June, 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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Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

Safety 363
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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.

Patients 356
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Don’t call it a comeback: Biotech’s CNS resurgence forges Big Pharma connections

PharmaVoice

Neuroscience pipelines are reawakening as biotechs prove to the pharma giants that the field is still worth the investment.

Pharma 307
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State of AI in Sales & Marketing 2025

AI adoption is reshaping sales and marketing. But is it delivering real results? We surveyed 1,000+ GTM professionals to find out. The data is clear: AI users report 47% higher productivity and an average of 12 hours saved per week. But leaders say mainstream AI tools still fall short on accuracy and business impact. Download the full report today to see how AI is being used — and where go-to-market professionals think there are gaps and opportunities.

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Mastering Sales Conversations with Customers

Integrity Solutions

We’re all familiar with the stereotype of the over-the-top, pushy, unscrupulous salesperson. They’re always in selling mode, always hustling, always doing whatever it takes to close the deal and win at all costs, regardless of whether they’re actually addressing (or even understanding) the customer’s needs. There’s no real sales conversation or dialogue.

Sales 269

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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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Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

FDA 352
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Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment

MedCity News

Physical and mental health are inextricably intertwined — senior-focused primary care can help bridge the treatment gap The post Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment appeared first on MedCity News.

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Avoiding the pharma ‘junk pile’ with launch readiness, pipeline rigor and ‘quick kills’

PharmaVoice

Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.

Pharma 299
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The Intersection of AI and Sales: Personalization Without Compromise

Speaker: Jesse Hunter and Brynn Chadwick

Today’s buyers expect more than generic outreach–they want relevant, personalized interactions that address their specific needs. For sales teams managing hundreds or thousands of prospects, however, delivering this level of personalization without automation is nearly impossible. The key is integrating AI in a way that enhances customer engagement rather than making it feel robotic.

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The Right Sales Training is Essential to Educating and Motivating Sales Teams

Integrity Solutions

Why are some salespeople uniquely successful? Do they have some special sales skills that others don’t? If your sales force is somewhat normal, just 20% are high performers. Imagine what a difference it would make if motivating sales teams was tied directly to sales training and increasing their ability develop stronger customer relationships and sell more.

Training 171
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Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In

MedCity News

Multiple stakeholders are to blame for prescription drug costs, including pharmaceutical companies and PBMs, according to Merith Basey, executive director of Patients for Affordable Drugs. The post Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In appeared first on MedCity News.

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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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Why the Cyberattack on Ascension Scared 5 Hospital Execs & How They’re Responding

MedCity News

As majorly disruptive cyberattacks continue to make headlines in the healthcare world, hospitals are prioritizing cybersecurity more than ever before. This piece explores reactions from five different health system executives about the recent attack on Ascension — as well as what they’re doing to prevent a similar fate at their own organization and how they want things to change going forward.

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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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Collaboration is Vital to Creating Inclusive Healthcare Technologies

MedCity News

The large-scale, multidisciplinary effort to improve the performance of pulse oximeters provides an example of the value of collaboration to solve problems and shows how industry partners can contribute in a significant way when they have a seat at the table. The post Collaboration is Vital to Creating Inclusive Healthcare Technologies appeared first on MedCity News.

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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

FDA 331
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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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Bernie Sanders Urges GAO To Investigate Payers Over Birth Control Coverage

MedCity News

Under the Affordable Care Act, most private health insurance plans are required to cover birth control methods approved by the FDA without out-of-pocket costs. But not all plans are doing this, Bernie Sanders declared in a letter. The post Bernie Sanders Urges GAO To Investigate Payers Over Birth Control Coverage 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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Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study

MedCity News

Palliative care provided by video was equivalent to in-person visits with a clinician, according to study results presented during the recent annual meeting of the American Society of Clinical Oncology. Investigators say these results indicate telehealth can make palliative care accessible to more cancer patients. The post Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study appeared first on MedCity News.

Patients 325
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SCOTUS Deals a Blow to Medical Debt Collectors

MedCity News

The Consumer Financial Protection Bureau, which has been targeting debt collection practices, survives a Supreme Court challenge. The post SCOTUS Deals a Blow to Medical Debt Collectors appeared first on MedCity News.

Medical 325
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FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP

MedCity News

Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. The post FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP appeared first on MedCity News.

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FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

MedCity News

FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. Peter Marks, the agency’s top biologics official, reviewed the same data and reached a different conclusion. The post FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff appeared first on MedCity News.

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

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Gameto Secures $33M To Support Clinical Development of Fertility Treatment

MedCity News

Gameto’s $33 million Series B funding round was led by Two Sigma Ventures and RA Capital. The funding will help with the clinical development of its in vitro maturation product called Fertilo. The post Gameto Secures $33M To Support Clinical Development of Fertility Treatment appeared first on MedCity News.

Biopharma 323
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Medicare Telehealth Flexibilities Will Expire In December. Congress Needs To Act Swiftly, Experts Say

MedCity News

Telehealth advocates are calling on Congress to act quickly on Medicare telehealth flexibilities, which are set to expire at the end of the year. Doing so would help key healthcare stakeholders prepare. The post Medicare Telehealth Flexibilities Will Expire In December. Congress Needs To Act Swiftly, Experts Say appeared first on MedCity News.

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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.

Patients 321
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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.

Biopharma 321
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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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Why Walgreens’ US Health President Is ‘Bullish’ on the Role of Retail in Healthcare

MedCity News

During a fireside chat at AHIP 2024, Mary Langowski, executive vice president and president of U.S. healthcare at Walgreens Boots Alliance, said she sees a bright future for retail in healthcare. The post Why Walgreens’ US Health President Is ‘Bullish’ on the Role of Retail in Healthcare appeared first on MedCity News.

Retail 321
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Hacking the Hippocratic Oath: Four Ways to Shield Patients from Ransomware Attacks

MedCity News

A proactive cybersecurity stance can maintain the integrity of healthcare, ensuring that care remains both continuous and secure. The post Hacking the Hippocratic Oath: Four Ways to Shield Patients from Ransomware Attacks appeared first on MedCity News.

Patients 317
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Cancer Biotech Day One Biopharma Expands to ADCs, Paying $55M to Nab a Phase 1-Ready Drug

MedCity News

Day One Biopharmaceuticals is adding an antibody drug conjugate to its pipeline, licensing rights to a molecule from MabCare Therapeutics. The MabCare ADC addresses PTK7, a protein found in many types of solid tumors. The post Cancer Biotech Day One Biopharma Expands to ADCs, Paying $55M to Nab a Phase 1-Ready Drug appeared first on MedCity News.

Biopharma 317