Alexion, AstraZeneca executives switch roles amid $39B buyout
Bio Pharma Dive
JUNE 4, 2021
Marc Dunoyer, the U.K. drugmaker's longtime finance chief, will move over to a strategy role and run Alexion as a rare disease unit within AstraZeneca.
Fri.Jun 04, 2021
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Personal responsibility in the obesity epidemic
World of DTC Marketing
JUNE 4, 2021
SUMMARY: The U.S. is one of the wealthiest countries in the world and accordingly has high obesity rates; one-third of the population has obesity plus another third is overweight. The cost of doing nothing is not an option. Yes, there are root causes for obesity that can’t be fixed quickly, but among the causes that we can try and change is our personal responsibility to live a healthier life.
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Bristol Myers sued over delayed approval of cancer cell therapy
Bio Pharma Dive
JUNE 4, 2021
A bank representing former Celgene shareholders claims Bristol Myers did not work diligently to secure FDA clearance of Breyanzi, one of three drugs covered by a $6.4 billion agreement between the two companies.
In the News: May 2021 Regulatory and Development Updates
Camargo
JUNE 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: Non-Opioid for Post-Surgical Pain Gets FDA Nod. Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair.
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
Novartis reports 'clinically relevant' survival data for Lutathera
Pharma Times
JUNE 4, 2021
The radioligand therapy was linked with a significant increase in progression-free survival and a clinically relevant increase in overall survival in patients with midgut neuroendocrine tumours
New patent for Vifor Fresenius drug VELPHORO
Drug Patent Watch
JUNE 4, 2021
Annual Drug Patent Expirations for VELPHORO Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Vifor Fresenius drug VELPHORO appeared first on DrugPatentWatch - Make Better Decisions.
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New patent for Allergan Holdings drug VIBERZI
Drug Patent Watch
JUNE 4, 2021
Annual Drug Patent Expirations for VIBERZI Viberzi is a drug marketed by Allergan Holdings and is included in one NDA. It is available from one supplier. There are fourteen patents…. The post New patent for Allergan Holdings drug VIBERZI appeared first on DrugPatentWatch - Make Better Decisions.
ASCO21: Lynparza aces adjuvant breast cancer therapy trial
pharmaphorum
JUNE 4, 2021
AstraZeneca and Merck & Co’s Lynparza is primed for even wider use in the treatment of breast cancer after a phase 3 trial showed it could extend the time for the cancer to return when used as adjuvant therapy. Giving Lynparza (olaparib) to women with BRCA-positive, HER2-negative breast cancer straight after chemotherapy and surgery to remove the tumour reduced the risk of recurrence, secondary cancers or death by 42% compared to placebo after 2.5 years of follow-up.
RXBAR Introduces its First Plant-Based Protein Bar
XTalks
JUNE 4, 2021
RXBAR has introduced its first-ever plant-based protein bars, which fans have been highly anticipating. . Traditionally, RXBAR uses egg whites as its main source of protein, but with the plant-based product, the company is replacing this signature ingredient with ten grams of plant-based protein. “Fans have been asking for a plant-based RXBAR for quite some time,” said Jenny Lindquist, director of experience planning at RXBAR, in a press release.
Prostate Cancer Drug Development Summit
pharmaphorum
JUNE 4, 2021
The inaugural Prostate Cancer Drug Development Summit is the only industry-led meeting uniting large pharma, biotech and pioneering academics with the ambitious objective of accelerating the clinical development of safe and effective therapies to treat prostate cancer. With sessions on both early and advanced stages of prostate cancer (Non-Metastatic Castrate-Resistant Prostate Cancer (nmCRPC) and Metastatic Castrate-Resistant Prostate Cancer (mCRPC) , this is a conversation not to mi
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
New patent for Chiesi drug FERRIPROX
Drug Patent Watch
JUNE 4, 2021
Annual Drug Patent Expirations for FERRIPROX Ferriprox is a drug marketed by Chiesi and is included in three NDAs. It is available from two suppliers. There are five patents protecting…. The post New patent for Chiesi drug FERRIPROX appeared first on DrugPatentWatch - Make Better Decisions.
