Pfizer set to double weekly production of coronavirus vaccine
Bio Pharma Dive
FEBRUARY 19, 2021
The drugmaker will use production lines at its plant in McPherson, Kansas to help fill vaccine vials, company CEO Albert Bourla said Friday.
Sat.Feb 13, 2021 - Fri.Feb 19, 2021
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DTC Review: Nucala
World of DTC Marketing
FEBRUARY 15, 2021
THE SHORT: According to Medical News Today “in the United States (U.S.), an estimated 25.7 million people have some form of asthma , and 15 percent of these people have severe asthma that is difficult to control with standard medications. In the population as a whole, eosinophilic asthma is rare, affecting only 5 percent of adults with asthma or about 1.2 million people.
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AstraZeneca/Oxford to trial COVID-19 vaccine in children
BioPharma Reporter
FEBRUARY 15, 2021
A new trial for the AstraZeneca/Oxford COVID-19 vaccine will investigate the efficacy of the vaccine in children aged six and over.
COVID-19 collaborations could ‘unlock’ the potential of the UK’s life sciences sector
Pharma Times
FEBRUARY 18, 2021
New report recommends continuing collaborations across the life sciences sector
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
10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model
Bio Pharma Dive
FEBRUARY 16, 2021
The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.
Pharma running online ads on vaccine misinformation sites
World of DTC Marketing
FEBRUARY 19, 2021
SUMMARY: More than 42,000 programmatic ads from 4,315 brands are running on websites spouting misinformation about the vaccine and COVID over the past year. Included in the programmatic ad errors is Pfizer, who developed a leading COVID vaccine. When will pharma stop using programmatic online ads? Programmatic has been a thorn in online advertisers.
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FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation
Camargo
FEBRUARY 16, 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. Part 1 offered an overview and side-by-side comparison of the three designations, and now in Part 2, we give a detailed explanation of ODD for rare disease drug sponsors.
Lilly wagers almost $1B on Rigel's drugs for immune and nervous systems
Bio Pharma Dive
FEBRUARY 18, 2021
For $125 million up front, Lilly secures rights to a drug about to enter mid-stage testing for autoimmune and inflammatory diseases, as well as preclinical assets targeting the central nervous system.
How much to spend on DTC TV
World of DTC Marketing
FEBRUARY 17, 2021
SUMMARY: By far, the biggest question I get as a consultant is, “how much should we spend on DTC ads?” It’s important to understand that no formula can be applied across all health conditions and products. It varies by the size of your audience and the number of diagnosed and undiagnosed patients. DTC marketers will do a lot of research on brand messaging, but what’s really important is what action your target audience will take due to being exposed to your message.
The Wholesome Value of Holistic Wellness Treatments
Pharma Mirror
FEBRUARY 19, 2021
Methods to Improve Mind, Body, and Spirit At a certain point, most people deal with obstacles to their health or wellness caused by aging, trauma, or the regular stressors of modern life. This past year in particular has been hard in the wake of COVID-19. Now more than ever, people are trying to find natural ways to improve their mental, physical, and spiritual wellbeing that don’t involve a doctor’s visit.
EU approves Tukysa combo for advanced HER2-positive breast cancer
Pharma Times
FEBRUARY 18, 2021
In the HER2CLIMB trial, Tukysa-treated patients had a 46% reduction in the risk of cancer progression or death
Bluebird stops studies of sickle cell gene therapy after new cancer cases
Bio Pharma Dive
FEBRUARY 16, 2021
The biotech is also suspending sales of its related treatment Zynteglo following a leukemia diagnosis in a clinical trial volunteer and a case of a cancer-like bone marrow disease in another.
Pharma needs to give the boot to McKinsey
World of DTC Marketing
FEBRUARY 16, 2021
SUMMARY: This month, McKinsey agreed to pay nearly $600m to settle claims that its advice had exacerbated the deadly US opioid crisis, yet pharma views McKinsey as business gurus. This has to stop, and NOW! McKinsey is loaded with MBAs addicted to spreadsheets and PowerPoint presentations, so of course, they know about patients and pharma? McKinsey’s recommendations to Purdue were directly aimed at extreme sales improvement, and the analysis failed to address the potential of specific ince
QS-21, the ‘Gold Standard’ of immune system activators used in Covid-19 and other vaccines to be presented by CEO Gaston Salinas at BIO CEO & Investor Conference
Pharma Mirror
FEBRUARY 18, 2021
A novel approach for ensuring the virtually unlimited production of QS-21, the ‘Gold Standard’ adjuvant for improving vaccine efficacy, will be the subject of an upcoming presentation at the BIO CEO & Investor Digital Conference, starting February 16. BSI is well- positioned to become the industry’s most reliable and cost-effective supplier of GMP quality QS-21 worldwide.
