STAT

JANUARY 19, 2023

WASHINGTON — Federal regulators’ green light for pharmacists to dispense abortion pills is crashing into legal questions and simmering court battles. The Food and Drug Administration earlier this month removed a longtime restriction that only doctors could dispense mifepristone, which is approved for abortions up to 10 weeks.

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STAT

MARCH 22, 2023

A potential class-action lawsuit against troubled digital prescribing startup Cerebral raises crucial questions about whether online marketing methods violate legal and ethical standards — an issue with important implications for dozens of other telehealth companies doing largely the same thing , experts tell STAT.

Hospitals 248

Hospitals 248

STAT

JANUARY 30, 2023

We spoke with Carl Tobias, a law professor at the University of Richmond and former legal consultant to the FDA, about the legal issues raised in the lawsuits and why he thinks the litigation is likely to succeed. What exactly is the legal issue here? This is an edited version of our conversation.

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STAT

APRIL 23, 2024

The Federal Trade Commission approved a far-reaching noncompete ban Tuesday that could force sweeping changes across the health care industry. But those changes may not take effect for years — if they ever do — because the contentious rule will almost certainly be held up in litigation.

Hospitals 356

Hospitals 356

STAT

OCTOBER 25, 2023

… Major drug companies are likely to ratchet up a sprawling legal attack aimed at challenging the Medicare drug-price negotiation process , Bloomberg Law reports. Meanwhile, here are a few items of interest. Have a grand day, and drop us a line if you hear something juicy.

Drug Pricing 243

Drug Pricing 243

STAT

FEBRUARY 29, 2024

Are biotech’s dog days over? What’s a PIPE? And what can unseat Wegovy? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.

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pharmaphorum

MARCH 22, 2024

Stay informed about the legal risks associated with AI in the life sciences sector. Understand how AI systems are being used in this industry and the potential legal implications that come with it.

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STAT

JANUARY 2, 2024

AUSTIN, Texas — The partnership between one of the nation’s largest Catholic health systems and a local government agency focused on caring for poor patients was supposed to be mutually beneficial for everyone involved. But it didn’t quite turn out that way.

Medical Schools 293

Medical Schools Hospitals 293

Pharmacy Times

APRIL 29, 2024

Retail sales were associated with lower e-cigarette use, although recreational legalization also increased the frequency of cannabis use among adolescents.

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Drug Patent Watch

NOVEMBER 17, 2023

The findings, published in JAMA, shed light… The post Navigating Legal Waters: Study Delves into Inequitable Conduct in Drug Patent Cases appeared first on DrugPatentWatch - Make Better Decisions.

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STAT

DECEMBER 18, 2023

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Today, we see a small biotech on the verge of ending a rare-disease program thanks to FDA difficulties  — and how that impacts patients.

Drug Pricing 250

Drug Pricing Drug Development 250

STAT

DECEMBER 4, 2023

OK, marijuana is now legal. Strictly speaking, marijuana use isn’t fully legal across the U.S. But when Montana and Missouri have legalized recreational use and the Senate is debating legal banking for cannabis companies, you know it’s all over but the shouting. So where’s the public health approach?

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STAT

NOVEMBER 10, 2022

She’d only started searching when she’d gotten a severe fetal diagnosis at 19 weeks; abortion was legal in Nebraska until 22. For some of them, she was already too far along. Another one was booking three weeks out.

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PharmExec

APRIL 22, 2024

In this Pharmaceutical Executive video interview, Jon Hamrick, Partner, Curatio Scientia Advisors and Jon Rawlson, President & Founder, Armory Hill Advocates, discusses how they went about testing their various hypotheses for the 2023 Patient Access: State Legal and Regulatory Environment Survey and how they collected the data.

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FDA Law Blog: Biosimilars

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. By Jeffrey N. Gibbs & Steven J.

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Express Pharma

DECEMBER 4, 2023

Lex Witness is set to host the 9th Annual Pharma Legal & Compliance Summit 2023, an event uniting legal experts, professionals, and leaders in the pharma, healthcare, and medtech industries. This summit offers an opportunity for legal professionals to engage in discussions, gain insights, and network with peers.

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Digital Pharmacist

SEPTEMBER 29, 2022

Let’s talk a bit more about these recalls and what nitrosamines exactly are, what to do if a patient inquires about this recall, and the legal actions that are being taken. Legal Action Occurring. The post Recalls Due to Nitrosamine & Legal Action Being Taken appeared first on Digital Pharmacist. What are Nitrosamines?

Pharmacy Management 98

Pharmacy Management 98

STAT

MARCH 12, 2024

Delta 8 THC is a quasi-legal psychoactive version of cannabis, which has skyrocketed in popularity after a loophole found in a 2018 federal law allowed it to be sold nationwide without the same restrictions placed on traditional marijuana.

