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?
Tue.Feb 09, 2021
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Elements of a great pharma website
World of DTC Marketing
FEBRUARY 9, 2021
OPENING: Online health seekers decide whether to stay on your website within the first five seconds of landing on your homepage. They decide if your site addresses their questions after looking at 1.24 pages. Here are what I found in over two years of research with online health seekers. Remember that every health condition has particular needs and wants by their audience, but it’s clear that certain qualities overlap.
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Lilly CFO steps down after investigation found 'inappropriate' behavior
Bio Pharma Dive
FEBRUARY 9, 2021
Josh Smiley had engaged in "consensual though inappropriate" personal communications with certain employees, according to Lilly. He's being replaced by Anat Ashkenazi, chief financial officer of Lilly Research Laboratories.
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.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Small biotech gets big win on treatment for rare swelling disorder
Bio Pharma Dive
FEBRUARY 9, 2021
An oral hereditary angioedema treatment from KalVista Pharmaceuticals looks similarly effective to standard injectables, which could threaten big-selling drugs from Takeda and others.
Labour accuses government of cronyism in COVID-19 contracts
pharmaphorum
FEBRUARY 9, 2021
The UK government’s massive spending on the coronavirus pandemic response has been “rife with conflicts of interest”, says the opposition Labour Party, and an independent watchdog should be set up to oversee procurement contracts. That was the message delivered by shadow Cabinet Office minister Rachel Reeves in a speech yesterday which claimed almost £2 billion of the £23.1 billion public sector spend on the pandemic went on contracts that were awarded to “Conservative friends and donors”
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Organ transplant patients can safely receive COVID-19 vaccine, suggests study
BioPharma Reporter
FEBRUARY 9, 2021
Johns Hopkins Medicine researchers have studied the reaction of nearly 200 solid organ transplant recipients to their first COVID-19 vaccine shot. The findings, they say, suggest that the Moderna and Pfizer/BioNTech mRNA vaccines can be safely given to this immunocompromised population.
COVID-19 May Trigger New-Onset Diabetes
XTalks
FEBRUARY 9, 2021
“Long COVID” refers to lingering COVID-19-related symptoms that persist for weeks or months, the most common of which are breathing difficulties, fatigue and brain fog, which may be associated with lung, heart and neurological damage. Now, have identified a rise in cases of new-onset diabetes in individuals recovering from COVID-19. While diabetes is associated with an increased risk of developing severe COVID-19, it appears that the opposite may also be true in that the infection itself may lea
Universal access to preventive drugs could reduce HIV incidence in sub-Saharan Africa
Scienmag
FEBRUARY 9, 2021
Credit: Gabriel Chamie Universal HIV testing with linkage to treatment and prevention may be a promising approach to accelerate reductions in new infections in generalized epidemic settings, according to a study published February 9th, 2021 in the open-access journal PLOS Medicine by Catherine Koss of the University of California, San Francisco, and colleagues.
Pulse Infoframe Releases Registry for Patient Advocacy Groups
pharmaphorum
FEBRUARY 9, 2021
Launching a rare disease patient registry often requires patient advocacy groups to design a registry themselves or pay for an expensive customized solution. With the launch of Rare Central , Pulse Infoframe offers patient advocacy groups an on-ramp to collecting real-world data, including natural history data, disease-specific data, and patient-reported outcomes.
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
PacBio Secures $900 Million Investment to Support Gene Sequencing
BioSpace
FEBRUARY 9, 2021
Shares of Pacific Biosciences soared more than 21% in premarket trading after it was announced SB Management, a subsidiary of SoftBank Group Corp., will make an investment of $900 million into the company to support its gene sequencing research.
ViiV’s Rukobia cleared in EU as rescue HIV therapy
pharmaphorum
FEBRUARY 9, 2021
The European Commission has given a green light to the use of ViiV Healthcare’s Rukobia as a treatment for people with HIV that has developed resistance to other antiretroviral therapy (ART). . The first-in-class HIV attachment inhibitor is cleared for use as an add-on therapy to other ARTs in adults “for whom it is otherwise not possible to construct a suppressive antiviral regimen,” according to ViiV, which is majority-owned by GlaxoSmithKline.
FDA Adcom Gives Merck’s Keytruda a Surprise Thumbs Down
BioSpace
FEBRUARY 9, 2021
The U.S. FDA Oncologic Drugs Advisory Committee voted against recommending the drug as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery, at least for now.
Researchers identify a new molecular mechanism related to severe anaphylaxis
Scienmag
FEBRUARY 9, 2021
Credit: JACI Anaphylaxis is a systemic allergic reaction that can affect the skin, the gastrointestinal tract, the respiratory system and the cardiovascular system. The most severe form of anaphylaxis is anaphylactic shock, which features hypotension and can cause death. This reaction can have several causes, such as allergic reactions to food, medicines or insect venom. […].
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Latest FDA COVID-19 updates and activity
Outsourcing Pharma
FEBRUARY 9, 2021
The federal agency continues to keep researchers, pharma firms and citizens apprised of current happenings and research related to the virus and pandemic.
