Bio Pharma Dive
OCTOBER 31, 2021
Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.
Pharma Mirror
OCTOBER 4, 2021
By Kambiz Shekdar, Ph.D. Open source drug discovery was proposed in the past in connection with third-world diseases like tuberculosis and malaria, but it is in the context of first-world indications where it is needed most. Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.
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World of DTC Marketing
OCTOBER 25, 2021
SUMMARY: One definitive trend to emerge from the pandemic is that more people are becoming healthcare consumers. They want healthcare to be easier to access and don’t want to wait for necessary medical tests. This could lead to an evolution in urgent care centers, but it will require disruptive thinking. Urgent care centers aren’t new, but they are evolving to become “total care” in some areas.
Drug Patent Watch
OCTOBER 4, 2021
This is my talk from the 14th Annual Portfolio Planning and Partnership for Generic Conference. I discuss: Identifying generic entry opportunities at the earliest stages Discovering opportunities that avoid litigation…. The post Generic Portfolio Management, Partnering with Brands, and Staying Competitive appeared first on DrugPatentWatch - Make Better Decisions.
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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
OCTOBER 27, 2021
Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. The agreement would provide royalty-free licenses to companies manufacturing molnupiravir – originally developed by Ridgeback Biotherapeutics – for distribution in 105 low- and middle-income countries around the world.
Pharma Times
OCTOBER 8, 2021
A chemotherapy drug, NUC-7738, which is derived from a Himalayan fungus has been found to have 40 times greater potency in killing cancer cells than its original parent compound.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
OCTOBER 2, 2021
“In a year when literally hundreds of our exhibitors have contributed to overcoming COVID, the greatest healthcare challenge of recent times, we are delighted to be welcoming back the pharma community. CPhI Worldwide is an essential conduit in helping pharma supply chains work, partners meet, empowering the industry with learning. But this year, more than ever, the event will also be a celebration of everything pharma has achieved.
World of DTC Marketing
OCTOBER 5, 2021
SUMMARY: Americans spend twice as much per capita on drugs as residents of other wealthy nations, because ours is the only country that lets drugmakers set any price they want for their products. Seventy-nine percent of Americans think the price of prescription drugs is “unreasonable,” according to a 2019 Kaiser Family Foundation poll , and about 9 in 10 say they support the idea of the government negotiating prices.
NY Times
OCTOBER 1, 2021
The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.
pharmaphorum
OCTOBER 8, 2021
The developer of a toolkit that promises to create a “digital twin” of individuals with chronic metabolic diseases like diabetes to help model the impact of lifestyle changes has secured $140 million in funding to develop the technology. US and India-based Twin Health says the Whole Body Digital Twin platform uses Internet of Things (IoT) sensors and self-reported data within an artificial intelligence-driven software platform to generate a virtual copy of a person’s unique met
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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
OCTOBER 8, 2021
Medtronic has expanded a Class I recall of remote controllers used with the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps over potential cybersecurity risks. The affected remote controller models are MMT-500 and MMT-503. The medtech giant has also expanded another Class I recall of the retainer rings on its 600 series insulin pumps.
Bio Pharma Dive
OCTOBER 26, 2021
A new alliance with Mammoth Biosciences marks the latest evidence of Vertex's interest in gene editing, which has already been the focus of multiple deals with emerging biotechs.
Pharma Mirror
OCTOBER 13, 2021
Paris, Pharmapack Europe (#PharmapackEU) announce the winners of the 2021 Pharmapack Awards and, due to the exceptional quality of this year’s entries, seven winners have been chosen across both the ‘Exhibitor Innovation’ and ‘Health Product’ awards. The Exhibitor Innovation awards recognise four winners plus one highly commended product. EVEON was given the ‘routes of administration’ innovation award for their Intuity® Spray.
BioPharma Reporter
OCTOBER 11, 2021
Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production.
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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.
NY Times
OCTOBER 21, 2021
The company said that in a study, boosters cut down the number of breakthrough infections among fully vaccinated people by more than 95 percent.
pharmaphorum
OCTOBER 19, 2021
The work of the UK’s HTA body, the National Institute for Health and Care Excellence (NICE), is often heatedly debated, and this time it’s for holding back a clinical guideline. Leela Barham looks into the controversy. Updating a previous clinical guideline. NICE began their work to update a 2007 clinical guideline on Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in January 2018.
BioSpace
OCTOBER 26, 2021
The decision to move forward with the trial comes on the heels of the FDA's approval of its IND application, allowing Cleveland Clinic and Anixa Biosciences to proceed.
Bio Pharma Dive
OCTOBER 8, 2021
Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharma Times
OCTOBER 27, 2021
Novartis is eyeing approval for Kymriah to treat adult patients with relapsed or refractory follicular lymphoma
Outsourcing Pharma
OCTOBER 19, 2021
To fully reap the benefits of tech advances, a company leader advises, a life-sciences firm must embrace change and connection throughout the operation.
NY Times
OCTOBER 18, 2021
The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.
pharmaphorum
OCTOBER 22, 2021
The FDA has approved an artificial intelligence-based test for early detection of dementia that can be carried out on an iPad in five minutes. The CognICA Integrated Cognitive Assessment (ICA) test developed by London, UK-based company Cognetivity Neurosciences has been approved by the FDA as an alternative to traditional pen-and-paper tests with some key advantages, according to its developer.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
BioSpace
OCTOBER 26, 2021
Nuravax is developing a vaccine to induce therapeutically potent concentrations of antibodies against pathological proteins associated with both AD and Parkinson's disease.
Bio Pharma Dive
OCTOBER 18, 2021
Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.
Pharma Times
OCTOBER 21, 2021
Givlaari uses ‘gene silencing’ RNA interference technology, to target the production of pathogenic compounds in people AHP
Outsourcing Pharma
OCTOBER 26, 2021
Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
NY Times
OCTOBER 9, 2021
Some poorer countries are paying more and waiting longer for the company’s vaccine than the wealthy — if they have access at all.
pharmaphorum
OCTOBER 5, 2021
Digital data collection, utilisation of real-word data and patient-centric thinking will all contribute to the rapid development of a new healthcare landscape, says Debiopharm Innovation Fund’s Tanja Dowe. In recent years, we have seen thinking shift from focusing on a disease’s treatment to seriously considering the wider potential for its prevention, enabled by dramatic advances in data science and supported by a pressing need to reduce healthcare costs.
BioSpace
OCTOBER 10, 2021
?The decision is based on promising results from the Marguerite RoAD and SCarlet RoAD open-label extension trials, showing a significant reduction in brain amyloid plaque in Alzheimer's patients.
Bio Pharma Dive
OCTOBER 11, 2021
The biotech still believes a speedy approval filing for the closely watched treatment is possible, but expects to have to wait for the results of the recently launched Phase 3 trial, CEO Doug Ingram said on a conference call.
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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.
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