Akebia stumbles and clouds the prospects of anemia pills
Bio Pharma Dive
SEPTEMBER 3, 2020
The biotech's drug was found to be less safe than an injectable anemia medicine in a Phase 3 trial, dimming its potential approval chances.
Thu.Sep 03, 2020
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Lessons From Bergamo: Halting the Complement Cascade May Stop COVID-19 in Its Tracks
BioSpace
SEPTEMBER 3, 2020
Treatments for COVID-19 may be focusing on at the wrong elements of the disease, according to physicians analyzing results from Bergamo, Italy, the epicenter of the pandemic in Europe.
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Catalent, seeing rising demand, to expand Indiana production plant
Bio Pharma Dive
SEPTEMBER 3, 2020
The planned $50 million infusion is the third investment in Catalent's Bloomington facility in two years, reflecting the need for vial filling for biologic drugs and vaccines.
Moncef Slaoui Will Quit Operation Warp Speed if Politics Plays Role in Vaccine Approval
BioSpace
SEPTEMBER 3, 2020
When Moncef Slaoui was tapped to helm Operation Warp Speed, he sought confirmation that politics would not play a role in driving certain treatments through an approval process without the proper supporting scientific data to back it up.
Amarin loses appeal of court ruling on heart drug patents
Bio Pharma Dive
SEPTEMBER 3, 2020
The federal appeals court decision makes the launch of generic competitors to Amarin's Vascepa more likely, dealing the drugmaker a major blow.
Alarming Research Shows COVID-19 Damage to Heart Muscle, At Least in Cell Cultures
BioSpace
SEPTEMBER 3, 2020
Researchers at San Francisco’s Gladstone Institutes published research on bioRxiv—which means it has not been peer-reviewed—that demonstrated, in culture, how the virus damages cardiac muscles.
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GSK opens £10m AI hub in London
pharmaphorum
SEPTEMBER 3, 2020
GlaxoSmithKline is opening a £10 million artificial intelligence (AI) research hub in King’s Cross, London, according to a press report. The area is being reimagined as a life sciences and technology hub and is already home to the Francis Crick Institute biomedical research organisation. King’s Cross is also home to Google’s DeepMind artificial intelligence company, which has already been involved in life sciences projects such as using the technology to predict acute kidney injury.
Sanofi, GSK, racing to catch up, begin first human study of coronavirus vaccine
Bio Pharma Dive
SEPTEMBER 3, 2020
The two vaccine developers are betting their proven technology will lead to a more potent shot than others, making up for their slower pace of testing.
Immunotherapies could target aggressive pancreatic cancer, research indicates
Pharma Times
SEPTEMBER 3, 2020
Scientists have discovered that hard-to-treat pancreatic cancer hijacks a key immune system response
The Sky Remains the Limit for AbbVie with New Collaborative Partnerships
BioSpace
SEPTEMBER 3, 2020
AbbVie and I-Mab announced today that they had entered a global collaboration agreement to develop and commercialize lemzoparlimab (also known as TJC4). The anti-CD47 monoclonal antibody was initially discovered and developed by I-Mab for the treatment of various cancers.
The New Age of Decentralized Clinical Trials
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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
Janssen disappointed with second NICE no for Spravato
Pharma Times
SEPTEMBER 3, 2020
NICE has concerns with the evidence submitted but Janssen insists the nasal spray is a cost-effective use of NHS resources
Medtronic Introduces New Minimed 770G For Type 1 Diabetes
XTalks
SEPTEMBER 3, 2020
A leader in the medical device sphere, Medtronic plc announced the release of a US Food and Drug Administration (FDA) approved device called the MiniMed 770G hybrid closed loop system. This is an insulin pump system that offers the company’s most advanced SmartGuard technology. The MiniMed 770G features technology from the MiniMed 670G but with added benefits of smartphone connectivity and an expanded age indication to include children as young as two years old.
Battling Depression In A World Of Isolation: Tips For Managing COVID Depression
Olympian Clinical Research
SEPTEMBER 3, 2020
Depression affects millions of Americans each year, significantly decreasing their quality of life while placing them at heightened risk of suicidal thoughts. The tough thing about depression is that the disease is wildly indiscriminate, affecting patients of every age, gender, and ethnicity. For patients that struggle with depression, the disease can have devastating impacts both mentally, physically, and emotionally.
Rare Disease Clinical Research: Strategies for Ensuring Endpoint Integrity
XTalks
SEPTEMBER 3, 2020
Rare disease clinical trials can be particularly challenging when it comes to endpoints. Not only are there typically a limited number of patients that can be included in the trial, but often the endpoints themselves are novel or complex. Collaboration between subject matter experts on the teams at Medpace and ATOM International has resulted in better training and improved data visualization, pattern detection, and problem solving in rare disease clinical trials.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Appeals Court Deals Blow to Patent Protections for Amarin’s Vascepa
BioSpace
SEPTEMBER 3, 2020
Shares of Amarin Corporation are down more than 3% in premarket trading after the company reported Thursday that a panel of three judges from the U.S. Court of Appeals upheld a lower court’s ruling that paved the way for generic competition for the company’s heart disease drug, Vascepa.
