Mon.Apr 08, 2024

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Methotrexate, Leflunomide Linked to Higher Risk of Adverse Pregnancy Outcomes in Patients With RA

Drug Topics

Due to the increased possibility of adverse pregnancy outcomes associated with methotrexate and leflunomid, it is crucial that patients with rheumatoid arthritis (RA) engage in thorough consultations with their physicians regarding pregnancy planning.

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Opinion: The time has come for over-the-counter antidepressants

STAT

Anyone can now walk into a pharmacy in the United States and buy oral contraceptives over the counter without a prescription, thanks to the FDA’s approval of norgestrel (Opill). This change reflects the drug’s safety and the public health imperative to ensure wider access to birth control. But another safe class of medicine that addresses a massive public health need remains unavailable except by prescription: the antidepressants known as selective serotonin reuptake inhibitor

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Pharmacist Strategies for Mitigating Patient Harm, Inequities During Drug Shortages

Drug Topics

Researchers addressed pharmacists’ role in mitigating drug shortages.

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STAT+: New liquid biopsy screening test for pancreatic cancer shows promise in early data

STAT

For the vast majority of pancreatic cancer cases, the tumor grows undetected until it has already spread locally or to distant parts of the body. That means most patients, over 80% by some estimates, are diagnosed when it’s already too late to do surgery — depriving them of their best chance for a cure. “For the majority of patients, we cannot resect the tumor.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Patient Preferences Play Essential Part in Contraceptive Care

Pharmacy Times

Although there are medical considerations for patients with psychiatric conditions, prescribers must consider patient preference to increase adherence and effectiveness of contraception.

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STAT+: HCA reports almost $1 billion more in charity care to Medicare than to its shareholders, drawing more taxpayer money

STAT

The country’s biggest hospital chain, HCA Healthcare , told the Centers for Medicare and Medicaid Services it doled out almost $1 billion more in financial assistance to needy patients than it reported on its financial statement in 2022, helping the enormously profitable company extract billions of dollars from taxpayer-funded programs. It’s normal for hospital systems to report more charity care — free and discounted care provided to low-income patients — in their an

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More Trending

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Patient with transplanted pig kidney had a ‘tense’ rejection episode before leaving the hospital

STAT

The world’s first recipient of a kidney transplant from a genetically modified pig experienced a rejection episode before recovering and leaving the hospital last week, a Massachusetts General Hospital doctor told STAT. But in his first few days back at home in Weymouth, Mass., the patient — 62-year-old Richard Slayman — had shown no further signs of organ distress.

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AstraZeneca, Daiichi Sankyo's Enhertu wins historic HER2 tumor-agnostic FDA nod

Fierce Pharma

With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s (ADC's) reach in the U.S.< | With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s reach in the United States.

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Medicaid redetermination cost community health centers an average of $600K each

STAT

It’s been a year since states began the process of Medicaid redetermination, going through their Medicaid rolls that had been frozen through the Covid-19 emergency period. According to data from KFF , about 21% of the people who were enrolled prior to the redetermination, or close to 20 million, lost coverage, while 45%, or 42 million, were confirmed.

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Jardiance doesn’t cut it in post-heart attack trial

pharmaphorum

SGLT2 inhibitors have transformed the treatment of heart failure in the last few years, but an attempt to extend their use into the setting of post-heart attack patients has suffered a setback.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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HCA’s charity care filings are on hyperdrive

STAT

You’re reading the web version of Health Care Inc.,  STAT’s weekly newsletter  following the flow of money in medicine.  Sign up  to get it in your inbox every Monday.  The funny business of reporting charity care The concept of charity care is simple: It’s the free and discounted care that hospitals provide to low-income people.

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'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study

Fierce Pharma

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. | Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.

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The latest updates on cancer research from the weekend

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hi, it’s Meghana. Lots happened this past weekend! We have news for you from the annual meeting of the American Association for Cancer Research, and also from the annual meeting of the American College of Cardiology.

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Women’s health and digital tech empowerment

pharmaphorum

Empower women's health with digital tools and technology. Learn about the latest advancements and resources to promote wellness and empowerment in women's health.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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STAT+: FDA agrees to review a rare disease drug that its developer was about to give up on

STAT

File this under “Not a moment too soon.” After years of back-and-forth deliberations, the U.S. Food and Drug Administration has agreed to review a rare disease drug developed by a small company that planned to shelve further work if the agency did not take this long-sought step. Specifically, the FDA accepted a new drug application from Stealth BioTherapeutics for a treatment to combat Barth syndrome, which causes an enlarged heart, muscle weakness, and a shortened life expectancy.

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With wider approval, J&J and Legend's Carvykti quickly leaps ahead of BMS' rival myeloma CAR-T

Fierce Pharma

Merely hours after Bristol Myers Squibb’s Abecma secured the FDA’s blessing to break into earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti received a simil | Merely hours after Bristol Myers Squibb’s Abecma secured the FDA’s blessing to break into earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti received a similar go-ahead—but in an even earlier setting and with expanded manufacturing specifications.

