Bio Pharma Dive
AUGUST 3, 2021
After reviewing animal study data submitted by the Swiss pharma, the FDA cleared spinal injections of Zolgensma for study in older patients with SMA.
NY Times
AUGUST 3, 2021
The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.
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Bio Pharma Dive
AUGUST 3, 2021
Nearly two months since Aduhelm became available, many physicians have yet to use the first treatment approved in the U.S. to slow Alzheimer's disease.
Outsourcing Pharma
AUGUST 3, 2021
A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques.
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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
AUGUST 3, 2021
The acquisition is a sign of how more and more large pharmaceutical companies view messenger RNA as an essential drug-making technology.
Outsourcing Pharma
AUGUST 3, 2021
The Psychae Institute, established by a global team of scientists, will conduct pre-clinical and clinical research around psychedelic medicine development.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Outsourcing Pharma
AUGUST 3, 2021
The success of mRNA vaccine technology could be one of the new opportunities for US pharmaceutical manufacturing looking forward, with pandemic investments helping turbocharge the sector.
BioSpace
AUGUST 3, 2021
Ophthalmology has become a focal point for private equity and venture capitalists in the past 18 months, despite being a small niche in the biopharmaceutical space.
pharmaphorum
AUGUST 3, 2021
The FDA has relaxed a clinical hold on clinical trials of Novartis’ intrathecal formulation of spinal muscular atrophy (SMA) gene therapy Zolgensma, allowing a new phase 3 trial to get underway. Zolgensma (onasemnogene abeparvovec) is already approved as an intravenous treatment in babies and very young children for the rare muscle-wasting disease, but the new OAV-101 IT version is designed to unlock use of the drug in older SMA patients.
BioSpace
AUGUST 3, 2021
Getting job-hunting and career advice is hard, especially when you get it from those who have worked for decades. Some advice is still helpful today, like making a good impression, but others are considered counter-productive.
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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 Times
AUGUST 3, 2021
The study will be the largest clinical trial of its kind in the UK, involving over 600 pregnant women
BioSpace
AUGUST 3, 2021
North Carolina’s biopharma business continues to expand at a rapid pace. Not only has the state’s hub in the Research Triangle Park continued to prosper, but companies are expanding in other areas across the state as well.
XTalks
AUGUST 3, 2021
After years of Johnson & Johnson baby powder ads targeted to black women, an advocacy group is seeking retribution by suing the healthcare conglomerate. The National Council of Negro Women (NCNW) filed a lawsuit last week asking courts to make Johnson & Johnson create equally targeted “corrective marketing,” and/or fund outreach efforts warning Black women and their families about the risk of ovarian cancer associated with its product.
BioSpace
AUGUST 3, 2021
Sonoma BioTherapeutics continues to work toward its goal of restoring immune system balance through complementary regulatory T cell therapy and effector T cell conditioning, this time with the help of an oversubscribed Series B round.
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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.
Pharma Times
AUGUST 3, 2021
Tecentriq is first and only cancer immunotherapy with positive Phase III results in adjuvant lung cancer setting
BioSpace
AUGUST 3, 2021
?Shares of Zymergen plummeted by 68% Tuesday from its April IPO price of $31 per share to just $11.7 per share after news that the company will not likely see revenue anytime soon.
Pharma Times
AUGUST 3, 2021
The £100m fine sends ‘a clear message’ to the pharma sector, said the CMA
BioSpace
AUGUST 3, 2021
Specifically, the FDA states Syntec has critical issues with how the pharmaceutical manufacturer handles active pharmaceutical ingredients, issues that may compromise the safety of the firm’s manufactured drugs.
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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.
Pharma in Brief
AUGUST 3, 2021
The Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board ( PMPRB ) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination. Procedural background. The PMPRB issued a decision in 2017 finding that Alexion Pharmaceuticals Inc. sold SOLIRIS (eculizumab) at an excessive price in Canada and ordering Alexion to remit excess revenues earned between 2009 and 2017.
BioSpace
AUGUST 3, 2021
?Biosimilars have gained traction in Europe, but not in the U.S. AbbVie’s Humira is often made as an example of how companies are using legal tactics to delay biosimilar competition.
BioPharma Reporter
AUGUST 3, 2021
Adoption of single-use technologies has grown exponentially over the last decade: but what will drive the tech forward in the coming years?
BioSpace
AUGUST 3, 2021
What is the culture like at your company? Are employees motivated to do their best work? Or are most people just going through the motions: clocking in, clocking out and collecting a paycheck?
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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
AUGUST 3, 2021
Sanofi will acquire Translate Bio for approximately $3.2bn, or $38.
BioSpace
AUGUST 3, 2021
The new $550 million site in N.C. follows the advanced packaging plant in Ohio that will significantly expand the company’s manufacturing capacity in the U.S.
BioPharma Reporter
AUGUST 3, 2021
Sanofi will acquire clinical-stage mRNA therapeutics company Translate Bio for $3.2bn.
BioSpace
AUGUST 3, 2021
Ardelyx indicates the restructuring plan will save $17 million in annual cash compensation although there will be a restructuring charge of about $3.4 million.
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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.
pharmaphorum
AUGUST 3, 2021
Sanofi has been forging ever-closer ties with its mRNA partner Translate Bio since the two started working together in 2018, and has now gone all in, offering $3.2 billion to buy the company outright. The $38-per-share deal – a 56% premium to Translate’s recent share price before an after-hours surge in the stock on rumours of the deal yesterday – has already been cleared by the boards of both companies and is due to close in the third quarter.
BioSpace
AUGUST 3, 2021
The company struck two separate collaborations over the past two days in order to advance the development of new, innovative medications.
pharmaphorum
AUGUST 3, 2021
The tectonic plates of healthcare technology assessment (HTA) have shifted – but where does the patient voice fit within this new evaluation paradigm? Recent advances in medical science, from genomics and gene therapies to artificial intelligence (AI), have transformed the healthcare landscape, and triggered a review of NICE’s methods and processes.
BioSpace
AUGUST 3, 2021
Schrödinger and Zai Lab have announced a worldwide development and commercialization collaboration to advance a novel oncology program targeting the DNA damage repair pathway.
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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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