FDA clears Rocket to resume testing gene therapy for a rare heart disease
Bio Pharma Dive
AUGUST 16, 2021
The decision from the regulator ends a three-month study pause that had stalled Rocket's development of of the Danon disease treatment.
Sat.Aug 14, 2021 - Fri.Aug 20, 2021
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Small versus big digital agencies for pharma
World of DTC Marketing
AUGUST 17, 2021
SUMMARY: You should never choose an agency based on size. It should be because they are a good fit with your brand team and can take your digital marketing to the next level while ensuring that everything they do is best in class. Debra called me up in a bit of a panic. She had received a proposal from her digital agency to build their product website and a proposal for paid media.
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F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday
NY Times
AUGUST 20, 2021
Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.
Moderna to Launch Clinical Trials for mRNA-Based HIV Vaccine
BioSpace
AUGUST 16, 2021
Moderna is expected to launch a human clinical trial as early as this week for an mRNA-based vaccine against HIV and indicated that it is looking for 56 people ages 18 to 50 who are HIV-negative.
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
Merck wins approval for cancer drug acquired in 2019 biotech buyout
Bio Pharma Dive
AUGUST 16, 2021
The FDA cleared Welireg, which Merck picked up in its $1 billion takeover of Peloton Therapeutics, to treat certain tumors associated with a rare genetic disease.
How pharma can attract and keep talented, employees
World of DTC Marketing
AUGUST 18, 2021
SUMMARY: I believe the biggest challenge facing pharma companies doesn’t come from legislation or R&D. It comes from being able to recruit and hold onto people who have a passion for the industry and get discouraged by a culture of endless meetings and matrix decision making. Here are some suggestions on how, I believe, pharma can attract and keep great employees.
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Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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Although Rare, New Data Suggests Higher Rate of Myocarditis with Moderna Shot
BioSpace
AUGUST 19, 2021
As governments and now even businesses push citizens to get vaccinated against COVID-19, anti-vaxxers are loading up more ammo for their argument with this week's report.
Lilly, preparing Alzheimer's drug plans, forms new neuroscience unit in company restructure
Bio Pharma Dive
AUGUST 17, 2021
Lilly Bio-Medicines will be split into separate neuroscience and immunology groups, while the Loxo cancer research division will merge with Lilly Oncology.
NICE’s health technology assessment methods and processes to be evaluated
Pharma Times
AUGUST 19, 2021
Public consultation launches on proposed changes aiming to provide earlier access to new treatments
Merck kicks off oral COVID-19 antiviral filing in Canada
pharmaphorum
AUGUST 16, 2021
Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics. The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results are positive.
Covid Vaccines Produced in Africa Are Being Exported to Europe
NY Times
AUGUST 16, 2021
Johnson & Johnson is sending shots from South Africa to other parts of the world. African countries are waiting for most of the doses they’ve ordered.
J&J chief Alex Gorsky to step down early next year
Bio Pharma Dive
AUGUST 20, 2021
Citing family health reasons, Gorsky will transition to the role of executive chairman and pass his torch to Joaquin Duato, currently vice chairman of J&J's executive committee.
UK approves monoclonal antibody treatment for COVID-19
Pharma Times
AUGUST 20, 2021
Regeneron/Roche's drug found to reduce hospitalisation
NICE says yes to Novartis’ Rydapt for rare blood disorder
pharmaphorum
AUGUST 19, 2021
Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS use, after getting a green light from NICE. The decision means around 170 people with advanced SM in England and Wales will be eligible for treatment with oral, twice-daily drug, which since 2018 has also been cleared for NHS treatment of a form of acute myeloid leukaemia.
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
Upcoming workshop on generic portfolio management
Drug Patent Watch
AUGUST 16, 2021
I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event…. The post Upcoming workshop on generic portfolio management appeared first on DrugPatentWatch - Make Better Decisions.
Cell, gene therapy company funding reaches new heights, despite setbacks
Bio Pharma Dive
AUGUST 19, 2021
Developers of the complex treatments raised $14 billion between January and June, nearly three-quarters of last year's record-setting total, according to numbers compiled by the Alliance for Regenerative Medicine.
FDA fast tracks breast cancer candidate samuraciclib
Pharma Times
AUGUST 17, 2021
Carrick Therapeutics’ oral CDK7 inhibitor may improve patient outcomes
Global regulators seek permanent working group on AI
pharmaphorum
AUGUST 17, 2021
Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report. The International Coalition of Medicines Regulatory Authorities (ICMRA) has recommended that a new permanent working group be set up to keep tabs on the use of AI and make sure that regulations can accommodate new developments.
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.
Researchers Discover On/Off Switch for Inflammatory Pain
BioSpace
AUGUST 15, 2021
?In a preclinical study published in PNAS, scientists from Feinstein Institutes for Medical Research presented a new approach to treating diseases that involve inflammation and pain, like arthritis.
Lilly's new eczema drug scores in late-stage studies
Bio Pharma Dive
AUGUST 16, 2021
Positive results help validate the $1 billion acquisition that gave Lilly access to lebrikizumab. Even so, the company could face tough competition from Regeneron and Sanofi's Dupixent.
MHRA nod for Moderna’s COVID-19 vaccine for 12- to 17- year-olds
Pharma Times
AUGUST 18, 2021
UK regulator confirms vaccine is “safe and effective” in this age group
Health Innovators: PureTech Health’s Daphne Zohar
pharmaphorum
AUGUST 17, 2021
In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health. They discuss the publicly-listed biotech’s pipeline projects and focus on the BIG (brain-immune-gut) axis as well as PureTech’s interest in digital therapeutics. Daphne explains how she built an impressive team of board advisors for her company, plus the challenges and experience of fund raising.
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.
E-Protein Channel Blockers May Lead the Next Fight Against COVID-19
BioSpace
AUGUST 19, 2021
Research emerging from Israel identified eight already-approved compounds that inhibit the activity of the E-protein channels in the virus’s membrane.
FDA approves Lilly, Boehringer diabetes drug for heart failure
Bio Pharma Dive
AUGUST 19, 2021
The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance.
NICE recommends Novartis’ Rydapt for AdvSM treatment
Pharma Times
AUGUST 20, 2021
Treatment provides therapeutic benefits to adults with the disease
Organicell on regenerative medicine: the pharmaphorum podcast
pharmaphorum
AUGUST 15, 2021
In the latest episode of the podcast Dominic Tyer speaks with Dr Maria Ines ‘Mari’ Mitrani, chief science officer at the clinical-stage biopharmaceutical company Organicell Regenerative Medicine. They looked at the development of regenerative medicine and where Organicell hopes to add to that field. Then, with the company pivoting to try and help tackle Covid, they also discussed how that change was made possible and where Organicell’s focus will be.
Accenture survey reflects changing patient experiences
Outsourcing Pharma
AUGUST 16, 2021
The check-in with nearly 1,800 US healthcare consumers reflects how COVID-19 and other factors have impacted patient access, equity, experience and trust.
Coherus, known for biosimilars, nears an immunotherapy battle with big pharma
Bio Pharma Dive
AUGUST 19, 2021
New lung cancer results could make Coherus the next entrant in an ultra-competitive market dominated by pricey drugs like Merck's Keytruda.
FDA OK's third dose of Moderna's COVID-19 vaccine for immunocompromised
Pharma Times
AUGUST 16, 2021
Recent trial showed improved immune response after third dose
Does draft RCT guide set the scene for future trials?
pharmaphorum
AUGUST 19, 2021
A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. The publication, which is out for public consultation until 15 September, said RCTs played a central role in generating the evidence needed to inform the de
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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