Bio Pharma Dive
JULY 28, 2021
Flagship Pioneering, the biotech incubator that created Moderna, is helping fund Ring Therapeutics, a startup hoping to disrupt gene therapy development through the use of a different viral vector.
World of DTC Marketing
JULY 28, 2021
SUMMARY: 62% of HCPs spend 3 hours per day accessing digtal resources. More HCPs chose to use smartphones to access digital resources as well and usage has increased when accessing a wide variety of professional content. HCPs increasingly turn to trusted colleagues on digital networks for reliable information. Source: Build Relationships and Personalize Your Interactions With HCPs (Wolters Kluwer).
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Bio Pharma Dive
JULY 28, 2021
The acquisition is the third Amgen has made since March and broadens its ability to develop bispecific antibodies, a drug class of intense interest to big biotech.
BioPharma Reporter
JULY 28, 2021
A study of more than a million vaccinated people has found 'similar safety profiles' for the AstraZeneca and Pfizer/BioNTech vaccines: adding the incidence of rare blood clots was far higher among people with COVID-19 than those who had received either vaccine.
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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
JULY 28, 2021
Pfizer previously predicted booster shots would be needed within a year. But the spread of the transmissible Delta variant may mean a booster is needed "a little earlier," CEO Albert Bourla said Wednesday.
Pharma Times
JULY 28, 2021
Rate of rare blood clots with low platelets after the second dose is comparable to background rates observed in unvaccinated populations
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Delveinsight
JULY 28, 2021
As per the WHO, “worldwide approximately 1.71 billion people have a musculoskeletal condition”. Musculoskeletal Disorders consist of over 150 conditions affecting the locomotor system of individuals involving the muscles, joints, bones, and spine. Among the various Musculoskeletal Disorders, low back pain causes the highest burden with an estimated prevalence of 568 million worldwide.
BioSpace
JULY 28, 2021
Ring Therapeutics hopes to bring in a “new era of gene therapies” to rise above the challenges of current options. A cohort of investors bought into the hope with a $117 million Series B funding round.
Pharma Times
JULY 28, 2021
AC Immune is set to acquire Affiris’ entire portfolio of therapeutics targeting alpha-synuclein
BioSpace
JULY 28, 2021
?The two companies announced their exclusive collaboration that will harness Kumquat’s small molecule immuno-oncology platform's capabilities to discover novel clinical candidates.
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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
XTalks
JULY 28, 2021
Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. The approval comes a month after pneumonia vaccine rival Pfizer received approval for its next-gen 20-valent pneumococcal shot, Prevnar 20, on June 8.
BioSpace
JULY 28, 2021
Biopharma and life sciences companies from across the globe provide updates on their pipelines and business operations including Takeda, Origin Therapeutics, ERS Genomics and more.
Pharma Times
JULY 28, 2021
Collaboration will focus on developing small molecule medicines targeting GPR75
BioSpace
JULY 28, 2021
bluebird bio and National Resilience signed a strategic alliance around cell therapies. As part of the deal, Resilience is buying bluebird’s manufacturing facility in Research Triangle Park, keeping more than 100 staffers.
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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
JULY 28, 2021
Pfizer has upped its COVID-19 vaccine revenue estimates for 2021 from $26bn to $33.5bn, with potential for the figure to rise further.
BioSpace
JULY 28, 2021
Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
Pharma Times
JULY 28, 2021
No serious side effects were observed in the Phase I trial
BioSpace
JULY 28, 2021
Clinical-stage biotech company Vaxart announced Thursday that a second dose of its oral norovirus vaccine boosted immunity in clinical trial participants who had previously received the vaccine more than a year prior.
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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 28, 2021
A new analysis has suggested that the rare blood clot side effects linked to AstraZeneca’s COVID-19 vaccine Vaxzevria don’t occur after a second dose. The study in The Lancet examined cases of thrombosis with thrombocytopenia syndrome (TTS) from an AZ database encompassing around 5.62 million people who had received two doses of Vaxzevria in the EU and UK.
BioSpace
JULY 28, 2021
?The research will focus on accelerating the capacities of BLU-222, an investigational therapy that Blueprint designed to target cyclin-dependent kinase 2 (CDK2).
pharmaphorum
JULY 28, 2021
A £6.6 million ($9.2 million) cash injection for UK digital health company Peppy will be used to scale up its business-to-business platform and expand its reach and range of services. The Series A financing, led by Felix Capital, will help the company reach more organisations and people in the UK, and also allow it to explore international expansion, according to Dr Mridula Pore, co-founder and co-chief executive of the startup.
BioSpace
JULY 28, 2021
The T cell response was measured with immunoSEQ® T-MAP™ COVID, a clinical test developed by Adaptive Biotechnologies.
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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.
pharmaphorum
JULY 28, 2021
AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted in three clinical trial-stage projects for immuno-oncology and neurological diseases, and 20 early-stage programmes.
BioSpace
JULY 28, 2021
AstraZeneca said in an earnings announcement on Thursday it will seek authorization for its COVID-19 vaccine in the U.S. sometime in the second half of this year.
pharmaphorum
JULY 28, 2021
Merck & Co’s Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The FDA has given a green light to the use of Keytruda (pembrolizumab) pre-surgery alongside chemotherapy in the neoadjuvant setting, as well as in the post-surgery (adjuvant) setting as a monotherapy, to prevent tumours from recurring.
BioSpace
JULY 28, 2021
?The company’s pipeline was strengthened in the second quarter with three strategic collaborations in immuno-oncology, immuno-neurology, and HIV.
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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.
NY Times
JULY 28, 2021
The decision comes after state health officials were worried about whether doses of the Johnson & Johnson coronavirus vaccine would expire and go to waste.
BioSpace
JULY 28, 2021
Three major pharmaceutical and biotechnology companies announce the success of their respective funding rounds to support future efforts.
The Pharma Data
JULY 28, 2021
– If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1. today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors.
BioSpace
JULY 28, 2021
Amgen will gain Teneobio's proprietary bispecific and multispecific antibody technologies, which have the potential to target multiple diseases across Amgen's core therapeutic areas.
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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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