European Pharmaceutical Review
JUNE 13, 2024
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.
Fierce Pharma
JUNE 20, 2024
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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MedCity News
JUNE 17, 2024
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.
Pharmaceutical Technology
JUNE 17, 2024
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.
PharmaVoice
JUNE 18, 2024
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.
pharmaphorum
JUNE 19, 2024
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
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Fierce Pharma
JUNE 7, 2024
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.
MedCity News
JUNE 9, 2024
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.
Pharmaceutical Technology
JUNE 26, 2024
AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).
PharmaVoice
JUNE 25, 2024
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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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.
Impetus Digital
JUNE 17, 2024
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.
European Pharmaceutical Review
JUNE 7, 2024
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.
Fierce Pharma
JUNE 11, 2024
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.
MedCity News
JUNE 24, 2024
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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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
pharmaphorum
JUNE 26, 2024
Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.
PharmaVoice
JUNE 25, 2024
A COVID and flu duo could ease manufacturing and administration, potentially driving higher vaccination rates, said Moderna’s VP of North American medical affairs.
Pharmaceutical Technology
JUNE 24, 2024
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.
European Pharmaceutical Review
JUNE 7, 2024
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
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.
Fierce Pharma
JUNE 26, 2024
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.
MedCity News
JUNE 10, 2024
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.
pharmaphorum
JUNE 5, 2024
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.
PharmaVoice
JUNE 5, 2024
Bucking conventional fundraising, FibroBiologics’ CEO Pete O’Heeron explains why the biotech company bet on themselves in the public market.
Impetus Digital
JUNE 28, 2024
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
European Pharmaceutical Review
JUNE 18, 2024
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.
Fierce Pharma
JUNE 18, 2024
Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.
MedCity News
JUNE 21, 2024
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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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
pharmaphorum
JUNE 2, 2024
An AI tool has shown impressive results in raising colorectal cancer screening rates in underserved populations, according to data presented at ASCO
Scott Burrows
JUNE 7, 2024
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.
Pharmaceutical Technology
JUNE 25, 2024
Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.
European Pharmaceutical Review
JUNE 20, 2024
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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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.
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