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STAT+: Device made by company J&J is buying for $13 billion clears hurdle in independent study

STAT

A fully independent clinical trial researchers thought might disprove a cardiac device made by Shockwave Medical, the company that Johnson & Johnson is buying for $13 billion, ended up providing some support for the device’s utility. The data, presented Monday at the annual meeting of the American College of Cardiology and published in The Lancet , could bolster the case for the device, which is available in Europe and the U.K. but was previously rejected by the U.S.

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FDA swats away Supernus’ Parkinson’s disease infusion pump for 3rd time

Fierce Pharma

The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The following year, the agency doled out a complete response letter, dashing Supernus' second try.

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Fitch: MA utilization spike clouds outlook for payers in early 2024

Fierce Healthcare

Health insurers are gearing up to release their first-quarter results over the next several weeks, and a new analysis from Fitch Ratings finds that ongoing concern about utilization in Medicare Adv | A new analysis from Fitch Ratings finds that ongoing concern about utilization in Medicare Advantage has made for a cloudy outlook.

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Creating a winning playbook for consistent digital product success

pharmaphorum

Creating a winning playbook for consistent digital product success involves strategic planning, execution, and continuous improvement. Discover key strategies and practices to ensure your digital products achieve lasting success.

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FDA Approves Dolutegravir/Lamivudine for Treatment of Adolescents With HIV-1 Infection

Pharmacy Times

The treatment is indicated for adolescents at least 12 years of age who weigh at least 25 kg without a previous treatment history of antiretroviral therapies.

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Ionis, Arrowhead hail data with triglyceride drugs at ACC

pharmaphorum

Drugs from Ionis and Arrowhead Pharma that block apolipoprotein C-III (apoC-III) have shown their value in treating diseases associated with elevated triglyceride levels in two studies presented at the American College of Cardiology annual congress. The two companies are racing to bring their apoC-III inhibitors to market for severe hypertriglyceridaemia (HTG) and ultra-rare disorder familial chylomicronaemia syndrome (FCS).

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Next-gen menopause treatments have blockbuster potential. Can women, doctors and payers be convinced?

PharmaVoice

The market is huge, but will companies overcome the triple hurdles of payer hesitance, prescriber reluctance and sluggish consumer demand?

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Study points to weaknesses in FDA accelerated approval path

pharmaphorum

Less than half of the cancer therapies given accelerated approval by the FDA in 2013 to 2017 showed a clinical benefit in a confirmatory trial within the next five years

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Unlocking growth: How GenAI can help pharma companies convert new clients

PharmaVoice

GenAI is profoundly reshaping various facets of the pharmaceutical industry. Projections indicate that the global GenAI market in pharma will soar to USD 2258.1 million by 2032.

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STAT+: Pharmalittle: We’re reading about Biocon eyeing weight loss drugs, Sanofi layoffs, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because the usual routine of online meetings, phone calls, and deadlines has inevitably returned. But you knew this would happen, yes? After all, what can you do? The world, such as it is, continues to spin. So in hopes of nudging it in a better direction, we are brewing cups of stimulation.

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Ed Schoonveld Discusses Drug Pricing in the US and Upcoming Articles

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value & Access Advisor, Schoonveld Advisory, offers his thoughts on lower drug prices in the US and provides a sneak peak into future PC features.

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Women want to participate in clinical trials. Lack of flexibility is still a problem.

PharmaVoice

Underrepresentation of women in clinical trials affects the resulting drugs that are available down the line. Encouraging more women to partake is a critical step in promoting more equitable healthcare.

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'Sobering' study finds nearly no benefits from medical debt relief efforts

Fierce Healthcare

A nonprofit organization’s work buying out and forgiving billions of dollars of medical debt may not be helping patients as much as it or its benefactors had hoped, economists say. | An experimental review of medical debts relieved by the charity RIP Medical Debt in 2018 to 2020 showed near-negligible changes in credit, no improvement in financial well-being, no changes in repayment or utilization behaviors and worsened mental health among those with the most debts.

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Changing Faces: Pharma and biotech hires from March 2024

pharmaphorum

Stay up to date with the latest pharma and biotech hires from March 2024, including notable companies like Sitryx, Oxford, and MaaT Pharma.

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More Research Needed for Treatment of Clozapine-Resistant Schizophrenia

Pharmacy Times

Current evidence and data regarding clozapine-resistant schizophrenia is unclear, but new treatment options are on the horizon that could show promise.

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Enhertu gets FDA nod for tumour-agnostic HER2 cancers

pharmaphorum

FDA approves AstraZeneca and Daiichi Sankyo’s Enhertu for all HER2-positive solid tumours, in a first for both the HER2 inhibitor and ADC category.

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Innovative personalised immunotherapy approved for multiple myeloma

European Pharmaceutical Review

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) is indicated for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.

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Safety Data Confirm Viability of Flu, RSV Vaccines For Patients at Risk of Heart Failure

Pharmacy Times

Investigators reported a low incidence of adverse events after simultaneous vaccination against seasonal influenza and respiratory syncytial virus.

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