STAT

JUNE 1, 2023

In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less. Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthri

Biosimilars 358

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 358

ALiEM - Pharm Pearls

JUNE 1, 2023

Are you using phenobarbital instead of benzodiazepines as the first-line monotherapy for patients in alcohol withdrawal in the Emergency Department (ED)? If not, you probably should be. Another old drug for a new indication, right? Well not exactly. Phenobarbital is indeed an older and relatively cheap drug (less than $20 per loading dose) that has gained some press recently for the treatment of acute alcohol withdrawal [1-3].

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Inpatient Hospitals 246

STAT

JUNE 1, 2023

Tempus, a company that combines DNA sequencing for cancer with artificial intelligence, said Thursday that it is launching a voice-and-text assistant called Tempus One that will give physicians much easier access to patient data. The AI assistant is being launched ahead of the annual meeting of the American Society of Clinical Oncology in Chicago. Eric Lefkofsky, Tempus’ founder and CEO, told STAT Tempus will be rolling the product, called Tempus One, out to the 6,000 doctors that prescri

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PharmaVoice

JUNE 1, 2023

Takeda's president of the global oncology business unit is always "scanning the horizon" for the partnerships that will drive the next big innovations.

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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 1, 2023

Last Thursday, after 15 hours of deliberation, the Indiana State Licensing board ruled that our friend and colleague Caitlin Bernard, an OB-GYN, violated patient privacy laws in discussing the case of a 10-year-old girl who traveled from Ohio for an abortion. She was given a letter of reprimand and a $3,000 fine. While a relatively minor punishment, this finding should send a chill through the medical community and beyond.

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BioPharma Dive

JUNE 1, 2023

The biotech will price its biosimilar Yusimry at 85% below Humira’s list price when it launches next month, and charge even less if bought through Mark Cuban’s pharmacy.

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Biosimilars 117

Pharma Times

JUNE 1, 2023

Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine

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STAT

JUNE 1, 2023

Microsoft-owned Nuance Communications sells its AI medical scribe platform to health care providers on a simple promise: If they shell out big bucks for the high-tech product, they can decrease doctor burnout and ultimately make more money by enabling doctors to see more patients. But executives at four health systems using the software, called DAX, told STAT that while the software might make it possible to see more patients, or justify higher charges to insurers for visits, the high price tag

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Hospitals Communication 246

Pharma Times

JUNE 1, 2023

Synaffix’s technology platform is intended to enhance and extend Lonza’s integrated ADC services - News - PharmaTimes

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STAT

JUNE 1, 2023

Having insurance coverage alone doesn’t guarantee that people can afford or would be willing to pay continuously for chronic disease medications like Ozempic, a new, large-scale study finds. Looking at insured patients with type 2 diabetes and heart failure, researchers found that people with higher prescription copayments were less likely to consistently take glucagon-like peptide-1 receptor agonists (GLP-1) and sodium-glucose cotransporter 2 inhibitors (SGLT2i) — two classes of d

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Diabetes 236

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Pharmacy Management

Commonwealth Pharmacists Association

JUNE 1, 2023

The CPA signs Pioneering Memorandum of Understanding with MOIC Press Release The Commonwealth Pharmacists Association (CPA) is delighted to announce a transformative partnership with the Medicines Optimisation Innovation Centre (MOIC). Formalized through a Memorandum of Understanding (MoU), the partnership aligns with both the CPA and MOIC‘s strategic objectives.

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STAT

JUNE 1, 2023

WASHINGTON — Researchers and health care advocates are warning that the debt ceiling deal would mean a harsh cut for science agencies like the National Institutes of Health. The debt ceiling deal hammered out by the White House and congressional leadership this weekend would freeze non-defense and veterans’ health spending at 2023 levels for next year and allow only a 1% bump in 2025.

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Pharmaceutical Technology

JUNE 1, 2023

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Pfizer ’s rimegepant (Vydura) to prevent migraine attacks. The therapy has been recommended as an option to prevent episodic migraines in adult patients, who have between four and 15 migraine attacks per month, and where a minimum of three preventive treatments have previously failed.

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STAT

JUNE 1, 2023

NEW YORK (AP) — Racial bias built into a common medical test for lung function is likely leading to fewer Black patients getting care for breathing problems, a study published Thursday suggests. As many as 40% more Black male patients in the study might have been diagnosed with breathing problems if current diagnosis-assisting computer software was changed, the study said.

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Pharmaceutical Business Review

JUNE 1, 2023

The designation for the investigational gene therapy was granted based on positive safety and efficacy data from the Phase I study in patients with Danon Disease. A favourable safety profile of RP-A501 was observed with improvements in multiple clinical and highly relevant laboratory parameters including LAMP-2 protein expression. The study also observed reduced autophagic vacuoles, high sensitivity troponin I, brain natriuretic peptide (BNP) and left ventricular mass and wall thickness.

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STAT

JUNE 1, 2023

Why are fake medical devices more lucrative than real ones? Is Ozempic a neurological treatment? And what’s at the cutting edge of oncology? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Lizzy Lawrence joins us to explain the shocking story of a medical device company that sold fake implants and the warped system that made the scam lucrative.

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). On 31 May, the FDA granted approval based on subgroup analysis of the Phase III PROpel trial (NCT03732820) in patients with BRCA mutations.

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Chemotherapy 97

STAT

JUNE 1, 2023

WASHINGTON — Despite pressure from Congress and advocates, Medicare isn’t changing its coverage plan for new Alzheimer’s drugs anytime soon. Medicare on Thursday issued a statement reiterating its intent to require patient registries to collect data about how medications perform even after they gain full Food and Drug Administration approval.

