Fri.Dec 22, 2023

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Beers Criteria Updates Refine, Introduce New Drug Criteria

Pharmacy Times

This latest revision introduces a new set of drug criteria, refines the existing ones, and enhances the overall formatting to ensure increased ease of use and clarity for its recommendations.

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2024 Outlook: Despite hurdles, stakeholders bullish on VR in behavioral health

Fierce Healthcare

Though often associated with gaming, virtual reality (VR) is a technology rapidly evolving in healthcare. | VR therapy is not a new concept, though it wasn’t until the last few years that the field became prominent. And as technology has improved and gotten more intuitive to use, it has also become less expensive.

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FDA Approves Eplontersen for the Treatment of Adult Patients With ATTRv-PN

Pharmacy Times

The drug is the first medicine to be approved for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis that can be self-administered.

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3 issues to watch in global health in 2024

STAT

As we enter the fifth year of this challenging decade, life finally appears to be inching toward normal — a new normal — on the infectious diseases front. Humans and the SARS-CoV-2 virus seem to be making progress toward a detente with each other. Covid is still a major disruptor, a significant cause of illness and death. But the massive disease waves of the early 2020s have calmed down.

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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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2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue

Fierce Pharma

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. | Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise.

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STAT+: AAFP’s CEO on how to keep primary care doctors in the field

STAT

In ten years, the United States could be short as many as 48,000 primary care doctors. The specialty is underpaid, to a point that doctors are lobbying Medicare to pay it extra. Even medical residents who chose the specialty are leaving primary care ; some 45% of residents who planned to be generalists changed their mind during their residencies. But R.

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Senate Inquiry Reveals Widespread Flaws in Maintaining Pharmacy Customer Data Privacy

Drug Topics

No major pharmacy chains across the United States require a warrant to release sensitive prescription data, including data regarding birth control or mental health conditions, with law enforcement agencies.

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STAT+: Bristol Myers to purchase Karuna, maker of schizophrenia drug, for $14 billion

STAT

Bristol Myers Squibb said Friday that it will acquire Karuna Therapeutics, a developer of medicines for neuropsychiatric conditions, for $14 billion. The deal values Karuna at $330 per share, or a 53% premium to its Thursday share price. The centerpiece of the transaction is a drug called KarXT to treat schizophrenia. KarXT is currently under review by the Food and Drug Administration, and if approved next year, would usher in the first new class of medicines for the treatment of schizophrenia i

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ChristianaCare pays $47M to resolve former compliance officer's kickback allegations

Fierce Healthcare

Wilmington, Delaware-based ChristianaCare has agreed to a $47.1 million settlement resolving illegal kickback allegations flagged by its former chief compliance officer, Ronald Sherman. | The agreement is the largest False Claims Act settlement in Delaware's history and paves the way for future cases against hospitals that provide private physician groups with free services from their employees, legal counsel said.

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Phase 2 Study Results Show Psilocybin Reduces Depressive Symptoms in Adult Patients With Cancer

Pharmacy Times

The investigators note that psilocybin’s effectiveness in treating depressive symptoms and the positive reception among patients with cancer are encouraging continued research.

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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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Opinion: The unique pain and joy of celebrating Christmas with a child in the pediatric intensive care unit

STAT

In the days leading up to Christmas in the pediatric intensive care unit (PICU), medical teams work to send as many children home as they can. Kids should be with their people for the holidays. And it makes sense. But for parents of children receiving in-home care — parents like me — it can be a relief to surrender to the hospital’s siren song.

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Researchers Link Pandemic-Associated Financial Hardships to Severe, Persistent COVID-19

Pharmacy Times

Families that reported a lower income before the pandemic were more likely to experience hardships if headed by an adult with COVID-19 illness.

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J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk

Fierce Pharma

As the FDA investigates a safety signal for approved CAR-T therapies, the agency has upgraded a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carv | As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carvykti.

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STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear

STAT

The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy.  While the label means that physicians will have to have a conversation about secondary malignancies occurring after Carvykti treatment, oncologists and CAR-T experts said the label update won’t change anything about the

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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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Korean Patients With IBD Face Higher Risk of C Difficile

Drug Topics

In a trend similar to that observed among Western patients with IBD, Korean patients with IBD have an elevated risk of Clostridioides difficile (C difficile).

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15 reasons you may have belly button pain

The Checkup by Singlecare

Almost everyone experiences stomach discomfort from time to time. But what if the pain is centered around your belly button? Belly button pain, known as periumbilical pain, can happen for many reasons. Sometimes, periumbilical pain is caused by temporary issues such as constipation, indigestion, or the stomach flu. In other cases, belly button pain can be a sign of serious health issues like appendicitis or a bowel obstruction.

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STAT+: Venture capital is still pouring into drug research despite Medicare price negotiation

STAT

WASHINGTON — Venture capitalists are still pouring money into drug research in spite of Medicare’s new power to negotiate drug prices, according to Congress’ nonpartisan budget experts. The Inflation Reduction Act includes two measures that directly lower drug prices. Medicare price negotiation is the most controversial of the two.

