Bio Pharma Dive
SEPTEMBER 23, 2021
Agency advisers supported giving a third Pfizer vaccine dose to older adults and those with medical conditions. But in a break with the FDA, they voted against recommending it for younger people in high-risk jobs.
World of DTC Marketing
SEPTEMBER 23, 2021
SUMMARY: Pfizer will earn over 26 billion dollars from their COVID vaccine, while Moderna and J&J also look to their vaccines for more profit dollars. The suggestion by Pfizer’s CEO that drug pricing negotiations with the government would slow innovation is PR doubletalk. Recently Pfizer’s CEO sent a video message to company employees urging them to fight proposed government drug price negotiations and expressing frustration with Congress, considering using the projected savings
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BioPharma Reporter
SEPTEMBER 23, 2021
Open Pharma wants to see articles in peer-reviewed medical journals provide plain language summaries: those written in everyday language that is easy to understand by anyone from patients to policymakers. It's now set out its recommendations on how to write a good plain language summary.
pharmaphorum
SEPTEMBER 23, 2021
A study has found that listening to a specially composed music track can achieve “clinically significant” reductions in pain intensity and unpleasantness, according to the researchers behind the work. The All of Us track – composed by musician Anatole with the help of psychologist Dr Claire Howlin of University College Dublin and available via Spotify – reportedly showed a benefit in 286 people suffering from various types of acute pain, including headache, backache or period pain in
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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
BioSpace
SEPTEMBER 23, 2021
Aside from the fraud trial of Theranos founder Elizabeth Holmes, other court-related cases are taking place, including between Takeda and AbbVie over cancer drug, Lupron.
pharmaphorum
SEPTEMBER 23, 2021
Novavax and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing for their COVID-19 vaccine, based on a conventional recombinant protein technology. Getting a WHO emergency use listing (EUL) is a requirement for approvals by many national regulatory authorities, as well as for participation in the COVAX mechanism, which has been set up to procure COVID-19 vaccines for lower-income countries.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 23, 2021
?Researchers from the Max Planck Institute for Heart and Lung Research reportedly achieved positive results after returning adult cardiomyocytes to their fetal-like state in mouse models.
pharmaphorum
SEPTEMBER 23, 2021
As the world passes the year and a half mark of the COVID-19 pandemic, the evolving ‘new normal’ experience across the healthcare sector has brought huge changes to the way pharma engages healthcare professionals. Joining the pharmaphorum podcast to discuss these changes is Impetus Digital’s co-founder and CEO Natalie Yeadon, in a special episode sponsored by the virtual engagement agency.
BioSpace
SEPTEMBER 23, 2021
Study: Adoptive cell transfer of tumor-infiltrating lymphocytes (ACT-TILs) is more effective in patients who have not been treated with checkpoint inhibitors than in those who have undergone one or more therapies.
Drug Patent Watch
SEPTEMBER 23, 2021
Annual Drug Patent Expirations for SAXENDA Saxenda is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are twenty-two patents protecting…. The post New patent for NOVO drug SAXENDA appeared first on DrugPatentWatch - Make Better Decisions.
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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
BioSpace
SEPTEMBER 23, 2021
A day after the FDA authorized a COVID-19 booster dose of the Pfizer-BioNTech vaccine, a U.S. Centers for Disease Control and Prevention advisory committee voted in support.
NY Times
SEPTEMBER 23, 2021
Scientific advisers to the C.D.C. have been discussing the details of federal guidance on who qualifies for a Pfizer-BioNTech booster shot and why. A decision is expected on Thursday.
BioSpace
SEPTEMBER 23, 2021
On Friday morning, Capricor announced positive final data from the HOPE-2 trial of its drug candidate, CAP-1002, indicating a slowing of disease progression in this population.
BioPharma Reporter
SEPTEMBER 23, 2021
AstraZeneca has announced a long-term research collaboration with VaxEquity for the discovery, development and commercialization of its self-amplifying RNA (saRNA) therapeutics platform.
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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.
BioSpace
SEPTEMBER 23, 2021
There are roughly 750 sales representatives for Amarin at present, which the company intends to whittle down to 300 as it adopts a more digital approach to marketing.
Drug Channels
SEPTEMBER 23, 2021
This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Update: Buy-and-Bill Market Trends. Click here to see the original post and comments from May 2021. Last week, Cigna released its earnings for the first quarter of 2021. Links below. I was struck by how quickly Cigna’s Express Scripts PBM business has increased revenues and prescriptions from its retail pharmacy network.
BioSpace
SEPTEMBER 23, 2021
September 24 is World Cancer Research Day, a time for patients, caregivers and companies on the forefront of cancer R&D to look back and look ahead.
Pharma Times
SEPTEMBER 23, 2021
Under the partnership, AZ will support VaxEquity with research and development funding
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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.
BioSpace
SEPTEMBER 23, 2021
The United States has seen companies launching left and right. Check out the top 10 biopharma Series A rounds in the U.S. so far this year.
Pharma Times
SEPTEMBER 23, 2021
Company will also begin recruiting adolescents into Phase III vaccine trial
BioSpace
SEPTEMBER 23, 2021
The National Kidney Foundation and the American Society of Nephrology recommend removing race from the equation in the assessment of kidney disease.
Pharma Times
SEPTEMBER 23, 2021
Novartis will also add Arctos’ proprietary technology to its ophthalmology portfolio
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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.
BioSpace
SEPTEMBER 23, 2021
Esker Therapeutics tapped Martin Babler to helm the company after founding CEO June Lee has stepped away to pursue other opportunities.
Scienmag
SEPTEMBER 23, 2021
LA JOLLA, CA—Scientists at La Jolla Institute for Immunology (LJI) have published a detailed map of where human antibodies bind to SARS-CoV-2, a map that was generated by a global collaboration comparing nearly all leading clinical candidates. The new research, published in Science, will guide the development of more effective COVID-19 antibody therapies and help […].
BioSpace
SEPTEMBER 23, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Pharma Times
SEPTEMBER 23, 2021
Earlier this week, the NHS also began offering booster jab appointments for vulnerable groups
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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.
Delveinsight
SEPTEMBER 23, 2021
Boston Scientific pays USD 336 Million to acquire blood clot medical device firm. Boston Scientific Corp. is shelling out as much as USD 336 million to take over the rest of medical device firm Devoro Medical, which it has held a stake in since 2019. The payment comprises USD 269 million paid upfront for the 84% of the company Boston Scientific does not already own, plus up to USD 67 million in possible milestone payments.
BioSpace
SEPTEMBER 23, 2021
Life sciences organizations strengthen their leadership teams and boards with these Movers & Shakers.
Drug Patent Watch
SEPTEMBER 23, 2021
Annual Drug Patent Expirations for CONTRAVE Contrave is a drug marketed by Nalpropion and is included in one NDA. It is available from three suppliers. There are fourteen patents protecting…. The post New patent for Nalpropion drug CONTRAVE appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
SEPTEMBER 23, 2021
Scientists at the University of East Anglia (UEA) have identified a way of determining the age of a lobster based on its DNA. Credit: Dr Martin Taylor – University of East Anglia Scientists at the University of East Anglia (UEA) have identified a way of determining the age of a lobster based on its DNA. […].
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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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