Fri.Apr 28, 2023

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STAT Wunderkinds discuss high-impact research, resilience, and social justice

STAT

Elenoe “Crew” Smith used to faint at the sight of blood. Still, she knew from a very young age that she wanted to help people living with sickle cell disease. Now, as a research director at Vertex Pharmaceuticals, she is working on potential sickle cell medicines. Smith was in STAT’s 2017 class of Wunderkinds , an annual selection of standout researchers who are launching their careers.

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5 minutes with — DTRA’s Dr. Amir Kalali

PharmaVoice

An industry veteran, innovator and curator, Dr. Amir Kalali’s vision for the future is patient-focused.

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STAT+: Once bullish on digital health, Orexo hits a wall on reimbursement

STAT

After several quarters of promising to deliver concrete progress on key digital therapeutics projects, Swedish pharmaceutical company Orexo on Thursday reported the somber news that its efforts remained stalled. Orexo, which made almost all of its $60 million in 2022 revenues from U.S. sales of Zubsolv, a drug used to treat opioid use disorder, earned negligible income from its three software-based treatments in the first quarter of the year.

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BMS’s CEO transition will be a major test for the pharma giant

PharmaVoice

Come November, Chris Boerner will take the top spot as the company approaches patent cliffs for three drugs in the next decade.

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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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Opinion: There’s a surprisingly easy way to avoid a huge number of major amputations

STAT

More than 400 Americans undergo major amputation of a leg , either above or below the knee, every day. Many of them suffer from what’s known as chronic limb-threatening ischemia (CLTI), a form of peripheral artery disease that narrows people’s arteries. At my health system, we perform about 70 major amputations every year for CLTI. Amputation can save the lives of patients with CLTI, but it brings with it a lifetime of disability , emotional distress, social burden, and increased h

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FDA clears Pfizer’s pneumococcal vaccine for infants and children

BioPharma Dive

Pfizer’s latest Prevnar shot covers 20 strains of the virus, more than the 13 covered by its previous version and the 15 by Merck’s Vaxneuvance.

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Discussing Sterile Aseptic Connectors with Todd Andrews (INTERPHEX 2023)

PharmaTech

Todd Andrews, global director of Applications and Business Development at CPC, discusses sterile aseptic connectors, flexibility in manufacturing, and more in an interview held at INTERPHEX 2023.

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STAT+: Bright Health looks to get out of health insurance entirely

STAT

Bright Health Group started as a health insurance company. But it will no longer be one. Bright is looking to sell off the Medicare Advantage plans it manages in California, the company said Friday. That is the last component of its health insurance business, after the company said this past October it was fully exiting all Affordable Care Act marketplaces.

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AbbVie weathers first months of biosimilar challenge to top-selling Humira

BioPharma Dive

While Humira sales declined, the drop was mostly due to price concessions AbbVie made to secure equal insurer access in the face of copycat competition.

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STAT+: Covid-19 burnished pharma’s reputation among patient groups, but access to medicines is now an issue

STAT

In the wake of the Covid-19 pandemic, the pharmaceutical industry enjoyed something of an afterglow, as far as patient advocacy groups were concerned. Not anymore.

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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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Editas grabs orphan drug status for sickle cell disease CRISPR therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

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Putting radiation to the test to heal irregular heartbeat

STAT

ST. LOUIS — Doctors are zapping the heart with radiation normally reserved for cancer, a bid to better treat people with life-threatening irregular heartbeats who’ve exhausted other options. While it’s highly experimental, surprising early research suggests it may reprogram misfiring heart cells to control heartbeats more like younger, healthier cells do.

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FAQs about the ABP Pediatrics Certifying Exam 

Board Vitals - Pharmacist

The American Board of Pediatrics (ABP) General Pediatrics Certifying Exam is the final step on your journey towards becoming a pediatrician. This exam tests you on the knowledge you’ll need to practice as a general pediatrician. What do you need to know about the ABP exam, and how can you best prepare to pass? What requirements are there for certification?

