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STAT+: Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug
Capricor Therapeutics accused Nippon Shinyaku and its U.S. subsidiary of failing to follow through on marketing plans for a Duchenne muscular dystrophy treatment, and refusing to fix a pricing glitch that was belatedly discovered in their exclusive distribution agreement.
A key issue is a “fatal flaw” in a pricing formula that would make it “economically impracticable” for the therapy to reach patients covered by Medicare, Medicaid, and private insurers, according to a lawsuit filed in a New Jersey state court on Thursday. Nippon Shinyaku and NS Pharma, the subsidiary, disclosed the problem in March 2025.
Basically, the formula ties Medicare reimbursement to the price that Capricor would charge NS Pharma, since it would be the only U.S. buyer. But as it stands, the lawsuit indicated that health care providers would get reimbursed less than they would pay to cover the cost of acquiring and administering the medicine, which is called deramiocel.
Capricor Therapeutics accused Nippon Shinyaku and its U.S. subsidiary of failing to follow through on marketing plans for a Duchenne muscular dystrophy treatment, and refusing to fix a pricing glitch that was belatedly discovered in their exclusive distribution agreement.
A key issue is a “fatal flaw” in a pricing formula that would make it “economically impracticable” for the therapy to reach patients covered by Medicare, Medicaid, and private insurers, according to a lawsuit filed in a New Jersey state court on Thursday. Nippon Shinyaku and NS Pharma, the subsidiary, disclosed the problem in March 2025.
Basically, the formula ties Medicare reimbursement to the price that Capricor would charge NS Pharma, since it would be the only U.S. buyer. But as it stands, the lawsuit indicated that health care providers would get reimbursed less than they would pay to cover the cost of acquiring and administering the medicine, which is called deramiocel.
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Spain readies for evacuations as a hantavirus-hit cruise ship heads for the Canary Islands
MADRID — Spanish authorities on Friday were preparing to receive more than 140 passengers and crew members on board a hantavirus-stricken cruise ship headed for the Canary Islands, where health officials have said they will perform careful evacuations.
The vessel is expected to arrive Sunday at the Spanish island of Tenerife, off the coast of West Africa, and passengers will be taken to a “completely isolated, cordoned-off area,” said the head of Spain’s emergency services, Virginia Barcones.
MADRID — Spanish authorities on Friday were preparing to receive more than 140 passengers and crew members on board a hantavirus-stricken cruise ship headed for the Canary Islands, where health officials have said they will perform careful evacuations.
The vessel is expected to arrive Sunday at the Spanish island of Tenerife, off the coast of West Africa, and passengers will be taken to a “completely isolated, cordoned-off area,” said the head of Spain’s emergency services, Virginia Barcones.
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STAT+: Roche to buy PathAI for $750 million
Roche has signed a deal to pay $750 million upfront for Boston-based PathAI, an acquisition by the Swiss pharmaceutical giant to speed up its use of artificial intelligence to help pathologists diagnose disease.
The agreement, which is expected to close in the second half of the year, could generate an additional $300 million for PathAI if it leads to the achievement of certain milestones.
“Joining forces with Roche marks a new era for PathAI, enabling us to realize our mission of improving patient outcomes through AI-powered pathology at unprecedented scale and speed,” said Andy Beck, chief executive and cofounder of PathAI, in a statement. “Roche’s global infrastructure and expertise will bring our digital diagnostics technology to patients worldwide.”
Roche has signed a deal to pay $750 million upfront for Boston-based PathAI, an acquisition by the Swiss pharmaceutical giant to speed up its use of artificial intelligence to help pathologists diagnose disease.
The agreement, which is expected to close in the second half of the year, could generate an additional $300 million for PathAI if it leads to the achievement of certain milestones.
“Joining forces with Roche marks a new era for PathAI, enabling us to realize our mission of improving patient outcomes through AI-powered pathology at unprecedented scale and speed,” said Andy Beck, chief executive and cofounder of PathAI, in a statement. “Roche’s global infrastructure and expertise will bring our digital diagnostics technology to patients worldwide.”
If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.
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STAT+: Roche to buy PathAI for $750 million
STAT+: Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug
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