Bio Pharma Dive
JULY 22, 2021
Three companies are testing their gene therapies in early clinical trials, with initial results due later this year. Others are in preclinical stages and aim to follow soon.
World of DTC Marketing
JULY 22, 2021
SUMMARY: Older, more experienced employees are being shoved aside in favor of more inexperienced ones. The culture within pharma is driving people away, including new hires. More and more meetings are based on ROI, not the voice of the patient. Don’t hire people who want big salaries; hire people who want to be part of an industry that helps patients.
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Bio Pharma Dive
JULY 22, 2021
A pill made of gut bacteria wasn't effective at treating ulcerative colitis in a closely watched study that was viewed as a proof point for the emerging field.
pharmaphorum
JULY 22, 2021
Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors – so are hormone sensitive – but test negative for HER2 receptors that would make them candidates for treatment w
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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 22, 2021
The company responded forcefully to controversy roiling around the Alzheimer's drug's approval, defending its data and interactions with the FDA.
Pharma Times
JULY 22, 2021
Verquvo cleared for the treatment of symptomatic chronic heart failure in patients with reduced ejection fraction
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JULY 22, 2021
PFIC is a rare and progressive liver disease affecting young children which can lead to cirrhosis and liver failure
pharmaphorum
JULY 22, 2021
In just over a year, Celltrion Healthcare says it has identified and delivered a potential treatment for COVID-19. pharmaphorum spoke to Kwon Ki-sung, Head of Celltrion’s R&D unit, to learn more. Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of antibody candidates from recovered patients and selecting those that showed the highest potency in neutralising the SARS-CoV-2
Pharma Times
JULY 22, 2021
Pemazyre recommended for the treatment of cholangiocarcinoma, a rare type of liver cancer that forms in the bile duct
BioSpace
JULY 22, 2021
The U.S. Food and Drug Administration (FDA) approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients as young as newborns.
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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
Drug Patent Watch
JULY 22, 2021
Annual Drug Patent Expirations for LENVIMA Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph…. The post New patent for Eisai Inc drug LENVIMA appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
JULY 22, 2021
With COVID-19 resurging in the U.S., particularly in states with the lowest vaccination rates, additional news and research about the vaccines and the virus is coming out. Here’s a look.
BioPharma Reporter
JULY 22, 2021
Generate Life Sciences is establishing a GMP facility in La Jolla, California that it says will enable end-to-end manufacturing of newborn stem cell biologics, bolstering supply and safeguarding clinical research.
BioSpace
JULY 22, 2021
Biosimulation is integral to drug development today, with fierce competition for expert scientists to run the simulations and interpret the results. Craig Rayner, president of Certara, a biosimulation company, is turning to Africa to unlock an untapped reservoir of talent.
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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.
XTalks
JULY 22, 2021
In this episode, Ayesha talks about the misleading headlines that ensued after WHO chief scientist Dr. Soumya Swaminathan made comments in a press briefing about mixing and matching COVID-19 vaccines and how there is currently no data to support additional doses and boosters at this time. News agencies like Reuters were at the helm of the misleading headlines, which took the comments out of context, stating that mixing and matching vaccines was outright dangerous.
BioPharma Reporter
JULY 22, 2021
Bluebirdâs Lenti-D, or elivaldogene autotemcel, has won approval from the European Commission to treat children with a rare neurodegenerative disease called early cerebral adrenoleukodystrophy (CALD).
XTalks
JULY 22, 2021
Impossible Foods announced that they would enter the vegan chicken market later this year by introducing their own plant-based Impossible Chicken Nuggets. This follows the recent news from their rival company, Beyond Meat , who introduced their vegan chicken to restaurants nationwide earlier in July. This already crowded market will now include more competition with the entry of Impossible Foods.
BioSpace
JULY 22, 2021
Updated trial data show patients treated with BioMarin Pharmaceutical’s severe hemophilia A gene therapy expressed substantially lower factor VIII levels after five years compared with one year, calling into question the drug’s long-term benefits.
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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.
