Trending Articles

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Optimizing Bispecific Antibodies in Multiple Myeloma for Efficacy, Safety

Drug Topics

A Q&A with Kirollos Hanna, PharmD, director of pharmacy at Minnesota Oncology, on the current and future landscape of bispecific antibodies in myeloma treatment.

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Massive amounts of H5N1 vaccine would be needed if there’s a bird flu pandemic. Can we make enough?

STAT

The unsettling reality of H5N1 bird flu circulating in dairy cow herds in multiple parts of the United States is raising anxiety levels about whether this dangerous virus, which has haunted the sleep of people who worry about influenza pandemics for more than 20 years, could be on a path to acquiring the ability to easily infect people. To be clear, there is no evidence that this is currently the case — the sole confirmed human case reported in Texas three weeks ago was in a farm worker w

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Optical Sensor Shows Promise in Non-Invasive Continuous Glucose Monitoring

Pharmacy Times

Optical glucose sensing techniques have been reported, but they require complex optical instrumentations found in laboratories, so feasibility for patient use has been challenging.

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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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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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FTC votes 3-2 on final rule to ban noncompete agreements, but legal challenges expected

Fierce Healthcare

The Federal Trade Commission (FTC) voted 3-2 Tuesday to issue a final rule striking new noncompete agreements for all workers and phasing out existing noncompetes for all but senior executives acro | The final rule, which does not apply to nonprofits, forbids noncompete contracts for all new hires and winds down existing noncompetes for all employees who are not senior executives.

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FDA Issues CRL for Epidermolysis Bullosa Gene Therapy

Drug Topics

Abeona Therapeutics’ pz-cel is an investigational autologous, COL7A1 gene-corrected epidermal sheet therapy for the treatment of recessive dystrophic epidermolysis bullosa.

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Considerations When Treating Migraines in Gender Diverse Patients Receiving Gender-Affirming Hormone Therapy

Pharmacy Times

The AAN speaker highlights what health care providers need to know when treating migraines in populations on hormone therapy, as well as how hormones can influence migraines.

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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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Simple HealthKit partners with Amazon to increase access to at-home diagnostics and chronic care

Fierce Healthcare

Simple HealthKit is bringing chronic condition diagnostics to front porches across the country via a new partnership with Amazon. | Consumers can now buy Simple HealthKit’s at-home tests for diabetes (HbA1c), respiratory wellness and sexual wellness and have it shipped to their door through Amazon.

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Scott Soefje, PharmD: Take a Site-Specific Approach to Optimize Care Delivery, Finances

Drug Topics

According to Scott Soefje, PharmD, understanding nuances across sites of care can help health care providers optimize patient care delivery while ensuring financial viability across all settings.

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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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Decline in heart failure deaths has been undone, led by people under 45

STAT

Heart failure mortality rates are moving in the wrong direction, a new analysis reports, reversing a decline in deaths that means more people in the United States are dying of the condition today than 25 years ago. The concerning conclusion comes as newer medications are raising hopes for better outcomes in the years to come. A research letter published Wednesday in JAMA Cardiology tracked U.S. death certificate data from 1999 through 2021, revealing a steady drop in deaths until 2012, when rate

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FDA Approves Ankiva Plus Bacillus Calmette-Guérin For Non-Muscle Invasive Bladder Cancer

Pharmacy Times

The approval was based on the QUILT-3.032 study, which included 77 adults with carcinoma in situ with or without papillary tumors after a transurethral resection.

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What happens when your Vyvanse dose is too low?

The Checkup by Singlecare

Vyvanse (lisdexamfetamine dimesylate) is a stimulant medication approved by the Food and Drug Administration (FDA) to treat attention deficit hyperactivity disorder (ADHD) and binge eating disorder (BED). Like other well-known ADHD medications—such as Adderall, Ritalin, and Concerta—it works by increasing the levels of certain neurotransmitters, including dopamine and norepinephrine, to help alleviate symptoms such as inattention, hyperactivity, and impulsivity.

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CMS sets Medicaid payments to home care workers at 80%

Fierce Healthcare

The Centers for Medicare & Medicaid Services is hoping to improve Medicaid enrollees’ access to care through a final rule that better compensates caregiving roles. | CMS released a series of final rules Monday, including Medicaid access regulations that some groups worry will cause providers to close.

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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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Recreational Marijuana Laws Did Not Increase Substance Use Among Adolescents

Drug Topics

With more states allowing the use of recreational marijuana than ever before, researchers examined its effects among youth populations.

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H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe

STAT

WASHINGTON — Testing conducted by the Food and Drug Administration on pasteurized commercially purchased milk has found genetic evidence of the H5N1 bird flu virus, the agency confirmed Tuesday. But the testing, done by polymerase chain reaction, or PCR, cannot distinguish between live virus or fragments of viruses that could have been killed by the pasteurization process.

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FDA Approves Lutathera for Pediatric Patients With SSTR+ Gastroenteropancreatic Neuroendocrine Tumors

Pharmacy Times

This approval makes lutetium Lu177 the first therapy to be approved for the treatment of gastroenteropancreatic neuroendocrine tumors in pediatric patients.

