Sat.Jun 17, 2023 - Fri.Jun 23, 2023

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Opinion: Peter Hotez is not alone: Online harassment of doctors is a public health issue

STAT

Father’s Day weekend was anything but calm on Twitter, which erupted as vaccine expert Peter Hotez was challenged online to a debate by podcaster and former reality TV host Joe Rogan. Rogan’s challenge began when Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine and vaccine expert, tweeted his  concern about Rogan’s three-hour interview with longtime anti-vaccine activist  and presidential candidate Robert F.

Vaccines 363
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10 years proud: Pharma’s top companies for LGBTQ+ inclusivity

PharmaVoice

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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WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

Vaccines 145
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First Duchenne gene therapy approved by FDA for young children

BioPharma Dive

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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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STAT+: Two type 1 diabetes patients now freed from insulin shots with cell therapy, Vertex reports

STAT

Vertex Pharmaceuticals said Friday that, over a year after receiving the company’s stem-cell therapy, two type 1 diabetes patients no longer need to take insulin injections and saw stark reductions in a biological marker of disease.  The results, presented at the American Diabetes Association conference in San Diego, bolstered experts’ hopes that the treatment could provide a functional cure for some patients.

Diabetes 363
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AI has secured a footing in drug discovery. Where does it go from here?

PharmaVoice

The AI revolution is bringing a new era of drug discovery, and the potential for more uses is greater and faster than ever before.

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More Trending

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UniQure stock tumbles on ‘confusing’ results for Huntington’s gene therapy

BioPharma Dive

While treated patients appear to be doing better than history suggests they would, mixed findings involving a key surrogate marker perplexed Wall Street analysts and sent shares falling 38%.

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Xylazine, or ‘tranq,’ is making opioid overdoses harder to reverse

STAT

For years, public health guidance about opioid overdoses has been relatively simple: Administer naloxone , then call 911. But the days of simply spraying naloxone into an overdose victim’s nose, then watching that person resume breathing and wake up within minutes, are over.

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The spotlight is on accelerated approvals — now FDA could run a tighter ship

PharmaVoice

As the fallout of the Aduhelm approval continues, scrutiny of the speedier pathway has increased and the pressure is on to close a key gap in the regulation.

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Avacta announces AVA6000 dose escalation results

Pharma Times

Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Sarepta prices Duchenne gene therapy at $3.2M

BioPharma Dive

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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Opinion: The FDA’s approval of a new gene therapy for Duchenne muscular dystrophy won’t help me — but it gives me hope

STAT

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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EU pharma trade body starts genomic profiling initiative to improve access

Pharmaceutical Technology

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and selected pharma and medical device companies have launched the European Coalition for Access to Comprehensive Genomic Profiling (ECGP), to promote the routine use of comprehensive genomic profiling. The ECGP aims to create multi-stakeholder outputs that will support wider coverage and reimbursement for genomic profiling through three key objectives.

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Alchemab Therapeutics reveals Alzheimer’s candidate

Pharma Times

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

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Flagship’s latest startup aims to take the guesswork out of small molecule drugs

BioPharma Dive

Empress Therapeutics claims its technology allows it to identify chemical drug candidates faster and more reliably. It has $50 million from Flagship to prove it can.

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Scientists successfully unfroze rat organs and transplanted them — a ‘historic’ step that could someday transform transplant medicine

STAT

The rat kidney was peculiarly beautiful — an edgeless viscera about the size of a quarter, gemstone-like and gleaming as if encased in pure glass. It owed its veneer to a frosty, minus 150-degree Celsius plunge into liquid nitrogen, a process known as vitrification, that shocked the kidney into an icy state of suspended animation. Then researchers at the University of Minnesota restarted the kidney’s biological clock, rewarming it before transplanting it back into a live rat ȁ

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Quality Medical Representative – A need for introspection

Express Pharma

Pharma companies sell their products by representing them to doctors through medical representatives (MRs) and generating prescriptions. These traditional MRs remain the mainstay of a pharma company’s business generation process, even with the emergence of newer modes of connection between healthcare providers and pharma companies, such as digital and omnichannel platforms.

