small trial Nearly a third of patients with advanced liver cancer who received a personalized vaccine developed by Geneos Therapeutics along with an immunotherapy drug in a small, early trial saw their tumors shrink, U.S. researchers reported on Sunday.
Following is a summary of current health news briefs.
Vatican says 'no' to sex changes and gender theory in new document
The Vatican on Monday reaffirmed its opposition to sex changes, gender theory and surrogate parenthood, as well as abortion and euthanasia, four months after supporting blessings for same-sex couples. The Vatican's doctrinal office (DDF) released the "Dignitas infinita" (Infinite dignity) declaration following fierce conservative pushback, especially in Africa, against its document on LGBT issues.
Bristol Myers' schizophrenia drug reduces symptoms without weight gain in late-stage studies
Bristol Myers Squibb said on Saturday data from late-stage studies of its experimental schizophrenia drug showed it helped reduce symptoms of the disorder without the common side effect of weight gain tied to other antipsychotics. The drugmaker gained access to the treatment, called KarXT, through its $14 billion deal to buy Karuna Therapeutics last year. Long-term data of the drug reinforced the findings that were seen in previous short-term studies, the company said.
Geneos cancer vaccine shrinks liver tumors in small trial
Nearly a third of patients with advanced liver cancer who received a personalized vaccine developed by Geneos Therapeutics along with an immunotherapy drug in a small, early trial saw their tumors shrink, U.S. researchers reported on Sunday. The result was roughly twice the response typically seen with the immunotherapy alone, the researchers said.
Exclusive-Synchron, a rival to Musk’s Neuralink, readies large-scale brain implant trial
Synchron Inc, a rival to Elon Musk's Neuralink brain implant startup, is preparing to recruit patients for a large-scale clinical trial required to seek commercial approval for its device, the company's chief executive told Reuters. Synchron on Monday plans to launch an online registry for patients interested in joining the trial meant to include dozens of participants, and has received interest from about 120 clinical trial centers to help run the study, CEO Thomas Oxley said in an interview.
U.S. FDA declines to approve Supernus' drug-device combination for Parkinson's disease
The U.S. Food and Drug Administration (FDA) declined to approve Supernus Pharmaceuticals' drug-device combination to treat movement-related symptoms of Parkinson's disease, the drugmaker said on Monday. The company said U.S. Food and Drug Administration's so-called "complete response letter" indicated the review cycle for the application was complete, but the treatment was not ready for approval in its present form.
Trump says US states should determine abortion law; no mention of national ban
Republican presidential candidate Donald Trump on Monday said abortion laws should be determined by U.S. states, stopping short of proposing a national ban and choosing a more moderate stance heading into November's general election. In a video post on his social media platform, the former U.S. president said he supported exceptions for rape, incest and to protect the life of the mother. He also reiterated that he supports the availability of in-vitro fertilization.
Novo Nordisk parent refiles US application on Catalent deal
The parent of Wegovy producer Novo Nordisk has refiled an application to the U.S. Federal Trade Commission (FTC) for approval of a $16.5 billion deal to buy manufacturing subcontractor Catalent, a spokesperson said on Monday. Novo Nordisk Foundation said last month it had agreed to buy Catalent to boost output of the weight-loss drug Wegovy. After the deal closes, it would sell three of Catalent's fill-finish sites on to Novo Nordisk for $11 billion.
(With inputs from agencies.)
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- Vatican
- KarXT
- Novo Nordisk Foundation
- Catalent
- Musk’s Neuralink
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- Thomas Oxley
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- schizophrenia drug
- Bristol Myers'
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