Bio Pharma Dive
AUGUST 27, 2021
The drugmaker is setting the price for Voxzogo high, at an annual price of around $300,000 per patient, although the company expects to make "material discounts" in the coming years.
XTalks
AUGUST 27, 2021
General Mills appears to be exploring and developing an animal-free dairy cheese brand called Renegade Creamery. Renegade Creamery makes plant-based cheese but adds milk proteins produced in strains of yeast and bacteria and uses an “artisan fermentation process.” This technique results in the same taste and texture as dairy cheese, is a sustainable product and reduces greenhouse gases by being animal-free.
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Drug Patent Watch
AUGUST 27, 2021
Annual Drug Patent Expirations for EPCLUSA Epclusa is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are twenty-six…. The post New patent for Gilead Sciences drug EPCLUSA appeared first on DrugPatentWatch - Make Better Decisions.
Delveinsight
AUGUST 27, 2021
Duchenne muscular dystrophy (DMD) is a rare genetic disorder usually diagnosed in young boys, gradually weakening muscles across the body until the heart or lungs fail. Symptoms often show up by the age of 5; as the disease progresses, patients tend to lose the ability to walk around the age of 12. As per a recent analysis by DelveInsight, DMD market is expected to achieve more than 8,000 million in revenue in the 7 Major Market (The United States, Germany, France, Italy, Spain, UK, and Japan) b
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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
Pharma Times
AUGUST 27, 2021
Accelerated assessment granted for company’s lead product candidate ganaxolone
pharmaphorum
AUGUST 27, 2021
Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for patients with certain types of lymphoma. The European Commission has approved tafasitamab in combination with Bristol-Myers Squibb’s Revlimid (lenalidomide), followed by the antibody on its own, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
AUGUST 27, 2021
Annual Drug Patent Expirations for NURTEC+ODT Nurtec Odt is a drug marketed by Biohaven Pharm and is included in one NDA. There are two patents protecting this drug. NURTEC ODT…. The post New patent for Biohaven Pharm drug NURTEC ODT appeared first on DrugPatentWatch - Make Better Decisions.
Pharma Times
AUGUST 27, 2021
The investigational drug targets the HSF1 pathway
Clinical Trial Gurus
AUGUST 27, 2021
Carla Vera-Navas is one of the most inspiring people I have ever interviewed. As soon as we finished this recording, I made her a brand ambassador for Latinos in Clinical Research. In this video we discuss her humble beginnings as a receptionist in a clinical trial center to study coordinator to clinical research associate, and finally, to CRO owner.
Pharma Times
AUGUST 27, 2021
Draft guidance shows concerns on cost-effectiveness of treatment
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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
pharmaphorum
AUGUST 27, 2021
New guidance from NICE has rejected a combination regimen based on Johnson & Johnson’s Darzalex for a group of previously-untreated patients with multiple myeloma, a type of bone marrow cancer. The draft document covers the use of Darzalex (daratumumab) as an add-on to standard induction treatment with Takeda’s Velcade (bortezomib) plus thalidomide and dexamethasone given to patients prior to a stem cell transplant.
NY Times
AUGUST 27, 2021
Numerosas emprendedoras dicen que suelen compararlas con Holmes, la fundadora de Theranos, que pronto enfrentará un juicio por fraude.
BioTech 365
AUGUST 27, 2021
Tramadol HCL Global Market Insights Report 2021 – Analysis and Forecast to 2026 by Manufacturers, Regions, Technology, Application, Product Type – ResearchAndMarkets.
Drug Patent Watch
AUGUST 27, 2021
This chart shows the pharmaceutical companies with the most spray dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most spray dosed drugs…. The post Which pharmaceutical companies have the most spray dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioTech 365
AUGUST 27, 2021
Biomerica Reports Fiscal 2021 Year End Results Biomerica Reports Fiscal 2021 Year End Results Revenues increase 7.6% for fiscal 2021 vs fiscal 2020. InFoods® IBS Endpoint Trial expected to be fully enrolled in less than 2 weeks.
World of DTC Marketing
AUGUST 27, 2021
SUMMARY: Over half of all clinical trial sites are outside the U.S. 78 % of all subjects were enrolled outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. More than 40 million patients are needed to meet the demand of currently enrolling trials.
