Bio Pharma Dive
AUGUST 16, 2021
The FDA cleared Welireg, which Merck picked up in its $1 billion takeover of Peloton Therapeutics, to treat certain tumors associated with a rare genetic disease.
BioSpace
AUGUST 16, 2021
Moderna is expected to launch a human clinical trial as early as this week for an mRNA-based vaccine against HIV and indicated that it is looking for 56 people ages 18 to 50 who are HIV-negative.
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Bio Pharma Dive
AUGUST 16, 2021
The decision from the regulator ends a three-month study pause that had stalled Rocket's development of of the Danon disease treatment.
pharmaphorum
AUGUST 16, 2021
UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies. The Oxford-based company had originally hoped to raise $50 million from the series B, and the scale of the financing is further evidence that repurposing psychedelic compounds as potential therapies for neuro-psychiatric disorders is a hot topic in biopharma.
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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 16, 2021
Positive results help validate the $1 billion acquisition that gave Lilly access to lebrikizumab. Even so, the company could face tough competition from Regeneron and Sanofi's Dupixent.
pharmaphorum
AUGUST 16, 2021
Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics. The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results are positive.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
AUGUST 16, 2021
I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event…. The post Upcoming workshop on generic portfolio management appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
AUGUST 16, 2021
CureVac and GSK said their jointly advanced second-generation mRNA COVID-19 vaccine candidate, CV2CoV, demonstrated improved immune response and protection in a preclinical study.
pharmaphorum
AUGUST 16, 2021
Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and will follow that with filings in Europe and elsewhere in the world in the coming weeks.
Pharma Times
AUGUST 16, 2021
VHL is a rare genetic disease which puts patients at risk of developing benign blood vessel tumours and several cancers
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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
NY Times
AUGUST 16, 2021
Johnson & Johnson is sending shots from South Africa to other parts of the world. African countries are waiting for most of the doses they’ve ordered.
XTalks
AUGUST 16, 2021
Due to changes brought on by the COVID-19 pandemic, where and how people work in the food and beverage industry are evolving. According to a recent report by Deloitte and FMI-The Food Industry Association (FMI), the industry is already looking ahead and planning for its next steps in the evolving post-pandemic workplace. The report, entitled “Future of work: The state of the food industry,” outlines conclusions from 150 surveys and 15 interviews with food industry leaders.
BioSpace
AUGUST 16, 2021
Two months after Athira placed its CEO Leen Kawas, on temporary leave, the company has appointed new execs to its team. It is also rigorously advancing its Alzheimer’s program.
pharmaphorum
AUGUST 16, 2021
Merck & Co has extended its range of cancer medicines in the US after claiming FDA approval for Welireg – a drug it acquired as part of its $2.2 billion takeover of Peloton Therapeutics in 2019 – for a family of rare tumours. The drug is part of Merck’s efforts to expand its oncology portfolio and reduce its reliance on big-selling cancer immunotherapy Keytruda (pembrolizumab), which is patent protected in the US and Europe until 2028.
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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 16, 2021
In the past few weeks, China reminded the world that it is, first and foremost, a Communist nation. The recent crackdowns on the high-tech and education industries make some wonder what other changes will be next.
Outsourcing Pharma
AUGUST 16, 2021
The check-in with nearly 1,800 US healthcare consumers reflects how COVID-19 and other factors have impacted patient access, equity, experience and trust.
Delveinsight
AUGUST 16, 2021
Depression is a common and serious medical condition that affects the way people behave, act and think in a negative manner. Also known as Major Depressive Disorder (MDD) or clinical depression, it leads to a persistent feeling of sadness. It affects more than 300 million people of all ages globally and is the leading cause of disability. In most severe cases, it can often lead to suicide.
BioSpace
AUGUST 16, 2021
While treatments exist to manage the symptoms of the disease, nothing has proven to be curative – yet. Several biopharma companies are working hard to change that.
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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 16, 2021
The funding will be used to complete an ongoing Phase Ib trial with low-dose psilocybin
BioSpace
AUGUST 16, 2021
?CureVac has revealed in its latest financial report that its lung cancer program with German biotechnology company Boehringer Ingelheim has been terminated.
Pharma Times
AUGUST 16, 2021
Endpoints of improved skin clearance, itch and quality of life were met
BioSpace
AUGUST 16, 2021
The FDA recommended additional clinical and statistical data analyses, as well as issues related to the company's Chemistry, Manufacturing and Controls.
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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 16, 2021
Recent trial showed improved immune response after third dose
BioSpace
AUGUST 16, 2021
The Canadian biotech announced the acquisition of two new pipeline assets that align with its focus on autoimmune and kidney-related disease.
NY Times
AUGUST 16, 2021
Covid made things worse for many people with obsessive-compulsive disorder. But it also came with a silver lining.
BioSpace
AUGUST 16, 2021
Eli Lilly is undertaking a strategic transformation that will result in the formation of new business units.
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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.
BioPharma Reporter
AUGUST 16, 2021
Lumen applies machine learning to increase biomanufacturing productivity of its spirulina-based biologic drugs.
BioSpace
AUGUST 16, 2021
As COVID-19 surges to earlier pandemic levels in the U.S., federal health officials are expected to authorize a third booster shot eight months after receiving the second of the Moderna and Pfizer-BioNTech vaccines, and probably the Johnson & Johnson vaccine as well.
ECRG Media's Clinical Research Podcast
AUGUST 16, 2021
Why The Clinical Trials Guru Moved to Arizona I sat down with Dan over facetime and we had a great interview. Check out Part 1 and stay tuned for the remaining parts. Don't forget to Subscribe for new content! Merch: [link] Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Review
BioSpace
AUGUST 16, 2021
The latest biopharma insider trading scandal stems from Pfizer’s acquisition of Medivation in 2016.
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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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