Sat.Jun 08, 2024 - Fri.Jun 14, 2024

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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

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BMS chief Boerner says company is still hungry for deals after spending more than $20B on M&A last year

Fierce Pharma

As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target | As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along.

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What Hospitals Need to Know about Patient Trust in GenAI

MedCity News

Hospitals need to start thinking about ways to build patients’ trust in generative AI in order for the healthcare industry to fully harness the technology’s potential. They can do this through methods like having transparent conversations, asking for patients’ consent to use the tools and training models on internal data, experts said. The post What Hospitals Need to Know about Patient Trust in GenAI appeared first on MedCity News.

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New study reveals how brain cell communication is linked to Alzheimer’s disease

PharmaTimes

Two support cells, microglia and astrocytes, were found to communicate with each other

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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New polymer-based drug delivery system developed for tuberculosis

European Pharmaceutical Review

Researchers have reported the successful formulation of clofazimine spray-dried poly (lactic acid-co-glycolic acid) (PLGA) microparticles as an “efficient” treatment for tuberculosis (TB). In treating this bacterial infection, the paper highlighted that oral therapy often fails to achieve therapeutic concentrations at the primary infection site, the lungs.

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Amid FTC crackdown, judge says Teva inhaler patents are 'improperly listed' in FDA Orange Book

Fierce Pharma

After being called out on some intellectual property claims late last year, Teva has fallen victim to the Federal Trade Commission’s (FTC’s) ongoing crusade against questionable drug patents. | A federal judge in New Jersey ruled that five of Teva’s patents on the metered dose inhaler for its asthma med ProAir HFA are “improperly listed” in the FDA’s Orange Book.

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Mahana’s DTx for IBS gets permanent reimbursement in Germany

pharmaphorum

Mahana Therapeutics has granted permanent reimbursement in Germany for its Cara Care digital therapeutic for irritable bowel syndrome

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New paediatric blood test to prevent sudden death from hereditary heart condition

PharmaTimes

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

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Europe taps CSL Seqirus to produce bird flu vaccines for pandemic preparedness efforts

Fierce Pharma

Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.

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Healthcare’s Smokejumpers: Filling Critical Clinical Gaps with Independent Contractor Physicians

MedCity News

What if working with independent contractor physicians is the key to unlocking a more stable sustainable healthcare workforce? The post Healthcare’s Smokejumpers: Filling Critical Clinical Gaps with Independent Contractor Physicians appeared first on MedCity News.

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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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Future of Pfizer’s Duchenne gene therapy in doubt

pharmaphorum

Pfizer is “evaluating next steps” for its Duchenne muscular dystrophy (DMD) gene candidate after it failed a phase 3 trial

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AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer

Pharmaceutical Technology

AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.

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Junshi, Coherus' PD-1 inhibitor Loqtorzi scores in phase 3 liver cancer trial

Fierce Pharma

Junshi revealed that a phase 3 trial of Loqtorzi plus Avastin prolonged the survival of first-line patients with hepatocellular carcinoma.

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Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial

MedCity News

An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses. The post Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial appeared first on MedCity News.

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

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Scotland first UK nation to clear Mounjaro use for obesity

pharmaphorum

Scotland has become the first country in the UK to back NHS use of Eli Lilly’s obesity therapy Mounjaro, with a lower BMI threshold than draft NICE guidance

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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. We are proud to be the first company planning to market MBK-01, the EU’s first biologic based on intestinal microbiota, full spectrum purified intestinal microbiota (FSPIM), in the form of lyophilised capsules for oral administration.

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Takeda circles leukemia rival to Novartis' Scemblix in up to $1.3B deal with Ascentage

Fierce Pharma

With a deal worth up to $1.3 billion, Takeda could get its hands on a “potentially best-in-class” third-generation BCR-ABL tyrosine kinase inhibitor (TKI) that could rival Novartis' Scemblix.< | In deal potentially worth up to $1.3 billion, Takeda has gained an option to license Ascentage's third-generation tyrosine kinase inhibitor, which could go up against Novartis' Scemblix in chronic myeloid leukemia.

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Reimagining the Language and Translation Space for Patients

MedCity News

Lack of adequate translation and interpreting services isn’t just an inconvenience, it is dangerous and potentially life-threatening. The post Reimagining the Language and Translation Space for Patients appeared first on MedCity News.

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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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Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

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Behind Big Pharma’s layoffs — is there an end in sight?

PharmaVoice

A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?

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After M&A stretch, Pfizer CEO says company needs 'breathing period' from large deals

Fierce Pharma

Amid a recent biopharma M&A resurgence, one major player plans to stay out of the waters after making multiple recent splashes. | Though not for lack of business development capacity, Pfizer is currently taking a large dealmaking “breathing period,” CEO Albert Bourla told investors this week at Goldman Sachs’ 2024 annual Global Healthcare Conference in Miami.

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Pfizer & Sarepta Gene Therapies Both Failed Phase 3, But Analysts Expect Sarepta Will Win Approval

MedCity News

A Pfizer gene therapy for Duchenne muscular dystrophy failed its Phase 3 clinical trial. But analysts draw distinctions between that therapy and Sarepta Therapeutics’ Elevidys, which awaits an FDA decision that could grant it full regulatory approval. The post Pfizer & Sarepta Gene Therapies Both Failed Phase 3, But Analysts Expect Sarepta Will Win Approval appeared first on MedCity News.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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AbbVie licenses FutureGen IBD drug in $1.7bn deal

pharmaphorum

AbbVie agrees $1.

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Francis Crick, UCL and AZ identify why treatment fails for NSCLC patients

PharmaTimes

NSCLC accounts for around 85% of all lung cancer cases, particularly in non-smoking patients

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GSK notches another Zantac win as plaintiff drops case in Illinois

Fierce Pharma

As the year rolls on, GSK continues to knock out personal injury lawsuits in the long-running legal saga over whether the popular heartburn medication Zantac can cause cancer. | Plaintiff Eugenia Kasza, who alleged her use of Zantac caused her to develop breast cancer, has voluntarily dismissed her case against GSK. The case was set to start trial in Illinois state court on Monday.

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Who Should Be Responsible for Rationing GLP-1s?

MedCity News

There is a shortage of GLP-1s in the U.S. But experts have differing opinions on whose responsibility it is to be rationing the drugs. The post Who Should Be Responsible for Rationing GLP-1s? appeared first on MedCity News.

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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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FDA clears Ipsen’s primary biliary cholangitis drug

pharmaphorum

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

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ICL receives £10m donation to advance heart and lung research

PharmaTimes

The donation will help scientists and clinicians collaborate and make new advances in research

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Pfizer expects 8 blockbuster cancer drugs to come from each of 4 focus areas: exec

Fierce Pharma

Pfizer's oncology division plans to have eight blockbusters by 2030, with contributions from each of its four focused therapeutic areas.

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The Potential for AI in Drug Design

MedCity News

Despite misconceptions about its use, artificial intelligence (AI), through modalities such as machine learning models, is poised to enable companies to expedite the drug design process. The post The Potential for AI in Drug Design appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time