FDA approves first CAR-T cell therapy for multiple myeloma
Bio Pharma Dive
MARCH 27, 2021
Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma.
March, 2021
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America’s healthcare costs are in deep crisis
World of DTC Marketing
MARCH 8, 2021
SUMMARY: The media loves to blame pharma companies for high healthcare costs, but unless we start to invest in healthy lifestyles, we’re headed for a healthcare crisis the likes of which we have never experienced. The media have targeted pharmaceutical companies for a long time because sensational headlines lead to clicks. Forget the fact that prescription drugs only account for $.10 of every healthcare dollar spent and that hospital chains are raking in cash with PBM’s and insurers
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The drug Fenbendazole can make tumors sensitive to radiotherapy just like agents of chemotherapy
Pharma Mirror
MARCH 8, 2021
Likewise, it was demonstrated by actualizing high throughput screening in-vitro framework that the drug fenbendazole is successful, not just against standard non-small cell lung cancer, NSCLC, yet in addition against the KRAS-mutant malignancy which seems, by all accounts, aggressive, barely accessible by chemotherapy and very normal (thirty percent of total cases of NSCLS) in people. [1] It became continually challenging in targeting KRAS transformation bearing tumors in view of the unclear con
In the News: February 2021 Regulatory and Development Updates
Camargo
MARCH 9, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA: Sponsors Seldom Disclose RTF Letters’ Existence or Contents and Often Ignore Agency Advice. The FDA revealed that pharma companies are not forthcoming when they publicly disclose the reasons behind a refuse-to-file (RTF) letter from the Agency.
Bridging Innovation & Patient Care: The Growing Role of AI
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Gilead’s HIV therapy Biktarvy demonstrates long-term sustained efficacy
Pharma Times
MARCH 8, 2021
Data from two Phase III studies demonstrated durable viral suppression in HIV-1 patients
Life-sciences pros believe in potential of AI, blockchain: survey
Outsourcing Pharma
MARCH 25, 2021
A survey by the Pistoia Alliance indicates most professionals believe the tech can accelerate R&D, but companies are stymied by a skills gap and data bias.
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Why hasn’t pharma embraced email marketing?
World of DTC Marketing
MARCH 9, 2021
SUMMARY : DTC marketers are spending tens of millions of dollars on programmatic ads that are full of fraud and have low click-through rates but they have yet to embrace email marketing which has an average click-through rate of 3.43%. There is no doubt that more people are using the Internet for online health searches, but the downside is that there is a lot of bad/false health information online. eMail represents an opportunity for pharmaceutical companies to get closer to their customers w
DeepVerge’s nanochip-based COVID breath test could be ready this year
pharmaphorum
MARCH 19, 2021
DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. The company has already completed of the system that resembles a breathalyser in phase 1 and phase 2 studies with the SARS-CoV-2 virus in the safety of laboratories.
U.S. Health Officials Question AstraZeneca Vaccine Trial Results
NY Times
MARCH 23, 2021
According to federal officials, an independent panel of medical experts said the promising results announced by the company on Monday may have relied on “outdated information.”.
Ocugen to Seek EUA for India-Developed COVID-19 Vaccine in the United States
BioSpace
MARCH 16, 2021
Pennsylvania-based Ocugen has struck a deal to sell 100 million doses of a COVID-19 vaccine India’s Bharat Biotech in the United States later this year.
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
Valneva and Pfizer start new Phase 2 study for Lyme disease vaccine candidate
BioPharma Reporter
MARCH 8, 2021
Valneva and Pfizer have initiated a Phase 2 study for their Lyme disease vaccine candidate: which is the only active Lyme disease vaccine in clinical development today.
Drugmakers flock to Vineti's fix for a cell, gene therapy problem
Bio Pharma Dive
MARCH 24, 2021
A group of drug companies, including Novartis, Takeda and Roche's Genentech, have agreed to collaborate with Vineti to usher in new identification standards for complex medicines.
The right balance in DTC: Tv versus digital ads
World of DTC Marketing
MARCH 22, 2021
SUMMARY: Television remains the most important medium for healthcare advertising , accounting for 54.7% of all spend in 2018, far higher than television’s 30.8% share of the advertising market as a whole. However, recent trends indicate that healthcare marketers are shifting more dollars to digital ads. The shift to digital advertising doesn’t make sense when pharma product websites don’t meet consumers’ needs.