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Anxiety Identified as Most Prevalent Comorbidity in Patients Using Isotretinoin For Acne

Drug Topics

Investigators recommended that isotetinoin be used with extreme caution among patients with a history of mental illness in light of study findings.

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A look back at 2023: Smith + Nephew

pharmaphorum

This year brought about a whole gambit of news and developments, of conferences and launches, all coming in thick and fast and excited about the pharmaceutical industry and healthcare system. Not least of these was Smith + Nephew’s opening of a new state-of-the-art surgical innovation and training centre in the heart of Munich, Germany, on 11th October.

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Sanofi stops development of lung cancer drug

European Pharmaceutical Review

French pharmaceutical giant Sanofi announced that it is ending the development programme evaluating tusamitamab ravtansine as a monotherapy for certain patients with metastatic non-squamous, non-small cell lung cancer (NSCLC). The decision comes after interim analysis from a Phase III clinical trial , CARMEN-LC03, did not meet a primary end point. CARMEN-LC03, a randomised, open-label study was evaluating tusamitamab ravtansine as monotherapy compared to docetaxel in patients with metastatic non

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More ‘Faux-zempic’ found, this time in ‘legitimate’ US supply chain, FDA warns

Fierce Pharma

The FDA and Novo Nordisk are warning of c | The FDA and Novo Nordisk are warning of counterfeit versions of popular weight-loss treatment Ozempic that have been discovered in the “legitimate” United States supply chain.

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As ALS research booms, one treatment center finds itself in the spotlight

PharmaVoice

The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists. Still, the complexities of the disease and of drug development have brought hard-felt losses.

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STAT+: Pharmalittle: Bristol Myers to buy schizophrenia-drug maker; Servier found guilty of fraud

STAT

And so, another working week will soon come to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we expect to promenade with the official mascots, catch up on our reading, and hang with a relative or two. We also hope to hold another listening party with Mrs.

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Technicians Can Help With Sterile Compounding

Pharmacy Times

Amid pharmacy strikes and ongoing challenges, technicians can identify new opportunities for growth

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The Transformative Potential of AI and Machine Learning in Biomedical Research and Healthcare

PharmExec

Oxford Academic report explores the positive improvements these technological capabilities could bring to the industry.

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The clock is ticking, and Cytokinetics is running out of December

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with the final edition of this newsletter for 2023. We’re taking a break for the holidays and will be back in your inbox bright and early on Jan. 3.

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BMS strikes $14bn deal for Karuna Therapeutics

European Pharmaceutical Review

Bristol Myers Squibb (BMS) has agreed to acquire Karuna Therapeutics for a total of $14.0 billion, strengthening its neuroscience portfolio. Under the terms of the deal, BMS will acquire all outstanding shares of Karuna Therapeutics common stock for $330.00 per share in cash. This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023.

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Morning Rounds: Our newsroom’s favorite stories of 2023

STAT

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter  here. Health data breaches set a record this year “We’re writing to inform you of a cybersecurity incident”: If you’ve gotten a message like this from your health care organization, you’re not alone.

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MeiraGTx sells XLRP gene therapy to Janssen

European Pharmaceutical Review

MeiraGTx has entered into an asset purchase agreement with Janssen Pharmaceuticals for the remaining interests in botaretigene sparoparvovec (bota-vec) a gene therapy for the treatment of X-linked retinitis pigmentosa (XLRP). Under the agreement, MeiraGTx is to receive $130 million in upfront and near-term milestone payments. The company will receive up to an additional $285 million in cash payments upon first commercial sales of bota-vec in the US and EU, as well as for manufacturing technology

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2023 in review: Cancer vaccines dose up on advances with tailored approaches 

Pharmaceutical Technology

As the number of patients with cancers continues to grow globally, research into personalised cancer vaccines is vital.

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FDA approves Ionis, AZ’s Wainua for ATTR polyneuropathy

pharmaphorum

AstraZeneca and Ionis get first approval for ATTR polyneuropathy drug Wainua (eplontersen), a rival to drugs from Alnylam and Pfizer

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Merry Christmas!

OctariusRx

Merry Christmas! Thank you to our clients, family, and friends for all your support this year. Our entire team is always grateful for our blessings and the wonderful people we work with. Whether you joined us this December, or have been with us for many years, thank you for allowing us to take care of you. We appreciate your trust and support. A successful year would be impossible without our hardworking team.

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Independent Rx Forum: Legal Frontiers and Updates From NCPA

Pharmacy Times

Tune in to this episode of the Independent Rx Forum for a comprehensive update on legal developments and insightful discussions on class action lawsuits and regulatory guidelines from the National Community Pharmacists Association.

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Vibrating pill may give dieters a feeling of fullness, study suggests

The Guardian - Pharmaceutical Industry

Research carried out on pigs showed they ate almost 40% less food after ingesting the capsule Dieters everywhere know that, no matter how inventive a chef you may be, nothing leaves you buzzing like sugary or fatty food. Now science might have the answer: a vibrating pill, swallowed before eating, that creates feelings of fullness. Continue reading.

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