April, 2024

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How Will Walgreens’ Expansion into Specialty Pharmacy Affect the Industry?

MedCity News

Walgreens announced that it is expanding its specialty pharmacy offerings. Experts think that this move could yield several strategic benefits, given the higher profit margins associated with specialty medications compared to traditional drugs. They also think Walgreens’ move could lead to greater competition, consolidation and innovation within the broader pharmacy industry.

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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As antimicrobial resistance looms large, a nonprofit teams up with Big Pharma to intervene

PharmaVoice

AMR is a growing threat, but with little financial incentive to pick up the torch, government and nonprofit collaborations are keeping the R&D flames burning.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

PharmaTech

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

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Smart sensor cleared for use with AZ asthma, COPD inhalers

pharmaphorum

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

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More Trending

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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Outrun Therapeutics announces launch with $10m seed funding

Pharmaceutical Technology

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

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Traditional gene therapies are uber-niche. Ocugen hopes to change that.

PharmaVoice

The biotech is developing a ‘gene-agnostic’ approach to expand the patient pool for gene therapies.

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FDA Releases Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

PharmaTech

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

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Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem

MedCity News

Nurse managers being too busy to train and support their team members is one of the biggest reasons nurses are exiting the healthcare industry, according to a new report. The post Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem appeared first on MedCity News.

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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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ESCMID 2024: Using AI in infection prevention and control

Pharmaceutical Technology

Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Benefits of 3D printing for personalised medicine formulation

European Pharmaceutical Review

A paper has reported the first time that 3D printing has facilitated two active pharmaceutical ingredients (APIs) to be combined in the same formulation. This method enables the number of administrations of the drug evaluated to be minimised, the researchers found. The authors aimed to evaluate and compare the efficacy and acceptability of chewable 3D printed medicines containing citrulline, isoleucine, and valine alone or in combination.

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The Relationship Between Cold Chain Logistics and Cell & Gene Therapies

Pharmaceutical Commerce

A one-on-one with Thermo Fisher’s Wilfredo Marin, who dives into the value of ultra-low temperature storage, the need for flexibility in the cold chain logistics space, and more.

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NHS trust bids to take license for abandoned gene therapy

pharmaphorum

Great Ormond Street Hospital is applying for the license to a gene therapy for rare disease ADA-SCID that was abandoned by a biotech developer on commercial grounds.

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Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines

MedCity News

Regeneron Pharmaceuticals is collaborating with CRISPR technologies startup Mammoth Biosciences to develop in vivo gene-editing therapies. The deal marks the third pharmaceutical industry partnership for Mammoth, which initially focused on developing CRISPR-based diagnostics. The post Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines appeared first on MedCity News.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Number of ongoing US drug shortages reaches new high, pharmacist group says

Fierce Pharma

As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.

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The 7 Ps of Marketing

Healthcare Success

As an engineering undergrad, I took a Marketing 101 class on a lark, seeking to better understand the psychology behind consumer behavior and developing products with a competitive edge. On the first day of class, we learned the fundamental concept of the 4 Ps of marketing. However, today, I like to use an expanded “7 Ps” definition. In any event, this marketing mix remains essential for any successful marketing strategy.

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Antibiotic demonstrates non-inferiority to a leading gonorrhoea treatment

European Pharmaceutical Review

New trial results for GSK’s oral gepotidacin, a potential first-in-class oral antibiotic, has shown that it was non-inferior with 92.6 percent success rates in patients with uncomplicated urogenital gonorrhoea (GC). “These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide” In the pivotal EAGLE-1 Phase III trial, comparatively, intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a

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LogiPharma Europe 2024: Niklas Adamsson Discusses Ways to Improve Visibility and Risk Management for Cold Chain Shipping

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Environtainer, suggests how to improve visibility and risk management for cold chain shipping.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA initiative puts AR/VR at heart of home health drive

pharmaphorum

A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system

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Report: How MA Plan Design Affects Utilization, Health Equity

MedCity News

A new study found that enrollees with zero-premium MA plans are three times as likely to be non-White compared to other MA enrollees and traditional Medicare enrollees. The post Report: How MA Plan Design Affects Utilization, Health Equity appeared first on MedCity News.

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Bristol Myers’ Abecma wins FDA nod in earlier multiple myeloma with updated boxed warning on secondary cancer

Fierce Pharma

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma. | After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers’ CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

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Next-gen menopause treatments have blockbuster potential. Can women, doctors and payers be convinced?

PharmaVoice

The market is huge, but will companies overcome the triple hurdles of payer hesitance, prescriber reluctance and sluggish consumer demand?

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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The New Authenticity: SXSW 2024 Insights, Part 2

Eversana Intouch

At SXSW 2024, amidst a confluence of marketing, technology, AI, and design, one word seemed to echo through every conversation, panel, and workshop: authenticity. It’s fascinating, isn’t it? The idea of being genuine, real, and true — qualities so deeply sought after in everything we do, yet so complex and rich when we pause to unpack them. Among the minds at EVERSANA INTOUCH, with leaders spanning the spectrum from Strategic Planning to Creative Direction, and from Experience Design to Customer

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Patent expiration to drive biosimilars market expansion to 2032

European Pharmaceutical Review

Expirations of biologic patents has enabled manufacturers to enter the market and offer lower-cost alternatives of these drugs, [which has] resulted in increased competition and price pressure, driving the growth of the biosimilar market” A report published by Towards Healthcare has estimated that the global biosimilar market will value $1,26,019.67 million by 2032, at 17.6 percent CAGR between 2023 and 2032.

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Owlstone secures $6.5M for breath-based diagnostics for infectious disease

pharmaphorum

Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of breath-based diagnostic solutions to improve outcomes in the developing world.

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FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.