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
CureVac’s COVID-19 vaccine begins rolling review with EMA
Pharma Times
FEBRUARY 15, 2021
CureVac’s CVnCoV is currently being investigated in a randomised, placebo-controlled Phase IIb/III clinical trial
Gates Foundation backs Novartis' search for a sickle cell cure
Bio Pharma Dive
FEBRUARY 17, 2021
An initial grant will support a research team at Novartis' R&D labs whose sole focus will be to develop a single-administration gene therapy for sickle cell disease.
Haven: The strategy that didn’t fix healthcare
pharmaphorum
FEBRUARY 17, 2021
John Singer discusses the disbanding of Haven, the joint healthcare venture by Amazon, JP Morgan and Berkshire Hathaway, and the strategies that can help fix US healthcare. . “The market” was terrified when Warren Buffett, Jamie Dimon and Jeff Bezos got together to disrupt healthcare three years ago with the launch of Haven – in response to that news, healthcare stocks comprising a significant chunk of the $3.5 trillion health economy in the United States shed billions in value overnight.
Maculus Therapeutix welcomes Privity FZ LLE and Prepares Capital Raise for Novel Drug Delivery Platform
Pharma Mirror
FEBRUARY 18, 2021
Maculus Therapeutix, a preclinical-stage biopharmaceutical company which has developed a SINGLE injection delivery platform for diseases such as wet AMD (Age-related Macular Degeneration) and DME (Diabetic Macular Edema) instead of the standard 8-12 monthly injections, is pleased to welcome Privity FZ LLE as a partner and advisor for upcoming fundraising activities.
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.
Kidney Research UK pledges support to Accelerate@Babraham initiative
Pharma Times
FEBRUARY 15, 2021
Accelerate@Babraham supports early-stage life sciences ventures within the Babraham Research Campus’ community
GSK returns to Vir with expanded deal to develop drugs for flu, other viruses
Bio Pharma Dive
FEBRUARY 17, 2021
The British drugmaker will pay the San Francisco-based biotech $225 million upfront, while also investing another $120 million in Vir shares.
Alzheimer’s Research UK starts AI-based drug hunt with Exscientia
pharmaphorum
FEBRUARY 16, 2021
Medical charity Alzheimer’s Research UK has teamed up with artificial intelligence specialist Exscientia to find new drug treatments for the devastating neurodegenerative disease. . The alliance will see Exscientia work with the charity’s Oxford Drug Discovery Institute (ODDI) to find therapeutics that target the neuroinflammation associated with Alzheimer’s disease (AD), focusing in particular on the NLRP3 inflammasome pathway.
University of Oregon Campus Could Be Cornerstone of New Biotech Hotspot
BioSpace
FEBRUARY 14, 2021
A new biotech hotspot could be on the horizon in Oregon thanks to a $500 million gift to the University of Oregon from Nike co-founder Phil Knight, an alumnus of the university.
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.
South Africa starts administering Janssen COVID-19 vaccine to health workers
BioPharma Reporter
FEBRUARY 18, 2021
South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country. Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following its application for EUA in the US.
Novartis expects sales lift from expanded heart drug approval
Bio Pharma Dive
FEBRUARY 17, 2021
The Swiss drugmaker's pill Entresto is now cleared in the U.S. for use in patients with stronger hearts, expanding the eligible population by two-thirds.
UK will start first COVID-19 challenge study “within a month”
pharmaphorum
FEBRUARY 18, 2021
Sometime within the next few weeks, young and healthy volunteers will be deliberately exposed to the COVID-19 coronavirus in the UK in what looks set to be the first study of its type worldwide. . The human challenge study has just secured ethics committee approval and will recruit up to 90 volunteers aged 18-30 years, according to the UK government, which is backing it with £33.6 million ($47 million) in funding.
AZ, Daiichi Sankyo’s Enhertu scores approval in the UK
Pharma Times
FEBRUARY 16, 2021
Antibody drug conjugate conditionally approved for HER2-positive metastatic breast cancer
Blockchain could accelerate drug development: Bloqcube
Outsourcing Pharma
FEBRUARY 15, 2021
With pharma firms seeking solutions to get products in the hands of patients faster, one company believes blockchain technology could provide answers.
Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot
Bio Pharma Dive
FEBRUARY 19, 2021
Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution.
GSK expands coronavirus antibody tie-up to include potential flu therapies
pharmaphorum
FEBRUARY 18, 2021
GlaxoSmithKline is expanding a coronavirus antibody collaboration with US biotech Vir, to include potential therapies for flu and other respiratory viruses. The big UK pharma is already working with Vir on antibody therapies for coronaviruses, and already have the antibody VIR-7831 in clinical trials including the US National Institutes of Health-backed ACTIV-3 study.
Evox raises £69.2m to advance exosome-based therapeutics pipeline
Pharma Times
FEBRUARY 18, 2021
Series C financing will also be used for the development of Evox's DeliverEX exosome drug platform
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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