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Home » Topics » Regulatory

Regulatory
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Biden administration concedes to court on copay accumulators

Jan. 22, 2024
By Mari Serebrov
With little fanfare, the Biden administration dropped its appeal Jan. 16 of a recent court decision that vacated a 2021 U.S. Health and Human Services rule permitting health insurance issuers and group health plans to use so-called copay accumulator adjustment programs that prevent drug manufacturers’ copay assistance from counting toward a patient’s deductible or out-of-pocket maximum.
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Judge's gavel with US flag

US FDA’s trade secret disclosure still a live legal question

Jan. 22, 2024
By Mari Serebrov
Is it an unconstitutional taking when U.S. FDA reviewers disclose a brand company’s claimed trade secrets or confidential commercial information to would-be competitors? That’s a question the U.S. Court of Federal Claims has yet to answer. While the court dismissed some of Vanda Pharmaceuticals Inc.’s claims against the FDA, its Jan. 18 opinion left open the debate of whether such disclosures, intentional or inadvertent, are a per se or regulatory taking.
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Doctor with stethoscope listening to heart of girl

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation

Jan. 22, 2024
By Tamra Sami
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
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U.S. Capitol building

Latest US continuing budget resolution leaves docs dyspeptic

Jan. 22, 2024
By Mark McCarty
The U.S. Congress has passed a continuing resolution (CR) for the fiscal 2024 budget, an exercise that has become all too common as a substitute for a full suite of spending bills in an era of growing deficits.
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Architectural pillars

US enforcement in life sciences off to robust start in 2024

Jan. 22, 2024
By Mark McCarty
One of the more significant enforcement actions to date in 2024 is the $13 million hit taken by the owner of a clinical lab in New Jersey for allegations of payment of kickbacks for unnecessary testing, suggesting that this new year will be a robust one for federal fraud enforcement in the U.S.
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FDA Approved stamp
Biopharma regulatory actions and approvals December 2023

2023 ends year with 191 US FDA approvals, including 55 NMEs

Jan. 19, 2024
By Amanda Lanier
The U.S. FDA approved 21 drugs in December, bringing the total for the year to 191, a 26% increase to the 151 U.S. approvals in 2022. New molecular entities (NMEs) fell from six in November to three in December, bringing the annual number of NMEs approved to 55.
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Osteoboost Belt

FDA clearance strengthens Osteoboost’s position as first osteopenia device

Jan. 19, 2024
By Annette Boyle
In a boon to older women worldwide, Bone Health Technologies Inc. received U.S. FDA clearance for its Osteoboost device, which reduces loss of bone strength in postmenopausal women. It is the first device cleared for intervention to slow loss of bone density or osteopenia before it advances to osteoporosis.
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Clarius PAL HD3

Clarius receives CE mark for latest wireless ultrasound scanner

Jan. 19, 2024
By Shani Alexander
Clarius Mobile Health Inc. received CE mark for its latest wireless hand-held whole-body ultrasound scanner, the Clarius PAL HD3. The scanner combines both phased and linear arrays on a single head which provides high image quality of superficial and deep anatomy allowing for better diagnostic capabilities and patient care.
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CMS logo and website

FDA, CMS statement debunks expanded CMS as appropriate for LDT oversight

Jan. 19, 2024
By Mark McCarty
The question of the U.S. FDA’s statutory authority to regulate lab-developed tests (LDTs) is still percolating, and the FDA and the Centers for Medicare & Medicaid Services (CMS) have issued a joint statement that takes aim at that very question.
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Neurology/Psychiatric

Endocannabinoid reuptake inhibitor SYT-510 granted EU IND

Jan. 19, 2024
Synendos Therapeutics AG has received approval from the European Medicines Agency (EMA) to initiate a first-in-human trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the endocannabinoid system (ECS) to restore healthy brain physiology.
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