BioTech 365
AUGUST 27, 2021
Nyxoah Appoints Rita Johnson-Mills to its Board of Directors Nyxoah Appoints Rita Johnson-Mills to its Board of Directors Nyxoah Appoints Rita Johnson-Mills to its Board of Directors Mont-Saint-Guibert, Belgium – August 27, 2021, 10:30pm CET / 4:30pm ET – Nyxoah … Continue reading →
Intouch Solutions
AUGUST 27, 2021
If you’ve been keeping up, you’ll likely know that most Intouchers spent their last days in the office — well, offices, there are many — on March 13, 2020. At the time, we thought, “this will just be for a couple of weeks.” Boy, did we get that wrong. And though everything and everyone was upended in those first few months, there was (and still is) one thing we could count on: Intouch’s commitment to its employees.
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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.
BioTech 365
AUGUST 27, 2021
Landmark trial demonstrates empagliflozin is the first therapy to show statistically significant improvement in heart failure outcomes in adults with preserved ejection fraction Landmark trial demonstrates empagliflozin is the first therapy to show statistically significant improvement in heart failure outcomes … Continue reading →
pharmaphorum
AUGUST 27, 2021
Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. His second column addresses the vital importance of prioritisation. There used to be times when every single task seemed important. Naturally. I’m a perfectionist and recognition-seeker.
BioTech 365
AUGUST 27, 2021
Conjunctivitis (Ophthalmology) Pipeline Landscape Report 2021: Stage of Development, Drug Target, Mechanism of Action (MoA), Route of Administration (RoA) and Molecule Type – ResearchAndMarkets.
pharmaphorum
AUGUST 27, 2021
Gilead Sciences’ Kite Pharma has won a key victory on appeal in its long-running dispute with Bristol-Myers Squibb over patents relating to CAR-T therapies, overturning a $1.2 billion fine levied last year. In December 2019, a jury found that Kite infringed on a patent owned by Juno Therapeutics, a division of BMS acquired through its $74 billion acquisition of Celgene, and awarded Juno $752 million in damages.
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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.
BioTech 365
AUGUST 27, 2021
The Worldwide Cardiac Marker Analyzer Industry is Expected to Reach $1.9 Billion by 2026 – ResearchAndMarkets.com The Worldwide Cardiac Marker Analyzer Industry is Expected to Reach $1.9 Billion by 2026 – ResearchAndMarkets.
NY Times
AUGUST 27, 2021
A lack of systematic evidence has kept scientists one step behind in the pandemic.
BioTech 365
AUGUST 27, 2021
Genentech Provides Update on Tecentriq U.S. Indication for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer Genentech Provides Update on Tecentriq U.S. Indication for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer SOUTH SAN FRANCISCO, Calif.
BioTech 365
AUGUST 27, 2021
Amber Specialty Pharmacy Launches Mobile App to Improve Specialty Pharmacy Patient Experience Amber Specialty Pharmacy Launches Mobile App to Improve Specialty Pharmacy Patient Experience OMAHA, Neb.
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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.
BioTech 365
AUGUST 27, 2021
2021 Analytics of the Microbiome Landscape Market – ResearchAndMarkets.com 2021 Analytics of the Microbiome Landscape Market – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “2021 Analytics of the Microbiome Landscape” report has been added to ResearchAndMarkets.com’s offering.
BioTech 365
AUGUST 27, 2021
Global Pharmaceutical Intermediates Market to 2028 – by Type, Applications, Distribution Channel and Geography – ResearchAndMarkets.com Global Pharmaceutical Intermediates Market to 2028 – by Type, Applications, Distribution Channel and Geography – ResearchAndMarkets.
BioTech 365
AUGUST 27, 2021
In H1 2021 Olainfarm Group continues stable growth In H1 2021 Olainfarm Group continues stable growth The compiled financial indicators for the first six months of this year confirm the growth of Olainfarm Group.
BioTech 365
AUGUST 27, 2021
Cassava Sciences Releases Statement Regarding Plasma p-tau Analysis from a Previously Disclosed Phase 2b Clinical Study in Alzheimer’s Patients Cassava Sciences Releases Statement Regarding Plasma p-tau Analysis from a Previously Disclosed Phase 2b Clinical Study in Alzheimer’s Patients AUSTIN, Texas, … Continue reading →
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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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