Bio Pharma Dive
JULY 27, 2022
The companies pitch their collaboration as a way to give young drugmakers backed by Versant a head start. “Our business is advanced by great ideas coming into the funnel,” said AbCellera’s CEO.
Pharmaceutical Technology
JULY 27, 2022
The US Food and Drug Administration (FDA) has granted priority review for Biogen ’s New Drug Application (NDA) for investigational drug, tofersen, to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). A decision from the regulatory agency on approval for the drug is anticipated on 25 January next year. The FDA also plans to hold an advisory committee meeting for the NDA.
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Bio Pharma Dive
JULY 27, 2022
Demand has increased faster than Bristol Myers can make Abecma, although the company said supply is improving. A manufacturing issue for Breyanzi, meanwhile, impacted sales.
World of DTC Marketing
JULY 27, 2022
A federal appeals court rejected Pfizer’s challenge to a U.S. anti-kickback law that the drugmaker said prevented it from helping heart failure patients, many with low incomes, afford the medicine that costs $225,000 annually. For many, these coupons represent the difference between filling a prescription and going without lifesaving care, but there is a lot more here than just a co-pay coupon.
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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
JULY 27, 2022
The small-scale study is part of the companies’ efforts to update their vaccine in time for a potential fall vaccination campaign to help boost waning immunity.
Pharmaceutical Technology
JULY 27, 2022
Novavax has r eceived expanded approval for provisional registration from the Australian Therapeutic Goods Agency (TGA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. Nuvaxovid is indicated for active immunisation for the prevention of Covid-19 in individuals of this age group. It is the first protein-based vaccine to be offered in Australia for adolescents aged 12 to 17 years.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 27, 2022
The proportion of pharmaceutical companies hiring for robotics related positions rose in June 2022 compared with the equivalent month last year, with 21.3% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 17.2% of companies who were hiring for robotics related jobs a year ago and an increase compared to the figure of 21.1% in May 2022.
Rethinking Clinical Trials
JULY 27, 2022
? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speaker. Susanna Naggie, MD, MHS. Professor of Medicine. Vice Dean for Clinical Research. Duke University School of Medicine. Slides. Keywords. ACTIV, ACTIV-6, COVID-19, Ivermectin, Inhaled Fluticasone. Key Points. The key clinical questions of the ACTIV-6 study are: how to help someone feel better faster with newly diagnosed mild-moderate COVID-19 and how to prevent hospitalizations or death in someone with n
Pharmaceutical Technology
JULY 27, 2022
The European Commission (EC) has granted approval for AbbVie ’s Rinvoq (upadacitinib) to treat moderate-to-severe active ulcerative colitis (UC) in adult patients. Treatment with upadacitinib 45mg (induction dose) and 15mg and 30mg (maintenance doses) are indicated for UC patients who have had an insufficient, lost response or were not tolerant to either standard therapy or a biologic agent.
Pharma Marketing Network
JULY 27, 2022
In the first two weeks after a cancer diagnosis, there are likely dozens of doctor’s visits, tests, consultations, and decision points. The patient care team supplies an abundance of information, although sifting through brochures and online resources can be daunting for the patient and their caregiver. Adhering to regulatory guidelines is an important step pharma takes to ensure that promotional medical materials contain balanced information that is accurate and relevant. 1 The marketer’s goal
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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
pharmaphorum
JULY 27, 2022
Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. The vaccine, codenamed BNT162b5, codes for “enhanced” prefusion spike proteins from the original wild-type strain of the virus and the Omicron variant that are designed to increase “the magnitude and breadth of the immune response.” The phase 2 trial will te
NPR Health - Shots
JULY 27, 2022
Fellows of Disability Futures for this year honors disabled lineages in art, which is to say, traces the links between elders and emerging artists across the country.
STAT News
JULY 27, 2022
To paraphrase Canadian-American speculative fiction writer William Gibson: The future of health care is already here; it’s just unevenly distributed. We live in a world where science continues to produce marvels: Researchers can load miniaturized human organs onto microchips to simulate how the human body will respond to experimental treatments.
NPR Health - Shots
JULY 27, 2022
After a car wreck, three siblings were transported to the same hospital by ambulances from three separate districts. The sibling with the most minor injuries got the biggest bill.
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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.
STAT News
JULY 27, 2022
Disease detectives investigating a pair of medical mysteries in Mississippi have come to an unwelcome conclusion. The bacterium that causes a rare but dangerous disease called melioidosis is likely endemic in parts of the southern United States, along the Gulf Coast. The bacterium, Burkholderia pseudomallei, was previously not thought to be found in the U.S., meaning people who had symptoms similar to those of melioidosis but who had no history of international travel were considered unlikely to
XTalks
JULY 27, 2022
Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. Known for her bright, Pepto Bismol-colored condiment, which reportedly features ingredients such as dragonfruit, raw honey and pink Himalayan sea salt, Chef Pii has been riding the wave of success on TikTok for some time, with many users interested in the novelty of the sauce.