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FDA initiative puts AR/VR at heart of home health drive

pharmaphorum

A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system

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Online chatter points to broad layoffs at Optum—but the full extent is unclear

Fierce Healthcare

UnitedHealth Group subsidiary Optum appears to have laid off a significant percentage of its workforce, Fierce Healthcare has learned, though the full extent of those job cuts remains unclear. | UnitedHealth Group subsidiary Optum appears to have laid off a significant percentage of its workforce, Fierce Healthcare has learned, though the full extent of those job cuts remains unclear.

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Swipe Right on Wellness: The Rise of Digital Therapeutics in Mental Health

Drug Topics

Digital therapeutics are positioned as front-runners in the increasingly digital future of health care.

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STAT+: Colombia issues a compulsory license for an HIV medicine and ‘plants a flag for global health equity’

STAT

After months of deliberation, the Colombian government has issued a compulsory license for an HIV medicine, the first time the country has taken such a step, one that also marks a significant move in the increasingly global battle over access to medicines. The license is designed so that tens of thousands of Colombians can obtain a lower-cost version of dolutegravir, a medicine that is manufactured and sold by ViiV Healthcare, a company that specializes in HIV treatments and is largely controlle

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Elevating Antimicrobial Stewardship: Insights From Pharmacist-Led Initiatives Combatting Health Care–Associated C diff

Pharmacy Times

Laura Gillespie, PharmD, discusses the impact of pharmacist-led initiatives on health care–associated C diff rates for health care systems.

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US Supreme Court rejects Vanda's bid to revive patents on sleep disorder drug Hetlioz

Fierce Pharma

The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. | The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. Supreme Court shot down the company’s attempt to challenge an appeals court decision invalidating several of the drug’s patents in 2023.

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UnitedHealth offers update on cyberattack data analysis, systems restoration

Fierce Healthcare

UnitedHealth Group provided an update late Monday on its analysis of the data accessed in the cyberattack on Change Healthcare, and said it identified files that contain personal and health informa | UnitedHealth Group provided an update late Monday on its analysis of the data accessed in the cyberattack on Change Healthcare, and said it identified files that contain personal and health information.

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Pharmacists’ Role in the Diagnostic Stewardship Team

Drug Topics

With expertise through antimicrobial stewardship experience, researchers believe antimicrobial stewardship pharmacists are vital in assisting diagnostic stewardship.

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STAT+: The evidence grows: Prices spike after mergers between far-flung hospitals

STAT

The trend is clear: When hospitals in the same community merge, prices spike. The government has such an easy time blocking those deals, hospitals rarely propose them anymore. 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. 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 d

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Practical Considerations of T-Cell Engagers in the Management of Relapsed/Refractory Multiple Myeloma

Pharmacy Times

Integration of these agents requires supportive care considerations for cytokine release syndrome, neurotoxicity, infection, and antigen-specific toxicities to ensure optimal care of patients with multiple myeloma receiving T-cell–engaging therapies.

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Sanofi's Zantac settlement is worth $100M, or $25K per claimant: Bloomberg

Fierce Pharma

Sanofi will pay $100 million—or approximately $25,000 each—to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (rani | Sanofi will pay approximately $25,000 per person to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (ranitidine) can cause cancer, Bloomberg reported.

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Headspace expands to direct-to-consumer mental health market

Fierce Healthcare

Headspace has launched direct-to-consumer text-based mental health coaching to expand its reach beyond employer customers and capture the cash-pay healthcare market. | Headspace is entering the direct-to-consumer mental health coaching market, broadening its reach beyond its model of contracting with health plans and employers.

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In Depth Perspectives: Psychedelic Medicine, Scope Creep, And More

Drug Topics

Check out these top featured stories from Drug Topics in April 2024.

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Opinion: Balancing hope and reality: The promise and peril of blood-based colorectal cancer screening

STAT

As a gastroenterologist and cancer researcher, my mission is to help my patients live longer, healthier, and cancer-free lives. A rise in the number of younger Americans diagnosed with colorectal cancer worries me — early-age onset colorectal cancer is expected to surge by more than 140% by 2030. But because colorectal cancer is preventable with early screening and detection, it’s possible to reduce the number of Americans diagnosed with this disease in the prime of their lives.

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Positive Data Demonstrates Gepotidacin is Non-Inferior to Alternative Treatment in GC

Pharmacy Times

In a trial that compared gepotidacin to ceftriaxone plus azithromycin in patients with urogenital gonorrhea, gepotidacin presented a 92.6% microbiological success rate.

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Soon-Shiong's ImmunityBio bags FDA approval for Anktiva to challenge Merck in bladder cancer

Fierce Pharma

After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. | After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. approval in the cancer immunotherapy Anktiva.

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Biden admin finalizing industry-opposed staffing requirements for nursing homes

Fierce Healthcare

The Biden administration will finalize a controversial nursing home staffing rule today that includes the more stringent requirements floated in last September’s proposal, Vice President Kamala Har | Later today the federal government will finalize the more stringent version of the Nursing Home Minimum Staffing rule floated last year, Vice President Kamala Harris' office said Monday morning.