Bio Pharma Dive
MAY 7, 2021
The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.
World of DTC Marketing
MAY 7, 2021
WTF? The Washington Post reported last year that health and pharmaceutical companies spent almost $1 billion on just Facebook mobile ads in 2019. A complete waste of money, time and effort. Unlike a traditional TV or radio ad, Facebook’s ad categories help those companies target their drug ads at users who likely suffer from a specific illness the drug treats.
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Camargo
MAY 2, 2021
Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. These therapies frequently target diseases in patients that are rare (affecting fewer than 200,000 people in the US), serious, and representing an unmet medical need.
NY Times
MAY 5, 2021
The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.
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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
MAY 5, 2021
The influential watchdog group found the evidence supporting aducanumab "insufficient" to determine a health benefit and suggested the drug would be cost effective at up to $8,300 per year, well short of what some analysts are predicting.
World of DTC Marketing
MAY 2, 2021
SUMMARY: A new survey from the Kaiser Family Foundation and the Purchaser Business Group on Health shows signs that corporate executives might be warming to the idea of government getting more involved to rein in the excesses of the healthcare system. It’s affecting their bottom lines, and they won’t stand for that. Big changes are coming.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
MAY 4, 2021
Cilta-cel is an investigational CAR-T cell therapy for the treatment of relapsed/refractory multiple myeloma
Bio Pharma Dive
MAY 6, 2021
A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy.
BioSpace
MAY 3, 2021
Fueled by billions of dollars invested by the federal government to battle the ongoing COVID-19 pandemic, companies across the BioCapital region have expanded their footprint and number of employees.
pharmaphorum
MAY 6, 2021
UK-based performance-io has added to its senior team through two promotions and the appointment of STEM Healthcare CEO Jason McKenna as a non-executive director. He will oversee the online performance marketing and digital benchmarking agency’s growth in the US joins Rob Wood and Barrie Brien on performance-io’s non-executive board. McKenna has been with STEM since 2010, founding it in the US and Brazil before taking over the CEO role from co-founder Rob Wood in 2018.
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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
Scienmag
MAY 3, 2021
International research team led by Göttingen University investigates landscape and farm-level man-agement in cocoa agroforests in Indonesia Credit: Manuel Toledo The importance of pollinators to ensure successful harvests and thus global food security is widely acknowledged. However, the specific pollinators for even major crops – such as cocoa – haven’t yet been identified and there […].
Bio Pharma Dive
MAY 4, 2021
The biotech's latest earnings call focused less on revenue and more on an experimental drug for depression that's close to having important study results.
BioSpace
MAY 6, 2021
Six months after receiving Emergency Use Authorization from the U.S. FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications.
pharmaphorum
MAY 6, 2021
UK biotech Inspira Pharmaceuticals has emerged from stealth mode with a deal with Vectura to develop an inhaled therapy for COVID-19 that could be ready for human testing within 12 months. . The start-up is focusing on processed and purified extracts from an undisclosed plant source that have been shown in lab studies to kill the SARS-CoV-2 virus, and also have potential applications in other respiratory infections.
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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.
Triage Cancer
MAY 4, 2021
Have you ever received a denial from your insurance company? Me too. Just days before my scheduled breast reconstruction surgery. You probably know how I felt. Blindsided. Frustrated. Angry. . I won't make you read this whole article to learn that I appealed that denial and won. So now I'm one of the 50% of patients who win their insurance appeals. You read that right. 50% of the patients who appeal, win.
Bio Pharma Dive
MAY 3, 2021
Vivek Ramaswamy's unusual biotech holding company will go public through a deal with Montes Archimedes Acquisition Corp. that nets Roivant $611 million.
Pharma Times
MAY 7, 2021
Decision brings the innovative treatment to early-stage lung cancer patients, helping to address unmet need in this setting
pharmaphorum
MAY 4, 2021
The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. Early life science pioneers in foreign markets earned a reputation for lax ethical behaviour, making them a prime target for regulators.
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.
BioSpace
MAY 4, 2021
Patients without diabetes who develop COVID-19 may be at a higher risk of actually developing diabetes following recovery, recent study claims.
Bio Pharma Dive
MAY 6, 2021
Completion of the buyout eases concerns the arrangement might be held up by the FTC, which has signaled it will step up scrutiny of life sciences deals.
NY Times
MAY 7, 2021
State lawmakers have voted to add the firing squad as an alternative to the electric chair or lethal injection, with the drugs used for capital punishment in short supply.
pharmaphorum
MAY 5, 2021
Pfizer expects revenues from its BioNTech-partnered COVID-19 vaccine to reach an eye-watering $26 billion this year, catapulting it to the top of the world’s biggest-selling medicines. . The company also said that it doesn’t expect the massive sales to be a one-off, as demand from governments around the world for coronavirus vaccines will continue to be strong in the coming years.
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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.
BioSpace
MAY 5, 2021
While mix-and-match sounds more like a meal deal at your local fast-food chain, it’s now the colloquial term being used for the approach currently under study in the U.K. for administering two doses of different types of COVID-19 vaccines.
Bio Pharma Dive
MAY 6, 2021
After inking three big pharma deals within a year of launching, the Harvard spinout has the backing of Andreessen Horowitz and several other top venture investors.
Outsourcing Pharma
MAY 3, 2021
On May 5, a panel of experienced industry experts will discuss recent developments during Innovations in Drug Delivery, a free one-hour industry webinar.
pharmaphorum
MAY 5, 2021
A medicine based on MDMA – the active ingredient in recreational drug ecstasy – is on the cusp of FDA approval as a treatment for post-traumatic stress disorder (PTSD), according to the organisation developing it. . The non-profit Multidisciplinary Association of Psychedelic Studies (MAPS) is leading the development of MDMA and has just reported top-line results from a phase 3 trial of the drug combined with psychotherapy that it says could form the basis of a marketing application to the US reg
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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
MAY 3, 2021
There is also a tacit acknowledgment in the industry that the ALSFRS-R (revised) scale needs to evolve.
Bio Pharma Dive
MAY 5, 2021
Led by a former MyoKardia executive, Esker Therapeutics is developing a drug that could eventually compete with one of Bristol Myers Squibb's most closely watched candidates.
Pharma Times
MAY 6, 2021
The cost regulator has rejecting funding the drug as maintenance treatment of advanced/metastatic urothelial cancer
Scienmag
MAY 7, 2021
Computational model demonstrates similarity in how humans and insects learn about their surroundings Credit: University of Sussex Even the humble fruit fly craves a dose of the happy hormone, according to a new study from the University of Sussex which shows how they may use dopamine to learn in a similar manner to humans. Informatics […].
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