8 key clinical trials to watch for the rest of 2021
Bio Pharma Dive
JUNE 21, 2021
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy.
Sat.Jun 19, 2021 - Fri.Jun 25, 2021
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The FDA and Aduhelm: WTF?
World of DTC Marketing
JUNE 23, 2021
SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Source: Fierce Pharma If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. sales alone, which is above co
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Improving the Pediatric Patient Journey with Decentralized Clinical Trials
Camargo
JUNE 23, 2021
While the COVID-19 pandemic has accelerated innovation in many areas, including clinical trial design, many recent advancements were already in motion before 2020 as sponsors and CROs sought to improve the patient journey and encourage trial participation. Traditional trials, especially those for pediatric populations, often place enormous burdens on patients and their families.
BioNTech takes its first cancer vaccine into phase 2
pharmaphorum
JUNE 21, 2021
It would be easy to forget that back in 2019, BioNTech was an early-stage biotech firmly focused on cancer vaccines, before being catapulted onto the world-stage with its COVID-19 shot. Now, the German company has issued a reminder of its original R&D mission with the start of the first phase 2 trial of BNT111 – the first of several cancer vaccine candidates – in patients with skin cancer.
FDA documents show how controversial Alzheimer's drug decision was reached
Bio Pharma Dive
JUNE 23, 2021
A group of statisticians who had argued for rejection were overruled, internal memos show, as high-ranking agency officials got behind an accelerated clearance for Biogen's drug.
Another reason change is needed at FDA? Fair balance
World of DTC Marketing
JUNE 24, 2021
SUMMARY: Consumers don’t real pay attention to fair balance in TV ads. Pharma TV ads drive people online to search for more information. Safety pages on Pharma product websites continue to have high utility. Only requirement in TV ads should be for “boxed” products. As we have seen over the past few years, Pharma companies are a business, a regulated business, but still a business.
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NHS England announces extra funding for young people’s mental health services
Pharma Times
JUNE 22, 2021
An extra £40m will go toward enhancing mental health services for children and young people
A year after getting UniQure's gene therapy, hemophilia patients are still doing better
Bio Pharma Dive
JUNE 22, 2021
New results from a key study show the treatment's benefit is holding up well over time. But the FDA wants to see more data, delaying when UniQure and partner CSL expect to file for approval.
Sanofi and Translate take first mRNA flu vaccine into clinic
pharmaphorum
JUNE 22, 2021
Sanofi and Translate Bio have started a first clinical trial of an mRNA-based seasonal flu vaccine, adding to the COVID-19 shot already in testing as part of their three-year old collaboration. Enthusiasm for mRNA vaccines is riding high amid the successful rollout of COVID-19 shots from Pfizer/BioNTech and Moderna, and attention is now turning toe the possibility of using the approach to tackle other infectious diseases.
Data Supports Use of Anti-Parasitic Drug Ivermectin in COVID-19 Patients, Study Shows
BioSpace
JUNE 21, 2021
Use of the anti-parasitic drug ivermectin could reduce COVID-19 related deaths, data from a peer-reviewed study shows.
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
Takeda reports promising results for potential lung cancer treatment
Outsourcing Pharma
JUNE 22, 2021
The pharmaceutical company reports favorable results in a recent study exploring mobocertinib in treating certain non-small cell lung cancer patients.
Third Rock-backed startup launches to develop cell therapies for MS, diabetes
Bio Pharma Dive
JUNE 23, 2021
Led by CEO Samantha Singer, Abata Therapeutics has $95 million to advance its plans to engineer regulatory T cells for treating autoimmune diseases.
Assessing the Association Between Social Gatherings and COVID-19 Risk Using Birthdays
JAMA Internal Medicine
JUNE 21, 2021
This cross-sectional study uses administrative health care data on 2.9 million households from the first 45 weeks of 2020 to assess the association between social gatherings and SARS-CoV-2 transmission by studying whether COVID-19 rates increase after birthdays in a household.
Is an mRNA Flu Vaccine on the Horizon?
BioSpace
JUNE 23, 2021
The two companies will assess the safety and immunogenicity of the vaccine candidate, which codes for the hemagglutinin protein in the A/H3N2 strain of the seasonal flu virus.
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.
Zolgensma shows promise in presymptomatic SMA patients
Pharma Times
JUNE 21, 2021
Children treated with gene therapy prior to symptom presentation achieved motor milestones not seen in the natural history of SMA
Merck says Keytruda extends survival in cervical cancer study
Bio Pharma Dive
JUNE 22, 2021
Results from a Phase 3 study could help Merck secure a full approval for use of Keytruda in the tumor type, potentially extending the therapy's edge over rival therapies.
Study Shows Amazon’s AI-Powered Halo App Can Accurately Assess Body Fat Percentage
XTalks
JUNE 21, 2021
In a new study, Amazon’s Halo app has been shown to predict body fat percentage with the same level of accuracy as standard lab testing. The app uses just four photos taken from a smartphone — of the front, back and each side of the body — to build a 3D model and produce body fat percentage results using the app’s built-in machine learning algorithms.
