Mon.Jun 05, 2023

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J&J sees trial data supporting earlier CAR-T use in multiple myeloma

Bio Pharma Dive

The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.

Trials 351
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Cybersecurity in pharma: Securing the future

Pharmaceutical Technology

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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Biogen scraps late-stage study for Parkinson’s drug

Bio Pharma Dive

The biotech, which has trimmed various research programs over the past year, cited the trial’s complexity and long timeline as reasons for its discontinuation.

Drugs 256
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Ketamine Can Treat Depression as Effectively as Electroconvulsive Therapy

AuroBlog - Aurous Healthcare Clinical Trials blog

The “dissociative anesthetic” ketamine looks ever more promising as a safe and effective treatment for intractable depression. A new randomized trial from researchers in the United States has shown that injections of ketamine are at least as effective as electroconvulsive therapy (ECT) when treating non-psychotic forms of major depression.

Trials 183
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Unlocking the impact of medical affairs: overcoming challenges in defining and measuring success

Bio Pharma Dive

Discover how medical affairs teams can overcome challenges to define and measure their impact, with a focus on KOL engagement, using a scientific journey approach and a comprehensive strategy.

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ITM raises $273 million to fund radionuclide therapy pipeline

Pharmaceutical Technology

ITM (Isotope Technologies Munich) has announced a €255 million ($273.16 million) equity investment funding raise. According to ITM’s CEO Steffen Schuster, the raise is one of the largest private biotechnology financing rounds to date in the company’s home market, per the 5 June announcement. The funding will be used to fuel the company’s pipeline of targeted radionuclide therapies alongside manufacturing capacities.

Trials 147

More Trending

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The Facilitation and Benefits of Clinical Studies with Home Visits for Patients

Deltaclinical

Clinical trials are an indispensable part of medical research, testing new treatments and pharmaceuticals to improve health care. Traditionally, these studies were conducted in medical facilities, but today clinical studies with home visits are becoming increasingly popular. In this blog post, we will explore the benefits of clinical trials with home visits from the patient’s perspective. 1.

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AstraZeneca study points to new uses for targeted cancer drug Enhertu

Bio Pharma Dive

Results from a “basket” trial of the antibody-drug conjugate show it shrank tumors across a half dozen cancers, suggesting a broader role to targeting the protein HER2.

Drugs 183
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The Facilitation and Benefits of Clinical Studies with Home Visits for Patients

Deltaclinical

Clinical trials are an indispensable part of medical research, testing new treatments and pharmaceuticals to improve health care. Traditionally, these studies were conducted in medical facilities, but today clinical studies with home visits are becoming increasingly popular. In this blog post, we will explore the benefits of clinical trials with home visits from the patient’s perspective. 1.

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Novo Nordisk in talks to acquire French device-maker Biocorp for $165M

Bio Pharma Dive

Biocorp’s “smart pen” technology could improve diabetes management and potentially be used in other areas Novo works in like obesity, one analyst said.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Kid EDV by ImmunityBio for Pediatric Diffuse Intrinsic Pontine Glioma: Likelihood of Approval

Pharmaceutical Technology

Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. According to GlobalData, Phase I drugs for Pediatric Diffuse Intrinsic Pontine Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report.

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Akero’s NASH therapy, paired with GLP-1 drugs, cuts liver fat in small study

Bio Pharma Dive

The biotech’s experimental NASH medicine, combined with drugs like Ozempic, helped to improve markers of the fatty liver disease.

Drugs 169
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ASCO 2023: Research backs chemo-only approach for some rectal cancer patients

Pharmaceutical Technology

Results unveiled at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting indicate that some patients with locally advanced rectal cancer can be treated with chemotherapy alone and may not need radiation therapy before surgery. After five years, the treatment efficacy demonstrated in patients who received chemotherapy (and radiation as needed) versus patients who just received radiation therapy was found to be non-inferior.

Research 130
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Tasked with steadying BIO, Rachel King faces biotech’s many challenges

Bio Pharma Dive

As the lobbying group holds its annual meeting in Boston, BIO’s interim leader is trying to focus attention back on the industry’s most pressing priorities, like pushing back on the IRA.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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China’s NMPA accepts Akeso’s NDA for ebronucimab

Pharmaceutical Technology

China’s National Medical Products Administration (NMPA) has accepted Akeso’s new drug application (NDA) for ebronucimab (AK102) for two indications. Ebronucimab is intended to treat heterozygous familial hypercholesterolemia (HeFH), primary hypercholesterolemia and mixed hyperlipidemia. It is a fully human anti-PCSK9 monoclonal antibody co-developed by the company and AD Pharmaceuticals.