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Drug Channels

FEBRUARY 14, 2024

Patient advocacy groups and some big legal wins are starting to reverse Cupid’s arrow. These programs’ growth continues to divert the value of a manufacturer’s copay support payments away from patients and toward plans and PBMs. Check out the data below.

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STAT

MARCH 22, 2024

The Texas Medical Board, responding to pressure from the state Supreme Court and widespread uncertainty among physicians, proposed draft guidance Friday in an attempt to clarify what constitutes emergency grounds for a legal abortion.

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STAT

APRIL 30, 2024

However, it would not legalize marijuana outright for recreational use. The DEA’s proposal, which still must be reviewed by the White House Office of Management and Budget, would recognize  the medical uses of cannabis  and acknowledge it has less potential for abuse than some of the nation’s most dangerous drugs.

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PharmaVoice

MARCH 6, 2024

An all-out blitz across U.S. courts is bolstering pharma’s goal to overturn Medicare drug price negotiations.

Drug Pricing 162

Drug Pricing 162

STAT

JUNE 9, 2023

In 2017, the Massachusetts state Legislature passed a law to ensure ease of access to birth control. It says there should be no copay for hormonal birth control prescriptions. It also allows women to fill a 12-month prescription at once. Infertility care has similar protections.

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STAT

APRIL 22, 2024

WASHINGTON — Biden officials are still pressing to shore up abortion protections amid an onslaught of legal challenges, one of which is slated for Supreme Court arguments this week.

HIPAA 327

HIPAA 327

pharmaphorum

SEPTEMBER 26, 2023

Inside the Inflation Reduction Act’s upcoming legal battles Mike.Hammerton Tue, 26/09/2023 - 10:00 Bookmark this

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FDA Law Blog: Biosimilars

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY.

Labelling 59

Labelling 59

STAT

MAY 2, 2024

In a boost for Gilead Sciences, the California Supreme Court agreed to review a contentious legal theory that thousands of HIV patients have used in a closely watched case to argue drugmakers can be held negligent for failing to develop a medicine.

Documentation 278

Documentation 278

STAT

MAY 7, 2024

appeals court must weigh how far FDA regulations for an abortion pill go in preempting state laws that regulate the practice of medicine — a largely untested area that legal analysts say will shape abortion access , Bloomberg Law explains. Legal analysts predict both sides are likely to appeal the ruling. On April 30, a U.S.

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Big Molecule Watch

JANUARY 19, 2024

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered on the Big Molecule Watch.

Biosimilars 73

Biosimilars Dosage Drug Pricing 73

Pharma Pathway

FEBRUARY 19, 2023

Aurobindo Pharma-Openings for QC/ QA/ Microbiology/ Legal Departments -Apply Now Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). aurobindo.com Aurobindo Pharma-Openings for QC/ QA/ Microbiology/ Legal Departments -Apply Now

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Pharmaceutical Manufacturing 52

STAT

DECEMBER 15, 2023

A Texas woman’s unsuccessful legal fight for an abortion on medical emergency grounds drew nationwide headlines in recent days, but her plight is hardly a rare occurrence amid vague and highly restrictive state laws in the post-Roe era.

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STAT

APRIL 23, 2024

The Federal Trade Commission has never tried to block such cross-market mergers, but antitrust experts say these latest findings add to what could become a strong legal argument against the deals. But a study released Tuesday adds to a growing body of evidence that prices still go up even if the merging hospitals are far apart.

Hospitals 359

Hospitals 359

STAT

APRIL 29, 2024

The agency’s action, which is expected to face legal challenges in courts, comes after Congress failed to pass a law to regulate such tests. The Food and Drug Administration will start actively regulating tests developed in laboratories, with some exemptions, the agency announced on Monday.

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STAT

JANUARY 10, 2024

The new, highly detailed legal filings also come right as MultiPlan and more than a dozen of the largest tax-exempt, nonprofit hospital systems are wooing investors at the J.P. Morgan Healthcare Conference.

Hospitals 308

Hospitals Health Insurance Companies 308

NY Times

APRIL 24, 2022

We answer a common reader question about the opioid crisis and legalizing drugs.

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pharmaphorum

FEBRUARY 13, 2024

Texas judge has thrown out the first lawsuit brought by PhRMA claiming Medicare negotiation of drug pricing is unconstitutional

Drug Pricing 113

Drug Pricing 113

Pharmaceutical Technology

AUGUST 3, 2023

GlobalData has revealed the top 20 global M&A legal advisers for H1 2023 in its latest league tables.

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