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.
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.
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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.
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.
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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
OCTOBER 27, 2021
The deal with the Medicines Patent Pool is meant to increase access in lower-income countries to molnupiravir, an experimental drug that could become the first oral treatment for COVID-19.
World of DTC Marketing
OCTOBER 27, 2021
SUMMARY : DTC message development and use is the most essential action to get patients interested in your product, but it can’t be based on unrealistic patient behavior modifications. Yesterday I received a call from a physician who is a thought leader in the diabetes area. He had read my BLOG post from yesterday and wanted to add something that he thinks DTC marketers need to hear. “Don’t promise results that most patients will never see.” As we talked, he mentioned a di
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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 25, 2021
The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content.
World of DTC Marketing
OCTOBER 26, 2021
LEAD-IN: “What is the reason to believe?” It seems like a simple question, doesn’t it yet? In today’s micro-segmented audience environment, it’s often hard to come up with one reason that might resonate with everyone in your target audience. I’ve noticed a trend that’s been emerging in the last couple of years.
pharmaphorum
OCTOBER 27, 2021
Bayer’s two-year-old digital health collaboration with One Drop has borne its first fruit, an artificial intelligence-powered software module for preventing cardiovascular disease (CVD). The German pharmaceutical company has been working with New York-based One Drop on digital health products that span multiple therapeutic areas, including oncology and women’s health as well as CVD in the alliance , which was expanded last year in a $98 million deal.
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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
Pharma Times
OCTOBER 27, 2021
Novartis is eyeing approval for Kymriah to treat adult patients with relapsed or refractory follicular lymphoma
Bio Pharma Dive
OCTOBER 26, 2021
Outside experts are reviewing Pfizer's application for emergency authorization of its vaccine in 5- to 11-year-olds. Follow their discussion with BioPharma Dive reporters live.
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.
pharmaphorum
OCTOBER 26, 2021
COVID-19 demonstrated the importance of robust supply chains and the dangers of an over reliance on overseas manufacturing. But can the Pharmaceutical Strategy for Europe help to redress the balance? Only sustainable, robust supply chains and business models will allow innovation to flourish, secure access to medicines, and minimise the industry’s impact on the environment.
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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.
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 29, 2021
The authorization makes the shot available to nearly 28 million kids between the ages of 5 and 11, though a CDC panel next week could hold significant sway over who among them should be vaccinated.
BioSpace
OCTOBER 25, 2021
Axcella announced it is initiating a new clinical program to study AXA1125 in patients with Long Covid. The trial will be conducted at the Oxford Centre for Clinical Magnetic Resonance Research.
pharmaphorum
OCTOBER 26, 2021
Novartis revealed today that it may consider divesting its generic medicines subsidiary Sandoz – amongst other options – which would further narrow its focus to innovative medicines. The company said in its third-quarter results statement that it was weighing options for Sandoz to “maximise shareholder value,” adding that could include retaining the business or a separation – which could involve a spin-off or outright sale.
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.
BioPharma Reporter
OCTOBER 26, 2021
The Biosimilars Forum, in partnership with the Pacific Research Institute (PRI), recently released a report and interactive tool highlighting the significant costs that biosimilars can save US states.
Bio Pharma Dive
OCTOBER 28, 2021
Executives based their projections on contracts already in place for the drug, known as molnupiravir. But sales could climb even higher if it works as a preventive treatment too.
Pharma Times
OCTOBER 29, 2021
Experts say that it is vital to ensure that every member who is eligible for a vaccine has received one
pharmaphorum
OCTOBER 28, 2021
Groups representing the biopharma industry have welcomed an increase in health-specific R&D to £5 billion in the UK autumn budget, despite a longer timeline for reaching the target of £22 billion in overall R&D spending. The Association of the British Pharmaceutical Industry (ABPI) and BioIndustry Association (BIA) both said that the increase acknowledges the enormous contribution made by the life sciences sector in helping to limit the impact of the pandemic through the rapid developmen
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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.
BioPharma Reporter
OCTOBER 26, 2021
Researchers say a new technique they have developed paves the way for stem cell therapies to treat central nervous system (CNS) injuries and disease.
Bio Pharma Dive
OCTOBER 25, 2021
The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug.
Pharma Times
OCTOBER 26, 2021
The drug acts by inhibiting SARS-CoV-2 from replicating in the human system
pharmaphorum
OCTOBER 25, 2021
Hard on the heels of some impressive clinical trial results, Luminopia has won FDA approval for its digital therapeutic (DTx) for amblyopia or lazy eye in children that is based on watching TV shows. The DTx is TV watching with a difference, of course – namely specially modified TV shows and movies that are viewed using a virtual reality headset designed to promote use of the weaker eye in amblyopia, which is a leading cause of vision loss in children.
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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.
BioSpace
OCTOBER 24, 2021
This is after the company shared positive results from its Phase III trial on Imfinzi, increasing the chances for survival in BTC patients when combined with standard-of-care chemotherapy regimens.
Bio Pharma Dive
OCTOBER 25, 2021
The trial results should allow the company to ask the FDA for approval of its vaccine in younger children, just as Pfizer nears a crucial decision for its shot in 5- to 11-year olds.
XTalks
OCTOBER 28, 2021
BioNTech has announced plans to build a manufacturing facility in Africa to help ramp up production of COVID-19 mRNA vaccines for countries in the continent. On Tuesday, the German biotech company inked a deal with Rwanda’s government and Institut Pasteur de Dakar in Senegal to begin construction of the facility in mid-2022. With less than ten percent of its population vaccinated, Africa continues to be deeply affected by global vaccine inequities.
pharmaphorum
OCTOBER 25, 2021
Consumer DNA testing company 23andMe has signed a deal to acquire privately-held Lemonaid Health in a $400 million deal that marks a move into the online health sector. Lemonaid operates an on-demand platform for remotely accessing medical care and pharmacy services, including online consultations and prescription medicines delivery across the US. 23andMe – which went public earlier this year through a blank cheque company backed by Virgin Group founder Sir Richard Branson – is making 25% of the
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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