Robots with T-ray technology to spot and remove cancer tumors in £8 million project
Scienmag
JUNE 4, 2021
New technology that will marry probes that can detect cancer tumours through the skin with high-precision robotic surgery is to be developed for use in hospital settings for the first time in a project led by the University of Warwick Credit: University of Warwick Scientists to investigate potential of terahertz radiation, or T-rays, to diagnose […].
New patent expiration for Cumberland Pharms drug VIBATIV
Drug Patent Watch
JUNE 4, 2021
Annual Drug Patent Expirations for VIBATIV Vibativ is a drug marketed by Cumberland Pharms and is included in one NDA. It is available from one supplier. There are eleven patents…. The post New patent expiration for Cumberland Pharms drug VIBATIV appeared first on DrugPatentWatch - Make Better Decisions.
New marine scale worm species first to provide evidence of male dwarfism
Scienmag
JUNE 4, 2021
Credit: Toba Aquarium In the Kumano Sea, off the southeast coast of Japan, an evolutionary mystery lay in wait. Researchers collected samples from the muddy sea floor, including hermit crabs, mollusks and discarded shells. Here, in and on these shells, they found scale worms living mostly in pairs with a striking difference compared to the […].
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.
New patent for Evoke Pharma drug GIMOTI
Drug Patent Watch
JUNE 4, 2021
Annual Drug Patent Expirations for GIMOTI Gimoti is a drug marketed by Evoke Pharma Inc and is included in one NDA. There are two patents protecting this drug. This drug…. The post New patent for Evoke Pharma drug GIMOTI appeared first on DrugPatentWatch - Make Better Decisions.
nTIDE May 2021 Jobs Report: Slow improvement as economy strives for recovery
Scienmag
JUNE 4, 2021
National Trends in Disability Employment (nTIDE) — issued semi-monthly by Kessler Foundation and the University of New Hampshire Credit: Kessler Foundation East Hanover, NJ – June 4, 2021 – Modest rises in the economic indicators for people with and without disabilities may be signs of continued economic recovery, according to today’s National Trends in Disability […].
ASCO21: Novartis’ prostate cancer radiotherapy extends survival
pharmaphorum
JUNE 4, 2021
Novartis’ big investment in radiopharmaceuticals for cancer seems to have paid off, after lead candidate 177Lu-PSMA-617 helped men with advanced prostate cancer and few treatment options live longer in a phase 3 trial. New data from the VISION study showed that 177Lu-PSMA-617 on top of standard care reduced the risk of death by 38% compared to standard care alone in men with PSMA-positive metastatic castration-resistant prostate cancer (CRPC) who had progressed after three or more anti-and
New findings offer improved therapy of early-stage, BRCA mutation-associated breast cancer
Scienmag
JUNE 4, 2021
Houston Methodist expert who led US component of trial available to address eagerly anticipated OlympiA trial results Credit: Houston Methodist HOUSTON-(June 3, 2021) – Results were released this week on a new treatment with the potential to improve the outcomes for patients with hereditary BRCA mutations and high-risk, early-stage breast cancer.
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.
What are some of dos and don’ts on starter materials for CGT manufacturing?
BioPharma Reporter
JUNE 4, 2021
Raw materials play a vital role in the development of cell and gene (CGT) therapies.
Most US adults may lack knowledge about palliative care
Scienmag
JUNE 4, 2021
Palliative care can improve outcomes and quality of life for patients with cancer Bottom Line: The majority of surveyed Americans had an inadequate understanding of palliative care, and frequency of health care utilization was one determinant of knowledge. Journal in Which the Study was Published: Cancer Epidemiology, Biomarkers & Prevention, a journal of the American […].