Andy Molnar named head of Digital Therapeutics Alliance
pharmaphorum
JUNE 25, 2021
Former Cognoa executive Andy Molnar has been appointed chief executive of the Digital Therapeutics Alliance, a global trade association for companies developing evidence-based DTx products. Molnar, who served as vice president of market access and government affairs at Cognoa, joins the four-year-old trade association at a time when the potential of using DTx to deliver remote healthcare has been thrust into the spotlight by the coronavirus pandemic.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
EC approves Sanofi’s Aubagio for paediatric MS patients
Pharma Times
JUNE 21, 2021
Aubagio has been authorised for the treatment of paediatric patients aged ten to 17 years living with RRMS
Arcus claims positive study results for lung cancer drug, but shares no details
Bio Pharma Dive
JUNE 24, 2021
The lack of specific data frustrated analysts, but shares in Arcus rose by double digits Thursday. Partner Gilead is expected to make a decision on whether to license the drug later this year.
COVID-19 Origin Story Plot Thickens as Researcher Unearths Deleted Early Virus Sequences
BioSpace
JUNE 24, 2021
Last summer, claims that the deadly SARS-CoV-2 virus emerged from a virology lab in Wuhan were generally dismissed by the scientific community as right-wing conspiracy theories. A year later, the theory isn’t sounding so far-fetched.
Medication adherence: how to ensure patients are not left behind
pharmaphorum
JUNE 24, 2021
Poor medication adherence is both a costly issue for pharma manufacturers – with some estimating a loss of $600 billion each year – and a deadly issue for patients, with more than 100k preventable deaths estimated from patients not taking medications correctly, or at all. Tara Herington explores why medication non-adherence is a complex issue. Communication is ever evolving and comes with distinct challenges for the pharma industry.
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
Carcinogen-exposed cells provide clues in fighting treatment-resistant cancers
Scienmag
JUNE 20, 2021
Researchers shed light on a potential intervention that could make tumors responsive to modern-day immunotherapies Credit: Mei Huang, PhD BOSTON – Researchers from Massachusetts General Hospital (MGH) have discovered a biological mechanism that transforms cells exposed to carcinogens from environmental factors like smoking and ultraviolet light into immunogenic cells that can be harnessed therapeutically to […].
European regulators push 8 drugs toward approval, including controversial anemia pill
Bio Pharma Dive
JUNE 25, 2021
A key committee of the EMA gave a positive review of Astellas and Fibrogen's roxadustat, as well as Bristol Myers Squibb's cell therapy Abecma and UCB's psoriasis drug Bimzelx.
Cuba’s COVID-19 Vaccine is 92% Effective, Late-Stage Trials Show
BioSpace
JUNE 22, 2021
Cuba’s Abdala vaccine is 92% effective against the novel coronavirus, according to a recent analysis of late-stage trials.
GSK sees £20bn peak sales potential in late-stage pipeline
pharmaphorum
JUNE 23, 2021
GlaxoSmithKline’s pitch to shareholders kicked off this afternoon with an optimistic view of its late-stage pipeline – including some big sales predictions for products like its respiratory syncytial virus (RSV) vaccine and new blood cancer drug Blenrep. By 2031, the UK drugmaker expects sales to top £33 billion ($46 billion), despite facing a patent cliff for big-selling HIV drugs including dolutegravir towards the end of this decade, with double-digit profit growth expected over the next
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.
The paths through which COVID-19 spread across Brazil
Scienmag
JUNE 21, 2021
The impact of super-spreader cities, highways, and intensive care availability in the early stages of the COVID-19 epidemic in Brazil Credit: Nicolelis, M.A.L. et al. 2021. Scientific Reports, doi.org/10.1038/s41598-021-92263-3 São Paulo, Brazil – A multidisciplinary analysis by a group of Brazilian scientists, published online in the journal Scientific Reports on June 21, 2021, revealed that […].
GSK, Vir build case for COVID-19 antibody drug with new study data
Bio Pharma Dive
JUNE 21, 2021
Final clinical trial results confirmed treatment dramatically reduced the risk of hospitalization and death among adults with mild-to-moderate COVID-19.
COVID-19 Might Have Long-Term Effects on Sense of Taste and Smell, According to UK Researchers
BioSpace
JUNE 21, 2021
Recent research shows those who had been hospitalized due to COVID-19 might already have a reduced sense of smell and taste, not just for the short term, but possibly for life.
Is cardiovascular disease a ‘pandemic hiding in plain sight’?
pharmaphorum
JUNE 25, 2021
Amarin’s Craig Granowitz discusses the impact of COVID on cardiovascular disease treatment and explains why there’s still a long way to go till we can truly tackle these diseases. COVID-19 has shone a light on the dangers of cardiovascular disease (CVD), with patients with these underlying conditions at much higher risk of dying from the virus. But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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