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STAT+: Pharmalittle: Amgen ends two lupus programs; Illumina sequencers have security vulnerability

STAT

Hello and happy Friday, with STAT reporter Andrew Joseph here steering the ship in place of Ed for the day. We’re treating ourselves to a cappuccino at the moment, which will perhaps inspire some of you to get yourself your own Friday reward. Or maybe the promise of a weekend is all that you need to get you through today. In the meantime, a few headlines for you.

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FDA Announces New Study on Endorsements and DTC Television Ads

Eye on FDA

In today’s Federal Register , the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The category of that body of research that is currently underway includes a range of topics, including an assessment of terms and phrases commonly used in prescription drug promotion, studying the comprehension and understanding of multiple indications used in consumer television advertisements, and endorser status and explicit

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Muscle Wasting and Hashimoto’s

The Thyroid Pharmacist

Years ago, I struggled just to get through each day. I had so many frustrating symptoms, including anxiety, irritable bowel syndrome (IBS) and acid reflux. I also had other seemingly odd symptoms for someone my age, like frequent muscle cramps, stiffness, carpal tunnel in both arms, and pain. (I’ve shared articles on pain and will be sharing one on carpal tunnel soon as well.

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Innovating pharma at the edge

European Pharmaceutical Review

NEW, FLEXIBLE, data-driven manufacturing models are emerging to address the pharmaceutical industry’s need for greater operational efficiency. While new approaches aim to solve the unique challenges of the sector, like adhering to strict compliance regulations, digitalisation has quickly developed into a pathway for achieving information technology (IT)/operational technology (OT) integration, edge-to-enterprise connectivity, and overall operational excellence.

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Positive CHMP opinion for UCB’s bimekizumab

Pharma Times

Therapy concerns the treatment of adults with axial spondyloarthritis and psoriatic arthritis

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Global research consortium to help address antimicrobial resistance

European Pharmaceutical Review

A new global research consortium is being established to address the global impact of antimicrobial resistance (AMR). Centres for Antimicrobial Optimisation Network (CAMO-Net) , brings together research teams from the University of Liverpool and Imperial College London in the UK, the University of Cape Town in South Africa, the Infectious Diseases Institute in Uganda and the Faculty of Medicine at the University of São Paulo in Brazil. ”… this network… represents a major commitment t

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Policies need to address the growing threat of antimicrobial resistance

PhRMA

Today, the House Energy & Commerce Subcommittee on Oversight and Investigations will be holding a hearing on the growing public health threat of antimicrobial resistance (AMR). AMR occurs when microorganisms such as bacteria, viruses, fungi and parasites develop the ability to survive against the drugs designed to kill them. Recognized by the World Health Organization (WHO) as “one of the biggest threats to global health, food security and development today,” AMR is a growing crisis that has

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Pharma responds to proposed EU pharmaceutical legislation reform

European Pharmaceutical Review

The European Commission ’s (EC’s) reform of the EU pharmaceutical legislation published on 26 April 2023, adopted a proposal for a new Directive and a new Regulation. These amend and replace the existing general pharmaceutical legislation. According to the EC, the revision is intended to: Ensure all EU patients can access safe, effective, and affordable medicines Enhance the security of medicine supply and availability, regardless of where patients live in the EU Continue to make Europe an attra

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Mobile health clinic: 'It makes healthcare easy to access'

The Pharmacist

Pete Horrocks, superintendent of the Knights Pharmacy Group, talks to Saša Janković about transforming a retired ambulance into a mobile health clinic. Service type: Mobile health clinic Name and location of service: Across County Durham Name of superintendent pharmacist: Pete Horrocks Why did you start offering this service? This follows on from a little project we did […] The post Mobile health clinic: 'It makes healthcare easy to access' appeared first on The Pharmacist.

