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BioWorld - Tuesday, May 5, 2026
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Cytomegalovirus in a human cell

Maribavir adcom a long time coming

Oct. 5, 2021
By Mari Serebrov
After nearly 20 years in development, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will get its day before the FDA’s Antimicrobial Drugs Advisory Committee Oct. 7. During the course of its development by various companies, the drug’s indication has morphed from a prophylaxis to a treatment of resistant or refractory cytomegalovirus infection in both solid organ and hematopoietic stem cell transplant recipients.
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Francis Collins, director, U.S. NIH

U.S.’ top scientist to step down at NIH

Oct. 5, 2021
By Mari Serebrov
Francis Collins, perhaps one of the U.S.’ biggest cheerleaders for the promise of medical science, announced Oct. 5 that he will be ending his nearly 13-year tenure as NIH director by the end of the year, but he won’t be hanging up his lab coat. The 71-year-old Collins will continue to lead his research lab at the NIH’s National Human Genome Research Institute.
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Laptop, stethoscope, medical icons, health professional
2021 Medtech Conference

AI or crystal ball? Panel predicts the future of digital health post-pandemic

Oct. 4, 2021
By Annette Boyle
Software-as-a-medical device (SaMD) came into its own during the pandemic as digital health applications enabled patients to receive care from home through telemedicine, apps and remote patient monitoring. At the 2021 Medtech Conference, a panel of regulators, advocates and digital health executives discussed how the last 18 months may permanently change the regulation of these devices, the steps manufacturers can take to secure the footholds they gained, and how the U.S. CMS can enable digital health to achieve its promise.
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Silhouette made of crumpled paper illustrating depression

Method for identifying neural circuits that cause depression may lead to tailored therapies

Oct. 4, 2021
By Nuala Moran
LONDON – Fixed and constant deep brain stimulation has been successful in treating Parkinson’s disease and epilepsy, but heterogeneity in individual response means that despite promise, clinical studies in serious depression have to date delivered inconsistent results. U.S. researchers have now developed a method for identifying the neural circuits underlying symptoms of depression in individual patients and applied this to deliver tailored therapy, using a commercially available device to stimulate the brain when these circuits are activated.
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Generic firms agree to pay $450M to resolve price-fixing allegations

Oct. 4, 2021
By Mari Serebrov
Three generic drug companies have agreed to pay a total of nearly $450 million to resolve U.S. Department of Justice (DoJ) price-fixing allegations.
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340B litigation grows with PhRMA challenge to state law

Oct. 4, 2021
By Mari Serebrov
In the latest skirmish over who can get the 340B discounts on prescription drugs that are supposed to help qualifying U.S. providers offer charity care, the Pharmaceutical Research and Manufacturers of America (PhRMA) is challenging a recently passed Arkansas law that seeks to regulate drug manufacturers’ participation in the federal drug pricing program.
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Scientists in lab

IDH1 mutations affect antitumor immunity in glioma

Oct. 1, 2021
By Anette Breindl
Low-grade gliomas with mutated isocitrate dehydrogenase-1 (IDH1) produced and secreted higher levels of the cytokine granulocyte colony-stimulating factor (G-CSF) than other glioma types, which improved their antitumor immune response in animal models.
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11th Circuit slaps FDA for violating orphan exclusivity

Sep. 30, 2021
By Mari Serebrov
The FDA’s 2019 approval of Jacobus Pharmaceutical Co. Inc.’s Ruzurgi to treat children ages 6 to 17 with Lambert-Eaton myasthenic syndrome must be set aside because it violated the Orphan Drug Act in light of Catalyst Pharmaceuticals Inc.’s seven-year orphan exclusivity for its LEMS drug, Firdapse, the U.S. Court of Appeals for the 11th Circuit ruled Sept. 30.
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Gavel and scales
2021 Medtech Conference

Courts often bar defense from raising FDA-related questions in product liability litigation

Sep. 30, 2021
By Mark McCarty
Jury trials for product liability litigation are not always the last stop for these lawsuits, but courts are more frequently banning device makers from presenting evidence related to premarket filings in these proceedings. One example of this was the pelvic mesh trial of McGinnis v. Bard, in which the trial judge allowed the plaintiff to make nearly two dozen references to the FDA without allowing rebuttal from counsel for the defense, thus biasing a jury that awarded the plaintiff $68 million without hearing the entirety of the evidence.
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Hand holding FDA blocks

FDA draft for investigator safety reporting offers little detail on combo product studies

Sep. 29, 2021
By Mark McCarty
The FDA unveiled a draft guidance addressing the responsibilities of clinical investigators for safety reporting for investigational drugs and devices, a novel attempt to combine the disparate adverse event reporting timelines for investigational drugs and devices.
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