Bio Pharma Dive
AUGUST 12, 2021
Clinical testing showed a clear benefit to using Keytruda with Merck and Eisai's Lenvima in patients with previously untreated advanced renal cell carcinoma.
BioSpace
AUGUST 12, 2021
The amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that have an “equivalent level of immunocompromised.
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Bio Pharma Dive
AUGUST 12, 2021
Women are largely absent from most healthcare companies' C-suites where major decisions are made, despite their large influence as consumers and workers in the industry.
pharmaphorum
AUGUST 12, 2021
The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third doses for 2021 have been given the go-ahead. A report in The Times claims that the government is paying £22 a dose – up from an earlier price of £18 – for the Pfizer/BioNTech vaccine as part of a £1 billion deal for additional supplies, which is needed because existing stocks will be depleted next 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
AUGUST 12, 2021
The decision, which does provide for certain exceptions, is another bump in what's become a rocky market rollout for Biogen's medicine.
pharmaphorum
AUGUST 12, 2021
With advertisers preparing to spend up to $15 billion on influencer marketing by 2022, pharmaceutical and biotech companies are increasingly (and carefully) engaging trusted health social influencers to connect more authentically with consumers. As pharma starts to leverage a multitude of high-engagement channels like influencer marketing, online communities and virtual health services, the industry finds itself in a unique position to reimagine traditional direct-to-consumer (DTC) efforts and p
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
AUGUST 12, 2021
Health insurer Excellus BlueCross BlueShield has said it will not cover treatment with Biogen and Eisai’s new Alzheimer’s disease drug Aduhelm because it has not been shown to be medically effective. The company – said to be the largest health insurer in New York – said in a statement that Aduhelm (aducanumab) remains an investigational drug, even though it was approved by the FDA in June for Alzheimer’s, according to a media report.
XTalks
AUGUST 12, 2021
WoodSpoon , a New York City-based home-cooked food delivery service, recently raised $14 million in a Series A funding round. The round was led by Restaurant Brands International (RBI), the owner of Burger King, Tim Hortons and Popeyes, with participation from World Trade Ventures (WTV) and other individual investors. So, what makes WoodSpoon different from the plethora of other food delivery services?
BioSpace
AUGUST 12, 2021
Obesity is implicated in multiple diseases that send health care costs skyrocketing. It’s not just a problem for the U.S. or Western society, either. Obesity is a global epidemic affecting adults and children alike.
Pharma Times
AUGUST 12, 2021
Combination treatment reduced the risk of disease progression or death by 61% versus Sutent
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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
BioSpace
AUGUST 12, 2021
?Viatris executive chairman Robert Coury said that seeking new stewards for the site is the best route to ensure that people will have jobs and that the property would remain useful.
Pharma Times
AUGUST 12, 2021
The 2021 Communications Awards will be closing its doors for entry on the 10th of September.
BioSpace
AUGUST 12, 2021
Amidst a chorus of pushback from scientific and health organizations, Philip Morris International’s $1.4 billion offer now has the backing of Vectura Group’s board.
pharmaphorum
AUGUST 12, 2021
Mahana Therapeutics has raised second-round financing of $61 million that will be used to launch what it says will be the first prescription digital therapeutics (DTx) for irritable bowel syndrome , one of several digital health products in its pipeline. The Mahana IBS tool – a three-month course that uses cognitive behavioural therapy (CBT) to log symptoms, and provide guidance on changing behaviour and thinking in a way that allows them to reduce the severity of IBS symptoms.
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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.
BioSpace
AUGUST 12, 2021
The drug is being developed for the prevention of heterotropic ossification, which is new bone formation in people with fibrodysplasia ossificans progressive.
Clairnes
AUGUST 12, 2021
The post How to address patient privacy and data-security concerns in clinical trials appeared first on Clinical Trial Recruitment & Management Services.
BioPharma Reporter
AUGUST 12, 2021
The World Health Organizationâs Solidarity PLUS trial will kick off in 52 countries, trialing three drugs to treat patients hospitalized with COVID-19.
BioSpace
AUGUST 12, 2021
Despite the apparent flop, the company noted Lomecel-B led to a significant dose-response curve in the 6MWT compared with placebo at 180 days.
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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.
Pharma Times
AUGUST 12, 2021
Cost-effectiveness watchdog initially rejected the drug in February
BioSpace
AUGUST 12, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Pharma Times
AUGUST 12, 2021
FDA has requested an additional clinical trial on the safety of roxadustat
BioSpace
AUGUST 12, 2021
This approval was based on the Phase III withdrawal study that showed clinically meaningful differences vs. placebo in change to the primary endpoint, Epworth Sleepiness Scale score.
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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.
Pharma Times
AUGUST 12, 2021
Trial will aim to generate additional safety and immunogenicity data
NY Times
AUGUST 12, 2021
Jazz Pharmaceuticals brought in more than $1.7 billion last year selling GHB to narcolepsy patients. With the new approval, sales could soar.
Outsourcing Pharma
AUGUST 12, 2021
The Heart of Athletes study, using Deloitteâs ConvergeHealth MyPath for Clinical platform, aims to examine heart inflammation in athletes with the virus.
BioSpace
AUGUST 12, 2021
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
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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.
ProRelix Research
AUGUST 12, 2021
Acceptance of foreign clinical trials data by US FDA Foreign Clinical Trials (FCTs) Prior to the 1962 Kefauver-Harrison Amendments, it was uncommon for a Sponsor to submit FCTs data. In […]. The post Acceptance of foreign clinical trials data by US FDA appeared first on ProRelix Research.
Drug Patent Watch
AUGUST 12, 2021
Annual Drug Patent Expirations for XOFLUZA Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are six patents…. The post New patent for Genentech Inc drug XOFLUZA appeared first on DrugPatentWatch - Make Better Decisions.
Clinical Trial Gurus
AUGUST 12, 2021
Clinical research coordinators are always in high demand and often worth their weight in gold. In this video I discuss the difference between a freelance study coordinator and an employed clinical research coordinator, some of the pros and cons of both, and how one can traverse back and forth between the two situations.
Drug Patent Watch
AUGUST 12, 2021
Annual Drug Patent Expirations for LEVULAN Levulan is a drug marketed by Dusa and is included in one NDA. It is available from one supplier. There is one patent protecting…. The post New patent for DUSA drug LEVULAN appeared first on DrugPatentWatch - Make Better Decisions.
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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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