Legal
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FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine
ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.
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BeiGene, Novartis Drug Alliance Ends; It’s Their Second Terminated Deal This Year
BeiGene welcomes the return of the immunotherapy’s rights as an opportunity to make it the backbone of its solid tumors strategy. But Novartis cedes an opportunity to gain a competitor to established cancer immunotherapies from Merck and Bristol Myers Squibb.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
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How the FTC Is Tackling ‘Below the Radar’ Healthcare Deals
The Federal Trade Commission only gets notified when a merger/acquisition deal value is above $100-$110 million, so smaller deals nonetheless lead to a slow consolidation of the market. In conference remarks, FTC Chair Lina Khan outlined the ways in which the agency is trying to counter this phenomenon.
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FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class
FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.
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Introducing MedCity FemFwd, a New Podcast on Women’s Health
MedCity News is launching a new podcast called MedCity FemFwd, which will discuss the breakthroughs and challenges in the women’s health space. In the inaugural episode, Michelle Long of KFF examines whether Opill — the first daily oral contraceptive approved for nonprescription use in the U.S. — will be covered by insurance.
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Civil Rights Groups File Complaint Against Florida for Medicaid Redeterminations Process
More than a dozen civil rights organizations alleged in a new complaint that Florida uses administrative practices that are preventing underserved communities from renewing their Medicaid coverage.
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Is Medicaid Expansion Still a Political Wedge Issue?
When Medicaid expansion was first enacted, it was a hot topic debate between Democrats and Republicans. But more and more states are starting to expand Medicaid, including several conservative states.
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Senators Introduce Bipartisan Bill To Impose Harsher Penalties On Those Who Assault Healthcare Staff
This week, senators introduced a bipartisan bill that would make it a federal crime to assault hospital workers. Even though nearly 40 states have passed laws to intensify penalties for violent acts committed against healthcare personnel, there is currently no federal law protecting hospital employees from assault or intimidation.
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How 4 Mental Health Firms Want the DEA to Handle Virtual Prescribing of Controlled Substances
Talkiatry, Array Behavioral Care, Iris Telehealth and Quartet Health sent a letter to the DEA asking for a special registration process that would allow for the prescribing of certain controlled medications via telemedicine.
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Enhancing Efficiency in your Practices: Unleashing the Power of Greenway Health’s Optimization Services
Resolve your healthcare information technology concerns by optimizing your technology, boosting workflows, improving staff productivity, and driving revenue.
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FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants
The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.
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HHS Issues Proposal Bolstering Nondiscrimination Protections For People With Disabilities
HHS released a new proposed rule to update nearly 50-year old regulations protecting people with disabilities from discrimination while seeking healthcare. With its new proposal, HHS is amending the regulations to be clearer in their language, as well as more aligned with the Americans with Disabilities Act, the Americans with Disabilities Amendments Act and amendments to the Rehabilitation Act.
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HHS Will Likely Face More Lawsuits Against Drug Price Negotiation Now That It Has Named the First 10 Meds Included In the Plan
Novartis became the seventh drugmaker to legally challenge the White House’s Medicare drug pricing negotiation program. The company filed its lawsuit three days after HHS announced the first 10 drugs that were selected for the program — its heart failure medication Entresto was one on the list. HHS can expect to face more lawsuits from the manufacturers of the 10 drugs it named last week, experts have warned.
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Amgen, FTC Settlement Allows $28B Horizon Acquisition to Move Forward
Amgen and the Federal Trade Commission are settling the lawsuit the regulator filed to block the pharmaceutical giant’s $28 billion Horizon Therapeutics acquisition. As part of the settlement, Amgen agrees not to “bundle” its products with Horizon’s drugs in negotiations with health plans.
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Senate Bill Proposes Slashing ‘Red Tape’ Around Biosimilar Interchangeability
Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.
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What Impact Will California’s New “Transaction Review” Law Have?
California passed a law last year aimed at controlling rising healthcare costs that gave the state the ability to scrutinize healthcare deals of a certain size involving California companies. What impact can it have?