Wed.May 31, 2023

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Opinion: Newly diagnosed cancer patients need help navigating the system

STAT

“Hey, I’m sorry to bother you, but I could really use your advice on something.” As fellows in oncology training programs, we’re both accustomed to fielding texts, emails, and calls that start out like the above from family, friends, and acquaintances seeking guidance for themselves or their loved ones after a cancer diagnosis.

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Woman of the Week: Mirati Therapeutics’ Laurie Stelzer

PharmaVoice

With the recent approval of Krazati, the biotech veteran is guiding Mirati into its next phase as a commercial-based organization.

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Trending Sources

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STAT+: CVS warns PBM reforms ‘could lead to higher costs’

STAT

As Congress considers wide-ranging reforms to pharmacy benefit managers, a top executive at CVS Health, which owns one of the largest PBMs in the country, said the company would find ways to maintain its level of profit if those reforms to things like drug rebates went into effect. “There’s other ways in the economic model that we can adjust to if one of those things changes,” Shawn Guertin, CVS’ chief financial officer, said at an industry conference Wednesday.

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Lawmakers look to crack down on Big Pharma tax breaks

PharmaVoice

As lawmakers shine a light on Big Pharma tax cuts, the industry’s business moves are coming under attack from multiple angles.

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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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FDA approves Pfizer’s RSV vaccine for older adults

STAT

The Food and Drug Administration approved a second vaccine to protect older adults against RSV on Wednesday, giving a green light to Pfizer’s Abrysvo for adults 60 and older. Early in May the FDA approved the first ever vaccine against respiratory syncytial virus, or RSV, when it licensed GSK’s Arexvy.

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Biohaven sends latest drug to FDA, despite past trial setback

BioPharma Dive

The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

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More Trending

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XtalPi announces $250m AI drug discovery collaboration with Eli Lilly

Pharmaceutical Technology

XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.

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STAT+: Pharmalittle: Appeals court rules Purdue can shield Sacklers from lawsuits; chemo shortage blamed on drugmakers’ lack of investment

STAT

Hey there. STAT reporter Andrew Joseph here welcoming you to Wednesday’s edition of Pharmalittle, with Pharmalot himself off for the day. We’re based here in London, so instead of firing up another cup of stimulation, we’re more focused on what post-lunch snack awaits us. As we ponder, we’ll leave you with the latest headlines.

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FDA pauses PepGen’s plans to test muscle disease drug

BioPharma Dive

The company’s experimental treatment for myotonic dystrophy became the latest neuromuscular disease therapy to face a regulatory roadblock before the start of human testing.

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eXmoor pharma raises $35m to boost cell and gene therapy production

Pharmaceutical Business Review

The fundraise saw the participation of new and existing investors Kineticos Ventures and MVM Partners , respectively. Kineticos Ventures president and CEO Frank Lis is joining eXmoor board as a result of the financing. The investment will allow eXmoor to launch its Cell and Gene Therapy Centre, a 65,000ft 2 good manufacturing practice (GMP) facility.

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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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Pfizer’s RSV vaccine wins FDA approval in older adults

BioPharma Dive

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

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Dr Bruce Warner retires as deputy CPhO

The Pharmacist

The deputy chief pharmaceutical officer (CPhO) for NHS England, Dr Bruce Warner, has retired today. Colleagues within the sector have thanked him for his work, including for championing the clinical role of community pharmacy and integrating pharmacists and pharmacy technicians within GP practices. Dr Warner has been the deputy CPhO since 2014, having previously worked […] The post Dr Bruce Warner retires as deputy CPhO appeared first on The Pharmacist.

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Big Pharma inventory management trends revealed

European Pharmaceutical Review

The inventory position of 28 major pharmaceutical manufacturers in 2022 has been revealed in an annual report. Analysis explored the impact of macro-trends on inventory management from corporate reports of Big Pharma companies including Merck, AstraZeneca and Pfizer. It investigated how excessive inventories are affecting the industry and what factors could influence inventory growth in 2023.

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Pharmacy bodies join call for publication of NHS workforce plan

The Pharmacist

The Royal Pharmaceutical Society (RPS) and the Pharmacists’ Defence Association (PDA) have joined nearly 40 organisations to call on the government to publish the long-awaited NHS workforce plan. The plan is set to put forward solutions to address NHS understaffing and was expected to be published imminently, but has been rumoured to be delayed due […] The post Pharmacy bodies join call for publication of NHS workforce plan appeared first on The Pharmacist.

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Stealth and Pharmanovia partner for commercialisation of elamipretide

Pharmaceutical Technology

Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.

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Sanofi drug, acquired from a startup, shows early potential in MS

BioPharma Dive

The medicine, licensed from biotech ImmuNext in 2017, is one of two later-stage MS drug prospects in the French drugmaker’s portfolio.

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Glenmark Pharma becomes part of SBTi, sets GHG emission targets for FY2035

Express Pharma

Glenmark Pharmaceuticals has joined the Science Based Targets initiative (SBTi) business ambition for well below 2°C. A company statement informed, “The SBTi’s has approved Glenmark’s commitment to reduce its absolute scope 1 and 2 GHG emissions by 35 per cent (from an FY2021 base year) by FY2035. The target boundary includes biogenic land‐related emissions and removals from bioenergy feedstock.

