Fri.May 31, 2024

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NIH documents show how $1.6 billion long Covid initiative has failed so far to meet its goals

STAT

More than three years ago, the National Institutes of Health launched a $1 billion-plus initiative to find the root causes and potential treatments for long Covid , the chronic disease that has quickly changed the lives of millions of Americans. But a lack of visible progress from the initiative, called RECOVER, has drawn months of criticism from patient advocates, researchers, and lawmakers, including at a Senate hearing last week on the NIH’s budget.

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Deadline looms for Chinese biotech contracts

PharmaVoice

The latest version of The Biosecure Act working its way through Congress could make waves in the U.S. biotech industry.

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STAT+: For one rare type of lung cancer, Pfizer pill reduces progression by 81%

STAT

There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal. The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2001, so in a sense they are not even that new. For Pfizer investors, Lorbrena isn’t that big a deal, either.

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MPs seek to hold government to account on Pharmacy First digital

The Pharmacist

A parliamentary committee has asked the government to set out what progress has been made on rolling out ‘the full digital product’ for the documentation of Pharmacy First consultations. In its report concluding its pharmacy inquiry earlier this week, the Health and Social Care Committee asked the government to share the percentage of community pharmacies […] The post MPs seek to hold government to account on Pharmacy First digital appeared first on The Pharmacist.

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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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Opinion: The Pandemic Treaty will succeed only with investment to build strong health systems

STAT

As the 77th World Health Assembly takes place this week, negotiations around the Pandemic Treaty are front and center of conversations. The treaty has been beset by delay and misinformation. The vested interests of pharmaceutical companies, lobbying groups, and conservative British broadcaster Nigel Farage bleating about “defending sovereignty” are threatening to derail the treaty process entirely.

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ASCO: Novartis’ Scemblix aces first-line CML study

pharmaphorum

Novartis’ Scemblix could be headed for first-line use in chronic myeloid leukaemia after outperforming TKI drugs in the ASC4FIRST study presented at ASCO.

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This week in clinical trials – 27th to 31st May

pharmaphorum

Stay updated with the latest clinical trials news from 27th to 31st May, featuring companies like Arcturus Therapeutics, AZ, Vesper Bio, Ultragenyx, and Incannex. Get insights into their latest developments and advancements in the field.

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STAT+: Ionis drug prevents swelling attacks caused by rare genetic disease in late-stage trials

STAT

Ionis Pharmaceuticals, a California company that pioneered a whole class of RNA-targeted medicines, reported on Friday that a pair of late-stage trials showed that its experimental therapy for hereditary angioedema benefitted patients — including those taking drugs currently on the market. In one of the Phase 3 trials, dubbed OASIS, patients with hereditary angioedema, a rare disease characterized by severe bouts of swelling, were given injections of donidalorsen either monthly or every t

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NHS platform announced to accelerate personalised cancer vaccine clinical trials

Pharma Times

The CVLP platform will speed up access to BioNTech and Genentech’s mRNA personalised cancer vaccines

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FDA grants RMAT status for BlueRock’s Parkinson’s therapy

Pharmaceutical Technology

The US FDA has granted RMAT designation for BlueRock Therapeutics' cell therapy, bemdaneprocel (BRT-DA01), for Parkinson's disease.

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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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Oligonucleotide ALS therapy approved in EU

European Pharmaceutical Review

The first treatment approved in the EU to target a genetic cause of amyotrophic lateral sclerosis (ALS), has been authorised by the European Commission (EC). QALSODY ® (tofersen) is indicated for adults with ALS associated with a mutation in the superoxide dismutase 1 gene ( SOD1 -ALS). The treatment is an antisense oligonucleotide (ASO) designed to bind to SOD1 mRNA to reduce SOD1 protein production, Biogen shared.

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Moderna gets FDA okay for RSV vaccine mResvia

pharmaphorum

Moderna has secured FDA approval for its RSV vaccine, setting up a three-way market battle with GSK and Pfizer.

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The Crick announces new partnerships with SMEs and MRC for research

Pharma Times

The projects will focus on a range of research areas, including Down’s syndrome and ALS

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New tentative approval for Annora Pharma drug brivaracetam

Drug Patent Watch

Brivaracetam is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms and, and is included in seven NDAs.

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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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FDA staff outline shortcomings of Lykos data for MDMA therapy

BioPharma Dive

Ahead of an advisory panel meeting, agency staff identified several sticking points in the clinical results backing Lykos’ ecstasy-based treatment for PTSD.

