Bio Pharma Dive
OCTOBER 3, 2022
Shares in LogicBio had lost nearly all their value since a 2018 IPO, bringing the company to the brink of Nasdaq delisting. The buyout deal represents a premium of over 600%.
Pharmaceutical Technology
OCTOBER 3, 2022
The UK National Institute for Health and Care Excellence (NICE) has recommended zanubrutinib (Brukinsa) as an option to treat Waldenstrom’s macroglobulinaemia (WM) patients. With the latest development, zanubrutinib became the first WM drug to receive the recommendation for routine National Health Service (NHS) usage in England. The recommendation will also be applicable in Wales and Northern Ireland.
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Bio Pharma Dive
OCTOBER 3, 2022
Part of a $1 billion alliance the companies formed in 2020, the drug will be tested in a large study of patients who test positive for mutations in a gene called LRRK2.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 3, 2022
After 50 years of research, eminent Stanford University sleep researcher William Dement reportedly said the only solid explanation he knows for why we sleep is “because we get sleepy” Even though sleep may be, as one researcher put it, “the only major behavior in search of a function”, it clearly does matter for our health […].
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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
OCTOBER 3, 2022
The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.
Pharmaceutical Technology
OCTOBER 3, 2022
Myovant Sciences has rejected an acquisition offer worth $2.5bn from Sumitovant Biopharma and its wholly-owned subsidiary Sumitomo Pharma, citing it 'significantly undervalues' the company. Sumitovant and Sumitomo submitted a non-binding proposal to the audit committee of the board of directors of Myovant for the acquisition of all outstanding shares of the company that are not currently held by Sumitovant for $22.75 for each share in cash.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 3, 2022
Indonesia has granted Emergency Use Authorization (EUA) for the patent-free Covid-19 vaccine, IndoVac, developed by the Texas Children’s Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine, US. PT Bio Farma will manufacture 20 million doses of the vaccine this year. Additionally, the company will produce another 100 million vaccine doses by 2024.
Bio Pharma Dive
OCTOBER 3, 2022
The biotech said the proposed offer “significantly undervalues” the company, but that it’s open to considering a higher bid.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 3, 2022
Multiple job opportunities can be created for the pharmacy graduates in Ayurveda provided the degree course in Ayurveda pharmacy (B Pharm Ayurveda) is redesigned as a combined pharmacy degree course for all the Ayush streams such as Ayurveda, Unani, Siddha and Homoeopathy which involve drugs for therapies. If the programme is reconfigured to a common […].
STAT News
OCTOBER 3, 2022
A Swedish scientist won the 2022 Nobel Prize in medicine or physiology on Monday for his groundbreaking research into the evolutionary history of humankind. Svante Pääbo, of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, accomplished something widely believed to be impossible: recovering and reading DNA from 40,000-year-old bones.
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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
NPR Health - Shots
OCTOBER 3, 2022
Planned Parenthood says it will provide abortions out of an RV-based clinic in southern Illinois by the end of the year. It will reduce travel time for some patients coming from surrounding states.
STAT News
OCTOBER 3, 2022
A biopsy that turns out to have benign results can be a relief. But in some cases, it could also mean a patient whose risk of cancer was low from the start has gone through an unnecessarily invasive procedure. By and large, radiologists recommend that patients whose breast MRI scans raise suspicion of a cancerous growth get a biopsy done. But MRIs often pick up on benign lesions that other mammograms and ultrasound may not.
pharmaphorum
OCTOBER 3, 2022
Gaurav Kapoor, co-founder and executive vice president of Indegene, tells pharmaphorum how pharma can take lessons from the entertainment industry and prepare for the Metaverse to enhance content engagement. Pharma companies’ customer communication methods require reimagining as technology progresses. Kapoor says, now, pharma can learn from the on-demand nature of content distribution that Hollywood utilises and simultaneously prepare for future needs in content delivery. “One of our
STAT News
OCTOBER 3, 2022
Epic Systems has revamped its widely criticized sepsis prediction model in a bid to improve its accuracy and make its alerts more meaningful to clinicians trying to snuff out the deadly condition. Corporate documents obtained by STAT show that Epic is now recommending that its model be trained on a hospital’s own data before clinical use, a major shift aimed at ensuring its predictions are relevant to the actual patient population a hospital treats.
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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.
NPR Health - Shots
OCTOBER 3, 2022
It started in July. The callers live in Gourd Island, and they were hoping to share an important message that they say was being ignored by their local authorities.
FDA Law Blog
OCTOBER 3, 2022
By Faraz Siddiqui & Jeffrey N. Wasserstein — On September 26, 2022, Biogen Inc. agreed to pay $900 million to the United States and various states to settle a False Claims Act (FCA) lawsuit. This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action.