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The Pharmacist

JUNE 1, 2023

A new report by Healthwatch England has recommended that GPs should offer over the counter (OTC) medications on prescription to those who cannot afford to pay for them. But some community pharmacists have suggested that a minor ailments scheme delivered through community pharmacies would be a more accessible solution for patients. Healthwatch England, which champions […] The post GPs should prescribe OTC medications, suggests report appeared first on The Pharmacist.

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Community Pharmacies 97

STAT

JUNE 1, 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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Pharmaceutical Technology

JUNE 1, 2023

A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. The centre will be established by UK-based technology innovation centre CPI, in collaboration with Medicines Discovery Catapult, the University of Strathclyde, the University of Liverpool, and Imperial College London.

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Vaccines Drug Development 97

STAT

JUNE 1, 2023

U.S. births were flat last year, as the nation saw fewer babies born than it did before the pandemic, the Centers for Disease Control and Prevention reported Thursday. Births to moms 35 and older continued to rise, with the highest rates in that age group since the 1960s. But those gains were offset by record-low birth rates to moms in their teens and early 20s, the CDC found.

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Express Pharma

JUNE 1, 2023

A private equity consortium led by PAG, an Asia-based investment firm, has hired Anil Khubchandani as Managing Director and CEO of Sekhmet Pharmaventures. Khubchandani has over 30 years of experience in strategic partnerships, global sales and marketing, operations management, and research & development. In his most recent role, he served as Co-CEO and Whole-time Director of Jubilant Ingrevia, where he focused on business transformation and growth strategy implementation.

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STAT

JUNE 1, 2023

Good morning, everyone. Damian Garde here, filling in for Ed Silverman on the back half of what is, at least in this part of the world, a shortened work week. Temperatures are climbing and with them the number of out-of-office email replies from colleagues who’ve thought better of working while it’s nice out. May you join them soon. In the meantime, here as always are some tidbits to get your day started.

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Vaccines Biosimilars 192

PharmaTech

JUNE 1, 2023

A partnership between Rentschler Biopharma and Ikarovec will support the accelerated development of novel gene therapies for the treatment of eye diseases.

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The Pharmacist

JUNE 1, 2023

NICE has approved rimegepant, a novel oral drug for preventing migraine, which it said could become available to 145,000 NHS patients. Rimegepant is the first drug of its class to come in pill form, with other similar medications administered as injections. The calcitonin gene-related peptide (CGRP) receptor antagonist is the first oral drug to be accepted […] The post Novel oral drug for migraine prevention approved by NICE appeared first on The Pharmacist.

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Express Pharma

JUNE 1, 2023

Venus Remedies secured a marketing authorisation from the largest market in the Gulf Cooperation Council (GCC) region for Docetaxel, a chemotherapy drug. The development comes three months after the company received good manufacturing practices (GMP) certification from the Saudi Food and Drug Authority (SFDA) for all its production facilities at its unit in Baddi, Himachal Pradesh.

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Chemotherapy 88

EMCrit Project

JUNE 1, 2023

Optimization of Emergency Medicine Teams EMCrit Project by Scott Weingart, MD FCCM.

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Express Pharma

JUNE 1, 2023

Lupin announced that its wholly-owned subsidiary, Novel Laboratories, based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, a generic equivalent of Diastat AcuDialTM Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US.

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European Pharmaceutical Review

JUNE 1, 2023

An oral treatment for preventing migraines has been recommended by the National Institute for Health and Care Excellence (NICE) for the first time. Rimegepant (Vydura) is recommended as an option for episodic migraine in adults after having at least three previous failed preventive treatments. The NICE final draft guidance recommends rimegepant in individuals who have at least four migraine attacks per month but less than 15, stated the UK regulatory body.

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Express Pharma

JUNE 1, 2023

The FDA recently announced the approval of Rinvoq (upadacitinib), AbbVie ’s Janus kinase inhibitor (JAKi), to treat adults with moderately to severely active Crohn’s Disease (CD) who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers. The decision was based on data from two randomised induction trials, U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849), and the subsequent maintenance study, U-ENDURE (NCT03345823).

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Dosage 81

European Pharmaceutical Review

JUNE 1, 2023

A study has shown an ultrasonic nanosieve within a microfluidic device concentrated and detected bacterial cells at low initial concentrations and small sample volumes for the first time. The results demonstrated an efficiency of 99 percent bacterial capturing using the microfluidic device. Additionally, the data showed that the concentrated bacteria can be recovered with an 80 percent efficiency.

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Big Molecule Watch

JUNE 1, 2023

Last Friday, Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in Delaware alleging their COVID-19 vaccine lipid nanoparticle technology infringes Alnylam’s patent rights. The patents-in-suit are U.S.

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Vaccines 82

Pharmaceutical Commerce

JUNE 1, 2023

While generics and adherence challenges are keeping drugmakers up at night, breakthroughs in the pipeline coupled with innovative uses of artificial intelligence and machine learning techniques are bringing optimism to the cardiovascular disease space.

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Drug Channels

JUNE 1, 2023

Today’s guest post comes from Vishali Amin, Chief of Staff to the Office of the President and Senior Director of Customer Success at Kalderos. Vishali discusses the persistent challenges of duplicate discounts between the 340B Drug Pricing Program and the Medicaid Drug Rebate Program. The Inflation Reduction Act of 2022 will further complicate duplicate discount issues.

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Drug Pricing 74