Bio Pharma Dive
JUNE 15, 2022
A closely watched study missed its goal, failing to prove the antiviral pill’s benefit in a broader population than the high-risk individuals for which it’s currently cleared.
Scienmag
JUNE 15, 2022
Did you know that more than 26,500 Canadians died from opioid intoxication between January 2016 and September 2021? Or that more than 350,000 people who used drugs containing opioids to relieve their pain did so problematically? Credit: CHUM Did you know that more than 26,500 Canadians died from opioid intoxication between January 2016 and September […].
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pharmaphorum
JUNE 13, 2022
Canary Wharf’s bid to become a new hub for the life sciences sector in the UK has been given a boost following the decision by Genomics England to relocate to the development. The organisation – which analyses sequenced genomes for the NHS and helps researchers access and use data to help identify the causes of disease – will “anchor” the new cluster, according to Canary Wharf Group (CWG), which is behind the initiative.
NY Times
JUNE 13, 2022
The drug, made by Eli Lilly, is already used for rheumatoid arthritis, and could be followed by two more drugs from other companies.
Bio Pharma Dive
JUNE 16, 2022
At a two-day meeting, experts argued drug divestitures may not be enough to prevent market concentration. Economists and regulators also appeared worried by the effect of buyouts on innovation.
BioPharma Reporter
JUNE 16, 2022
Valneva has reached a settlement with the UK government over an abandoned COVID-19 vaccine contract. Meanwhile, the future of its COVID-19 vaccine in the EU could become clearer next week after an EMA committee vote.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NY Times
JUNE 13, 2022
Outside experts will make their recommendations this week on how the agency should rule on applications from Pfizer and Moderna to vaccinate the nation’s youngest children.
Bio Pharma Dive
JUNE 11, 2022
Positive data from 75 patients with either sickle cell disease or beta thalassemia keep the companies’ therapy on track to become the first CRISPR-based treatment submitted to drug regulators, possibly by the end of the year.
BioSpace
JUNE 16, 2022
Moderna's study, dubbed BabyCove, is expected to begin recruiting in September and will include up to 700 babies three to six months of age.
pharmaphorum
JUNE 17, 2022
It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19.” . At the time of authorisation, the United States federal government had already purchased 10 million doses of the drug.
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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
Outsourcing Pharma
JUNE 14, 2022
During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.
Bio Pharma Dive
JUNE 16, 2022
The failure is an upset not only to Roche, but also a blow to the wider Alzheimer’s research field, which has for years kept focus on a protein called beta amyloid.
Scienmag
JUNE 15, 2022
On any given day between 2016 and 2019, Heather Stewart could be found snorkeling in between mangroves in the Bocas del Toro archipelago along Panama’s Caribbean coast. For years she visited these forests at the interface between land and sea, trying to understand what drove corals to grow inside them. Corals and mangroves often grow […].
pharmaphorum
JUNE 14, 2022
Eli Lilly and Incyte’s Olumiant has secured the first FDA approval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair loss that affects more than 700,000 people in the US. The JAK1/2 inhibitor has been cleared for adults who are severely affected with the condition at a dose of 2mg once-daily, which can be stepped up to 4mg/day if needed, and according to the FDA will “help fulfil a significant unmet need for patients.” It is estimated tha
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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.
Drug Channels
JUNE 14, 2022
Last week, the authors of a new JAMA study claimed that “prices for new drugs are skyrocketing.” Their research, along with a simultaneously released New York Times op-ed, received widespread media coverage. Links below. But as I explain, the study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations.
Bio Pharma Dive
JUNE 15, 2022
Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.
Scienmag
JUNE 12, 2022
Many dog lovers want to know what goes on in their furry friends’ minds. Now scientists are finally getting closer to the answer. In a new study just published in the journal of Animal Cognition, researchers from the Family Dog Project (Eötvös Loránd University University, Budapest) found out that dogs have a “multi-modal mental image” […].
BioPharma Reporter
JUNE 16, 2022
The BIO International Convention in San Diego this week heard the US-based Center for Breakthrough Medicines (CBM) is to speed up plans to build what it calls the largest cell therapy manufacturing operation worldwide.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Drug Channels
JUNE 17, 2022
Today’s guest post comes from Shawn Seamans, Chief Commercial Officer at CoverMyMeds. Shawn discusses how technology can be combined with human intervention to better help patients access, afford, and adhere to their therapies. He then describes how three patients benefited from support solutions. For more information about how CoverMyMeds’ solutions can support the patient journey for your brand, visit their digital commercialization experience.
Bio Pharma Dive
JUNE 15, 2022
The fund, Third Rock’s sixth, comes amid a significant downturn in the biotech stock market, which has raised questions about the viability of young drug startups.
Scienmag
JUNE 16, 2022
Drab urban environments tend to increase our stress, whereas nature can soothe the soul, but how do you get the best of both? One option is to increase color and vegetation in cities, but finding the best approach can be tricky. A new study in Frontiers in Virtual Reality tested the effects of vegetation and […].
XTalks
JUNE 17, 2022
Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. Olumiant oral tablets — in 4 mg, 2 mg and 1 mg doses taken once daily — were approved for the treatment of adults with the rare hair loss condition.
Pharma Times
JUNE 17, 2022
Verzenios in combination with endocrine treats people with early breast cancer who are at high-risk of recurrence
Bio Pharma Dive
JUNE 14, 2022
The partners’ JAK inhibitor Olumiant is the first systemic treatment for an autoimmune disease that causes hair loss. But known risks of heart attacks and cancer could complicate its launch.
Scienmag
JUNE 17, 2022
Media contacts: Credit: Richard Pasley for UMass Lowell Media contacts: Emily Gowdey-Backus, Emily_GowdeyBackus@uml.edu Nancy Cicco, Nancy_Cicco@uml.edu UMass Lowell Chancellor Jacquie Moloney has been honored for her role in founding the Deshpande Symposium for Innovation and Entrepreneurship in Higher Education. Now in its 11th year, the international conference is dedicated to integrating entrepreneurship education and […].
Drug Channels
JUNE 13, 2022
Informa Connect’s IDN & Bio/Pharma Partnering Summit Hybrid Event August 16-17, 2022 | Philadelphia, PA www.informaconnect.com/IDN. Don’t miss the IDN & Bio/Pharma Partnering Summit coming up this summer in Philadelphia, where you'll be part of the important discussions on how to best optimize strategic partnerships to improve patient access and outcomes.
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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 12, 2022
Ahead of a scheduled Advisory Committee meeting this week, the FDA released favorable remarks about the Pfizer-BioNTech and Moderna COVID-19 vaccines for children under the age of five.
Bio Pharma Dive
JUNE 13, 2022
The Massachusetts-based biotech is awaiting a decision in the U.S., where the FDA recently extended its review after agency advisers narrowly voted against the treatment.
Pharma Times
JUNE 14, 2022
Funding will enable the development of Spirea’s pipeline of antibody drug conjugate therapeutics for the treatment of solid tumours
pharmaphorum
JUNE 16, 2022
When creating engagement plans for individual Digital Key Opinion Leaders (DOLs), it’s best to look at a range of data-led metrics about each DOL to fine tune the engagement and maximise benefit for all parties. The simplest, and often easiest metrics to obtain, relate to the activity characteristics of the Digital KOL. In Twitter for example, this may equate to the DOL’s activity levels, follower numbers, and so on.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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