STAT

JUNE 22, 2023

When I was diagnosed with Duchenne muscular dystrophy 20 years ago, there was no hope. The guidance the diagnosing doctor gave my parents was simple: Love your child as much as you can now because he won’t be here very long. That was the inspiration that my mom needed to start CureDuchenne. Her intention — our whole family’s intention — was to cure this disease so no other parents would have to go through the same traumatic prognosis.

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PharmaVoice

JUNE 22, 2023

These six Big Pharma companies have ranked among the best places to work for LGTBQ+ equality by the Human Rights Campaign Foundation for over 10 years. Here’s why.

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STAT

JUNE 22, 2023

The Food and Drug Administration granted conditional approval Thursday to the first gene therapy for Duchenne muscular dystrophy. Regulators restricted the treatment to younger patients, with additional data required to broaden its use. The gene therapy, called Elevydis, is made by Sarepta Therapeutics. The company will charge $3.2 million for the treatment, making it the U.S.

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BioPharma Dive

JUNE 22, 2023

The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.

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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.

STAT

JUNE 22, 2023

The number of people with diabetes worldwide is set to more than double to 1.3 billion by 2050, a new study finds, a trend accelerated by widening inequities both between and within countries. By 2050, about 1 in 10 people around the world are predicted to have the disease, representing a 60% surge in the prevalence of diabetes, according to the study, published Thursday in the Lancet as part of a wide-ranging series on global inequities in diabetes.

Diabetes 269

Diabetes 269

PharmaVoice

JUNE 22, 2023

Marwan Fathallah came onboard earlier this year to lead the organization into an era of change.

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BioPharma Dive

JUNE 22, 2023

The cost makes Sarepta’s treatment, called Elevidys, among the most expensive medicines in the world. But company executives said they don’t expect significant insurer pushback.

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STAT

JUNE 22, 2023

Medical device makers may soon have an easier path to securing health insurance reimbursement for their products, following the notice Thursday of a long-awaited rule by the Centers for Medicare and Medicaid Services. The program , called Transitional Coverage for Emerging Technologies, would apply to medical products deemed “breakthrough devices” by the Food and Drug Administration.

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Insurance Coverage and Processing 245

Pharma Times

JUNE 22, 2023

ATLX-1088 is regarded as a possible first-in-class human antibody targeting CD33 – a cell surface protein - News - PharmaTimes

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STAT

JUNE 22, 2023

WASHINGTON — The Food and Drug Administration is ramping up its efforts to force vape shops and other retailers to stop selling unauthorized disposable vape brands that are increasingly popular with young people. The FDA recently issued 189 formal warning letters to shops selling two brands of vape products, Elf Bar and Esco Bars, the agency announced in a press release Thursday.

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Pharmacy Management

The Pharmacist

JUNE 22, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) will consider whether further action is needed after a coroner warned doctors were unaware of a rare risk of suicide linked to the commonly used antibiotic ciprofloxacin. A prevention of future deaths report said that a respected and experienced consultant cardiologist, who had recently retired, died by […] The post MHRA investigating ciprofloxacin suicide risk awareness appeared first on The Pharmacist.

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STAT

JUNE 22, 2023

Over 1,000 times a day, distressed people call crisis support lines operated by Protocall Services. Its counselors are carefully trained for the sensitive and taxing conversations, but even with supervision on the job, major errors, like failing to screen for suicide, can go undetected. So Portland, Ore.-based Protocall is working with a company called Lyssn to investigate if technology can help keep call quality high.

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The Pharmacist

JUNE 22, 2023

Almost 100,000 more people have died with cardiovascular disease in England than expected in the three years since the pandemic began, a new analysis from the British Heart Foundation (BHF) shows. And pharmacy leaders have commented that the findings demonstrate the need for 'life-saving' interventions based in community pharmacy. Data from the Office for Health […] The post Excess cardiovascular deaths 'demonstrate need' for pharmacy services appeared first on The Pharmacist.

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Community Pharmacies 96

STAT

JUNE 22, 2023

Who’s watching the drug price watchmen? Are RSV vaccines too expensive? And is it finally time for Novavax to shine? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Bob Herman joins us to explain his year-long investigation into some brazen conflicts of interest in the world of prescription drug pricing.

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Vaccines Drug Pricing 209

The Pharmacist

JUNE 22, 2023

Pressures within community pharmacy and subsequent closures are having a negative knock-on effect on some NHS community services, The Pharmacist has been told. One trust in the West of England has reported that such pressures have indirectly impacted its supply of medicines to community hospitals, clinics, nursing teams and a prison. Susan Watkins, chief pharmacist […] The post Pharmacy pressures impacting medicine supply to NHS community teams appeared first on The Pharmacist.

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Community Pharmacies Hospitals 96

STAT

JUNE 22, 2023

WASHINGTON — The health care system is on the precipice of broad access to a treatment for Alzheimer’s for the first time — and it’s scrambling to figure out how to handle it. Right now, most people with mild cognitive impairment who would qualify for Eisai and Biogen’s drug Leqembi are in the Medicare program, which has restricted which patients can receive the medication to those who are enrolled in clinical trials.

