No Child Developmental Harm From Antidepressants In Pregnancy: Study
Risk of autism, ADHD, behavioral disorders, and other issues in children up to age 14 are not related to the taking of antidepressants during pregnancy, according to new data. Separately, reports cover scientists researching why CAR-T therapies work against only some cancers.
CNN:
Antidepressant Use During Pregnancy Doesn't Harm Child Development, Study Says
Antidepressant use during pregnancy was not associated with autism, attention-deficit hyperactivity disorder (ADHD), behavioral disorders, developmental speech, language, learning and coordination disorders or intellectual disabilities, according to a study of over 145,000 women and their children across the United States followed for up to 14 years. (LaMotte, 10/4)
In other pharmaceutical research —
Stat:
CAR-T Therapy Doesn’t Always Work For Cancer. Now There Are Clues Why
When CAR-T therapy works against blood cancer, it can work spectacularly, but cancer still returns for many patients. In lymphoma, scientists are just beginning to work out why over half of treated patients don’t experience lasting remission, depending on the product. (Chen, 10/4)
Stat:
Many Trials To Confirm Benefits Of Drugs Granted Accelerated Approvals Are Running Late
Amid heightened debate over a regulatory program for speeding the approval of some medicines, a new government analysis finds extensive delays in the clinical trials that drug makers are required to conduct after approvals. (Silverman, 10/3)
More pharmaceutical industry news —
Reuters:
U.S. Supreme Court Turns Away Biogen Bid To Reinstate MS Drug Patent
The U.S. Supreme Court on Monday declined to hear Biogen Inc's bid to win reinstatement of a patent on the company's blockbuster multiple sclerosis drug Tecfidera in a dispute with Viatris Inc subsidiary Mylan Pharmaceuticals Inc. (Brittain, 10/3)
Reuters:
Supreme Court Asks U.S. To Weigh In On Teva Patent Dispute With GSK
The U.S. Supreme Court on Monday asked President Joe Biden's administration for its opinion on whether the court should hear Teva Pharmaceuticals USA Inc's challenge to a $235 million award for GlaxoSmithKline LLC in a patent dispute over generic heart medication. (Brittain, 10/3)
The Wall Street Journal:
Theranos Founder Elizabeth Holmes Gets Hearing On New Trial
Theranos Inc. founder Elizabeth Holmes is due back in court this month to make the case that she deserves a new trial based on her allegations that the government manipulated testimony from a key witness who testified against her. The hearing was granted Monday by the judge who presided over Ms. Holmes’s monthslong criminal-fraud trial. (Somerville, 10/3)
Modern Healthcare:
Express Scripts-Kroger Contract In Jeopardy
Kroger is threatening to exit Express Scripts' network if the pharmacy benefit manager does not agree to a more “equitable and fair” contract. Kroger said it has attempted--to no avail--to negotiate more favorable rates with Cigna subsidiary Express Scripts dozens of times over the past eight months, the company said in a news release. Express Scripts’ proposal is “far out of line” with the industry standard, according to the supermarket company. (Tepper, 10/3)
The Wall Street Journal:
World’s Most Expensive Drugs Can’t Cure What Ails This Biotech
Bluebird Bio is about to become the seller of the two most expensive drugs in the U.S., and by extension the world, each fetching nearly $3 million. While the high price tag is already leading to public backlash, one would think the company and its investors would at least see a huge payoff as the drugs finally hit the market. Not quite. Two approvals by the Food and Drug Administration this past summer might have rescued the company from the financial abyss, but the Boston-area-based Bluebird, which in April announced significant cost cuts to stay afloat, is going to be cash-strapped for a while. (Wainer, 10/3)