NPR Health - Shots
OCTOBER 3, 2022
Measures being considered represent renewed interest in restricting abortion on the island after the U.S. Supreme Court threw out its 1973 Roe v. Wade decision that protected abortion rights.
STAT News
OCTOBER 3, 2022
In August, the White House’s Office of Science and Technology Policy released a memo directing all federal agencies to form plans to make all federally funded research publications and data publicly available without embargo by the end of 2025. Most people who heard the news likely envisioned making a cup of coffee on Jan. 1, 2026, opening up JAMA’s or Nature’s website, and being able to read any article for free.
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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.
NPR Health - Shots
OCTOBER 3, 2022
Medical debt can ruin people's credit rating — making it hard to get a loan, mortgage or credit card. People of color are most impacted by this issue and programs designed to help are falling short.
STAT News
OCTOBER 3, 2022
In just seven days last June, the U.S. Supreme Court set back public health by 50 years. The court’s conservative majority rolled back efforts to address the pressing threat of climate change , expanded access to deadly firearms , and eliminated the right to abortion by overturning Roe v. Wade. Earlier, it had eviscerated public health powers to curb the Covid-19 pandemic.
ACRP blog
OCTOBER 3, 2022
Talking about diversity, raising awareness about inequities, and challenging others to think about facing inclusivity challenges in new ways are vital, but there’s nothing quite like rolling up your sleeves and tackling a problem directly at the grassroots level. Just ask Michaele Linden-Johnson, FACHE, MBA, LCSW, director of clinical trials and business development at the Medical Center of the Americas (MCA) Foundation Cardwell Collaborative in El Paso, Texas.
STAT News
OCTOBER 3, 2022
Today, 9 in 10 Americans have health insurance, more than ever before, yet health care is less affordable than ever. Up to 100 million U.S. adults carry medical debt. Skyrocketing inflation is forcing people to decide between spending money on medical care or other necessities like food and housing. People typically spend thousands of dollars, in addition to premiums, before insurance kicks in.
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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.
Antidote
OCTOBER 3, 2022
Complement 3 Glomerulopathy, most commonly shortened to C3G or C3G kidney disease, is a rare type of kidney disease that has only been diagnosed since 2013. “C3” refers to a blood protein that has a vital role in the immune system, and “G” is for the damage to glomeruli in the kidneys.
STAT News
OCTOBER 3, 2022
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-too familiar routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, keeps spinning. So to nudge it in a good direction, we are firing up the coffee kettle and brewing a cup of stimulation.
BioPharma Reporter
OCTOBER 3, 2022
Vitamin D supplementation does not influence the efficacy or immunogenicity of SARS-CoV-2 vaccinations in patients with sub-optimal levels prior to vitamin treatment, according to a new study.
STAT News
OCTOBER 3, 2022
Amid heightened debate over a regulatory program for speeding the approval of some medicines, a new government analysis finds extensive delays in the clinical trials that drug makers are required to conduct after approvals. At issue is accelerated approval, which the U.S. Food and Drug Administration established in 1982 in an effort to get medicines for hard-to-treat diseases to patients sooner than they might under the usual pathways to the marketplace.
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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 Discovery World
OCTOBER 3, 2022
Join Anne Hammerstein, Ph.D., Product Manager at SPT Labtech, for a fascinating deep dive into the practical considerations of how, when and why you should automate your laboratory’s liquid handling processes. The talk will take place at ELRIG’s Drug Discovery 2022 Tech Theatre, supported by DDW. The event will take place on 4-5 Oct, London Excel, UK and topics will include: The lab of the future is now.
XTalks
OCTOBER 3, 2022
Effective energy management in the food and beverage industry is not just a preference, but a business necessity. With increased competitive pressures, tighter margins and rising energy prices, food and beverage plants are being forced to change their historical approach of treating energy usage as an unmanaged trade expense. Not to mention, with the need for consistent heating and refrigeration, the food and beverage industry is a massive energy hog.
pharmaphorum
OCTOBER 3, 2022
In draft guidance published on Friday, it emerged NICE does not recommend PTC Therapeutics’ Translarna (ataluren) for the treatment of Duchenne muscular dystrophy (DMD) caused by a nonsense mutation. The decision came following a re-evaluation of Translarna in order to decide whether to make it available for routine funding on the NHS. The re-evaluation followed a six-year period during which the DMD drug had been available under a managed access agreement (MAA), which ends in January next year,
Pharma Times
OCTOBER 3, 2022
Events will raise awareness around the impact of atopic dermatitis across cultures
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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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