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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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.

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If Passed, This New Bill Could Send PE Execs to Jail for Hospital Mismanagement

MedCity News

Two senators recently introduced a bill that seeks to regulate private equity firms’ involvement in the healthcare industry. If passed, the act would establish a criminal penalty of up to six years in prison for private equity executives whose business decisions result in a patient’s death. The post If Passed, This New Bill Could Send PE Execs to Jail for Hospital Mismanagement appeared first on MedCity News.

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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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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.

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Blood test could spot Parkinson’s years earlier

pharmaphorum

An AI-powered blood test that may be able to predict Parkinson’s years before symptoms develop could allow earlier treatment and guide trials of new treatments

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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.

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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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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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Ahead of its upcoming decision date, a competitor takes aim at KarXT

PharmaVoice

The FDA isn’t slated to render a decision about BMS and Karuna’s potential breakthrough schizophrenia med until September — but a biotech is already hoping to be hot on its heels.

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

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Top 10 Medical Education Trends of 2024

Impetus Digital

A version of this article was previously published in the Journal of mHealth. The days of cookie-cutter medical education sessions and unengaging, didactic data presentations are–mostly–over. These days, medical education and training programs are all about customization, personalization, and innovation. In this article, we take a look at 10 of the hottest trends in medical education and learning programs. 1.

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Regulation and legislation in the era of automation and digitalisation

European Pharmaceutical Review

Friend or foe? Pharmaceutical companies ask themselves this question before embracing the latest technologies because every innovation comes with both opportunities and risks. Today, technological advancements in artificial intelligence (AI), machine learning (ML), digitalisation, and robotic manufacturing automation solutions stand to revolutionise R&D, clinical trials, and manufacturing in the pharmaceutical industry.

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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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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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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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Osteoporosis market expected to reach $17.9bn across 7MM by 2033

Pharmaceutical Technology

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.

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Can Moderna’s COVID-flu combo shot improve flagging vaccination rates?

PharmaVoice

A COVID and flu duo could ease manufacturing and administration, potentially driving higher vaccination rates, said Moderna’s VP of North American medical affairs.

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Virtual Publication Planning, Co-Development, and Reviews

Impetus Digital

Pharma-exclusive Webinar: Virtual Publication Planning, Co-Development, & Reviews About the webinar Join our exclusive small-group webinars to dive deep into the trends, strategies, and tips on all things Medical Publications. Learn from our expert speakers about the latest best practices for planning, co-developing, and reviewing publications and other medical materials such as peer-reviewed journal articles and consensus papers, conference abstracts and posters, educational slide decks, an

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GLP-1 treatment displays best-in-class potential for MASH

European Pharmaceutical Review

New sub-analysis data from a Phase II clinical trial show that after 48 weeks of survodutide treatment, 83.0 percent of adults with liver fibrosis achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH). This is compared to 18.2 percent with placebo. With its novel mechanism of action, the glucagon/GLP-1 receptor dual agonist is the first to show this level of fibrosis benefit in a Phase II MASH trial following 48 weeks of treatment, according

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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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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

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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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Scott Burrows: Empowering Financial Advisors with Vision and Resilience

Scott Burrows

In my journey as a keynote motivational speaker within the financial services industry, I’ve had the privilege of addressing esteemed organizations such as Merrill Lynch, Janney Montgomery, Morgan Stanley, Met Life, Farmers and Edward Jones, among others. Through these engagements, I’ve shared my life-transforming story and principles of success anchored in Vision, Mindset, and Grit.

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Regenerative cell therapy biotech uses IPO to blast into human trials

PharmaVoice

Bucking conventional fundraising, FibroBiologics’ CEO Pete O’Heeron explains why the biotech company bet on themselves in the public market.

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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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Novavax seeks EMA approval for updated JN.1 Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.

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Novel immunotherapy combination approved for endometrial cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the first anti-PD-1 therapy in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Merck (MSD outside of the US and Canada)’s KEYTRUDA (pembrolizumab) is authorised alongside treatment with carboplatin and paclitaxel, followed by KEYTRUDA monotherapy, for these patients.

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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.

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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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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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First rare disease therapies chosen for FDA START programme

pharmaphorum

An initiative set up by the FDA to accelerate the development of therapies for rare disease in the same way that Operation Warp Speed delivered COVID-19 vaccine has chosen its first pilot programme candidates.

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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.

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Bridging Authenticity: The Transformative Power of Allyship

ALULA

Since our Pride Month series is all about prompting more open conversations about LGBTQIA+ allyship, I took the opportunity to interview my colleague Brian Cole about his allyship journey. Not only is Brian my colleague , but he is also my dad, so it was powerful to address how features of allyship show up across our shared work, home, and social spaces.

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Semi-automation of manual interventions in high-speed filling lines

European Pharmaceutical Review

Researchers have developed a novel, gloveless intervention method with remote robotic interventions for high-speed pharmaceutical isolator filling lines. While these high-speed lines are currently fully automated, Dekker et al. noted that operator interventions are still done manually. For example, a common intervention is the removal of erroneous plungers or stoppers.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time