Bio Pharma Dive
JUNE 9, 2021
Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look.
Camargo
JUNE 9, 2021
Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species. We have collaborated with sponsors on many niche programs that have shone a light on both the creativity and the broad range of specialized capabilities needed for such complex development programs.
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Bio Pharma Dive
JUNE 9, 2021
Though most of Merck's COVID-19 efforts have come up short, its antiviral pill could still have a role, as signaled by the U.S. government's sizable financial commitment.
BioSpace
JUNE 9, 2021
An immunocompromised patient in South Africa became a veritable COVID-19 variant laboratory as the virus mutated more than 30 times in 216 days of her infection, according to recent, not-yet-peer-reviewed research paper published in medRxiv.
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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
JUNE 9, 2021
The fast-growing biotech will work with Shoreline to develop cancer treatments using natural killer cells, an emerging alternative to T-cell based therapies.
pharmaphorum
JUNE 9, 2021
“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience voices. The experts discussed the benefits and merits of co-creation during a session on bridging the digital divide, held during the recent Patient Experience Digital Summit.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JUNE 9, 2021
June appears to be a busy month for Series A financing rounds, with Kurome, Onchilles Pharma, and Hawthorne Effect closing in on millions of dollars worth of startup investments.
BioPharma Reporter
JUNE 9, 2021
The World Health Organization (WHO), as part of its International Nonproprietary Names (INN) system, has recently made progress in developing and harmonizing the definition paragraphs that support the naming of cell-based substances.
BioSpace
JUNE 9, 2021
If you’re considering preparing for your next interview, know that you need to learn the art of drafting a perfect cover letter to show that you’re a great match for the position.
XTalks
JUNE 9, 2021
Biogen has been working vigorously over the past couple of years to get its potentially disease-modifying drug Aduhelm (aducanumab) approved for Alzheimer’s disease, and it has finally happened. This Monday, the US Food and Drug Administration (FDA) granted accelerated approval to the drug for the treatment of the disease. The historic and highly anticipated approval created a flurry of excitement in the Alzheimer’s disease space for patients, healthcare practitioners, advocacy groups and Biogen
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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
JUNE 9, 2021
Two of the company’s largest shareholders call for the ouster of a company director at Regeneron as top executives are under fire for their enormous compensation packages.
Scienmag
JUNE 9, 2021
Credit: Schiff, et al, Substance Use & Misuse, 2021. PITTSBURGH, June 10, 2021 – Americans are consuming more craft beer with higher alcohol content but are drinking less beer by volume, according to a new analysis led by epidemiologists at the University of Pittsburgh Graduate School of Public Health. The study, published online and in […].
BioSpace
JUNE 9, 2021
David S. Knopman and Joel S. Perlmutter both resigned from the committee after the approval of the drug aducanumab.
Scienmag
JUNE 9, 2021
Researchers identified the protein responsible for cancer’s aggressiveness Credit: Dorothy Kozlowski/UGA Prostate cancer is the second most common cancer among men, according to the American Cancer Society. It’s also one of the trickiest cancers to diagnose and treat. But new research from the University of Georgia has identified a protein that appears to prevent the […].
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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
JUNE 9, 2021
The first biopharma interview after college will increase your stress and anxiety. However, we offer a few time-tested tips to help you nail your first interview.
Scienmag
JUNE 9, 2021
Credit: Source: IFJ PAN / Dual Color Inside each proton or neutron there are three quarks bound by gluons. Until now, it has often been assumed that two of them form a “stable” pair known as a diquark. It seems, however, that it’s the end of the road for the diquarks in physics. This is […].
Pharma Times
JUNE 9, 2021
The NIHR-supported RECOVERY trial found that the anti-inflammatory drug does not improve survival for hospitalised patients with COVID-19
Scienmag
JUNE 9, 2021
Credit: Daniel Montgomery/MIT Picower Institute To focus on what’s new, we disregard what’s not. A new study by researchers at MIT’s Picower Institute for Learning and Memory substantially advances understanding of how a mammalian brain enables this “visual recognition memory.” Dismissing the things in a scene that have proven to be of no consequence is […].
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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
JUNE 9, 2021
This week, multiple companies have partnered in attempts to bring forth new therapies. BioSpace takes a look at some of these announcements.
Scienmag
JUNE 9, 2021
Researchers from CRAG and IRTA find the gene that determines Japanese plum skin colour due to the presence or absence of anthocyanins, a group of plant antioxidant pigments with health-promoting effects Credit: CRAG-IRTA The presence and accumulation of the antioxidant pigment anthocyanin dictates fruit hue in plums, and the synthesis of this compound is known […].
BioSpace
JUNE 9, 2021
The new study findings may pave the way for Bristol Myers Squibb to receive additional approval for Breyanzi in a vulnerable patient population.
Scienmag
JUNE 9, 2021
Foreseen drop in 2020 sales-related e-waste: 4.9 million metric tonnes or ~6.4%; Pandemic intensified digital divide between high, middle and low income countries Credit: UNU / UNITAR In the first three quarters of 2020, the COVID-19 pandemic caused a 30% fall in electronic and electrical equipment sales in low- and middle-income countries but only a […].
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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.
Pharma Times
JUNE 9, 2021
Under Operation Pangea, officers were also able to shut down or block 113,000 illegally operating websites
pharmaphorum
JUNE 9, 2021
The unexpected approval and lofty pricing of Biogen’s Alzheimer’s therapy Aduhelm is clearly the biopharma event of the year so far, but what are the broader implications for the industry as a whole? Analysts at RBC Capital Markets say that the decision points to an unprecedented shift in position for the FDA when it comes to regulating drugs for neurological and psychiatric disorders – and while the potential for Aduhelm may still be speculative , other drug developers could see big
Scienmag
JUNE 9, 2021
Credit: ESO/M. Kornmesser An international group of collaborators, including scientists from NASA’s Jet Propulsion Laboratory and The University of New Mexico, have discovered a new, temperate sub-Neptune sized exoplanet with a 24-day orbital period orbiting a nearby M dwarf star. The recent discovery offers exciting research opportunities thanks to the planet’s substantial atmosphere, small star, […].
BioSpace
JUNE 9, 2021
?Synthekine and Bright Peak made announcements on their Series B rounds, while Hawthorne Effect and Owl Peak Labs also secured their funding. Let us take a look.
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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
JUNE 9, 2021
Credit: Georgina Gurney / ARC Centre of Excellence for Coral Reef Studies. New research shows what is often assumed to be ‘fair’ in conservation practice may not be considered so by the very people most affected by it–and a new approach is needed if protected areas are to be effective. Lead author Dr Georgina Gurney, […].
BioSpace
JUNE 9, 2021
The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.
XTalks
JUNE 9, 2021
In the food and beverage industry, mergers and acquisitions are big news. But the other side of the coin — selling off or scrapping plans to acquire businesses — is just as significant. Now, two of the world’s largest food companies , Nestlé and Mondelez, are rethinking some of their prior business decisions and conducting strategic reviews. So, why are these two food giants changing directions?
BioSpace
JUNE 9, 2021
John Edwards, newly-appointed CEO of Verseau Therapeutics, is continually searching for something special.
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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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