Mon.Mar 18, 2024

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STAT+: As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’

STAT

The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceutical companies. PBMs, the middlemen of drug pricing negotiations, also claim portions of those lucrative rebates for themselves.

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FDA Advisory Committee Votes in Favor of Ide-Cel for Adult Patients With Multiple Myeloma

Pharmacy Times

The decision to vote in favor of idecabtagene vicleucel comes after positive phase 3 trial results demonstrating its efficacy compared with standard regimens.

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AstraZeneca Caps Out-of-Pocket Inhaler Costs at $35 Per Month

Drug Topics

AstraZeneca is the second pharmaceutical company to cap out-of-pocket costs for eligible patients.

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STAT+: FDA approves first gene therapy for a fatal neuron disease in children

STAT

The Food and Drug Administration on Monday approved a gene therapy for metachromatic leukodystrophy, a devastating genetic disorder that eats away at affected children’s neurons. The medicine, marketed as Lenmeldy, is the first treatment for MLD, which is otherwise fatal. Lenmeldy has to be given before symptoms appear or, in some cases, after the first signs of disease, so it won’t be helpful for many patients living with MLD today.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Bacterial Load in Spinal Fluid Could Predict Pneumococcal Meningitis Outcomes

Pharmacy Times

High bacterial load in cerebrospinal fluid was associated with unfavorable outcomes and death for adults with pneumococcal meningitis.

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STAT+: As AI marches into medicine, investors eye security, privacy startups

STAT

Investors are starting to back startups that offer privacy and security services to bolster health AI products already on the market while they wait for crucial safety and privacy regulations to take shape. Though health leaders are racing to deploy generative AI products that can automatically transcribe doctor-patient conversations during medical appointments or churn through massive repositories of scientific research, they’re still flummoxed about how to measure their quality.

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Pfizer set to collect roughly $2.6B in selloff of Haleon shares, reducing stake from 32% to 24%

Fierce Pharma

Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is | Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is prepared to do the same with a larger selloff, according to the consumer healthcare company. Pfizer is set to reduce its stake in Haleon from 32% to 24% by selling 630 million shares in a public offering.

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Topical Minoxidil Improves Hair Growth in 87% of Pediatric Patients With Chemotherapy-Induced Alopecia

Pharmacy Times

The FDA-approved topical and oral agent is currently indicated for adult patients with patterned alopecia.

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#FierceMadness: Grab a bracket and vote for the most overused buzzword in healthcare!

Fierce Healthcare

The NCAA basketball tournament gets underway today, and the Fierce Healthcare team is gearing up yet again for our annual #FierceMadness competition. | The NCAA basketball tournament gets underway today, and the Fierce Healthcare team is gearing up yet again for our annual #FierceMadness competition.

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STAT+: I was wrong about Geron’s blood cancer drug. Now, is it a takeover target?

STAT

I was wrong about Geron. For years, I’ve believed — and declared publicly — that Geron’s effort to develop a blood cancer drug called imetelstat would end in disappointment. The drug was never getting approved , I said. On Thursday, a group of outside experts convened by the Food and Drug Administration voted 12-2 in imetelstat’s favor, concluding the drug’s benefits outweighed its risks for the treatment of patients with myelodysplastic syndrome.

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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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Study Results Show Evolving DNA Methylation Can Help Understanding of Hematologic Diseases

Pharmacy Times

The authors note that understanding the DNA methylation profile in leukemia can help predict whether or not a patient will respond to treatment.

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Akums introduces Hydroxyurea oral suspension for sickle cell disease

Pharmaceutical Technology

Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.

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After Kyowa Kirin buyout, Orchard scores FDA approval for first MLD gene therapy in the US

Fierce Pharma

Kyowa Kirin’s bet on Orchard Therapeutics has paid off, furnishing the Japanese drugmaker with a newly approved gene therapy in the U.S. | The FDA on Monday gave a thumbs up to Lenmeldy as the first gene therapy in the U.S. for kids with certain types of metachromatic leukodystrophy (MLD).

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Pharmacist Role in Addressing Operational Challenges of Bispecifics in MM

Pharmacy Times

Michael Singel, PharmD, discusses the role of pharmacists in the operationalization of bispecifics to treat multiple myeloma, including the creation of treatment plans and standard of care order sets.

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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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Patient-centricity and HCP engagement: 7 Challenges in pharma and life sciences outreach

pharmaphorum

Discover the top 7 challenges faced by pharmaceutical and life sciences companies in achieving patient-centricity and engaging healthcare professionals (HCPs). Explore strategies to overcome these obstacles for successful outreach efforts.

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AstraZeneca, GSK make case for broad immunotherapy uses in endometrial cancer. But questions remain

Fierce Pharma

After a quick FDA approval in a subset of endometrial cancer, GSK is back with more data for two Jemperli regimens in hopes of reaching a broader patient population. | After a quick FDA approval in a subset of endometrial cancer, GSK is back with more data for two Jemperli regimens—including one with a PARP drug—in hopes of reaching a broader patient population.

