Pharmaceutical Technology
MAY 17, 2024
With patients taking control over health, experts discuss how different players in the healthcare system are responding to the shifting relationship.
Bio Pharma Dive
MAY 17, 2024
Imdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.
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Pharmaceutical Technology
MAY 17, 2024
The US Senator took another swipe at the US prices of Novo Nordisk’s blockbuster GLP-1 receptor agonist drugs Ozempic and Wegovy.
Bio Pharma Dive
MAY 17, 2024
The cancer biotech is laying off one-fifth of its staff and scrapping three drugs. Elsewhere, Novartis secured sufficient support for its $3B buyout and Bristol Myers won a new CAR-T approval.
Pharmaceutical Technology
MAY 17, 2024
J&J has gained access to several bispecific antibody programmes, including the Phase I-ready asset PX128 for atopic dermatitis and asthma.
Fierce Pharma
MAY 17, 2024
After Moderna last year suffered a loss in its heated patent fight against Pfizer and BioNTech, the mRNA drugmaker can now celebrate a win. | The win comes after a prior decision from the European Patent Office that invalidated Moderna's other asserted patent.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
MAY 17, 2024
Seven months after Amgen’s chief medical officer referred to trial | Seven months after Amgen’s chief medical officer referred to trial results for the company's investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC).
Pharmaceutical Technology
MAY 17, 2024
Galapagos has signed a partnership with Blood Centers of America to expedite decentralised production of CAR-T cell therapies across the US.
Fierce Pharma
MAY 17, 2024
Following a controversy over Covis’ preterm birth drug Makena in the U.S. last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. | A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.
Pharmaceutical Technology
MAY 17, 2024
The US FDA has granted breakthrough therapy designation (BTD) for Nuvalent’s NVL-655 for the treatment of non-small cell lung cancer.
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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
pharmaphorum
MAY 17, 2024
Explore sustainable catalysis and its potential to transform chemical reactions in drug discovery. Learn how green chemistry plays a pivotal role in shaping the future of catalysis.
Pharmaceutical Technology
MAY 17, 2024
CinDome Pharma has secured $40m in a Series B financing extension round to develop deudomperidone for chronic gastroparesis.
pharmaphorum
MAY 17, 2024
Brainomix gets FDA approval for e-Lung, an AI tool that assists in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical images.
Pharmaceutical Technology
MAY 17, 2024
Moxifloxacin is under clinical development by Laboratorios Sophia and currently in Phase I for Bacterial Conjunctivitis.
pharmaphorum
MAY 17, 2024
Navigating maternal vaccine trials: addressing safety, efficacy, and preterm birth risks. Insights on vaccines for pregnant women and maternal health.
Pharmaceutical Technology
MAY 17, 2024
IL13R alpha 2 CAR-T is under clinical development by TCR Cure Biopharma Technology and currently in Phase I for Glioma.
Pharma Times
MAY 17, 2024
Areas include health research across life stages, from paediatrics to health ageing and resilience
Pharmaceutical Technology
MAY 17, 2024
TNT-119 is under clinical development by Eliem Therapeutics and currently in Phase I for Membranous Glomerulonephritis.
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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.
pharmaphorum
MAY 17, 2024
Amgen gets FDA approval for Imdelltra as a treatment for small cell lung cancer, becoming the first DLL3-targeted drug and the company's second BiTE therapy.
Pharmaceutical Technology
MAY 17, 2024
Erasca has made operational cuts while licensing a molecular glue therapy and a KRAS inhibitor for $22.5m upfront.
pharmaphorum
MAY 17, 2024
Johnson & Johnson has agreed a $850m deal to acquire Proteologix that will give it a pair of early-stage bispecific antibodies for atopic dermatitis and asthma.
Pharmaceutical Technology
MAY 17, 2024
Cannabidiol is under clinical development by Cannamore Biotechs and currently in Phase II for Ulcerative Colitis.
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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
BioPharma Reporter
MAY 17, 2024
Endeavor BioMedicines, a clinical-stage biotech company, has announced promising phase 2a trial results for its lead investigational candidate, ENV-101.
Pharmaceutical Technology
MAY 17, 2024
PF-08046040 is under clinical development by Pfizer and currently in Phase I for Myelodysplastic Syndrome.
pharmaphorum
MAY 17, 2024
Bernie Sanders says high prices being charged for new obesity therapies like Novo Nordisk’s Wegovy could end up bankrupting US healthcare systems
Pharmaceutical Technology
MAY 17, 2024
PH-6452 is under clinical development by PHAIT and currently in Phase I for Lung Cancer.
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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.
Fierce Pharma
MAY 17, 2024
Following a reportedly bullish assessment from Medicare, Eisai has projected a significant sales increase for Leqembi. | Eisai has projected a significant sales increase for Leqembi. Takeda put down $100 million upfront for an option to license an anti-amyloid vaccine from AC Immune. The House oversight committee has voted overwhelmingly to advance a tweaked version of the BIOSECURE Act.
Pharmaceutical Technology
MAY 17, 2024
PH-7563 is under clinical development by PHAIT and currently in Phase I for Lung Cancer.
Pharma Times
MAY 17, 2024
The mosquito-borne disease affected around 249 million people globally in 2022
Pharmaceutical Technology
MAY 17, 2024
Gene Therapy for Parkinson’s Disease is under clinical development by Innervate Therapeutics and currently in Phase II for Parkinson's Disease.
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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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