Pfizer taps McKinsey executive to lead dealmaking efforts
Bio Pharma Dive
AUGUST 26, 2021
Aamir Malik, a managing partner at the consulting firm, will replace longtime Pfizer executive John Young as chief business innovation officer next week.
Sat.Aug 21, 2021 - Fri.Aug 27, 2021
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The Constitution and vaccinations
World of DTC Marketing
AUGUST 26, 2021
SUMMARY : Via Marci Hamilton is a professor at the University of Pennsylvania “the Constitution is not a suicide pact guaranteeing a right to harm others. The government has latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” Prof Hamilton goes on to say, “One frequently heard pushback against vaccine mandates is that there is a “constitutional right” to choose whether to be vaccinated or not for adult
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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?
Camargo
AUGUST 22, 2021
When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance. This validation check determines if the submission is uploaded into the FDA’s system, or if it is technically rejected.
Novartis’ Kymriah fails to hit primary survival endpoint in late-stage trial
Pharma Times
AUGUST 24, 2021
Phase III study was investigating treatment for B-cell non-Hodgkin lymphoma
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
Pfizer stocks cancer drug pipeline with $2.3B deal for Trillium
Bio Pharma Dive
AUGUST 23, 2021
The acquisition reflects growing industry interest in the cancer-linked protein targeted by Trillium's drugs, most notably shown by Gilead's acquisition of Forty Seven last year.
“Take off the gloves” for COVID anti-vaxxers
World of DTC Marketing
AUGUST 24, 2021
SUMMARY: We, as a nation, can not afford people who chose not to get vaccinated because of misinformation. They are a danger to all of us and must be held accountable for their inaction. This includes financial penalties for making a terrible choice. According to KFF, “our analysis of CDC data indicates there were 37,000 preventable COVID-19 hospitalizations in June and another 76,000 preventable COVID-19 hospitalizations in July, among unvaccinated adults in the U.S.
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Ivermectin Should Not Be Used to Treat Covid, F.D.A. Says
NY Times
AUGUST 21, 2021
“You are not a horse,” the Food and Drug Administration said. “Stop it.”.
Gilead wins reversal of $1.2B penalty in CAR-T patent case
Bio Pharma Dive
AUGUST 26, 2021
A federal appeals court overturned an earlier verdict that had ruled Gilead's Kite Pharma unit infringed on a patent held by Bristol Myers Squibb.
Clinical trial DTC? It may not be right for your drug candidate
World of DTC Marketing
AUGUST 27, 2021
SUMMARY: Over half of all clinical trial sites are outside the U.S. 78 % of all subjects were enrolled outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. More than 40 million patients are needed to meet the demand of currently enrolling trials.
Home antibody tests for COVID-19 to be made available in UK
Pharma Times
AUGUST 26, 2021
Up to 8,000 people per day can access the tests
India’s Breathe Well-being raises $5.5m for diabetes reversal app
pharmaphorum
AUGUST 24, 2021
Digital health startup Breathe Well-being has raised $5.5 million in first-round financing, which it will use to scale up its clinical tool that it says helps people “prevent, manage and reverse type 2 diabetes.” . The Series A – led by US venture capital group Accel with participation from General Catalyst and Scott Shleifer, global managing director of hedge fund Tiger Global, which is a highly active investor in privately-held tech firms.
FDA grants full approval to Pfizer, BioNTech's coronavirus vaccine
Bio Pharma Dive
AUGUST 23, 2021
The long-awaited decision could strengthen the case for vaccine mandates as public health officials seek to boost rates of immunization amid a wave of COVID-19 cases.
Should you change your DTC marketing buckets?
World of DTC Marketing
AUGUST 25, 2021
SUMMARY: There is a huge issue that’s challenging DTC marketers: online health misinformation. While we’re still trying to research the changes it has led to for DTC marketers, there are some observable behaviors taking place that we have examined through Google analytics. They paint a picture of people who are spending more time online looking to answer their questions and relying on HCPs to help sort out treatment choices.
Existing drug could offer hope as new therapy for ALL in children
Pharma Times
AUGUST 26, 2021
Early stage research found 5-azacytidine may be used to treat 'devastating' disease
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
Digital mental health firms Headspace and Ginger in $3bn merger
pharmaphorum
AUGUST 26, 2021
A merger between two digital mental health companies – Headspace and Ginger – will create a $3 billion giant in a category that has been growing at breakneck speed as a result of the COVID-19 pandemic. The deal brings together Headspace’s meditation and mindfulness app – used by millions of people around the world – and Ginger’s platform which provides therapy and psychiatric support as an on-demand, video-based service.
