Bio Pharma Dive
JULY 25, 2024
Some analysts described Sanofi’s pipeline of immune system therapies, which includes more than half a dozen drugs in mid- to late-stage testing, as “underappreciated” by investors, as sales of Dupixent rose over the last quarter.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 25, 2024
The search for alcohol hangover cures is as old as alcohol itself. Many cures and remedies are sold, but scientific evidence for their effectiveness is lacking. Recently, the notion that taking a shot of olive oil before consuming alcohol can prevent hangovers has garnered attention.
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Pharmaceutical Technology
JULY 25, 2024
JNJ-2056 is being investigated in the Phase IIb ReTain study which enrols participants who are yet to show Alzheimer’s symptoms.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 25, 2024
Ahead of the upcoming Union Budget, prominent voices in the healthcare sector are urging the government to allocate substantial funds to support early diagnosis and intervention for children with autism and neurodevelopmental delays, alongside enhanced training for medical personnel on early disease detection.
Bio Pharma Dive
JULY 25, 2024
CEO Thomas Schinecker claimed the company has “many opportunities” to stand out in the competitive field, and can get to market “much faster” than investors expect.
Pharmaceutical Technology
JULY 25, 2024
The US FDA has expanded approval to BioMarin Pharmaceutical's BRINEURA to include children aged below three years with neuronal CLN2.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 25, 2024
Sandoz launched the biosimilar of J&J’s Stelara in Europe in partnership with Samsung Bioepis to treat psoriasis and Crohn’s disease.
Fierce Pharma
JULY 25, 2024
Three months after bagging FDA approval, Pfizer’s hemophilia B gene therapy has been cleared to expand its reach across the pond. | The company's first gene therapy will debut in Europe as Durveqtix. In the U.S., the drug is approved under the brand name Beqvez.
Pharmaceutical Technology
JULY 25, 2024
The UK MHRA has authorised Pfizer-BioNTech’s adapted Comirnaty vaccine against the JN.1 Covid-19 subvariant for adults and children.
Fierce Pharma
JULY 25, 2024
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessmen | In a discussion prompted by AstraZeneca's application for Imfinzi, the FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable 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
Pharmaceutical Technology
JULY 25, 2024
Ipsen will pay $111m in cash and equity upfront to gain the global rights, excluding the US, to Day One’s paediatric glioma therapy, Ojemda.
Fierce Pharma
JULY 25, 2024
While Roche touted sales and market share increases for eye disease drug Vabysmo on Thursday, there is evidence of a slowdown of its momentum as it battles Regeneron and Bayer’s powerhouse Eylea fr | While Roche touted sales and market share increases for eye disease drug Vabysmo on Thursday, there is evidence of a slowdown of its momentum as it battles Regeneron and Bayer’s powerhouse Eylea.
Pharmaceutical Technology
JULY 25, 2024
Dren Bio has entered a strategic partnership with Novartis Pharma to develop therapeutic bispecific antibodies to treat cancer.
pharmaphorum
JULY 25, 2024
There has been a gene therapy on the market for people with the bleeding disorder haemophilia A since 2022, but take-up has been very slow. Pfizer and Sangamo are hoping for a faster trajectory with their experimental treatment.The partners' one-shot giroctocogene fitelparvovec therapy has cleared a phase 3 trial, showing it was better than regular prophylaxis injections with Factor VIII (FVIII) replacement therapies at reducing bleeding episodes, and could now be heading for regulatory review.
Pharmaceutical Technology
JULY 25, 2024
The UK NICE has issued final guidance endorsing Boehringer Ingelheim’s tenecteplase for acute ischaemic stroke for NHS use.
pharmaphorum
JULY 25, 2024
Tune in to the Reverba podcast featuring CEO Cheryl Lubbert as she discusses patient engagement throughout the product lifecycle, sharing insights and strategies for success.
Pharmaceutical Technology
JULY 25, 2024
A Phase II study for ConSynance’s triple monoamine reuptake inhibitor CSTI-500 is slated to begin in 2025.
Fierce Pharma
JULY 25, 2024
While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus (RSV) drug, the near-term expected approval of a pair of new filling lines is giving the | While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus drug, the near-term expected approval of a pair of new filling lines is giving the French pharma assurance that its AstraZeneca-partnered antibody Beyfortus can breach the billion-dollar thre
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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
JULY 25, 2024
Ipsen has signed yet another portfolio-expanding deal – its fifth of the year so far – claiming rights outside the US to a drug for common brain cancer glioma from Day One Biopharmaceuticals.
Fierce Pharma
JULY 25, 2024
Just three months after scoring an accelerated FDA approval for Ojemda, Day One Biopharmaceuticals is teaming up with another fellow oncology specialist to grow the medicine's global reach.
pharmaphorum
JULY 25, 2024
Exploring the impact of ageing on Europe and the need to prioritise neurological conditions. Understand the role of neuroscience in addressing these issues.
Fierce Pharma
JULY 25, 2024
Among AstraZeneca’s growth drivers with $5 billion or more in peak sales potential, the company is counting on Daiichi Sankyo-partnered Enhertu to chart new territory. | Among AstraZeneca's growth drivers with $5 billion or more in peak sales potential, the company is counting on Daiichi Sankyo-partnered Enhertu to chart new territory. And stalling sales underscore the challenges facing the HER2 drug.
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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
Drug Patent Watch
JULY 25, 2024
Developing a competitive edge in generic drug development is crucial for companies to gain a significant market share and dominate the market.
Fierce Pharma
JULY 25, 2024
Following last week’s R&D day, argenx continues to demonstrate that its flagship drug, FcRn inhibitor Vyvgart, has plenty of room to grow in its inaugural generalized myasthenia gravis (gMG) in | Following last week’s R&D day, argenx continues to demonstrate that its flagship drug, FcRn inhibitor Vyvgart, has plenty of room to grow in its inaugural generalized myasthenia gravis (gMG) indication.
BioPharma Reporter
JULY 25, 2024
When she was young, Suzanne used to love hearing her father, a cardiologist, talking to his colleagues on the phone about patients and the care they needed.
Fierce Pharma
JULY 25, 2024
With a new chief at the helm and higher profit projections in sight, AbbVie is entering a “new chapter," CEO Robert Michael told analysts Thursday. | Skyrizi's recent ulcerative colitis nod sets it up as a first-line option, while Rinvoq is poised to handle later lines.
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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.
BioSpace
JULY 25, 2024
Bristol Myers Squibb on Friday reported strong second-quarter results, led by the blood thinner Eliquis and cancer therapy Opdivo, as it looks to cut $1.5 billion in costs by 2025.
Fierce Pharma
JULY 25, 2024
Large pharma companies are still looking for deals in China. AstraZeneca and Daiichi Sankyo's antibody-drug conjugate star Enhertu experienced a slow quarter. | Large pharma companies are still looking for deals in China. AstraZeneca and Daiichi Sankyo's ADC star Enhertu slowed down. Samsung Biologics' quarterly revenue crossed the 1 trillion Korean won mark for the first time.
Drug Patent Watch
JULY 25, 2024
The generic drug market has been significantly impacted by the COVID-19 pandemic, with both challenges and opportunities arising from the crisis.
pharmaphorum
JULY 25, 2024
NICE clears NHS use of Boehringer's clot-busting drug Metalyse for acute ischaemic stroke, saying it could 'save millions'
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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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