Bio Pharma Dive
SEPTEMBER 1, 2021
A group of advisers convened by the regulator will spend Thursday and Friday weighing a range of safety worries with gene therapy, and how best to prevent them.
pharmaphorum
SEPTEMBER 1, 2021
An artificial intelligence algorithm already shown to be able to detect atrial fibrillation (AF) in clinical testing has also shown its worth in a real-world setting, according to its developers. The AI – developed by the Bristol Myers Squibb-Pfizer Alliance on cardiovascular disease – was developed using machine learning from a UK dataset of almost 3 million patients and previously found to be more effective than existing testing at identifying patients at risk of AF based on retrospective stud
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Bio Pharma Dive
SEPTEMBER 1, 2021
Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year.
BioSpace
SEPTEMBER 1, 2021
The pandemic and its subsequent effect on the workplace has been the source of stress for many professionals and executives in various industries.
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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
SEPTEMBER 1, 2021
The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors.
NY Times
SEPTEMBER 1, 2021
The ruling in bankruptcy court caps a long legal battle over the fate of a company accused of fueling the opioid epidemic and the family that owns it.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
SEPTEMBER 1, 2021
The US National Institutes of Health (NIH) has begun a clinical trial to assess the antibody response to a COVID-19 vaccine booster in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen.
Bio Pharma Dive
SEPTEMBER 1, 2021
An agreement between Novartis and England's national health system is an important commercial step for Leqvio, the cholesterol lowering medicine the Swiss drugmaker acquired in its $10 billion buyout of The Medicines Co.
XTalks
SEPTEMBER 1, 2021
Global medical technology leader Zimmer Biomet (NYSE and SIX: ZBH) and Canadian medical data startup Canary Medical received de novo clearance and market authorization from the US Food and Drug Administration (FDA) for a tibial extension for Persona IQ, the world’s first “smart” knee implant. The Persona IQ system is the first and only smart knee with FDA clearance for total knee replacement surgery.
BioSpace
SEPTEMBER 1, 2021
BioLabs is opening its next hub in Dallas in a 37,000-square-foot flexible life science facility. The Biotech+ Hub can accommodate 35 startups, for which it's now accepting applications.
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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
BioPharma Reporter
SEPTEMBER 1, 2021
As a relatively new player in the field of cell therapy, Santen Pharmaceutical has outlined how it is looking to collaborate with key stakeholders in order to shape relevant policies, forge meaningful partnerships and create an optimal environment for the launch of an eye disorder focused therapy.
BioSpace
SEPTEMBER 1, 2021
Henceforth, all JAK-inhibiting drugs like AbbVie’s Rinvoq, Pfizer’s Xeljanz, and Lilly’s Olumiant, have been ordered to include a warning label on the medicine to be sold in the U.S.
NY Times
SEPTEMBER 1, 2021
“I got fevers, sweats, and I knew what was going on,” he said in a video on Instagram on Wednesday, after returning from a series of shows in Florida.
pharmaphorum
SEPTEMBER 1, 2021
Novartis’ cholesterol-lowering drug Leqvio will be made available on the NHS in England and Wales, and could help to prevent up to 30,000 deaths, according to NICE. The PCSK9-targeting oligonucleotide – which is already available in Scotland – requires dosing just twice a year and has been approved by the health technology assessment (HTA) agency for use in people with atherosclerotic cardiovascular disease (ASCVD) who can’t reach target cholesterol levels with oral statins alone.
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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.
BioPharma Reporter
SEPTEMBER 1, 2021
Orgenesis has set up a partnership with Savicell Diagnostics to advance the development, QC testing and manufacturing of its cell and gene therapies.
pharmaphorum
SEPTEMBER 1, 2021
The new Cancer Care in Europe: Recovering from COVID-19 Disruption white paper assesses the disruption to patient care and the changes physicians implemented during the acute phase of the pandemic, with a focus on the way in which treatment strategies were altered. The publication, which has been supported by Accord Healthcare, also provides a series of recommendations for how the pharmaceutical industry can continue to support cancer care for the next 12 months and looks at what physicians want
BioSpace
SEPTEMBER 1, 2021
?Takeda said that Phase III PANTHER, which studied the effectiveness of pevonedistat for different types of leukemia, did not produce significant results in terms of event-free survival.
pharmaphorum
SEPTEMBER 1, 2021
One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson’s pharma unit Janssen is trumpeting a new version of its Invega drug that could solve that problem. The FDA has just approved Janssen’s Invega Hafyera (paliperidone), a twice-yearly injectable formulation that extends the company’s big-selling brand and offers the fewest doses per year of any schizophrenia medicine.
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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.
BioSpace
SEPTEMBER 1, 2021
?The Sacklers did not admit to any wrongdoing and have never been charged directly for the issue. Still, Purdue Pharma has pleaded guilty twice in its erroneous marketing efforts for OxyContin.
Pharma Times
SEPTEMBER 1, 2021
Agreement will allow NICE to make ‘efficient and effective’ updates to recommendations in its guideline portfolio
BioSpace
SEPTEMBER 1, 2021
Between April 2020 and today, the executive board of Kyowa Kiran North America (KKNA) has grown from being predominantly male to a 50/50 gender split.
pharmaphorum
SEPTEMBER 1, 2021
Astellas has halted dosing in a study of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM) for the second time after another serious adverse event (SAE) linked to possible liver damage. The ASPIRO trial of AT132 has been paused after abnormal liver function tests (LFTs) were seen in a patient receiving the gene therapy, and information on the adverse event has been shared with regulators, according to the drugmaker.
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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.
BioSpace
SEPTEMBER 1, 2021
The approval was built on data from the Phase III ASPEN trial that compared Brukinsa to ibrutinib in a total of 201 patients with MYD88 mutation.
Delveinsight
SEPTEMBER 1, 2021
Drones, also referred to as unmanned aerial vehicles (UAVs)/unpiloted aircraft, are remotely piloted to meet various needs. Drones are one of the emerging technologies that are reshaping the transportation system. Earlier, the main use of drones was for a military expedition, however, today the drones can be seen in commercial & civilian use, making their way in several other sectors such as e-commerce, mining, chemicals industry, forest conservation, construction, geography mapping, filmmak
BioSpace
SEPTEMBER 1, 2021
Disc’s first program, DISC-0974, is an anti-hemojuvelin (HJV) monoclonal antibody designed to suppress hepcidin and enhance iron levels in order to treat anemia of inflammation.
Pharma Times
SEPTEMBER 1, 2021
Phase III study finds risk reduced by 52% compared with control group
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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
SEPTEMBER 1, 2021
Shares of Assembly Biosciences have fallen more than 20% in premarket trading after the company discontinued the development of a hepatitis B therapeutic candidate.
BioPharma Reporter
SEPTEMBER 1, 2021
Johnson & Johnson has announced results from the primary analysis of its Imbokodo Phase 2b HIV vaccine clinical trial, with data showing the investigational HIV vaccine candidate did not provide sufficient protection against HIV infection. A Phase 3 trial with a different composition of the vaccine regimen and different populations, however, will continue.
BioSpace
SEPTEMBER 1, 2021
A study published in The Lancet Infectious Diseases found that the Pfizer-BioNTech, Oxford-AstraZeneca or Moderna vaccines resulted in a drop in “long-haul” COVID-19 by 50%.
Pharma Times
SEPTEMBER 1, 2021
Large-scale phase III study met all primary and secondary endpoints
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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.
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