FDA Will Put Brain Tumor Warning On Depo-Provera Birth Control Shot

NBC News: FDA Approves Label Change For Depo-Provera, Adding Brain Tumor Warning
The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor in the lining of the brain. Pfizer is currently battling a lawsuit in which more than 1,000 women claim the company knew about the risk and failed to warn patients. (Brooks and Essamuah, 12/16)

The Hill: Mike Pence Group Demands Robert F. Kennedy Jr. Removal Over Abortion Pill
Former Vice President Mike Pence’s organization said Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. “must go,” accusing the secretary of refusing to review the abortion pill mifepristone. In a statement posted on the social platform X, Pence’s nonprofit, Advancing American Freedom, said, “HHS Secretary RFK Jr. continues to refuse to review the dangerous chemical abortion pill, mifepristone. Despite the calls of state attorneys general across the country and pro-life promises made to Congress, RFK Jr. has followed in the footsteps of the Obama and Biden administrations by stonewalling pro-life efforts at HHS.” (Choi, 12/16)

More pharmaceutical developments —

San Francisco Chronicle: Global Biotech Company Exits Silicon Valley, 121 Jobs Cut
A major biotechnology company is exiting Silicon Valley. French diagnostics giant bioMérieux plans to permanently close its San Jose office and lay off 121 employees, according to a state filing, ending the company’s Bay Area operations. The layoffs were filed with California officials last week. (Vaziri, 12/16)

Bloomberg: GSK Says US FDA Approved Its Twice-Annual Asthma Drug
GSK Plc said it won US approval for a drug to treat severe asthma, boosting its prospects as a potential blockbuster. The US Food and Drug Administration approved Exdensur as an add-on maintenance treatment of severe asthma for patients aged 12 years and older, the company said in a statement on Wednesday. (Furlong, 12/17)

Bloomberg: Kenvue Faces FDA Petition To Remove Benadryl’s Active Ingredient
Kenvue Inc. is dealing with another challenge to a top-selling product as it attempts to close its $40 billion acquisition by Kimberly-Clark Corp. US President Donald Trump linked the use of Kenvue’s Tylenol to autism in September. More recently three doctors filed a petition with the Food and Drug Administration that requested the agency remove the active ingredient — diphenhydramine — in over-the-counter cold, cough and allergy medications such as Kenvue’s Benadryl because there are more effective products with fewer side effects. (Brown, 12/16)

Bloomberg: DBV’s Peanut Allergy Patch Desensitized Kids In Crucial Study
DBV Technologies SA said its experimental skin patch helped young children with a peanut allergy in a crucial study. The product, called Viaskin, showed it could help desensitize children aged four to seven who wore it for a year, the French company said Tuesday. The patients then consumed peanut protein to mimic an accidental ingestion, and researchers found they could tolerate it better. DBV said it plans to seek US regulatory approval in the first half of next year. (Pham, 12/16)

On cancer treatments —

The Colorado Sun: CSU Professor Tries New Approach To Cancer Immunotherapy
This is a story that starts with a dog named Ella. She was a goldendoodle, nothing but bouncy blonde curls. She was 11 years old. And she had cancer. Bad cancer, in her liver. Veterinarians performed surgery to remove the tumor, but it had what are known as diffuse margins — meaning it had snuck into surrounding healthy tissue. The vets couldn’t get all of it. (Ingold, 12/17)

Bloomberg: How Cancer Drug Trials Make Big Money For Doctors, Hospitals
The future of cancer drug research just might be in Omaha, Nebraska, between a Panda Express and a Mattress Firm. Here, in an otherwise unremarkable storefront, a little-known clinic called XCancer has become one of the most trusted research partners of pharmaceutical companies seeking to test experimental prostate cancer medicines. XCancer and its sole physician, Luke Nordquist, have participated in more than 200 trials over 15 years, and played a leading role in testing Novartis AG’s widely advertised blockbuster, Pluvicto. (Melby and Langreth, 12/16)



Iowa Public Radio: More Iowans Are Surviving Cancer. But With It Can Come Mental Health Challenges 
When Morgan Newman was 24, she had an abnormal pap smear. She wasn’t concerned about the result until she was in the middle of her follow-up screening. “I went back for a follow-up screening called a colposcopy and ended up hemorrhaging on the table,” she said. “And so they had to stop, and they referred me to a gynecologic oncologist at that point.” (Krebs, 12/16)

On artificial intelligence —

NPR: Psychologists Are Increasingly Using – And Worrying About – AI Tools, Poll Finds
Psychologist Cami Winkelspecht decided to familiarize herself with artificial intelligence tools like ChatGPT and Gemini, after patients started asking her for advice about how they could use the technology responsibly. "One of the interesting questions that kids and teenagers, in particular, brought in is how can you utilize AI to help support ideas or editing process or things like that for papers and assignments and presentations, but also make sure that you're not utilizing it to write something for you, [so] that you're not violating your school's honor code" says Winkelspecht, who is a child and adolescent psychologist with a private practice in Wilmington, Delaware. (Chatterjee, 12/16)

Modern Healthcare: Is There An AI Bubble In Healthcare? Why Investors Are Concerned 
The healthcare industry has been transfixed by the promises of artificial intelligence and this past year has seen investors, health tech vendors, providers and payers buying big into the technology. Now there is fear within healthcare, like other industries, that the AI bubble could burst as expectations for both companies and their products fail to match reality. (Perna, 12/16)