FDA approves Merck lung disease drug acquired in $11B deal
Bio Pharma Dive
MARCH 26, 2024
Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.
Tue.Mar 26, 2024
280 
US FDA grants approval for Alexion’s NMOSD treatment
Pharmaceutical Technology
MARCH 26, 2024
The US FDA has approved Alexion’s Ultomiris to treat adults with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD).
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Viking stays in obesity drug race with early data for weight loss pill
Bio Pharma Dive
MARCH 26, 2024
The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects.
Astellas secures approval for gastric cancer antibody in Japan
Pharmaceutical Technology
MARCH 26, 2024
The approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) is based on positive results from two studies.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
Advertisement
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
SQZ, Portal founder Armon Sharei on starting over in biotech
Bio Pharma Dive
MARCH 26, 2024
After his first biotech startup was sold off in parts, Sharei is applying the lessons he’s learned to a new company with a different business model.
GlycoMimetics files patent for treating cancer and related conditions with compound of formula (i)
Pharmaceutical Technology
MARCH 26, 2024
Discover GlycoMimetics Inc.'s groundbreaking patent for treating cancer and related conditions with Formula (I) compound. Learn how this method can reduce chemotherapy side effects and improve patient outcomes.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Syros Pharmaceuticals files patent for treating cancer with compound of formula (i)
Pharmaceutical Technology
MARCH 26, 2024
Discover Syros Pharmaceuticals' groundbreaking patent for treating cancer by targeting CDK7 with compounds of Formula (I). Learn about the innovative method and potential new treatment options for solid tumors.
Supreme Court weighs abortion opponents’ standing in mifepristone case
Bio Pharma Dive
MARCH 26, 2024
The high court's treatment of the case, which centers on a conservative challenge to FDA decisions expanding abortion pill access, is seen as potentially consequential for the drug agency.
Nurix Therapeutics files patent for bifunctional compounds for hpk1 degradation in disease treatment
Pharmaceutical Technology
MARCH 26, 2024
Discover how Nurix Therapeutics' patent for bifunctional compounds targeting HPK1 activity offers a groundbreaking method for treating diseases, including cancer. Learn more about this innovative approach in pharmaceutical compositions.
Pfizer Terminates Phase III Sickle Cell Study Due to Slow Patient Recruitment
BioSpace
MARCH 26, 2024
While Pfizer has ended one of its two Phase III studies for inclacumab in sickle cell disease, the company is still eyeing an approval for the antibody in the inherited blood disorder by 2026.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pfizer files patent for multi-drug antibody drug conjugates with site-specific construction
Pharmaceutical Technology
MARCH 26, 2024
Discover Pfizer's innovative patent for multi-drug Antibody Drug Conjugates and Linking Assembly Units, enabling precise and effective drug delivery. Explore the cutting-edge technology behind site-specific construction and versatile drug linking options.
Moderna Secures Up to $750M in Funding from Blackstone to Advance Flu Program
BioSpace
MARCH 26, 2024
Moderna has entered into a development and commercialization funding agreement with asset management firm Blackstone Life Sciences to help advance its pipeline of flu vaccine candidates.
Sanofi files patent for method for high-level expression of multiple target polypeptides
Pharmaceutical Technology
MARCH 26, 2024
Discover Sanofi's innovative patent for expressing multiple target polypeptides in mammalian cells using unique cell surface markers. This method could revolutionize protein expression technologies.
Nanoscope preps filing for retinitis pigmentosa gene therapy
pharmaphorum
MARCH 26, 2024
Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.
Roles and Responsibilities of Specialized Clinical Supply Experts
Advertisement
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.
Genmab files patent for treatment of diffuse large B-cell lymphoma using bispecific antibody
Pharmaceutical Technology
MARCH 26, 2024
Discover Genmab AS's innovative patent for treating DLBCL with a bispecific antibody and R-CHOP regimen. Learn about specific dosages and administration schedules for improved patient outcomes.
Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair
Fierce Pharma
MARCH 26, 2024
After three years, the crown jewel of Merck’s $11.5 billion acqu | After three years, the crown jewel of Merck’s $11.5 billion acquisition of Acceleron is ready to pay dividends. With the FDA’s approval of Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), Merck is set to launch the first disease-modifying treatment for the condition.