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Psylo signs research deal with Daiichi Sankyo for psychiatric therapies

Pharmaceutical Technology

Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.

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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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Patient death spurs FDA to pause test of Arcellx’s Gilead-partnered cell therapy

BioPharma Dive

The company said limitations on "bridging treatment" used to hold cancer in check could be to blame, and is working with the FDA to change the study's protocol.

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STAT+: ‘It’s beyond unethical’: Opaque conflicts of interest permeate prescription drug benefits

STAT

Employers across the country — from big names like Boeing and UPS to local school systems — pay consulting firms to handle a straightforward task with their prescription drug coverage: Get the best deals possible, and make sure the industry’s middlemen, known as pharmacy benefit managers, aren’t ripping them off with unfair contracts.

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Greener NHS and NHS Innovation Accelerator collaborate

Pharma Times

Partnership will help NHS to prepare for fundamental change, including reducing carbon emissions - News - PharmaTimes

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First RNA CAR-T therapy autoimmunity trial shows potential

European Pharmaceutical Review

Study data from a major trial has demonstrated RNA CAR-T (rCAR-T) therapy Descartes-08 facilitated significant and long-lasting clinical improvement in generalised myasthenia gravis (gMG). This is the first clinical trial using rCAR-T to treat autoimmunity. It is also the first successful Phase II trial using an engineered cell therapy for autoimmunity.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Top FDA official overruled review team in approval of Sarepta’s Duchenne gene therapy

BioPharma Dive

In a memo made public Friday, Peter Marks, head of the agency office that oversees gene therapies, wrote that he disagreed with other reviewers and saw “compelling” evidence to clear Elevidys.

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STAT+: After promising early data, gene therapy trial for Huntington’s takes puzzling turn

STAT

Last year, after a string of high-profile trial failures , the Huntington’s disease community got positive news in the form of very early data from an experimental gene therapy for the rare neurodegenerative condition. On Wednesday, however, the company behind the drug released updated figures that were more mixed — even befuddling. The study from Uniqure, a Dutch biotech, randomized early stage Huntington’s patients to receive low-dose treatment, a high-dose treatment, or a

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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.

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Gene therapy approved for Duchenne muscular dystrophy

European Pharmaceutical Review

The first gene therapy has been approved for certain patients from four to five years old with Duchenne muscular dystrophy (DMD). Elevidys has been authorised by the US Food and Drug Administration (FDA) for individuals with a confirmed mutation in the DMD gene without a pre-existing medical reason preventing treatment with this therapy. “Today’s approval addresses an urgent unmet medical need and is an important advancement in the treatment of Duchenne muscular dystrophy,” reported Dr Peter M

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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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Medicare has no surprises in planned registry for new Alzheimer’s drugs

BioPharma Dive

Ahead of Leqembi’s possible full approval next month, the agency released details emphasizing how the required registry to track patient outcomes will be free and easy to use.

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Opinion: Bloated patient records are filled with false information, thanks to copy-paste

STAT

I recently took care of a patient whose medical records included multiple notes about her past open-heart surgery. Only she had never undergone open-heart surgery.

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CSL doses first patient with haemophilia B gene therapy Hemgenix

Pharmaceutical Technology

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). Hemgenix is the first and only gene therapy approved for haemophilia B. At $3.5m per dose, it is the most expensive single-use gene therapy in the US. The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective.

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FDA grants priority review to bluebird bio’s BLA for SCD gene therapy

Pharmaceutical Business Review

Bluebird is seeking approval for treating a rare genetic disease, SCD, in patients aged 12 years and above having a history of vaso-occlusive events. A modified form of the β-globin gene added to lovo-cel produces anti-sickling adult hemoglobin thereby treating the underlying cause of SCD. The BLA includes efficacy data from the HGB-206 study’s Group C cohort including 36 patients with median 32 months of follow-up and HGB-210 study including two patients, each followed for 18 months.

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Cell and gene therapy manufacturing: the next generation of startups

BioPharma Dive

Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.

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