STAT News
JULY 27, 2022
It’s a problem so complex, so fraught with stigma and treatment complications, that innovation has crept forward slowly even as a crisis escalates: suicide prevention. But for several years, a small New Haven, Conn.-based startup has quietly been building technology to move the needle on suicide rates among the people at highest risk: those with a history of attempts or who have suicidal thoughts and have expressed a strong desire to die.
pharmaphorum
JULY 27, 2022
Health innovation and technology specialist Healthware Group has added another element to its business with the launch of a dedicated medical communications and education division. The new unit – dubbed Healthware MedComms – promises to take a fresh approach to medical communications that meets “the always-on, audience-centric, evidence-driven demands of today’s modern clinical environment.” It adds to Healthware’s fast-growing presence in the healthcare communications se
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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.
STAT News
JULY 27, 2022
As the cost of DNA sequencing plummets, we’re fast approaching a point when decoding a human genome could cost $100 — about as much as the average American’s weekly grocery store run. The ever-lower cost is helping to drive fast-moving changes in sequencing. Health systems are preparing to test programs that could lead to the use of whole-genome screening in millions of newborns.
ACRP blog
JULY 27, 2022
Promoting a diverse clinical trial workforce is a key pillar of any effective effort to promote patient population diversity , Samit Hirawat, MD, chief medical officer for global drug development with Bristol Myers Squibb, told attendees of a July 27 webinar sponsored by The Conference Forum. “The workforce must be diverse, with sites located in areas where underserved populations live,” he said.
STAT News
JULY 27, 2022
Whether created from sunlight or taken in by food, vitamin D assists in the mineralizing and maintenance of bone. It is also thought to keep bones healthy as they age, prompting one in three adults aged 60 and older in the U.S. to take a vitamin D supplement and another third to take a multivitamin. Yet, it has long been unclear just how beneficial the vitamin is in preventing the bone fractures that many older adults dread as they age.
ACRP blog
JULY 27, 2022
It’s probably an understatement to suggest the COVID-19 pandemic altered our lives in ways both significant and unimaginable. In a matter of days back in early 2020, the entire clinical trial industry infrastructure was upended, as site visits became uncertain and, in many cases, untenable, the workforce risked health and life daily on the front lines of care, and patients were buffeted by the challenges of dealing with their conditions in daily life in a brave new world.
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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.
STAT News
JULY 27, 2022
The FDA’s decision to delay its highly anticipated review of AMX0035 , a new drug for treating amyotrophic lateral sclerosis, until September highlights an ongoing rift between the needs of people directly affected by ALS and those responsible for bringing forth treatments and cures. ALS is a devastating neurodegenerative disease that typically kills within three years of diagnosis.
Antidote
JULY 27, 2022
Kidney diseases are one of the top causes of death in the United States , and worldwide, they impact nearly 10% of the population each year. Because chronic kidney disease typically has no cure, it is vital that medical research takes place to find new and more effective treatments for those who have been diagnosed.
STAT News
JULY 27, 2022
On Tuesday, White House officials gathered scientists, pharmaceutical executives, and experts in public health at a summit to try to lay out a path toward creating better vaccines. What was the upshot? For starters, there was tremendous optimism about the prospects for developing next-generation vaccines. And there were, in fact, glimmers of a tractable path to better products — if Congress will provide billions of dollars to speed things up.
pharmaphorum
JULY 27, 2022
Latest UK Life Sciences Competitive Indicators “ought to ring alarm bells across Government,” says ABPI. Despite the UK’s potential as an international life sciences leader, it lags many competitors in a number of key metrics, including access to new medicines and global share of clinical trial recruitment. Richard Torbett, chief executive at the Association of the British Pharmaceutical Industry (ABPI) said Life Sciences Competitive Indicators (LSCI) data published last week “ought to ring alar
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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.
STAT News
JULY 27, 2022
In an embarrassing episode for AbbVie, the company was reprimanded by a U.K. pharmaceutical industry trade group for appearing to condone “strategic loitering” by one of its sales reps, who visited a hospital in hopes of encountering numerous health care providers. The incident raised questions about the extent to which the company sufficiently addressed the issue.
Pharma Times
JULY 27, 2022
First carbon minimal pMDI is on track with the joint goal of benefitting patients and the planet
STAT News
JULY 27, 2022
Drug treatment of veterans with opioid use disorder increased during the first year of the pandemic, according to a new study, suggesting that the rapid shift from in-person to telehealth visits at VA medical centers enabled patients to get access to care despite Covid-related disruptions. The study, published Thursday in the American Journal of Psychiatry, found that the number of Veterans Health Administration patients receiving buprenorphine for opioid use disorder increased 14% in the first
Pharma Times
JULY 27, 2022
Predicting which women are likely to develop pre-eclampsia will help clinicians to decide on the most appropriate care
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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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