XTalks
JULY 22, 2021
Pfizer is recalling three more lots of its smoking cessation drug Chantix (varenicline) after having issued a voluntary recall of the drug earlier this month due to carcinogen concerns, bringing the total number of affected lots to 12. The Chantix recall is over the finding of the purported carcinogen N-nitroso-varenicline (a nitrosamine) in levels above Pfizer’s pre-set acceptable daily intake (ADI), according to the company in an announcement posted on the US Food and Drug Administration (FDA)
BioSpace
JULY 22, 2021
Shares of Adverum Biotechnologies plunged more than 20% in premarket trading after the company announced it was revising its clinical development plan for investigational gene therapy candidate ADVM-022 based on safety concerns in patients with diabetic macular edema (DME).
Scienmag
JULY 22, 2021
Researchers from Osaka University uncover a mechanism by which chromosomal rearrangements occur, with implications for novel cancer therapies Credit: Osaka University Osaka, Japan – Gross chromosomal rearrangements–where portions of the genome become moved, deleted, or inverted–can lead to cell death and diseases such as cancer in complex multicellular organisms.
Delveinsight
JULY 22, 2021
BlueRock Therapeutics secures FDA fast track for Parkinson’s disease cell therapy. BlueRock, a Bayer subsidiary, is currently assessing the pluripotent stem cell-derived dopaminergic neuron therapy in a phase 1 study. This early-stage trial is set to enroll ten patients across the US and Canada, with its primary aim to evaluate the safety and tolerability of DA01 cell transplantation at one year post-transplant.
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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.
Scienmag
JULY 22, 2021
In sum the Oncotarget data support a paradigm where signaling molecules bound to a Numb scaffold in a signalsome are activated by RA-induced Fgr expression Credit: Correspondence to – Andrew Yen – ay13@cornell.edu Oncotarget published “Role for Fgr and Numb in retinoic acid-induced differentiation and G0 arrest of non-APL AML cells” which reported that retinoic […].
pharmaphorum
JULY 22, 2021
Bluebird bio has its first approval for Skysona (formerly Lenti-D), its gene therapy for children with the rare disease cerebral adrenoleukodystrophy (CALD), after getting the nod from the EU regulatory authority. The EMA has cleared Skysona (elivaldogene autotemcel) for use in CALD patients aged under 18 who have an ABCD1 genetic mutation and no matched sibling donor who could provide a stem cell transplant.
Scienmag
JULY 22, 2021
New chip can revolutionize the current data rate for processors using microwave photonics Credit: Justin Baetge, Texas A&M Engineering According to the United Nations’ telecommunications agency, 93% of the global population has access to a mobile-broadband network of some kind. With data becoming more readily available to consumers, there is also an appetite for more […].
Pharma Times
JULY 22, 2021
Partnership will aim to develop nasal spray drug products for prophylactic use against respiratory viruses
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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.
Scienmag
JULY 22, 2021
‘Superfuge’ test combines multiple environments on a full-scale weapons system Credit: Photo by Randy Montoya/Sandia National Laboratories. LIVERMORE, Calif. — A team of Sandia National Laboratories engineers developed a new testing capability in support of its nuclear weapons mission. The team completed their first combined-environments test on a full-scale weapons system at the Sandia Superfuge/Centrifuge […].
BioSpace
JULY 22, 2021
As disgraced Theranos founder Elizabeth Holmes awaits her day in court, a long-awaited documentary series focused on the Stanford dropout who became a billionaire before losing it all is set to air on streaming service Hulu.
Scienmag
JULY 22, 2021
Study in mice, human blood samples, suggests HDL from the intestine may prevent liver inflammation Credit: Brad W. Warner The body’s so-called good cholesterol may be even better than we realize. New research from Washington University School of Medicine in St. Louis suggests that one type of high-density lipoprotein (HDL) has a previously unknown role […].
XTalks
JULY 22, 2021
We’ve heard of cell-based meat — meat produced by in vitro cell cultures of animal cells — but its seafood equivalent could be on the horizon. Cell-based fish has been making a splash in recent years, with several alt-seafood companies making the semi-finals of a recent alternative protein competition. So, will consumers be seeing cell-based fish on sushi menus any time 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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