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The FDA’s Office of Orphan Products Development has granted orphan drug status to VAL-083 (DelMar Pharmaceuticals), a first-in-class small-molecule chemotherapeutic, for the treatment of women with ovarian cancer. VAL-083 previously received an orphan drug designation for glioma and medulloblastoma in the United States.

Encouraging data from the MS-SPI trial were presented on April 21 at the annual meeting of the American Academy of Neurology. The study tested the efficacy of MD1003, a pharmaceutical-grade biotin, administered at a dosage of 300 mg/day in patients with “not active” progressive multiple sclerosis (MS), for which there is no approved treatment.

Responding to concerns raised by hospitals and a majority of House and Senate lawmakers, the Centers for Medicare and Medicaid Services (CMS) has announced that it will delay until July the public release of an overall hospital quality star rating, according to a report from the American Hospital Association. The ratings were originally scheduled to be announced on April 21.

Nearly half of the nation’s academic medical centers are being punished through one of the federal government’s sternest attempts to promote patient safety, according to a report from Kaiser Health News (KHN).

FDA staff reviewers have issued a negative assessment of eteplirsen (Sarepta Therapeutics), a potential treatment for certain patients with Duchenne muscular dystrophy (DMD), ahead of an April 25 meeting that will consider the drug’s suitability for accelerated approval.

Positive results have been reported from a phase 3, open-label, randomized study evaluating nivolumab (Opdivo, Bristol-Myers Squibb) in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SCCHN) after platinum therapy compared with the investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab).

Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in its Covidien Oridion-labeled Capnostream 20 and Capnostream 20p patient monitors. The voluntary recall is being conducted because of a battery manufacturing defect that may increase the risk of thermal damage in the battery pack.

Positive results have been reported from a phase 3 trial of palbociclib (Ibrance, Pfizer), an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6.

Positive results have been reported from a pivotal phase 3 study of deflazacort (Marathon Pharmaceuticals), an investigational glucocorticoid with anti-inflammatory and immunosuppressant properties, in patients with Duchenne muscular dystrophy (DMD). Deflazacort significantly improved muscle strength in DMD patients compared with placebo.

A microdevice implanted into a tumor could release up to 100 individual cancer therapeutics or combinations and, upon retrieval from the tumor, could identify the best treatment option for that tumor, according to findings presented at the annual meeting of the American Association for Cancer Research, held from April 16 to 20 in New Orleans, Louisiana.

The Centers for Medicare and Medicaid Services (CMS) will no longer enforce inpatient payment cuts under the controversial “two-midnight” rule, according to a statement released by the agency. Instead of continuing plans for a 0.2% cut in Medicare reimbursement, the CMS plans a temporary increase of 0.6% in fiscal year 2017 to offset the estimated cost of the two-midnight rule policy.

With rising health care costs and higher health insurance deductibles, hospitals could find themselves in trouble with patient bad debt if they don’t make improvements in collecting out-of-pocket payments, according to an article in HealthData Management.

Antimicrobial resistance to antibiotics will present a greater danger to mankind than cancer by the middle of the century unless world leaders agree on international action to tackle the threat, according to George Osborne, Britain’s Chancellor of the Exchequer.

Federal prosecutors have launched a criminal investigation into whether the blood-testing company Theranos Inc. misled investors about the state of its technology and operations, according to a report in the Wall Street Journal.

The total immuno-oncology market will be worth approximately $14 billion by 2019, rising to $34 billion by 2024, as the treatment of cancer patients undergoes drastic changes over the next decade, according to GlobalData, a research and consulting firm.