Antibody 130
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Element to increases lab equipment presence

Pharma Times

New division aims to provide laboratories with the equipment and support to uphold analytical data - News - PharmaTimes

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Open Philanthropy awards $1.7m to Evotec for henipavirus therapy discovery

Pharmaceutical Technology

German biotechnology company Evotec has secured a $1.7m grant from a philanthropic funder, Open Philanthropy, to research RNA-targeting henipavirus therapeutics. The company will use the funding for the discovery and development of small molecule antivirals that target viral RNA in henipaviruses, a genus of zoonotic viruses that can cause fatal encephalitis in humans.

RNA 130
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What is Hunter’s disease?

Antidote

Hunter’s disease, also known as Hunter syndrome or MPS II, is an inherited disease that impacts the X chromosome. Though it is a rare condition, it is one that can significantly impact children and their families. Currently, there is no known cure for Hunter syndrome , but there are ways that care providers can help diagnosed individuals manage their symptoms.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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NICE recommends Bristol-Myers Squibb’s mavacamten

Pharmaceutical Technology

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Bristol-Myers Squibb’s mavacamten (Camzyos) as an add-on to standard care to control symptoms of obstructive hypertrophic cardiomyopathy (HCM). The symptoms of obstructive HCM include fatigue, palpitations and shortness of breath.

Medicine 130
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Pfizer’s RSV Vaccine Abrysvo Is a New Step for RSV Prevention

XTalks

Pfizer has announced that its respiratory syncytial virus (RSV) vaccine, Abrysvo, has received approval from the US Food and Drug Administration (FDA). Abrysvo, the bivalent RSV prefusion F (RSVpreF) vaccine, is intended for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older. Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains.

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PharmaEssentia picks Pint-Pharma to market BESREMi in Latin America

Pharmaceutical Technology

PharmaEssentia has chosen Pint-Pharma as commercial partner for BESREMi (ropeginterferon alfa-2b-NJFT) in Latin America. The companies have entered into an exclusive licence agreement to register and promote BESREMi to treat polycythemia vera (PV), a rare type of blood cancer, in Ecuador, Chile, Mexico, Argentina, Brazil, Colombia and Peru. PharmaEssentia may be entitled to receive certain milestone payments along with royalties based on sales of the product.

Marketing 130
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Encouraging results for Parkinson's Disease drug in Biovie study as more patients retain sufficient muscle control

Outsourcing Pharma

Encouraging clinical data has been released by Biovie, a company developing drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.

Drugs 98
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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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AB-1003 by Asklepios BioPharmaceutical for Limb-Girdle Muscular Dystrophy: Likelihood of Approval

Pharmaceutical Technology

AB-1003is under clinical development by Asklepios BioPharmaceutical and currently in Phase II for Limb-Girdle Muscular Dystrophy.

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FDA Warns About Compounded Versions of Ozempic and Wegovy

XTalks

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. Wegovy, in conjunction with diet and exercise, is authorized to assist adults and children aged 12 years and older struggling with obesity, or some adults grappling with excess weight alongside weight-related medical conditions, in their eff

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Camidanlumab tesirine by ADC Therapeutics for Myelodysplastic Syndrome: Likelihood of Approval

Pharmaceutical Technology

Camidanlumab tesirineis under clinical development by ADC Therapeutics and currently in Phase II for Myelodysplastic Syndrome.

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BenevolentAI progresses BEN-34712 for ALS treatment

BioPharma Reporter

BenevolentAI, a clinical-stage AI development company, has announced the successful delivery of its pre-clinical candidate for the potential treatment of amyotrophic lateral sclerosis (ALS), BEN-34712.

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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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Darovasertib by Ideaya Biosciences for Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

Darovasertibis under clinical development by Ideaya Biosciences and currently in Phase II for Colorectal Cancer.

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AZ notches postmarket win for bleeding reversal agent Andexxa, plans to seek full approval

Fierce Pharma

After a postmarketing study of AstraZeneca's bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.< | The phase 4 study ended ahead of schedule after it quickly established the benefits of Andexxa. AZ now plans to seek full approvals for the drug.

Drugs 97
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GRWD-5769 by Grey Wolf Therapeutics for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

GRWD-5769is under clinical development by Grey Wolf Therapeutics and currently in Phase II for Solid Tumor.

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New Research and Innovation Hub to Open in Former Merck HQ in New Jersey

BioSpace

A Kenilworth, NJ, R&D campus that formerly served as Merck’s global headquarters is now set to reopen and become the Northeast Science and Technology (NEST) Center.

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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.