FDA Warns Breast Implant Scar Tissue Linked To Cancers
Though cancers caused by breast implants may be rare, the Food and Drug Administration is now warning that all types of implants may be linked to increased risk of malignancies in scar tissue around them. Separately, the FDA approved a new anti-wrinkle drug.
The New York Times:
Breast Implants May Be Linked To Additional Cancers, F.D.A. Warns
The Food and Drug Administration on Thursday warned women who have breast implants or are considering getting them that certain cancers may develop in scar tissue forming around the implants. The malignancies seem to be rare, but they have been linked to implants of all types, including those with textured and smooth surfaces, and those filled with saline or silicone. (Rabin, 9/8)
The Hill:
FDA Issues Safety Alert Over Reports Of Cancer In Scar Tissue Around Breast Implants
The Food and Drug Administration (FDA) issued a warning for doctors and patients on Thursday after it received reports of people with breast implants being diagnosed with multiple types of cancer. Binita Ashar, the director of the Office of Surgical and Infection Control Devices in the agency’s Center for Devices and Radiological Health, said in a release that the FDA received reports of squamous cell carcinoma and various lymphomas in the capsule or scar tissue near the implants. (Gans, 9/8)
In other pharmaceutical industry news —
The New York Times:
FDA Approves Daxxify, A New Anti-Wrinkle Drug
The Food and Drug Administration has approved a new drug that reduced the appearance of facial wrinkles for about six months, spurring competition in a market that for decades has been dominated by Botox. Revance Therapeutics, the maker of the new treatment, Daxxify, announced the approval on Thursday morning, saying its effects — by injection into the face along worry lines — lasted longer than other products on the market. (Jewett, 9/8)
Reuters:
Oxford Malaria Vaccine Data Bodes Well For Effort To Combat Deadly Disease
Encouraging new data on a malaria vaccine from Oxford University bodes well for global effort to combat the mosquito-borne disease that kills a child every minute, its makers said on Wednesday. After decades of work, the only approved malaria vaccine, Mosquirix, made by British drugmaker GSK (GSK.L), was recently endorsed by the World Health Organization (WHO). Oxford’s vaccine, called R21/Matrix-M, is likely more effective than Mosquirix in preventing the disease that kills about 600,000 a year despite roughly $3 billion spent annually on insecticides, bednets and anti-malarial drugs, Oxford scientist Adrian Hill said. (Grover, 9/8)
Stat:
Will Pharma Rely On Remote Trials More Than Ever?
Running clinical trials remotely or virtually can provide substantial financial savings for pharmaceutical companies, according to a new pilot study. And the findings may prompt still further use of such techniques, which have been increasingly adopted during the Covid-19 pandemic. (Silverman, 9/8)
Stat:
What Disclosure? Clinical Trials Run In Canada Fail To Take Basic Steps Toward Transparency
Amid ongoing controversy over clinical trial transparency, a new analysis found that just 3% of the more than 3,700 studies run exclusively in Canada over a recent 10-year period were registered prospectively, reported results, and published the findings. (Silverman, 9/8)