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Insulin Injections

RX Note

Introduction In 2017, the Malaysian Diabetes Educators Society published the Forum for Injection Technique Malaysia (FIT-MY) to provide evidence-based injection technique recommendations for people with diabetes mellitus who use injectable therapy in their daily management. Proper subcutaneous administration of diabetes injectable medications requires careful consideration of factors such as The injection sites Needle length Use of a lifted skin fold Angle of injection NovoPen 3, NovoPen 4 and N

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Algiax Pharmaceuticals 'convinced' they can provide new treatment for chronic pain relief

Outsourcing Pharma

A small molecule drug candidate from Algiax Pharmaceuticals can reduce excitability of neurons in relation to chronic pain, dampening signal and reducing pain, a study shows.

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CRISPR-based microbial gene therapy delivers promise

European Pharmaceutical Review

The novel CRISPR-Cas therapeutic selectively targets antibiotic-resistant E. coli which can cause life-threatening bloodstream infections” Positive interim results from a Phase I trial have demonstrated that the first CRISPR-armed phage microbial gene therapy can reduce Escherichia coli ( E. coli ) levels in the GI tract. “With the combined killing effects of bacteriophages and CRISPR-Cas technology, SNIPR001 has demonstrated the ability to target and eliminate antibiotic-resistant E

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Amgen’s Otezla shows promise in psoriatic arthritis

Pharma Times

The inflammatory form of arthritis is estimated to affect nearly 38 million people worldwide

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Bayer launches unit to develop new precision health consumer products

World Pharma News

The Consumer Health Division of Bayer has launched a business unit focused on developing new Precision Health products across its range of everyday health categories. Bayer will prioritize developing products that enable people to take greater control of their own personal health through digital solutions that facilitate more informed choices based on personal insights and novel delivery mechanisms.

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ASCO 2023 preview: Prioritising the exploration of patient differences to enhance cancer care and research

pharmaphorum

ASCO 2023 preview: Prioritising the exploration of patient differences to enhance cancer care and research Mike.

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Sanofi announces positive data for frexalimab in relapsing MS

Pharma Times

The neurological disease affects approximately 2.

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Merck Study: mRNA technology a ‘game changer’ for apac vaccine manufacturers

Express Pharma

According to a recent study sponsored by Merck, mRNA technology is a “game-changer” for Asia-Pacific (APAC) vaccine manufacturers. Nearly 40 manufacturers participated in the survey. “Vaccine manufacturers in APAC are looking to build capacity for mRNA technology over the next two to three years, while continuing to produce both traditional and modern cell-based vaccines.

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PM Society’s ‘Securing Market Access to Medicines for England, Ireland, Scotland & Wales’ – part one

pharmaphorum

PM Society’s ‘Securing Market Access to Medicines for England, Ireland, Scotland & Wales’ – part one Mike.

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Alvotech and Advanz Pharma Extend Partnership to Commercialize Five Proposed Biosimilars in Europe

Big Molecule Watch

Advanz Pharma (“Advanz”) and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development and commercial supply of the biosimilars, and Advanz responsible for registration and commercialization in Europe. Per the announcement, the agreement includes proposed biosimilars to SIMPONI® (golimumab) and ENTYVIO® (vedolizumab) and three undisclosed, early stage biosimilar cand

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Episode 822: How Much IV levothyroxine is Enough for Myxedema Coma?

Pharmacy Joe

In this episode, I’ll discuss the dose of IV levothyroxine used for myxedema coma. Episode 822: How Much IV levothyroxine is Enough for Myxedema Coma? Subscribe on iTunes , Android , or Stitcher Myxedema coma is a rare medical emergency with in-hospital mortality of ~30% When it occurs, myxedema coma is often a result of either: 1. Withdrawal of thyroid therapy or 2.

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Another Mystery Solved: DEA Issues a Final Decision Revoking Morris & Dickson’s Registration: Or Has It?

FDA Law Blog: Biosimilars

By John A. Gilbert — CBS News caused a bit of commotion last week in reporting that after a four-year delay, DEA issued a final order revoking Morris & Dickson’s DEA registration. However, until today there had been no public information about this decision. This morning, the Federal Register published two DEA notices on the Morris & Dickson matter ( here and here ).

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University of Sydney will use AI to boost cancer drug research

Pharmaceutical Technology

The University of Sydney and Australian company Pharos Therapeutics have reached an agreement to leverage artificial intelligence (AI) to progress drug discoveries for the treatment of cancer and rare diseases. The university and Pharos have drawn up a memorandum of understanding (MoU) to use AI technology to identify potential compounds for the rapid development of treatments.

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Sanofi scores in MS with CD40 antibody frexalimab

pharmaphorum

Sanofi scores in MS with CD40 antibody frexalimab Phil.

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Unveiling Depression: The Potential of Methylene Blue

Welltopia Pharmacy

Discover the wide range of medical applications of Methylene Blue, from treating methemoglobinemia to potential Alzheimer's disease treatments. Learn more in our comprehensive guide.

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Roller Compaction: New Trends, Challenges and Solutions

PharmaTech

When developing a tablet or capsule formulation, three widely used technologies are often considered to produce solid dosage forms: direct compression, wet granulation and dry granulation (including roller compaction). This article discusses why roller compaction is a robust option.

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ZNA-1041 by F. Hoffmann-La Roche for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

ZNA-1041 is under clinical development by F. Hoffmann-La Roche and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ZNA-1041’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Direct Compression of Probiotics with PROSOLV® EASTtab Nutra

PharmaTech

Although probiotics are mostly administered in the form of capsules, there are some advantages of tablets in terms of production effort, cost efficiency and stability of the probiotic bacteria.

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