Lynparza shows promise in preventing cancer recurrence
Pharma Times
JUNE 4, 2021
Lynparza is the first medicine targeting BRCA mutations to show clinical benefit in adjuvant setting
Nutritional supplement proves 92% effective in boosting brain function
Scienmag
JUNE 4, 2021
An international subject pool was studied to confirm the effectiveness of a whole food complete vitamin and meal replacement product, IQed. The article, co-authored by Lisa Geng; Francine Hamel, EdD, SLP-CCC; Doreen Lewis, Ph.D., appeared in the peer-reviewed journal, Alternative Therapies (Altern Ther Health Med 2021 Mar;27(2):11-20(. The findings indicate that the carefully developed nutritional supplement, IQed […].
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.
Bayer props up sagging radionuclide business with Noria acquisition
pharmaphorum
JUNE 4, 2021
Bayer has agreed to buy Noria Therapeutics and its subsidiary PSMA Therapeutics, adding to its pipeline of radionuclide drugs for cancer as sales of its lead product in the category – Xofigo – continue to decline. . Just over three years ago, Bayer was forced to concede that its blockbuster expectations for Xofigo (radium Ra 223 dichloride) would come to nothing, after the castration-resistant prostate cancer drug was linked to more fractures and deaths when combined with Zytiga (abiraterone ace
NTU scientists establish new records of Singapore’s sea-level history
Scienmag
JUNE 4, 2021
Nation’s ability to predict sea-level rise boosted with record going back to 10,000 years ago Credit: NTU Singapore Climate scientists at the Nanyang Technological University, Singapore (NTU, Singapore) have extended the known record of Singapore’s sea-level to almost 10,000 years ago, providing a more robust dataset to aid future predictions of sea-level rise.
NICE turns down GSK's IV Benlysta for systemic lupus
Pharma Times
JUNE 4, 2021
The cost watchdog said uncertain trial evidence and cost-effectiveness estimates are behind the preliminary decision
New study into green tea’s potential to help tackle COVID-19
Scienmag
JUNE 4, 2021
As India continues to be ravaged by the pandemic, a Swansea University academic is investigating how green tea could give rise to a drug capable of tackling COVID-19 As India continues to be ravaged by the pandemic, a Swansea University academic is investigating how green tea could give rise to a drug capable of tackling […].
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.
Clinical Research Site Owner Gets 28 Years in Prison For Research Fraud
Clinical Trial Gurus
JUNE 4, 2021
This is the type of story that should be featured on American Greed and is also an unfortunate story of a clinical research site owner who lost control of his addictions and ambitions while continuously attempting to cover up lie after lie.
ADHD medications associated with reduced risk of suicidality in certain children
Scienmag
JUNE 4, 2021
In large observational study, CHOP researchers find ADHD drugs are associated with less suicidal behavior and thoughts in preadolescent children with substantial externalizing behaviors like hyperactivity and oppositional defiance Credit: CHOP Philadelphia, June 4, 2021–ADHD medications may lower suicide risk in children with hyperactivity, oppositional defiance and other behavioral disorders, according to new research from […].
Forever Welcome Moves Forward With a Foundation
Intouch Solutions
JUNE 4, 2021
Sunayana Dumala lost her husband Srinu Kuchibhotla to a hate crime in early 2017, and Intouch was there to help. Today, his legacy lives on in the foundation she created. Check out our conversation to learn more about the foundation and this extraordinary Intoucher! The post Forever Welcome Moves Forward With a Foundation appeared first on Intouch Solutions.
Study finds lower mortality rate for men at high risk for death from prostate cancer who received early postoperative radiation therapy
Scienmag
JUNE 4, 2021
In a large, international retrospective study, men at high risk for death from prostate cancer had a significant reduction in all-cause mortality if treated with radiation shortly after surgery In a large, international retrospective study, men at high risk for death from prostate cancer had a significant reduction in all-cause mortality if treated with radiation […].
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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