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New tentative approval for MSN drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five… Source

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Pfizer's LORBRENA® CROWN study shows majority of patients with ALK-positive advanced lung cancer living beyond five years without disease progression

World Pharma News

Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

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Scottish Government 'unable' to announce community pharmacy contract before election

The Pharmacist

The community pharmacy contract in Scotland will not be announced until after the election, although negotiations are ongoing, the Scottish Government has confirmed to The Pharmacist. 'Owing to the pre-election period we are unable to announce the financial settlement for community pharmacy,' a spokesperson said. But they added that 'negotiations are ongoing' and the Scottish […] The post Scottish Government 'unable' to announce community pharmacy contract before election appeare

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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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Gilead’s Trodelvy woes rise with failed bladder cancer trial

pharmaphorum

Gilead's TROP2 ADC Trodelvy has missed the target in another clinical trial, this time in urothelial carcinoma.

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FDA delays decision on Dupixent in COPD; Summit makes a bold claim

BioPharma Dive

Regeneron and Sanofi now expect an FDA verdict in September. Elsewhere, Summit claimed victory over Keytruda and Neurocrine’s longtime CEO revealed plans to step down.

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IGNAZ trial interim results highlight HI-Bio’s potential to differentiate in IgAN space: GlobalData

Express Pharma

At this year’s European Renal Association, positive results were presented from Human Immunology Bioscience’s (HI-Bio) interim results of the Phase II IGNAZ clinical trial. According to the results, the use of MOR-202 (felzartamab) demonstrated a deep and durable reduction in proteinuria in patients with immunoglobulin A (IgA) nephropathy (IgAN). The drug potentially fills an unmet need in the IgAN space as it has an alternate mechanism of action to current marketed therapies, says GlobalData.

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Validation master plan (VMP) – when and how to create one?

GMPSOP

Validation master plan (VMP) – when and how to create one? Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Have you ever wondered why the regulatory inspectors are naturally keen to examine your validation master plan? That’s because a well-crafted validation master plan gives them a high-level view of your site validation activities (e.g., products, processes, systems, equipment, facility, utilities, etc.

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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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AbbVie gains positive CHMP opinion for Skyrizi for treatment of UC

Pharmafile

AbbVie has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to Skyrizi (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to conventional or biologic therapy. […] The post AbbVie gains positive CHMP opinion for Skyrizi for treatment of UC appeared first on Pharmafile.

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New patent for Maia Pharms drug ANGIOMAX RTU

Drug Patent Watch

Annual Drug Patent Expirations for ANGIOMAX+RTU Angiomax Rtu is a drug marketed by Maia Pharms Inc and is included in one NDA. It is available from three suppliers.

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Pharma Pulse 5/31/24: Gen Z’s Passion for Skincare Falls Short on Sun Protection, A Long, But Promising Road Ahead in Clinical Trials & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Overcoming AMR market failure: Three start-up stories

pharmaphorum

As AMR spreads globally, innovative startups are racing to develop solutions. Learn how Revagenix, LimmaTech and Lumen are using novel approaches to overcome AMR market failure.

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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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Drug Shortages (Resolution 120-1-24)

National Association of Boards of Pharmacy

RESOLUTION NO: 120-1-24 TITLE: Drug Shortages ACTION: PASS WHEREAS, in recent years, there have been many drug shortages resulting in pharmacies being unable to meet patient demand; and WHEREAS, many prescription drugs have been in critically short supply; and WHEREAS, these shortages have resulted in interruptions and changes to patient therapy, which may impact quality of life and cause notable strain in attempting to secure drugs in shortage at the pharmacy level; and WHEREAS, United States F

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Regeneron Global Program Head of Linvoseltamab Discusses the Potential for Linvoseltamab to Become a Frontline Treatment for Multiple Myeloma

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvoseltamab, Regeneron talks about the possibility of linvoseltamab becoming a frontline treatment for multiple myeloma (MM) as well as the company's VelociSuite technology.

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Task Force to Assess Expanding Access to NABP Competency Assessment Examinations (Resolution 120-2-24)

National Association of Boards of Pharmacy

RESOLUTION NO: 120-2-24 TITLE: Task Force to Assess Expanding Access to NABP Competency Assessment Examinations ACTION: PASS WHEREAS, the public at large relies on the professionals who the state boards of pharmacy license and regulate to provide critical health care services; and WHEREAS, state boards of pharmacy have a common duty to protect the public while ensuring a safe and streamlined process for pharmacist licensure; and WHEREAS, it is vital that appropriate measures are in place to ensu

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Scemblix Shows Improved Major Molecular Response Treating Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

PharmExec

Results of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

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Development of a National Forum for Pharmacy Professional Recovery Programs (Resolution 120-3-24)

National Association of Boards of Pharmacy

RESOLUTION NO: 120-3-24 TITLE: Development of a National Forum for Pharmacy Professional Recovery Programs ACTION: PASS WHEREAS, state pharmacist recovery programs provide a vital resource for pharmacy staff who may be at risk of impairment from mental illness or substance use disorders; and WHEREAS, the goal of these recovery programs is to support the successful continuation of, or return to, practice; and WHEREAS, these recovery programs could greatly benefit from the establishment of a natio

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