Positive outcomes for Lenti-D trial, bluebird chasing regulatory approvals
BioPharma Reporter
SEPTEMBER 3, 2020
Bluebird bio has reported end points were met in a clinical trial involving its candidate ALD cell therapy, branded as Lenti-D.
NanoViricides Outlines Two-Pronged Approach to Developing COVID-19 Therapies
BioSpace
SEPTEMBER 3, 2020
NanoViricides, based in Shelton, Connecticut, outlined its approach to developing therapies against COVID-19 at the LD 500 investor conference yesterday.
COVID-19 treatment study predicts adverse drug events
Outsourcing Pharma
SEPTEMBER 3, 2020
Innovative research by Tabula Rasa Healthcare uses simulation technology to analyze potential adverse drug events of potential therapies for the virus.
The New Age of Decentralized Clinical Trials
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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.
Reducing barriers to mainstream gene therapy
BioPharma Reporter
SEPTEMBER 3, 2020
AskBio, which develops adeno-associated virus (AAV) gene therapies for genetic disorders, has won an R&D grant valued at Â2m (around US$2.7m) from Scottish Enterprise.
Biopharma Update on the Novel Coronavirus: September 4
BioSpace
SEPTEMBER 3, 2020
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
Analysts tip COVID-19 vaccines to generate $40bn next year
BioPharma Reporter
SEPTEMBER 3, 2020
Morningstar analysts tip a handful of COVID-19 vaccine developers to share a $40 billion market next year.
The Possibility of Simultaneous COVID-19 and Flu Infections Poses a Double-Threat
BioSpace
SEPTEMBER 3, 2020
As we head into cold and flu season, the question arises: Can you get COVID-19 and the flu at the same time?
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Sanofi and GSK start Phase 1/2 clinical trial of COVID-19 vaccine candidate
BioPharma Reporter
SEPTEMBER 3, 2020
Sanofi and GSK today start the Phase 1/2 clinical trial for their COVID-19 adjuvanted recombinant protein-based vaccine candidate.
Signing up for Marketplace Health Insurance During COVID-19: An Important Update
Triage Cancer
SEPTEMBER 3, 2020
Have you lost your health insurance coverage through work, anytime since January 1 st of this year? Have you thought about signing up for an individual plan through the Marketplace? Now’s your chance. A recent change to the Marketplace at HealthCare.gov could help. Normally, the Special Enrollment Period (SEP) to apply for a plan in the Marketplace is 60 days after you lose qualifying coverage or have a qualifying life event (like moving or getting married).
UK bladder cancer patients get early access to Bavencio
Pharma Times
SEPTEMBER 3, 2020
UK MHRA has issued positive scientific opinion enabling the drug's inclusion on the Early Access to Medicines Scheme
Texas A&M researchers develop treatment for canine ocular condition using turmeric
Scienmag
SEPTEMBER 3, 2020
A College of Veterinary Medicine and Biomedical Sciences and College of Pharmacy team believes the medication may also translate to the treatment of cataracts and uveitis in humans Credit: Texas A&M University College of Veterinary Medicine & Biomedical Sciences Researchers at Texas A&M University have produced a therapeutic derived from turmeric, a spice long-praised for […].
How Machine Learning Drives Clinical Trial Efficiency
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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.
Elligo: increasing diversity can elevate trials
Outsourcing Pharma
SEPTEMBER 3, 2020
A company leader outlines the importance of increasing diversity in clinical trial patient populations, and how researchers can improve their results.
High levels of toxic flame retardant chemicals found in dust inside college classrooms
Scienmag
SEPTEMBER 3, 2020
School spaces with newer furniture show significantly lower levels of hazardous exposures There are good reasons to be worried about indoor air quality right now, in light of COVID-19. In addition to transmitting infectious agents, indoor spaces can also be a source of harmful chemicals in consumer products. A new analysis of indoor spaces on […].
Research Roundup: Promising New ALS Drug Candidates, Bee Venom Kills Cancer Cells and More
BioSpace
SEPTEMBER 3, 2020
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Vaccine researchers testing human hookworm vaccines in Brazil
Scienmag
SEPTEMBER 3, 2020
A team at the George Washington University Vaccine Research Unit has developed a controlled human hookworm infection model, accelerating the development of human hookworm vaccines WASHINGTON (August 26, 2020) – A team led by researchers at the George Washington University (GW) has established a controlled human hookworm infection (CHHI) model to accelerate the development of […].
Accelerating Clinical Supply Through Integrated Drug Development
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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.
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