Bio Pharma Dive
FEBRUARY 26, 2024
Zealand shares rose by more than one-third on the data, which provide further evidence so-called incretin drugs could help treat people with the liver disease.
Pharmaceutical Technology
FEBRUARY 26, 2024
Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.
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AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 26, 2024
Do bacteria mutate randomly, or do they mutate for a purpose? Researchers have been puzzling over this conundrum for over a century. In 1943, microbiologist Salvador Luria and physicist turned biologist Max Delbrück invented an experiment to argue that bacteria mutated aimlessly.
Pharmaceutical Technology
FEBRUARY 26, 2024
Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 26, 2024
The Department-related Parliamentary Standing Committee on Health and Family Welfare has recommended to the government to persuade private insurance companies to include Ayurveda, Yoga, Unani, Siddha and Homoeopathy (Ayush) treatments in their products and look at global acceptance for these systems of medicines through legalisation and insurance support in other countries.
Pharmaceutical Technology
FEBRUARY 26, 2024
SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving WHO prequalification.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
FEBRUARY 26, 2024
Dr. Oluwaseun Adeyemi, lead author of the report Communication skills training using the EM Talk model reached a high proportion of clinicians in participating emergency departments and improved their serious illness conversation skills, according to a qualitative study conducted as part of the PRIM-ER trial. The observed reach and effectiveness of the training program has the potential to improve use of these skills in clinical practice.
Pharmaceutical Technology
FEBRUARY 26, 2024
The upcoming Clinical Trial Supply Europe 2024 conference will round-up pharma and biotech delegates to discuss the trends and challenges in clinical trial supply industry.
Bio Pharma Dive
FEBRUARY 26, 2024
Making equipment choices with employee experience in mind can help researchers build top-performing teams while enhancing operational efficiencies.
Pharmaceutical Technology
FEBRUARY 26, 2024
The US FDA has granted approval for Alvotech and Teva Pharmaceuticals’ SIMLANDI injection, which is an interchangeable biosimilar to Humira.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
FEBRUARY 26, 2024
The companies didn’t reveal their planned price for Simlandi, which will be the 10th Humira copycat to reach the U.S. market.
Pharmaceutical Technology
FEBRUARY 26, 2024
The Phase II prospective, randomised trial will evaluate three doses of PKM-01 to select the optimal dosage for a Phase III study.
Bio Pharma Dive
FEBRUARY 26, 2024
The deal would mark a retreat from public markets for the once notable biotech, which was forced to cut staff last year to save cash after trial setbacks.
Pharmaceutical Technology
FEBRUARY 26, 2024
The EMA's decision on the marketing authorisation application for Biogen Qalsody is expected in Q2 of this year.
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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
Bio Pharma Dive
FEBRUARY 26, 2024
The drug, one of several GSK is developing for drug-resistant bacteria, has now succeeded in testing against two different infections.
Pharmaceutical Technology
FEBRUARY 26, 2024
Moderna has announced the conclusion of construction works at its new mRNA manufacturing facility in Canada.
Fierce Pharma
FEBRUARY 26, 2024
Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million- | Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million-dollar expansion expected to add hundreds of new jobs in the coming years.
BioPharma Reporter
FEBRUARY 26, 2024
Neuraxpharm Group, a European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, has announced the first launch of BRIUMVI (ublituximab) in Europe for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease.
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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.
Drug Patent Watch
FEBRUARY 26, 2024
Switching pharmaceutical excipients, the inactive components used in drug formulations, can have significant implications for both production costs and market appeal. These components, while not contributing directly to the therapeutic… The post Cost-Cut Without Compromise: Navigating Excipient Switching in Pharma appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
FEBRUARY 26, 2024
Sanofi gets a win for its oral BTK inhibitor rilzabrutinib in chronic hive disorder CSU, setting up a phase 3 programme as it chases after Novartis’ remibrutinib in this indication.
Fierce Pharma
FEBRUARY 26, 2024
Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” | Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” Dubbed “Amgen Ohio,” the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the “latest innovation and technology.
pharmaphorum
FEBRUARY 26, 2024
GSK has reported topline results from a phase 3 trial of its novel antibiotic gepotidacin that could spell the end of a decades-long drought in new oral therapies for gonorrhoea.
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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.
Fierce Pharma
FEBRUARY 26, 2024
Not even one year after becoming a commercial biotech, Krystal Biotech has blockbuster dreams for its flagship product. | In its first six months of commercial availability, Krystal's topical gene therapy Vyjuvek raked in more than $50 million. Now, the company is looking toward bringing the drug to Europe and Japan and testing a new eye-drop formulation.
Pharmaceutical Technology
FEBRUARY 26, 2024
Access and buy GlobalData’s databook on the latest filings and grants activity for Jacobio Pharmaceuticals Group here.
Fierce Pharma
FEBRUARY 26, 2024
The chilling wind of the biotech winter has apparently spared BeiGene. | The chilling wind of the biotech winter has apparently spared BeiGene. While layoffs have been commonplace in the industry, BeiGene employed 1,400 more people at the beginning of 2024 than it did a year ago.
Pharmaceutical Technology
FEBRUARY 26, 2024
Access and buy GlobalData’s databook on the latest filings and grants activity for Praxis Precision Medicines here.
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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.
Pharma Times
FEBRUARY 26, 2024
Every year, tuberculosis, malaria and HIV cause over five million deaths worldwide
Pharmaceutical Technology
FEBRUARY 26, 2024
Access and buy GlobalData’s databook on the latest filings and grants activity for Arcutis Biotherapeutics here.
pharmaphorum
FEBRUARY 26, 2024
AstraZeneca has moved a step closer to EU approval of oral Factor D inhibitor danicopan in the EU, after the EMA’s human medicines committee, the CHMP, backed the drug as a treatment for residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria (PNH).
Pharmaceutical Technology
FEBRUARY 26, 2024
Access and buy GlobalData’s databook on the latest filings and grants activity for Aligos Therapeutics here.
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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.
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