Bio Pharma Dive
FEBRUARY 16, 2021
The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.
World of DTC Marketing
FEBRUARY 16, 2021
SUMMARY: This month, McKinsey agreed to pay nearly $600m to settle claims that its advice had exacerbated the deadly US opioid crisis, yet pharma views McKinsey as business gurus. This has to stop, and NOW! McKinsey is loaded with MBAs addicted to spreadsheets and PowerPoint presentations, so of course, they know about patients and pharma? McKinsey’s recommendations to Purdue were directly aimed at extreme sales improvement, and the analysis failed to address the potential of specific ince
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Bio Pharma Dive
FEBRUARY 16, 2021
The biotech is also suspending sales of its related treatment Zynteglo following a leukemia diagnosis in a clinical trial volunteer and a case of a cancer-like bone marrow disease in another.
Camargo
FEBRUARY 16, 2021
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Part 1 offered an overview and side-by-side comparison of the three designations, and now in Part 2, we give a detailed explanation of ODD for rare disease drug sponsors.
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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
Bio Pharma Dive
FEBRUARY 16, 2021
Simplify serious adverse events reconciliation operations with a customizable and GxP validated platform solution.
pharmaphorum
FEBRUARY 16, 2021
Medical charity Alzheimer’s Research UK has teamed up with artificial intelligence specialist Exscientia to find new drug treatments for the devastating neurodegenerative disease. . The alliance will see Exscientia work with the charity’s Oxford Drug Discovery Institute (ODDI) to find therapeutics that target the neuroinflammation associated with Alzheimer’s disease (AD), focusing in particular on the NLRP3 inflammasome pathway.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 16, 2021
A news agency is claiming that North Korea launched a cyber-attack on Pfizer in a bid to steal information about its BioNTech-partnered COVID-19 vaccine, citing South Korea’s National Intelligence Service (NIS). The Yonhap agency said the revelation was made during a closed-door meeting of the intelligence committee of South Korea’s National Assembly.
BioSpace
FEBRUARY 16, 2021
The U.S. FDA granted Amgen Priority Review for sotorasib for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), after at least one previous systemic therapy.
BioPharma Reporter
FEBRUARY 16, 2021
AstraZenecaâs COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO): meaning the vaccine can be rolled out globally through COVAX.
BioSpace
FEBRUARY 16, 2021
With the COVID-19 vaccine rollout underway and a renewed sense of hope stemming from an aggressive vaccine dispersal plan, a common question has begun to emerge.
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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
Pharma Marketing Network
FEBRUARY 16, 2021
It’s 2019, your plane is booked, your outfits for the next three days are all planned out and packed away in your suitcase. You have a list of all of the presentations you plan on attending during the three-day pharmaceutical conference in New Orleans, and all of your lines have been practiced in front of a mirror for when you go to interview some of the keynote speakers.
BioSpace
FEBRUARY 16, 2021
The company announced this morning it is merging with special purpose acquisition company Alpha Healthcare Acquisition Corp. and will begin trading on the Nasdaq exchange under the ticker symbol “HUMA” in the second quarter of 2021.
Scienmag
FEBRUARY 16, 2021
Laschamp excursion occurred in Australia and seen by first humans Credit: Associate Professor Michael-Shawn Fletcher Drilling a 270,000-year old core from a Tasmanian lake has provided the first Australian record of a major global event where the Earth’s magnetic field ‘switched ‘- and the opportunity to establish a precedent for developing new paleomagnetic dating tools […].
BioSpace
FEBRUARY 16, 2021
The Prostate Cancer Foundation has been an early accelerator of research that is now coming to fruition, including the early research into PSMA and the discovery that two FDA-approved PARP inhibitors, olaparib (Lynparza) and rucaparib (Rubraca) could work against mutant genes in prostate cancer.
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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.
Outsourcing Pharma
FEBRUARY 16, 2021
A study by two trial technology firms reportedly indicates that decentralized trials are outperforming on-site in recruitment, retention and other aspects.