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The Pharmacist

JUNE 22, 2023

The UK should introduce routine vaccination for respiratory syncytial virus (RSV) to protect babies and older adults, the Joint Committee on Vaccination and Immunisation (JCVI) has recommended. It has made the early recommendations after reviewing several vaccines currently in development to allow sufficient lead time for the government to get a policy and programme in place, […] The post JCVI recommends RSV vaccination scheme for babies and older adults appeared first on The Pharmacist.

Vaccines 91

Vaccines 91

STAT

JUNE 22, 2023

The U.S. government asked a federal judge to overturn a recent case in which a jury decided that Gilead Sciences did not infringe on patents held by the Centers for Disease Control and Prevention for a pair of groundbreaking HIV pills. In a lawsuit , the U.S. Department of Health and Human Services argued the CDC helped fund academic research into HIV prevention that later formed the basis for the pills, and that Gilead overstated its role in developing the treatments.

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Drug Pricing 206

Pharma Times

JUNE 22, 2023

Poolbeg’s platform will possess the capability to generate vaccines for a wide range of diseases - News - PharmaTimes

Vaccines 106

Vaccines 106

STAT

JUNE 22, 2023

The U.S. Covid-19 Public Health Emergency declaration may have ended, but the virus remains. Now is the moment to leverage the successes and challenges of fostering innovative Covid therapeutics to prepare for the future waves that we inevitably face from new variants. On June 13, the House Energy and Commerce Committee’s Subcommittee on Health convened to discuss solutions to ensure preparedness for the next generation of public threats and hazards, including infectious diseases suc

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World Pharma News

JUNE 22, 2023

Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing treatment with this therapy.

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STAT

JUNE 22, 2023

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Express Pharma

JUNE 22, 2023

The healthcare industry continues to face the challenges such as persistent inflation in a post-COVID-19 world. Healthcare professionals (HCPs) believe that biosimilars could provide costs savings for the patients and healthcare systems and their use should be encouraged, according to a survey by GlobalData. GlobalData survey, “The Impact of Inflation on the Healthcare Sector – Physician Perspective – H1 2023*,” reveals that the majority of physicians thought the use of biosimilars could p

Biosimilars 86

Biosimilars 86

STAT

JUNE 22, 2023

The Food and Drug Administration rejected Intercept Pharmaceuticals’ investigational treatment for NASH on Thursday, derailing what would have been the first approved medicine for a prevalent liver disease. The FDA’s rejection made clear that reapplying for approval would require waiting about three years for a large, ongoing clinical trial to conclude, the company said in a statement.

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European Pharmaceutical Review

JUNE 22, 2023

A study published in Pharmaceutics has illustrated the superior sensitivity of mechanistic compartmental analysis for nanomedicines. The paper described how both techniques were applied to two small molecule, nanomaterial-based formulations for intravenous injection: albumin-stabilised rifabutin nanoparticles and rifabutin-loaded PLGA nanoparticles.

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STAT

JUNE 22, 2023

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will celebrate this notion by brewing still more cups of stimulation and invite you to join us.

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Diabetes Pharmaceutical Companies Pharmaceutical Companies Vaccines 188

European Pharmaceutical Review

JUNE 22, 2023

On 6 June 2023, the British Standards Institute (BSI) launched its Minimized Risk of Antimicrobial Resistance (AMR) certification for antibiotic manufacturing. According to the information sharing platform AMR Insights , AMR is considered one of the biggest global threats to health and food safety. Combatting AMR calls for international cooperation based on the One Health Approach. 1 Adopting both the Antibiotic Manufacturing Standard and certification will help to “mitigate the risk of the deve

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STAT

JUNE 22, 2023

Doctors’ lobbyists in Washington tend to focus their energies on ensuring Medicare pays well, and on issues like so-called scope of practice laws. But in the early aughts, the American Medical Association had a surprising new focus: PubMed Central. The National Institutes of Health was on the verge of enacting a policy that would require any publications resulting from NIH-funded research be posted on the government-owned PubMed Central publication repository so the American public could

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Pharmaceutical Technology

JUNE 22, 2023

Eli Lilly and Boehringer Ingelheim have received approval from the US FDA for Jardiance to treat type 2 diabetes in children

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Diabetes 98

pharmaphorum

JUNE 22, 2023

Trials and tribulations of drug development: What does it take to establish new treatment for rare diseases? Mike.

Drug Development 92

Drug Development 92

Pharmaceutical Technology

JUNE 22, 2023

The SFDA of the KSA has granted approval to Amarin’s VASCEPA (icosapent ethyl) capsules for reducing cardiovascular risk.

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pharmaphorum

JUNE 22, 2023

Swiss hospital adopts Bayer’s AI platform for radiology Phil.

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Hospitals 110

Pharmaceutical Technology

JUNE 22, 2023

The recommendation comes after GSK published data showing its vaccine’s protection lasts over two RSV seasons.

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Vaccines 97

Drug Channels

JUNE 22, 2023

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding. Click here to see the original post from May 2023. In my March video webinar , I explored how the rapid expansion of patient-paid prescriptions—via cash-pay pharmacies and discount card vendors—is transforming the prescription market.

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BioPharma Dive

JUNE 22, 2023

The company, which emerged from Paragon Therapeutics, is developing bowel disease drugs similar to Takeda's Entyvio and an experimental Prometheus drug just bought by Merck & Co.

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