Bio Pharma Dive
SEPTEMBER 15, 2021
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months.
World of DTC Marketing
SEPTEMBER 15, 2021
SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times. My doctor’s office recently sent me an email that they had plenty of telehealth appointments available for patients who didn’t want to come to the office.
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Bio Pharma Dive
SEPTEMBER 15, 2021
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.
Pharma Mirror
SEPTEMBER 15, 2021
The use of opioids for pain relief in patients awaiting hip and knee replacement surgery increased dramatically during the pandemic according to new research from the University of Aberdeen. Published in the BMJ Quality & Safety, the study found that the numbers of patients using opioids while waiting for surgery increased by 40% compared to pre-pandemic levels.
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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
SEPTEMBER 15, 2021
In a briefing document released Wednesday, agency reviewers did not make a strong case either for or against the broad authorization of boosters for the general public.
Pharma Mirror
SEPTEMBER 15, 2021
HONG KONG, Legend Capital led a new round of investment of PT Etana Biotechnologies Indonesia (Etana), along with Innovent Biologics, Inc. (Innovent) (HKEX: 01801), and a consortium led by UOB Venture Management (UOBVM). This round of funds will be used to further strengthen the company’s production, registration, clinical and commercialization capabilities, promote the company’s extensive and in-depth cooperation with biopharmaceutical companies, and lead the development of the Indo
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 15, 2021
?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.
pharmaphorum
SEPTEMBER 15, 2021
The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week. A French government source told Reuters that the EU is considering using the VLA2001 vaccine as part of its booster campaign plans, along with a shot from Sanofi and GlaxoSmithKline.
Pharma Times
SEPTEMBER 15, 2021
Researchers discovered that treating mice with broad-spectrum antibiotics increased the rate at which their breast cancer tumours grew
pharmaphorum
SEPTEMBER 15, 2021
Researchers in the UK are working on an artificial intelligence (AI) algorithm to help diagnose deep vein thrombosis (DVT) from ultrasound images – and potentially prevent patients from receiving drugs unnecessarily. The team from Oxford University, Imperial College London and the University of Sheffield are working with German tech company ThinkSono on the smartphone-based app, called AutoDVT, and estimate it could cut the cost to health services of each examination by up to $150.
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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
XTalks
SEPTEMBER 15, 2021
From macaroni-and-cheese flavored ice cream to a McDonald’s’ burger featuring Spam and crushed Oreos , food mashups have been taking 2021 by storm. The unconventional pairings can be found at all sorts of different food establishments, from grocery stores to fast food chains, and tend to be limited-time offerings. So, why have unconventional food mashups exploded in popularity in 2021?
Drug Patent Watch
SEPTEMBER 15, 2021
Annual Drug Patent Expirations for ENTRESTO Entresto is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Novartis Pharms drug ENTRESTO appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
SEPTEMBER 15, 2021
Not enough is being done to ensure that patient voices are included in policymaking around digital health, says a new patient organisation in the UK, which aims to set that situation right. The Patient Coalition for AI, Data and Digital Tech in Health has brought together members of patient organisations, medical colleges and health charities to tackle issues such as ensuring equitable access to digital health services.
BioPharma Reporter
SEPTEMBER 15, 2021
Cytiva, in collaboration with China's Wego Pharmaceutical Co Ltd, is expanding manufacturing capacity for bioprocessing single-use consumables in China.
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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.
pharmaphorum
SEPTEMBER 15, 2021
Swiss biopharma company ObsEva has filed its oral GnRH antagonist linzagolix for the treatment of uterine fibroids in the US, hoping to expand the number of women eligible for this type of therapy. If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva.
BioSpace
SEPTEMBER 15, 2021
?The FDA awarded a number of designations for Takeda's candidate drug EXKIVITY in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
Drug Channels
SEPTEMBER 15, 2021
Sometimes, a little knowledge can be a bad thing. I want to share with you, dear reader, the strange but true tale of my recent foray into the wonderful world of hospital price transparency for routine lab services. I discovered—with great effort—that the rates my health plan negotiated with the largest local health system in Philadelphia were greater than the self-pay, cash price.
BioSpace
SEPTEMBER 15, 2021
FDA external advisors will meet to consider Pfizer and BioNTech data in support of booster shots. The two companies also expect to file for Vaccine Authorization for children in the coming months.
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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.
JAMA Internal Medicine
SEPTEMBER 15, 2021
This cross-sectional study examines associations of nursing home characteristics with COVID-19 vaccination rates among nursing home staff and residents.
BioSpace
SEPTEMBER 15, 2021
With multiple job openings across the industry, biotech and biopharma employers have to come up with different strategies to retain top talent.
Pharma Times
SEPTEMBER 15, 2021
New evidence collected through the CDF shapes recommendation
BioSpace
SEPTEMBER 15, 2021
Moderna will leverage AbCellera’s AI-powered technology to search and analyze natural immune responses in the hopes of identifying antibodies for up to six targets.
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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
SEPTEMBER 15, 2021
Coalition unites a range of stakeholders across healthcare
BioSpace
SEPTEMBER 15, 2021
Biopharma and life sciences companies and organizations from across the globe provide updates on their businesses and pipelines.
Pharma Marketing Network
SEPTEMBER 15, 2021
Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape. In recent years the European Union has updated their requirements for Medical Device reporting following the FDA in the United States mainly with the EU Medical Device Regulation. Medical device companies continue to look at new strategies, tools, and technologies to achieve a more comprehensive medical device monitoring and reporting framework to ensure t
Delveinsight
SEPTEMBER 15, 2021
Oncology is the study of cancer and encompasses the diagnosis and treatment of cancer. The treatment of cancer requires a multidisciplinary approach which includes medications, surgical, and radiation. The type of approach adopted depends upon the stages, age, and the patient’s preference. Cancer encompasses a group of diseases, which can affect any organ or tissue of the body.
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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.
Scienmag
SEPTEMBER 15, 2021
Breathe in, breathe out. That’s how easy it is for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. And though remarkable progress has been made in developing intramuscular vaccines against SARS-CoV- 2, such as the readily available Pfizer, Moderna and Johnson & Johnson vaccines, nothing yet – like a nasal vaccine – has […].
Pharma Marketing Network
SEPTEMBER 15, 2021
Fairfield, N.J. (15 September, 2021)—With gender inequality a continued area of focus for corporations and workplaces around the globe, the Healthcare Businesswomen’s Association (HBA) is proud to recognize Merck & Co., Inc. and Otsuka America Pharmaceutical, Inc. for exemplary workplace initiatives working to close the gender gap in the healthcare and life science industries.
Scienmag
SEPTEMBER 15, 2021
BOSTON, MASS. (Sept. 15, 2021) – A new landmark study of over 300 sharks found that some species are extremely resilient to the stress of being caught and released in commercial longline fisheries while other species are much more likely to die. Credit: New England Aquarium BOSTON, MASS. (Sept. 15, 2021) – A new landmark […].
Delveinsight
SEPTEMBER 15, 2021
The mobile app is one of the fine examples of communications systems. The mobile app comes in various forms and formats to meet the various needs of the user. We have moved so much over a short period that it is extremely difficult to imagine a day without using smartphones or tablet PCs and the apps in it. For every task or requirement, we have a dedicated app that provides all the possible information and solutions.
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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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