Function identified of ‘mystery protein’ that kills brain cells of people with Parkinson’s
Scienmag
FEBRUARY 9, 2021
Scientists have made a ‘vital step’ towards understanding the origins of Parkinson’s Disease – the fastest growing neurological condition in the world. Credit: Kateryna Kon via Shutterstock A study published in Nature Communications today (Wednesday 10 February) presents a compelling new evidence about what a key protein called alpha-synuclein actually does in neurons in the […].
WHO Wuhan Report Suggests Animal Origin for COVID-19 Virus
BioSpace
FEBRUARY 9, 2021
The origins of COVID-19 continue to be debated in the halls of government, and the findings from a recent investigation conducted by the World Health Organization are unlikely to change many minds as the world continues to grapple with the pandemic.
Emerging robotics technology may lead to better buildings in less time
Scienmag
FEBRUARY 9, 2021
Credit: Jiansong Zhang/Purdue University WEST LAFAYETTE, Ind. – Emerging robotics technology may soon help construction companies and contractors create buildings in less time at higher quality and at lower costs. Purdue University innovators developed and are testing a novel construction robotic system that uses an innovative mechanical design with advances in computer vision sensing technology […].
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.
F.D.A. Authorizes Another Antibody Treatment
NY Times
FEBRUARY 9, 2021
Researchers hope Eli Lilly’s new combination therapy may be better able to fight virus variants than a similar treatment already in use.
New study finds climate change shrinks and shifts juvenile white shark range
Scienmag
FEBRUARY 9, 2021
Credit: Monterey Bay Aquarium, 2010 New research led by Monterey Bay Aquarium reveals that even the revered white shark cannot escape the impacts of a changing ocean. The study, published in Scientific Reports, finds that unprecedented sightings of juvenile white sharks at the northern end of Monterey Bay signal a significant shift in the young […].
Entries now open for the Patient Partnership Index 2021
Pharma Times
FEBRUARY 9, 2021
The Patient Partnership Index 2021 provides a unique opportunity for UK and global pharmaceutical companies to showcase, benchmark and measure the quality and impact of their advocacy with patient groups
Can super-Earth interior dynamics set the table for habitability?
Scienmag
FEBRUARY 9, 2021
Are super-Earths capable of creating conditions that are hospitable for life to arise and thrive? Credit: Image is courtesy of Yingwei Fei. Sandia Z Machine photograph by Randy Montoya, courtesy of Sandia National Laboratories. Washington, DC– New research led by Carnegie’s Yingwei Fei provides a framework for understanding the interiors of super-Earths–rocky exoplanets between 1.5 […].
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
The Stroke Association to fund study investigating strokes caused by COVID-19
Pharma Times
FEBRUARY 9, 2021
The research forms part of the CVD-COVID-UK flagship project consortium
Notch Soars Out of the Gate with $85 Million; Two More Follow Closely Behind
BioSpace
FEBRUARY 9, 2021
There have been a few life sciences companies that have been attracting attention this week with strong Series A rounds.
Seventeen from Argonne recognized with Secretary of Energy’s Honor Awards
Scienmag
FEBRUARY 9, 2021
Credit: Argonne National Laboratory Six groups that included 17 scientists, engineers and other staff from the U.S. Department of Energy’s (DOE) Argonne National Laboratory were recipients of the recently announced DOE 2020 Secretary of Energy’s Honor Awards. “The Laboratory can be very proud. The number of Argonne researchers who earned this prestigious recognition from DOE, the […].
Eli Lilly's Antibody Combo Wins FDA Approval for Mild to Moderate COVID-19
BioSpace
FEBRUARY 9, 2021
This combination therapy has been authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
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.
New factor in the carbon cycle of the Southern Ocean identified
Scienmag
FEBRUARY 9, 2021
GEOMAR scientists show that besides iron, manganese can also limit the growth of photosynthesis-performing plankton Credit: Thomas Browning/GEOMAR The term plankton describes usually very small organisms that drift with the currents in the seas and oceans. Despite their small size, they play an important role for our planet due to their immense quantity.
With Evidence of Efficacy, South Africa to Test J&J Vaccine on Health Care Workers
BioSpace
FEBRUARY 9, 2021
South Africa recently announced it was halting distribution of the AstraZeneca-University of Oxford COVID-19 vaccine after data suggested it “provides minimal protection” against mild disease from the South African variant.
You don’t need to know nature to love it – study
Scienmag
FEBRUARY 9, 2021
Research involving farmers in Brazilian Amazon is first of its kind in Global South Credit: Photo by Katarzyna Mikolajczak A common belief in nature conservation is that people need to “know nature” in order to care about it. However, new research has found that farmers in the Brazilian Amazon can develop strong connections with nature […].
BigHat Plans to Take Antibody Engineering to a Whole New Level
BioSpace
FEBRUARY 9, 2021
BigHat is a Bay-area startup that’s reimagining antibody development with the help of AI and ML (machine learning) technologies through data-driven discovery.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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