Bristol Myers Squibb drug Augtyro now has a tumor-agnostic approval permitting the drug to be used to treat all solid tumors positive for NTRK gene fusions. Augtyro came from BMS’s $4.1 billion acquisition of Turning Point Therapeutics.

The post New FDA Nod Brings Bristol Myers Squibb Cancer Drug to a Wider Range of Solid Tumors appeared first on MedCity News.

The Supreme Court sided with the FDA and unanimously ruled to uphold access to abortion pill mifepristone. The decision quells worries about what it might look like if the Supreme Court sided with the physician group — many healthcare leaders feared that if the top court could overturn mifepristone’s FDA approval, the same could happen to other drugs.

The post How Healthcare Leaders Are Reacting to the Supreme Court Preserving Abortion Pill Access appeared first on MedCity News.

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer.

The post Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease appeared first on MedCity News.

Geron Corporation’s Rytelo is now FDA approved for treating anemia caused by myelodysplastic syndromes. The new drug will compete against Reblozyl, a blockbuster Bristol Myers Squibb medicine.

The post Geron Drug Lands a First-in-Class FDA Approval in Type of Blood Cancer appeared first on MedCity News.

The Consumer Financial Protection Bureau, which has been targeting debt collection practices, survives a Supreme Court challenge. 

The post SCOTUS Deals a Blow to Medical Debt Collectors appeared first on MedCity News.

Three upcoming Supreme Court decisions have the potential to radically change FDA regulation of medications.
The cases, which involve “Chevron deference” and the abortion pill mifepristone, were discussed on a panel during the BIO conference in San Diego.

The post Why a SCOTUS Ruling on Fishing Rules Could Change How FDA Regulates Drugs appeared first on MedCity News.

Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year.

The post FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products appeared first on MedCity News.

The PTC Therapeutics drug Translarna failed its confirmatory study in Duchenne muscular dystrophy. Analysts say the European Commission’s decision to not adopt the Committee on Medicinal Products for Human Use’s negative opinion on the drug is unusual, if not unprecedented.

The post European Commission Decision Is a Reprieve for PTC Therapeutics’ Rare Muscle Disease Drug appeared first on MedCity News.

A good outsourced partner can work alongside in-house accountants and stay on top of the moving target of healthcare accounting regulations, addressing tax risks and identifying cost-saving opportunities.

The post Tax Challenges for Healthcare Accounting Teams Bring Opportunity for Innovation appeared first on MedCity News.

The U.S. Department of Justice recently launched a task force on healthcare monopolies. Experts have varying opinions on how it will impact the healthcare industry.

The post DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference? appeared first on MedCity News.

Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.

The post FTC Seeks More Information on the $16.5B Novo-Catalent Deal, Leading to Another Delay appeared first on MedCity News.

Is a widened enforcement net squeezing physicians unfairly? That’s the belief of one high-profile author and health policy expert.

The post Stark Law Crackdown Jacks Up Fines, Settlements and Physician Pressures appeared first on MedCity News.

We must realign the financial incentives and democratize access through data sharing. Pharma needs to lead the charge, but employers and pharmacies must also be agents of change. Here’s how we can do it.

The post An Ohio Pharmacy Was Fined $250K. It Represents Everything Wrong With the Prescription Drug Industry. appeared first on MedCity News.

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary.

The post Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency appeared first on MedCity News.

Labcorp’s $239 million offer was selected as the winning bid for the assets of genetic testing company Invitae, which filed for bankruptcy protection earlier this year. The acquisition deal, Labcorp’s second in the past month, will enable it to expand in oncology and rare diseases.

The post Labcorp Makes Another Acquisition, Plucking Invitae Assets From Bankruptcy Auction appeared first on MedCity News.

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder.

The post Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B appeared first on MedCity News.

More than 33,000 Providence employees filed a class-action complaint against the health system in 2021, alleging that it had been withholding their wages by denying them breaks and rounding down their working hours. Last week, Providence was ordered to pay more than $200 million in damages — a decision that “sends a message to healthcare corporations,” according to an attorney representing the workers.

The post Providence Ordered to Pay $200M for ‘Systemic Wage Violations’ appeared first on MedCity News.

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.

The post FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer appeared first on MedCity News.

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells.

The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News.

Questions about whether acetaminophen use during pregnancy can lead children to develop neurological problems have sparked scientific inquiry and litigation. Lawsuits are continuing, but a new National Institutes of Health-sponsored study has results that show no causal link between acetaminophen and neurodevelopmental disorders.

The post NIH Study: Use of Popular Pain Reliever During Pregnancy Not Linked to Neuro Disorders in Kids appeared first on MedCity News.

The FDA expanded the approval of Roche’s Alecensa to include adjuvant treatment of non-small cell lung cancer. The targeted therapy addresses cancers driven by the ALK genetic mutation.

The post Roche Drug Scores Label Expansion for Earlier Use in Lung Cancer appeared first on MedCity News.

Major malpractice verdicts have spiked in recent years. 

The post Healthcare Docket: Help Wanted — Doctor Expert Witnesses appeared first on MedCity News.

This week, the FTC ordered Cerebral to pay a $7 million fine, accusing the company of mishandling users’ sensitive health data and misleading consumers about cancellation policies. Experts agree that other virtual healthcare providers need to work on their legal and compliance strategies in order to avoid a similar fate.

The post What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry? appeared first on MedCity News.

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder.

The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

Following an extensive investigative report from the New York Times, the AHA is calling for the Labor Department to probe into the business practices of data analytics firm MultiPlan. The report revealed that MultiPlan works with major payers to negotiate reduced reimbursements for out-of-network medical providers — and that this practice ends up costing patients and employers.

The post AHA Urges Labor Department to Investigate MultiPlan’s ‘Unconscionable Practices’ appeared first on MedCity News.

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.

The post AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med appeared first on MedCity News.

The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.

The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020. The FDA rejected the drug two years ago due to concerns about cardiovascular safety.

The post Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug appeared first on MedCity News.

AliveCor CEO Priya Abani argues that Apple has made a habit of taking intellectual property from smaller medical device firms in order to improve the functionalities its Apple Watch. She also believes that Apple has been able to avoid taking accountability for this by “bombarding” smaller companies with litigation it knows they won’t be able to afford — a claim that medical IP lawyers have backed up.

The post AliveCor Isn’t Backing Down from Apple, Its ‘Bully’ appeared first on MedCity News.

One year after the Medicaid continuous enrollment provision ended, 19.2 million people have been disenrolled from Medicaid, according to KFF. This is higher than many expected, and experts have mixed reviews on how they think this process has gone.

The post 1 Year Later: How Has the Unwinding of Medicaid Continuous Enrollment Gone? appeared first on MedCity News.