Bio Pharma Dive
AUGUST 2, 2021
The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.
World of DTC Marketing
AUGUST 2, 2021
SUMMARY: The biggest barrier to great healthcare marketing is corporate politics. As more companies merge or are bought out big bureaucratic processes run counter to what online marketing is all about. Those people who are willing to disrupt pharma cultures will have a great career but it takes time, effort, and empathy for patients to make changes.
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Bio Pharma Dive
AUGUST 2, 2021
Biopharmaceutical companies have an opportunity to work alongside new healthcare ecosystem entrants for mutual benefit and better customer value.
BioPharma Reporter
AUGUST 2, 2021
With Scancell taking its DNA-based COVID-19 vaccine tech into clinical trials this year, it is already focusing its attention on the techâs potential to be used as a needle-free booster shot to address Variants of Concern.
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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
pharmaphorum
AUGUST 2, 2021
Ipsen’s new chief executive David Loew pledged to ramp up spending on the company’s pipeline when he took the helm last year, and a flurry of licensing deals in the last few weeks shows that push is starting to gather momentum. The French company – which focusing on cancer, neuroscience and rare diseases – has just snapped up two programmes from US biotech Exicure that span the latter two areas, targeted at rare neurodegenerative disorders Huntington’s disease and Angelman synd
BioPharma Reporter
AUGUST 2, 2021
According to the neurodegenerative-disease-focused biotechnology firm, their research could bring hope to patients with amyotrophic lateral sclerosis.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
AUGUST 2, 2021
Arcturus Therapeutics and its Vietnam partner Vinbiocare will take ARCT-154, a next-generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, into a Phase 1/2/3 trial. The companies will also establish a vaccine manufacturing centre in Vietnam.
BioSpace
AUGUST 2, 2021
?Eli Lilly and Company is in the news with positive Olumiant data in COVID-19, a drop in COVID-19 product sales for the quarter and a protest of one of their ads. Here’s a look.
BioPharma Reporter
AUGUST 2, 2021
The mRNA vaccine developed by Pfizer and BioNTech generates far higher levels of antibodies against the coronavirus than Sinovacâs inactivated virus prophylactic, according to a study.
BioSpace
AUGUST 2, 2021
With its acquisition, Sanofi aims to establish a firm toehold in the mRNA space by integrating dedicated research and development capabilities, chemistry, manufacturing and controls.
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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
Delveinsight
AUGUST 2, 2021
Peanut allergy (PA) is one of the most common food allergies that affect children in Western nations. It is diagnosed at early stages and often persists till adulthood in approximately 75%–80% of the cases. DelveInsight estimates that approximately 10,578,543 Peanut allergy prevalent cases were reported in 7MM (the US, EU5 (the UK, Italy, Spain, Germany and France) and Japan) out of which the US accounted for the highest prevalence with over 6 million cases.
BioSpace
AUGUST 2, 2021
Iterative Scopes closed on a $30 million Series A round. It was led by new investor Obvious Ventures, with participation from Eli Lilly, Johnson & Johnson Innovation – JJDC, Breyer Capital and Seae Ventures, in addition to Lee Shapiro, Zach Weinberg and Nat Turner.
BioPharma Reporter
AUGUST 2, 2021
The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.
BioSpace
AUGUST 2, 2021
BeiGene is building a new research and development and manufacturing facility on a 42-acre campus in New Jersey, while MorphoSys is now growing its presence in the greater Boston area.
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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 2, 2021
Bimekizumab is the first to follow NICE’s new expedited appraisal process
BioSpace
AUGUST 2, 2021
The FDA initiated the partial hold after Novartis’ subsidiary AveXis, the developer of the therapy, told health authorities it found dorsal root ganglia mononuclear cell inflammation associated with the treatment in preclinical animal studies.
Pharma Times
AUGUST 2, 2021
The approval is based on Phase III results from the CheckMate-577 trial
BioSpace
AUGUST 2, 2021
Sage announced the termination of the REDWOOD and RAINFOREST studies of zuranolone, which is being assessed to treat both major depressive disorder and post-partum depression.
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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 Times
AUGUST 2, 2021
Over 88% of adults have had a first dose and over 72% both doses
BioSpace
AUGUST 2, 2021
?The company announced that it is withdrawing its peripheral T-cell lymphoma drug Istodax from the market after recent trials showed that it does not achieve its primary efficacy endpoint.
BioPharma Reporter
AUGUST 2, 2021
Moderna has dosed the first participant in a Phase 1 study of its IL-2 mRNA therapeutic, mRNA-6231.
BioSpace
AUGUST 2, 2021
The drug, created by Vaxart, has just completed its Phase I trial and had submitted an Investigational New Drug application to move forward.
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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.
pharmaphorum
AUGUST 2, 2021
A digital therapeutic for patients with heart failure has been awarded breakthrough device status by the FDA – said by its developer Biofourmis to be the first time the US regulator has given this designation for this type of product. Boston-based Biofourmis claimed the accolade for its BiovitalsHF prescription digital therapeutic (DTx), which is used to make sure that patients who have heart failure with reduce ejection fraction (HFrEF) get the right drug treatment in accordance with clinical
BioSpace
AUGUST 2, 2021
The filing accused Mayne Pharma, which also has operations in the U.S., of breaching disclosure obligations with regard to anti-competitive conduct.
Drug Patent Watch
AUGUST 2, 2021
Annual Drug Patent Expirations for ELESTRIN Elestrin is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. There are two…. The post New patent expiration for Mylan Speciality drug ELESTRIN appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
AUGUST 2, 2021
Shares of Autolus were up more than 12% this morning after it forged an exclusive licensing agreement with Moderna to develop new messenger RNA therapeutics for cancer.
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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 Patent Watch
AUGUST 2, 2021
Annual Drug Patent Expirations for ARNUITY+ELLIPTA Arnuity Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent expiration for Glaxosmithkline drug ARNUITY ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
AUGUST 2, 2021
The FDA offered specific recommendations, including additional clinical and statistical data related to the primary and secondary endpoints of the pivotal Phase III trial.
Drug Patent Watch
AUGUST 2, 2021
Annual Drug Patent Expirations for FLONASE+SENSIMIST+ALLERGY+RELIEF Flonase Sensimist Allergy Relief is a drug marketed by Glaxosmithkline Cons and is included in one NDA. It is available from one supplier. There…. The post New patent expiration for Glaxosmithkline Cons drug FLONASE SENSIMIST ALLERGY RELIEF appeared first on DrugPatentWatch - Make Better Decisions.
Pharma Marketing Network
AUGUST 2, 2021
EHSx can connect your brand with your target audiences on over 4,000 quality whitelist healthcare publishers, and 10,000 pharma-safe, non-endemic properties. Download our EHSX one-pager to learn more! Name *. First. Last. Email *. Title Company Hidden Lead Source * Web Active Prospecting Sales Ad-Label Advertising - Offline Advertising - Online Advertising - Online - FocalPoint Advertising - Online - Mobile Advertising - Online - TrendMD Conference/Trade Show Date Connected on LinkedIn Domains D
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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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