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.
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.
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.
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.
BioSpace
OCTOBER 4, 2021
After serving three presidential administrations, Dr. Francis S. Collins is stepping down as director of the National Institutes of Health at the end of the year.
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.
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.
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.
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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.
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.
pharmaphorum
OCTOBER 19, 2021
A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels. The survey by Veeva Systems found a big increase in the adoption of technologies that enabled remote trials during COVID-19, with increased use of tools such as remote monitoring, electronic data collection and consent forms, and web portals for studies.
BioPharma Reporter
OCTOBER 11, 2021
Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production.
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.
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.
Pharma Times
OCTOBER 27, 2021
Novartis is eyeing approval for Kymriah to treat adult patients with relapsed or refractory follicular lymphoma
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.
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.
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.
BioPharma Reporter
OCTOBER 29, 2021
Construction of Samsung Biologicsâ new facility is on track, with the CDMO saying pre-sales activities are ongoing for Plant 4, as it is known, despite the challenging business environment amid the COVID-19 pandemic.
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.
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.
Pharma Times
OCTOBER 26, 2021
The drug acts by inhibiting SARS-CoV-2 from replicating in the human system
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
BioSpace
OCTOBER 5, 2021
Unlike most companies addressing the diseases associated with aging, Rejuvenate Bio tackles multiple cardiac, metabolic and renal issues at once.
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.
XTalks
OCTOBER 20, 2021
Despite major accomplishments in the plant-based dairy space over the last few years, the animal-based dairy sector is proving there is still room for innovation. Taking notes from the VegTech sector , the dairy industry is diversifying to meet personal and planetary health targets, prioritizing nutrition and sustainability, along with flavor and accessibility. .
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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