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NICE approves expanded use of Yescarta and Tecartus

Pharma Times

Kite’s two CAR T-Cell therapies involve treating several different types of blood cancer

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CPCS expanded to include A&E referrals

The Pharmacist

The Community Pharmacy Consultation Scheme (CPCS) will be expanded to include referrals from emergency departments and urgent treatment centres from 15 May 2023. This comes alongside the announcement of controversial regulative easements around opening hours and rest breaks, as well as a reduction in the scope of the Pharmacy Quality Scheme (PQS). ‘No point’ introducing […] The post CPCS expanded to include A&E referrals appeared first on The Pharmacist.

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Don’s Story: Patients Shouldn’t Have to be Resilient to Get Their Medications

Drug Channels

Today’s guest post comes from Megan Marchal, Director of Specialty Strategy at CoverMyMeds. Megan shares the story of Don, a cancer patient who struggled to access and afford his medications. She describes how human care plus an innovative, technology-driven patient support solution can help patients start therapy and get on the road to recovery. To learn more about CoverMyMeds’ specialty therapy solutions , visit Booth 1519 at Asembia's Specialty Pharmacy Summit in Las Vegas, April 30-May 4

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Driving the potential of gene-based medicine through cutting-edge technologies to target undruggable diseases

World Pharma News

19 - 20 June 2023 , London, UK. SAE Media Group is proud to announce the inaugural Cell and Gene Therapy Conference. As part of SAE Media Group's leading series of drug discovery conferences, this year's event will bring together expertise from individuals across the advanced therapeutics community. The two-day conference will offer a series of presentations, through which delegates will gain insight into the latest developments in discovery, development and delivery of cell and gene therapies.

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‘Divisive’ easements for 100-hour pharmacies introduced

The Pharmacist

Pharmacies contracted to open for 100 hours a week will be allowed to reduce their core hours under new regulatory easements introduced by the Department of Health and Social Care (DHSC) and NHS England (NHSE). And all pharmacies will be able to close for rest breaks – provided their total number of core opening hours […] The post ‘Divisive’ easements for 100-hour pharmacies introduced appeared first on The Pharmacist.

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FDA clears Pfizer’s PREVNAR 20 vaccine for IPD prevention

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20 , to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. PREVNAR 20 has been designed to avert IPD caused by 20 streptococcus pneumoniae (pneumococcal) serotypes. It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained

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Eli Lilly’s tirzepatide achieves 15.7% weight loss in adult patients

Pharmafile

Eli Lilly has announced that tirzepatide (10mg and 15mg) achieved significant and superior weight loss compared to a placebo over 72 weeks of treatment. This data follows results from the SURMOUNT-2 trial which met all co-primary and secondary endpoints.

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Exploring the Future of Outsourcing with Sarah Stevens (DCAT Week)

PharmaTech

Sarah Stevens, senior vice-president and head of Drug Product Development & Manufacturing at Quotient Sciences, discusses various facets of the modern outsourcing industry.

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Boehringer Ingelheim invests €350m in Europe’s largest biotech development centre

Pharmafile

Boehringer Ingelheim (BI) have announced that it will invest €350m in a state-of-the-art Biologicals Development Centre (BDC) in Germany. It will join the company’s largest R&D and biopharmaceuticals site, which has more than 7,000 employees.

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Phase 3 study for people with painful, highly inflammatory condition initiated by Galapagos

Outsourcing Pharma

Galapagos NV has announced it has initiated a phase 3 study with small molecule drug filgotinib in patients with the chronic, highly inflammatory condition, active axial spondyloarthritis(AxSpA).

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FDA approves Pfizer’s pneumococcal conjugate vaccine for infants and children

Pharmafile

Pfizer has announced that the US Food and Drug Administration (FDA) has approved its PREVNAR 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease (IPD) in infants and children from six weeks to 17 years of age.

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New patent for Abbvie Inc drug VUITY

Drug Patent Watch

Annual Drug Patent Expirations for VUITY Vuity is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are two patents… The post New patent for Abbvie Inc drug VUITY appeared first on DrugPatentWatch - Make Better Decisions.

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