AstraZeneca reports study success for rare disease drug acquired in Alexion deal
Bio Pharma Dive
AUGUST 26, 2021
With positive results from a Phase 3 trial in hand, the British pharma intends to soon seek regulatory approval for the Wilson disease treatment.
Inflammasome develops combo HIV/birth control implant
Outsourcing Pharma
AUGUST 23, 2021
Thanks in part to grants from the Gates Foundation, the company has come up with a bioerodible implant that combines HIV prevention and birth control.
New BRCA-targeting drug could treat advanced prostate cancer
Pharma Times
AUGUST 23, 2021
Talazoparib delayed disease progression in Phase II trial
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.
Starpharma's Nasal Spray Reduces SARS-CoV-2 by Over 99.9% in Animal Studies
BioSpace
AUGUST 22, 2021
?Starpharma's Viraleze has reduced the viral load by over 99.9% when it was administered nasally into the trachea and lungs of animals who were positive with the virus, compared to saline control.
UPS delivers coronavirus vaccines via temperature-controlled drone
Bio Pharma Dive
AUGUST 25, 2021
Drones have emerged as a speedy logistics option for time- and temperature-sensitive vaccine doses, potentially helping boost the availability of shots in rural areas.
Amplifying the patient voice for better engagement, recruitment and retention
pharmaphorum
AUGUST 26, 2021
Everyone is familiar with the phrase ‘patient-centricity’ but, where it might once have been seen as a ‘checkbox exercise’, it has gained preeminent status in the era of COVID-19, says Prime Global’s Ross Jackson. The pandemic has transformed many aspects of our industry and one area that change has come to is patient engagement within clinical trials, where it would now seem unusual were we to not consider the patient voice when it comes to recruiting trial participants.
NHS to roll out same-day pre-eclampsia test for pregnant women
Pharma Times
AUGUST 25, 2021
New blood test rules out life-threatening condition
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.
Humacyte Combines with Alpha Healthcare in Latest Biopharma SPAC
BioSpace
AUGUST 26, 2021
The combined company out of the Humacyte SPAC will be called Humacyte and is expected to trade shares of common stock and warrants on the Nasdaq Global Select Market.
BioMarin wins European approval to sell drug for dwarfism
Bio Pharma Dive
AUGUST 27, 2021
The drugmaker is setting the price for Voxzogo high, at an annual price of around $300,000 per patient, although the company expects to make "material discounts" in the coming years.
UK real-world study finds COVID-19 jab protection wanes
pharmaphorum
AUGUST 25, 2021
A study has found evidence that protection from the AstraZeneca and Pfizer/BioNTech COVID-19 vaccines starts fall off after a few months, but a UK government advisor says there’s no need to rush into a large-scale booster campaign. The results of the ZOE COVID study found that initial protection against infection a month after the second dose of the Pfizer vaccine was 88%, and after five to six months fell to 74%.
Valneva starts MHRA regulatory process for COVID-19 vaccine
Pharma Times
AUGUST 23, 2021
VLA2001 is an inactivated, adjuvanted vaccine candidate
Avera Health, Sema4 join forces on precision cancer care
Outsourcing Pharma
AUGUST 24, 2021
The regional US healthcare system will collaborate with the health intelligence specialist to advance precision medicine focused on oncological care.
Lilly puts more money into protein degradation
Bio Pharma Dive
AUGUST 25, 2021
The pharma has struck its second research pact focused on drugs that break down harmful proteins in as many years, this time with California biotech Lycia Therapeutics.
Cara’s Korsuva is first drug cleared for itching in dialysis patients
pharmaphorum
AUGUST 24, 2021
One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment. The US regulator has cleared Cara Therapeutics’ Korsuva (difelikefalin) as an injectable treatment for chronic itching, also known as pruritus, in these patients after a priority review.
Study finds protection against COVID-19 ‘waning’ in fully vaccinated people
Pharma Times
AUGUST 25, 2021
The ZOE COVID Study app assessed data on positive COVID-19 PCR test results between May and July 2021
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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