Gamification for patient care, medical education, and virtual engagement
pharmaphorum
MARCH 23, 2021
“Gamification” – adding game-like elements into non-game or real-world settings – has become a popular concept in the pharmaceutical, healthcare, and event industries, especially as virtual engagement becomes more common during COVID-19. However, it is proving more than a mere buzzword. With diverse applications and approaches, it is quickly becoming a promising tool for patient adherence, chronic disease management, preventive medicine, rehabilitation, and paediatric care, as well as for medica
Cancer Research UK launches new ‘cancer tech accelerator’ programme
Pharma Times
MARCH 26, 2021
New initiative aims to help researchers translate their ideas into innovations for cancer patients
One and Done: Why People Are Eager for Johnson & Johnson’s Vaccine
NY Times
MARCH 4, 2021
Johnson & Johnson’s one-shot vaccine is allowing states to rethink distribution, even as health officials and experts worry some will view it as inferior.
Inside the Pfizer/BioNTech COVID-19 vaccine trial: ‘We knew the world was watching and waiting for results’
BioPharma Reporter
MARCH 3, 2021
The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the learnings from the trial â and how could they be applied to vaccine development in the future?
Takeda takes full control of drug for rare epilepsies
Bio Pharma Dive
MARCH 3, 2021
A new agreement with Ovid Therapeutics has Takeda paying almost $200 million to secure global rights to soticlestat, an experimental treatment for certain brain diseases, including Dravet syndrome and Lennox Gastaut syndrome.
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
Should doctors refuse to treat obese patients?
World of DTC Marketing
MARCH 28, 2021
IN BRIEF: Doctors are not required to treat obese patients who won’t do anything to lose weight but the problem is more than reminding patients they need to get exercise and drop pounds. One study found that only 50 percent of patients follow the instructions associated with taking their medication, and even fewer implement necessary lifestyle changes suggested by their doctor.
Health tech and digital transformation lessons from the NHS
pharmaphorum
MARCH 25, 2021
In the year since the UK went into its first lockdown to limit the spread of COVID-19 the country’s health service has undergone an unprecedented digital transformation. . The NHS quickly scrambled to reduce face-to-face contact between patients and healthcare professionals, and manage demand for services that would soon be overstretched by dealing with the pandemic.
New research adds to evidence that POTS may be an autoimmune disorder
Scienmag
MARCH 16, 2021
Persistent work from scientists at The University of Toledo could aid in diagnosing and treating postural orthostatic tachycardia syndrome Credit: Daniel Miller / The University of Toledo The symptoms of postural orthostatic tachycardia syndrome, or POTS, can be as varied as they are confounding. There can be fatigue, pain, bleeding disorders and anxiety.
Technology Transfer: What Is It, and How Is It Done?
Camargo
MARCH 10, 2021
Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages. A sponsor may be looking for a contract development and manufacturing organization (CDMO) for clinical trial manufacturing; to transfer a manufacturing process to a larger, commercial-scale CDMO; or to replace a CDMO that has quality issues.
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.
Pfizer and BioNTech ramp up COVID-19 vaccine production to 2.5 billion doses
BioPharma Reporter
MARCH 31, 2021
Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.
Roche stops giving Huntington's disease drug in closely watched study
Bio Pharma Dive
MARCH 23, 2021
A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals.
Can ROI ever be used with patient-centric?
World of DTC Marketing
MARCH 21, 2021
SUMMARY: The goal of business is to maximize profits for shareholder returns but when a company that serves the public good pays CEOs millions of dollars in compensation while having among the highest profit margins within ANY industry I would argue that something is dreadfully wrong. The U.S. pharmaceutical firms behind the approved coronavirus vaccines — Johnson & Johnson, Moderna, and Pfizer — have quietly touted plans to raise prices on coronavirus vaccines in the near future and to capi
The digital transformation of pharma’s physician engagement strategies
pharmaphorum
MARCH 19, 2021
The exact shape of healthcare’s post-COVID ‘new normal’ is still being framed, but it is clear that some trends are already taking shape – and one of the key ones is digital transformation in pharma. The pandemic has ushered in a number of major changes to healthcare systems, notably in the ways in which pharmaceutical companies communicate, visit and engage with physicians.
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.
India's Covaxin Covid-19 Vaccine, Already in Use, Shows Promise in Trials
NY Times
MARCH 4, 2021
Interim results from clinical trials suggested that Covaxin could be safe and effective, potentially removing one hurdle to New Delhi’s ambitious campaign to inoculate a vast population.
Machine Learning Model Predicts Innovation’s Brilacidin Highly Effective Against COVID-19
BioSpace
MARCH 9, 2021
A machine learning model that screened 1,482 compounds potentially effective for treating coronavirus disease 2019 (COVID-19) has ranked Innovation Pharma’s COVID-19 candidate brilacidin in the top 3% of compounds predicted to be most effective against the novel coronavirus.
FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease Designation
Camargo
MARCH 25, 2021
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Subscribe to our mailing list at the bottom of this page to be notified when future installments are published.
A year with COVID-19: The impact of data on pharma marketing
Bio Pharma Dive
MARCH 29, 2021
Learn how three pharma brands used data to validate and adjust their promotional spend in 2020.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
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