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CAR-Ts set to move earlier in multiple myeloma therapy

pharmaphorum

FDA advisors have said that two BCMA-targeted CAR-T therapies can be used earlier in the treatment pathway for multiple myeloma, setting up FDA approvals for use in a broader patient population.

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Bluebird bio secures loan lifeline from Hercules Capital to help support 3 gene therapy launches

Fierce Pharma

As bluebird bio works to make the most of three gene therapy launches, cash-flow concerns have been looming over the drugmaker. | The funding should extend bluebird bio's cash runway through the first quarter of 2026 as it advances three gene therapy launches. Previously, the company expected its cash to run out by this year's second quarter.

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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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Contineum Therapeutics files for IPO

STAT

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 ponder the vast open spaces of Boston’s unused life sciences labs, see a new biopharma IPO in the works, and expect a label expansion for some CAR-T blood cancer therapies.

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Agreement reached on EU health data framework

pharmaphorum

Agreement has been reached in the EU on a European Health Data Space (EHDS), which will make it easier to exchange and access electronic health data.

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Clover Health, Quarter Health team up against serious mental illness

Fierce Healthcare

High-risk Clover Health members can now take advantage of Quartet Health's behavioral health offerings to help individuals suffering from serious mental illness. | Quartet Health is partnering with Clover Health to help the insurtech's most complex patients suffering from serious mental illness.

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NHS will expand use of waiting list-busting AI after pilot

pharmaphorum

AI software designed to tackle missed appointments and reduce waiting lists will see its use by NHS England ramp up after a successful pilot deployment.

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Promoting Nutrition Education and Sustainable Eating Practices for National Nutrition Month

Pharmacy Times

Laura Brown, MS, RDN, LDN, discusses the importance of National Nutrition Month, collaborating with pharmacists, promoting sustainable eating habits, and overcoming common nutrition misconceptions

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OS data set up wider Jemperli use in endometrial cancer

pharmaphorum

GSK's PD-1 inhibitor Jemperli improves overall survival when used first-line in an all-comer endometrial cancer trial

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Biden's new executive order directs federal agencies to prioritize women's health

Fierce Healthcare

President Joe Biden will sign an executive order Tuesday instructing federal agencies to ramp up research into women’s health, with cross-department priorities ranging from women’s midlife health c | The White House is greenlighting new federal research into post-menopause healthcare conditions, Medicare coverage, data collection, provider resources and AI-supported women's health research.

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Mould study highlights safer far-UVC light cleaning alternative

European Pharmaceutical Review

A study has determined that intermittent low-intensity far-UVC light can inhibit mould growth below the threshold limit value of 23 mJ/cm 2. At 222nm, far-UVC light was shown to prevent development of common mould-producing fungi , specifically Penicillium candidum. The on-off duty cycle pattern of the far-UVC light used in the study is “consistent with its use in real-world settings”, the corresponding paper stated.

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Reading the Tea Leaves on Recent Surge in Pharma Dealmaking

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, discusses the positive signs from rising activity levels in biopharma M&A— and what the momentum may mean for industry dealmaking and partnership efforts in the months ahead.

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BMS completes $14bn takeover of Karuna

pharmaphorum

Bristol-Myers Squibb gets its $14bn takeover of Karuna Therapeutics over the finish line, taking control of schizophrenia candidate KarXT ahead of an FDA decision in September

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STAT+: Pharmalittle: We’re reading about CAR-T drugs for myeloma, CVS rebate credits, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and inspiring, because that oh-so familiar routine of online meetings, phone calls, and deadlines has returned. You knew this would happen, yes? After all, the world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup of stimulation.

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MS and fibrosis drug developer Contineum files $150m IPO

pharmaphorum

Contineum Therapeutics joins IPO queue, seeking $150m for its pulmonary fibrosis and multiple sclerosis candidates

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EPA bans asbestos, a deadly carcinogen still in use decades after partial ban

STAT

WASHINGTON — The Environmental Protection Agency on Monday announced a comprehensive ban on asbestos , a carcinogen that is still used in some chlorine bleach, brake pads and other products and that kills tens of thousands of Americans every year. The final rule marks a major expansion of EPA regulation under  a landmark 2016 law  that overhauled regulations governing tens of thousands of toxic chemicals in everyday products, from household cleaners to clothing and furniture.

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Efficacy of Tapinarof Cream 1% Demonstrated in Atopic Dermatitis in Skin of Color

Drug Topics

A lack of diversity in clinical trials has hampered health care providers from understanding the nuances of diseases across specific patient populations.

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Orchard's gene therapy for MLD finally gets US approval

pharmaphorum

Orchard's gene therapy for MLD finally gets US approval Jonah.

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