BioSpace
FEBRUARY 16, 2021
Charles River Laboratories will acquire Cognate BioServices in an $875 million cash deal that will significantly expand the company’s capabilities in the high-growth cell and gene therapy sector.
Pharma Times
FEBRUARY 16, 2021
Antibody drug conjugate conditionally approved for HER2-positive metastatic breast cancer
BioSpace
FEBRUARY 16, 2021
In 2020, Vir and GlaxoSmithKline partnered to develop strategies against COVID-19. The two companies have expanded that collaboration to include work into new treatments for influenza and other respiratory viruses.
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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.
Scienmag
FEBRUARY 16, 2021
Tourists could be spreading the virus causing COVID-19 to wild mountain gorillas by taking selfies with the animals without following precautions Credit: Andrew Walmsley Tourists could be spreading the virus causing COVID-19 to wild mountain gorillas by taking selfies with the animals without following precautions. Researchers from Oxford Brookes University examined nearly 1,000 Instagram posts […].
NY Times
FEBRUARY 16, 2021
A health journalist is getting a front-row seat to one of the most-anticipated pediatric trials in history.
BioSpace
FEBRUARY 16, 2021
In Phase III studies, Eli Lilly’s tirzepatide led to significant A1C and body weight reductions from baseline in adults with type 2 diabetes.
pharmaphorum
FEBRUARY 16, 2021
KOL identification and KOL mapping are often spoken about together, often treated as the same entity would simply a difference in terminology. They are however very different, yet synergistic. KOL identification is about identifying those that can impact your work – clinicians, authors, speakers, nurses, tweeters, or the medics building cutting edge apps.
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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.
Scienmag
FEBRUARY 16, 2021
Some of the planet’s rarest metals – used in the manufacture of smartphones and other electrical equipment – are increasingly being found in everyday consumer plastics, according to new research. Scientists from the University of Plymouth and University of Illinois at Urbana-Champaign tested a range of new and used products including children’s toys, office equipment […].
Outsourcing Pharma
FEBRUARY 16, 2021
A leader from the clinical data solutions firm explains how the challenges created by the pandemic have helped fuel creativity and innovation in studies.
Scienmag
FEBRUARY 16, 2021
Credit: Aleksi Lehikoinen A study recently completed in Europe and North America indicates that the composition of wintering and breeding bird communities changes in line with global warming. However, wintering bird communities are considerably faster at tracking the changing climate compared to breeding communities. Climate change is driving species’ distribution towards the poles and mountaintops, […].
BioSpace
FEBRUARY 16, 2021
The Foundation will offer funding for development of the therapy.
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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.
Scienmag
FEBRUARY 16, 2021
CORVALLIS, Ore. – Statistical modeling developed by Oregon State University researchers has confirmed that changes to melanoma patients’ gut microbiome led them to respond to a type of treatment capable of providing long-term benefit. Findings were published in Science. The modeling technique invented by Andrey Morgun of the OSU College of Pharmacy and Natalia Shulzenko […].
Drug Patent Watch
FEBRUARY 16, 2021
Annual Drug Patent Expirations for GOPRELTO Goprelto is a drug marketed by Genus Lifesciences and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Genus Lifesciences drug GOPRELTO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
FEBRUARY 16, 2021
Credit: Purdue University/Mohammad Rahman WEST LAFAYETTE, Ind. – A new tool using an artificial intelligence platform may help doctors better prepare patients for surgery. Mohammad Rahman, a Purdue University associate professor of management, and his team developed the tool to help improve health care outcomes. They have received a Phase I SBIR grant from the […].
pharmaphorum
FEBRUARY 16, 2021
UK health chiefs have urged caution over any relaxation of lockdown rules amid signs that the impact of vaccination and social distancing regulations are beginning to work. Latest figures from the Office for National Statistics (ONS) covering England and Wales showed that for the week ending 5th February there were 7,320 deaths registered mentioning coronavirus , a decrease of 1,113 compared with the previous week.
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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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