Bio Pharma Dive
AUGUST 24, 2021
A freshly inked agreement gives Vertex the right to use tools from Arbor Biotechnology to develop "ex vivo" cell therapies for diseases like Type 1 diabetes and sickle cell, among others.
World of DTC Marketing
AUGUST 24, 2021
SUMMARY: We, as a nation, can not afford people who chose not to get vaccinated because of misinformation. They are a danger to all of us and must be held accountable for their inaction. This includes financial penalties for making a terrible choice. According to KFF, “our analysis of CDC data indicates there were 37,000 preventable COVID-19 hospitalizations in June and another 76,000 preventable COVID-19 hospitalizations in July, among unvaccinated adults in the U.S.
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Bio Pharma Dive
AUGUST 24, 2021
The company's cancer cell therapy Kymriah failed to top standard care in patients with an aggressive form of lymphoma, a setting in which treatments from Bristol Myers Squibb and Gilead recently succeeded.
pharmaphorum
AUGUST 24, 2021
Digital health startup Breathe Well-being has raised $5.5 million in first-round financing, which it will use to scale up its clinical tool that it says helps people “prevent, manage and reverse type 2 diabetes.” . The Series A – led by US venture capital group Accel with participation from General Catalyst and Scott Shleifer, global managing director of hedge fund Tiger Global, which is a highly active investor in privately-held tech firms.
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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 24, 2021
Theravance, which agreed to co-develop a next-generation JAK inhibitor with J&J three years ago, said the experimental drug failed a mid-stage study in ulcerative colitis, leaving its future in doubt.
pharmaphorum
AUGUST 24, 2021
One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment. The US regulator has cleared Cara Therapeutics’ Korsuva (difelikefalin) as an injectable treatment for chronic itching, also known as pruritus, in these patients after a priority review.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
AUGUST 24, 2021
Novartisâs Kymriah CAR-T therapy did not meet its primary endpoint of event-free survival in a phase 3 study in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment.
XTalks
AUGUST 24, 2021
Warren Buffet’s Berkshire Hathaway has sold off the $180 million worth of Biogen shares it purchased in 2019 when the company began reviving its Alzheimer’s drug Aduhelm (aducanumab). The move comes as a surprise to many, as the business magnate and world’s most successful investor is known for his buy-and-hold investment strategy. But it seems this was not Buffet’s game plan for Biogen.
BioSpace
AUGUST 24, 2021
?Merck has announced its potential treatment for pneumococcal disease in infants has succeeded in meeting key safety, tolerability, and immunogenicity endpoints in its first 30 days.
Drug Patent Watch
AUGUST 24, 2021
Annual Drug Patent Expirations for SYNJARDY+XR Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five…. The post New patent for Boehringer Ingelheim drug SYNJARDY XR appeared first on DrugPatentWatch - Make Better Decisions.
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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 24, 2021
The development of COVID-19 vaccines, which took only months from the initial gene sequencing to the time shots were in arms, was the biggest story of 2020 alongside the pandemic itself.
Pharma Times
AUGUST 24, 2021
Phase III study was investigating treatment for B-cell non-Hodgkin lymphoma
BioSpace
AUGUST 24, 2021
The Bay State biopharma industry continues to boom, even during the height of a global pandemic that has caused an economic downturn in other business sectors.
Delveinsight
AUGUST 24, 2021
AstraZeneca’s Newly Occupied Alexion Hits Rock Bottom After Ultomiris (Ravulizumab) Fails to Show Efficacy in Patients with Amyotrophic Lateral Sclerosis. AstraZeneca’s 39 billion USD complete acquisition of Alexion took over just a few months back. Unpleasant news strike hard for their first deal in the rare neurodegenerative disease domain.
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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.
Outsourcing Pharma
AUGUST 24, 2021
The regional US healthcare system will collaborate with the health intelligence specialist to advance precision medicine focused on oncological care.
Pharma Times
AUGUST 24, 2021
Biologics License Application approved to prevent COVID-19 in individuals 16 years of age and older
BioSpace
AUGUST 24, 2021
Studies are also continuing on the value and efficacy of booster shots, particularly against the Delta variant. Read on for more information.
Outsourcing Pharma
AUGUST 24, 2021
According to the study, the countryâs overreliance on pharmaceutical ingredients manufactured in overseas factories threatens national security and health.
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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.
BioPharma Reporter
AUGUST 24, 2021
Full approval for the Pfizer BioNTech COVID-19 vaccine, announced by the FDA yesterday, has spurred hopes that more people will take up the vaccine.
Outsourcing Pharma
AUGUST 24, 2021
The CRO has launched an initiative that offers help navigating regulatory issues for ultra-rare disease patient advocacy groups that demonstrate a need.
BioSpace
AUGUST 24, 2021
Funds will be used to advance the clinical development of Cardior’s lead program, CDR132L, an oligonucleotide-based ncRNA inhibitor targeting micro-RNA-132.
Pharma Times
AUGUST 24, 2021
The approval is supported by three pivotal Phase III trials
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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
AUGUST 24, 2021
?Early data from a Phase III study for COVID-19 shows significant promise with its combo therapy reduced death and hospitalization in trial patients at high risk of progression by 78%.
BioPharma Reporter
AUGUST 24, 2021
Swedenâs Biotage says its expanded facility in the UK will allow it to triple its production capacity for equipment crucial in the supply chain for the production of mRNA vaccines, and thus eliminating a bottleneck for COVID-19 vaccines.
BioSpace
AUGUST 24, 2021
The current continues as investment dollars flow into the life sciences. Here’s an overview who is catching the drift this week.
Pharma Times
AUGUST 24, 2021
Data presented at ESC Congress 2021
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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
AUGUST 24, 2021
BioSpace recently spoke with Yoav Kimchy, founder and chief technology officer of Check-Cap, a company developing the C-Scan® system to detect precancerous polyps.
pharmaphorum
AUGUST 24, 2021
Joint working could hold at least part of the answer to getting the NHS back on its feet after COVID, according to the ABPI. As the NHS begins to recover from the biggest crisis in its history, the biopharmaceutical industry is stepping up to the plate to offer its support and a new online repository of joint working case studies aims to help make that as easy as possible for both sides.
BioSpace
AUGUST 24, 2021
Rubix Life Sciences has launched a dedicated therapeutics division to focus on infectious and neurodegenerative diseases.
NY Times
AUGUST 24, 2021
Female entrepreneurs said they were constantly compared to Ms. Holmes, the disgraced founder of Theranos, who faces trial soon.
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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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