Sosei Group files patent for novel compounds for treating disorders associated with apelin receptors
Pharmaceutical Technology
MARCH 26, 2024
Discover the groundbreaking patent by Sosei Group Corp. for novel compounds targeting apelin receptors. Learn about the compound's potential in treating cardiovascular disease, diabetes, cancer, and more.
Nanoscope Claims Phase II Win for Gene Therapy After Changing Primary Endpoint
BioSpace
MARCH 26, 2024
Nanoscope Therapeutics nabbed a victory on the changed primary endpoint of its Phase IIb vision loss gene therapy trial Tuesday, teeing the biotech up to file for FDA approval of the candidate this year.
The New Age of Decentralized Clinical Trials
Advertisement
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.
Bicycle Therapeutics files patent for method for determining cyclisation extent of peptide ligand
Pharmaceutical Technology
MARCH 26, 2024
Discover how Bicycle Therapeutics Plc's patent revolutionizes peptide cyclisation analysis on genetic display systems. Learn more about this innovative method now!
Aduhelm and an expensive failure to launch
pharmaphorum
MARCH 26, 2024
Aduhelm (aducanumab) and Leqembi are examples of controversial drugs that faced challenges with FDA approval. Learn more about the expensive failure to launch of these medications.
Ingersoll Rand to expand life science presence with $2.3bn ILC buyout
Pharmaceutical Technology
MARCH 26, 2024
Ingersoll Rand has signed an agreement for the acquisition of ILC Dover for an upfront cash purchase price of approximately $2.325bn.
World Bipolar Day 2024: Innovations in Bipolar Disorder Treatment
XTalks
MARCH 26, 2024
World Bipolar Day, observed on March 30th each year, is an important global awareness day focusing on bipolar disorder and eliminating the social stigma often associated with mental health issues. March 30 is also the birthday of the well-known Dutch artist Vincent van Gogh who was posthumously diagnosed to have had bipolar disorder. World Bipolar Day started as a partnership initiative of the International Bipolar Foundation (IBPF), the Asian Network of Bipolar Disorder (ANBD) and the Internati
Accelerating Clinical Supply Through Integrated Drug Development
Advertisement
As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Innovent Biologics files patent for patent filed for novel heterodimeric fc scaffold proteins
Pharmaceutical Technology
MARCH 26, 2024
Discover Innovent Biologics' groundbreaking patent for novel proteins with heterodimeric antibody Fc, revolutionizing antibody engineering and drug development.
Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US
Fierce Pharma
MARCH 26, 2024
Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc
Arcturus Therapeutics files patent for modified human otc protein for treating OTC deficiency
Pharmaceutical Technology
MARCH 26, 2024
Discover how Arcturus Therapeutics' patent for a modified human OTC protein revolutionizes OTC deficiency treatment with codon optimized mRNA sequences.
Female leadership and lessening disease burden
pharmaphorum
MARCH 26, 2024
As Women’s History Month comes to its final week, today’s podcast sees web editor Nicole Raleigh in conversation with Debra Weiss, COO of the Bill & Melinda Gates Medical Research Institute (Gates MRI), discussing her role as a female leader in the leader and the non-profit organisation’s work in developing novel biomedical interventions and lessening the burden of disease in LMICs.
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
Experts flag concerns with drug compliance in osteoporosis landscape
Pharmaceutical Technology
MARCH 26, 2024
KOLs interviewed by GlobalData emphasised urgent action to address inconsistent drug compliance rates in the osteoporosis disease landscape.
Novocure Gets Phase III Win in Patients with Brain Metastases from Lung Cancer
BioSpace
MARCH 26, 2024
Novocure’s stock spiked more than 15% Wednesday morning after the company announced its Tumor Treating Fields therapy met the primary endpoint in a late-stage trial.
Nuvation Bio to acquire AnHeart to form global oncology company
Pharmaceutical Technology
MARCH 26, 2024
Nuvation Bio has entered into a definitive agreement to acquire AnHeart Therapeutics in a strategic move to bolster its oncology pipeline.
COPD Market Poised for ‘Paradigm Shift’ with Potential Approvals in 2024: GlobalData
BioSpace
MARCH 26, 2024
Data analytics firm GlobalData expects potential FDA approvals this year of Sanofi and Regeneron’s Dupixent and Verona’s ensifentrine to transform the treatment of chronic obstructive pulmonary disease.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
Advertisement
The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
Let's personalize your content