As COVID-19 becomes a business, vaccine makers confront thorny pricing questions
Bio Pharma Dive
FEBRUARY 9, 2021
Yearly vaccinations could be required after the pandemic ebbs. Will drugmakers change how they approach pricing their shots?
February, 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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Top 5 Common Misconceptions About Meeting with the FDA
Camargo
FEBRUARY 24, 2021
Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success. Others find themselves needing to dispel incorrect preconceptions about this interactive process for board members or investors.
Jazz Pharmaceuticals to acquire GW Pharma for $7.2bn
Pharma Times
FEBRUARY 8, 2021
Jazz will add GW's plant-derived cannabinoid treatment Epidiolex to its roster
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 Accused of Holding Some Countries to “Ransom” Over COVID-19 Negotiations
BioSpace
FEBRUARY 23, 2021
Pfizer has been accused of bullying governments in Latin America over coronavirus disease 2019 (COVID-19) vaccine negotiations, a recent investigative article revealed.
Clinical trial set to test efficacy of mixing Sputnik V and COVID-19 Vaccine AstraZeneca
BioPharma Reporter
FEBRUARY 9, 2021
Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.
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Pharma’s horrible website metrics
World of DTC Marketing
FEBRUARY 5, 2021
SUMMARY: The number of visitors to your website doesn’t mean anything if you have high bounce rates and low page views/time on site. More than half of mobile users leave a website that takes more than three seconds to load, yet too many pharma sites are not optimized for mobile. Houston, we have a problem. Attention spans online are declining rapidly.
Johnson & Johnson Will Test its Vaccine in Infants
NY Times
FEBRUARY 28, 2021
The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
Synairgen’s inhaled COVID-19 treatment included in US trial
Pharma Times
FEBRUARY 10, 2021
Trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID)
Israel Real-World Study: Pfizer-BioNTech COVID-19 Vaccine Prevents 98.9% of Deaths
BioSpace
FEBRUARY 22, 2021
Israel’s Health Ministry announced results of a study in the country that showed that the Pfizer-BioNTech COVID-19 vaccine was 98.9% effective at preventing COVID-19 deaths.
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.
Bristol Myers finally wins FDA approval for cancer cell therapy
Bio Pharma Dive
FEBRUARY 5, 2021
Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.
The biggest threat to the pharma industry
World of DTC Marketing
FEBRUARY 3, 2021
SUMMARY: The biggest threat to the pharma industry isn’t the coming tsunami of healthcare changes. It’s reshaping the company to once again focus on patients instead of profits. At the end of last year, I worked with a leading cancer company on a test program that involved an email program. We started with research to uncover the needs and wants of current cancer patients (NSC lung) and caregivers.
White paper reveals pathway for digital therapeutics use in Italy
pharmaphorum
FEBRUARY 4, 2021
A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month. The book features insights and recommendations from 40 leading experts in the field, who hope that Italy will begin to follow in the footsteps of early adopters of digital therapeutics such as Germany, France and
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
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
COVID-19 Long-Hauler Therapy Space Beginning to Take Shape
BioSpace
FEBRUARY 8, 2021
While the space is just beginning to emerge, therapies for long-haul COVID-19 patients are still very much an unmet need.
Pfizer/BioNTech to trial COVID-19 vaccine in pregnant women and children
BioPharma Reporter
FEBRUARY 22, 2021
Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.
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.
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.
Pharma throwing money away on digital ads
World of DTC Marketing
FEBRUARY 1, 2021
SUMMARY: Digital ad spend in pharmaceutical brands is up 111% so far in 2020 and 80% of that money is being thrown away by fraud and the popularity of programmatic advertising. While popular, digital advertising wasn’t an immediate hit in the pharmaceuticals arena due to the strict regulations. Pharmaceutical advertisers have traditionally been slow to join with the latest trends simply because it’s more complicated for regulated industries.
LSD biotech MindMed buys digital trial firm HealthMode
pharmaphorum
FEBRUARY 19, 2021
Psychedelic medicine biotech MindMed is to acquire digital medicine and therapeutics startup HealthMode for around $32.2 million, which uses artificial intelligence (AI) technology to speed up drug development. The move will also see ex-Pfizer digital medicine executive Dr Daniel Karlin join the MindMed executive team, along with former Google AI guru Bradford Cross.
How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product
Camargo
FEBRUARY 10, 2021
Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products.
Semaglutide Brings Significant Weight Loss in Obese Patients
NY Times
FEBRUARY 10, 2021
In a clinical trial, participants taking semaglutide lost 15 percent of their body weight, on average.
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.
First look inside BioNTech's Marburg site as it starts production for COVID-19 vaccine
BioPharma Reporter
FEBRUARY 10, 2021
BioNTech announced this morning it has started the production of mRNA at its new facility in Marburg, Germany: which will become one of the largest mRNA manufacturing sites in Europe.
FDA authorizes J&J's one-shot coronavirus vaccine
Bio Pharma Dive
FEBRUARY 27, 2021
The agency's emergency clearance makes J&J's vaccine the third available in the U.S., adding much-needed reinforcements at a critical time.
Jazz Pharma uses flying pig for huge grey area DTC
World of DTC Marketing
FEBRUARY 22, 2021
SUMMARY: One of the biggest complaints people have about their health is the lack of sleep caused by many factors, from diet and weight to chronic stress. DTC for a product that can keep people awake for nine hours is a message for potential abuse. Did I mention that they are using a flying pig in their DTC? One of the most common complaints people have is “lack of energy” Consumers have turned to energy drinks which was valued at $53.01 billion in 2018, and is expected to grow at a
Why we need the human element of remote clinical trials
pharmaphorum
FEBRUARY 5, 2021
Over the last year, we’ve noticed that “connectivity” doesn’t always equate to “connected” – and that’s just as true in the realm of clinical trials as it is in our personal lives. Amanda Barrell reports from a panel at the Patients as Partners Europe conference on remote clinical trials. Decentralised trials have been growing in popularity in recent years, and the COVID-19 pandemic has served to accelerate that progress.
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.
Bristol Myers Takes $470 Million Write-off and Scraps Orva-Cel CAR-T Program
BioSpace
FEBRUARY 10, 2021
The company’s head of drug development, Samit Hirawat, told analysts in a conference call last week that the decision was about working with the best drugs, particularly in a crowded field like BCMA.
In the News: January 2021 Regulatory and Development Updates
Camargo
FEBRUARY 4, 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. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication. Pfizer’s Xalkori (crizotinib) was approved in 2011 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive.
How CureVac is creating a ‘broad pipeline’ of both first and second generation COVID-19 vaccines
BioPharma Reporter
FEBRUARY 8, 2021
CureVac aims to bring together expertise from both its own company and other stakeholders to provide âbroader and faster protection against current and future viral threatsâ: through collaborations with the UK Government, Bayer and GSK all announced this month.
Gilead partners with a cancer biotech, seeking to develop an HIV immunotherapy
Bio Pharma Dive
FEBRUARY 1, 2021
Gritstone Oncology, known for its cancer research, is drawing attention in infectious disease, signing a deal with Gilead two weeks after announcing plans to develop a coronavirus vaccine.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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