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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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
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.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
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.
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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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.
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.
Shareholders versus patients: Who is more important?
World of DTC Marketing
JUNE 22, 2021
SKIMMERS SUMMARY: There is one and only one social responsibility of business–to use its resources and engage in activities designed to increase its profits so long as it stays within the rules of the game, which is to say, engages in open and free competition without deception or fraud. Milton Friedman A newly approved drug to treat Alzheimer’s disease is expected to become a multibillion-dollar expense for Medicare.
US approves Pradaxa as oral blood thinning med for children
Pharma Times
JUNE 22, 2021
First oral blood thinning drug approved for paediatric patients in the US
Top 10 Career Options for Pharmacy Graduates
Pharma Mirror
JUNE 24, 2021
There are widespread misunderstandings about pharmacists’ job that make many prospective students give up on their dreams. But we are here to bring some light about what pharmacists do and don’t do. If you ask 10 different people “What do pharmacists do?”, they will all reply “They sell medications in drug stores”. But if you ask us, we have a far cry from that answer.
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.
Will Intellia Make Gene Editing History Saturday?
BioSpace
JUNE 24, 2021
In what will be a big moment for CRISPR technology, Intellia and development partner, Regeneron Pharmaceuticals will share the world’s first data from a therapy that edits flawed genes inside the body.
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
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
What is Registration Drift in pharmaceutical manufacturing, and how can I avoid it?
Pharma Mirror
JUNE 24, 2021
By Dr Ash Ramzan, founder and principal consultant, Woodley BioReg During a pharmaceutical product’s lifetime, it’s widely known and accepted that manufacturing processes will drift within their specified ranges — typically due to equipment wear-and-tear and operator variance. To maintain the ‘validated state’, diligent producers spend a lot of time and effort in ensuring validation and periodic re-validation of processes to ensure that any process drift is accounted for and controlled.
With Alzheimer's drugs in focus, Bristol Myers rejoins the hunt
Bio Pharma Dive
JUNE 24, 2021
The pharmaceutical giant is spending $80 million for an exclusive license to an experimental drug developed by Prothena.
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.
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
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.
Vectura Signs Pre-Clinical Development Agreement with Incannex to Advance IHL-216A for the Treatment of Traumatic Brain Injury
Pharma Mirror
JUNE 23, 2021
Vectura Group plc, an industry leading inhalation CDMO, today announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide pre-clinical development services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI). Under the terms of the agreement, Vectura will undertake formulation screening studies, manufacturing process optimisation studies and stability assessments
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.
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.
US approval for OTC use of Bayer’s Astepro
Pharma Times
JUNE 21, 2021
Approval makes Astepro the first and only OTC steroid free antihistamine nasal spray available in the US
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.
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.
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.
Novartis announces digital collaboration with Hewlett Packard Enterprise
Pharma Times
JUNE 24, 2021
Collaboration aims to accelerate Novartis’ use of data and digital technologies
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.
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 News: New COVID-19 Vaccine Efficacy, MIS-C and More
BioSpace
JUNE 22, 2021
Please check out the biopharma industry's COVID-19 stories that are trending for June 22, 2021.
Blood test can detect more than 50 types of cancer
Pharma Times
JUNE 25, 2021
Findings of the latest study assessing the test back its use as a screening tool, researchers say
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.
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