2024

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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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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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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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Introducing the Clarivate Academic AI Platform

Clarivate

We have released the first version of the Clarivate Academic AI Platform, serving our suite of AI-powered Research Assistants. Discover how it is going to help address the needs of students, researchers and librarians for trusted AI. At Clarivate TM , we understand the transformative power of artificial intelligence (AI) in the academic realm and the imperative to introduce AI thoughtfully and responsibly into research, teaching and learning environments.

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

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Enhancing Patient Care: 4 Strategies for Life Sciences Companies

Salesforce

For many people, a sudden tingling in the leg or a feeling of numbness in the arm isn’t too much cause for alarm. The tingling or the numbness goes away after a little while, and they go on with their lives. But for Brooke Eby, an abrupt limp on her way to a conference one day ultimately led to a diagnosis of amyotrophic lateral sclerosis (ALS) at the age of 33.

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COVID-19 vaccinations now ‘alarmingly low’ in Europe

pharmaphorum

COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.

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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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Data for First-in-Class IV-Administered Gene Therapy to Treat Epilepsy Presented at ASGCT 2024

PharmaTech

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

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Return-to-Office Pushes Can Cause a ‘Riot’

Copyright Clearance Center

A growing number of managers want workers in the office more often, citing the connections, collaborations, and innovations that in-person work can bring.

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Researchers combine herpes virus with cancer vaccine to treat brain cancer in children

PharmaTimes

High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours

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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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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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FDA Grants Breakthrough Device Designation to Assay Supporting Earlier Diagnosis of Alzheimer Disease

Pharmacy Times

If approved, the test could provide more timely and accurate diagnosis, hopefully mitigating the impact of Alzheimer disease (AD) on individuals and the community.

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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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Reimagining research impact: Introducing Web of Science Research Intelligence

Clarivate

Discover how the Web of Science Research Intelligence platform will revolutionize research evaluation by driving responsible innovation and demonstrating societal impact. At Clarivate , we recognize the pivotal role that research plays in shaping the future. That’s why we’re excited to announce the development of Web of Science Research Intelligence , a next-generation software solution powered by AI that will empower researchers to accelerate breakthroughs and research institutions to better me

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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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Why patient-centricity is essential to accelerate rare disease clinical research

European Pharmaceutical Review

Rare diseases affect up to 36 million people in the EU, and as many as 400 million people globally. 1,2 they are often progressive, life-limiting and incurable. Half of people diagnosed with a rare disease are children, 30 percent of whom die before they reach the age of five. 3 Significant unmet needs The path to diagnosis of a rare disease is complex, taking on average five to eight years from the onset of symptoms before a patient receives an accurate diagnosis. 4 In some countries, limited a

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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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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Exploring the Potential of mRNA (BIO 2024)

PharmaTech

Pharm Tech Group sits down with Bernard Sagaert, CEO of etherna, to examine the role of mRNA in the treatment of autoimmune diseases.

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Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

Fierce Pharma

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.

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Takeda, amid restructuring campaign, plots 641 layoffs at two Massachusetts sites

Fierce Pharma

A recently announced $900 million restructuring drive is already making waves at Takeda, wi | From early July to March 2025, the Japanese drugmaker will cut 495 staffers at its Cambridge location and 146 in Lexington, Massachusetts. Takeda is the largest life sciences employer in the state.

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At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria

Fierce Pharma

Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European | Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With Pfizer struggling in 2023, CEO Bourla hit with 35% pay cut to $21.6M

Fierce Pharma

Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.

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House's updated biosecurity bill sets 2032 decoupling deadline for industry's work with WuXi AppTec

Fierce Pharma

Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. | Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. The new draft lays out a 2032 deadline for the separation mandate.

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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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BioNTech hit with 'notice of default' from NIH in COVID-19 vaccine royalty dispute

Fierce Pharma

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

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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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BioNTech, flush with $145M from CEPI, looks to expand mRNA vaccine production in Africa

Fierce Pharma

As various efforts to produce next-generation vaccines in Africa are being carried forward by the likes of the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, BioNTech | Under an expansion of the partners’ existing deal, the Coalition for Epidemic Preparedness Innovations (CEPI) is committing up to $145 million to bolster BioNTech’s efforts to establish vaccine R&D and manufacturing capabilities at the German company’s facility in Kigali, Rwanda.

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Lilly wins NICE endorsement for tirzepatide in obesity—with a catch

Fierce Pharma

A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has retu | A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has returned with an endorsement in obesity.

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Former Pfizer statistician found guilty of insider trading on Paxlovid trial results

Fierce Pharma

A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.

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Bristol Myers puts more than 860 jobs on chopping block in NJ as $1.5B savings campaign rolls ahead

Fierce Pharma

The scope of Bristol Myers Squibb’s $1.5 billion savings drive is beginning to come into focus. | Starting this month, BMS will begin the process of laying off around 863 employees in Lawrenceville, New Jersey, according to a Worker Adjustment and Retraining Notification (WARN) alert from the state. The move forms part of BMS’ campaign to shave off $1.5 billion in costs by the end of 2025, a company spokesperson said over email.

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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.