FDA declines to review Brainstorm’s ALS therapy
Bio Pharma Dive
NOVEMBER 11, 2022
It’s the latest setback for Brainstorm’s NurOwn, an engineered cell therapy that has been on a winding journey since failing a key study in ALS patients two years ago.
Fri.Nov 11, 2022
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EC grants approval for Sanofi-GSK’s Covid-19 booster
Pharmaceutical Technology
NOVEMBER 11, 2022
The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine. The latest development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on vaccine use.
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EMA backs restrictions on certain immune-regulating drugs
Bio Pharma Dive
NOVEMBER 11, 2022
Once the European Commission signs off, use of several so-called JAK inhibitors sold by Eli Lilly, Pfizer and other drugmakers will be limited among smokers and patients who are at high risk of certain health complications.
AstraZeneca reports 9% rise in Q3 2022 total revenue
Pharmaceutical Technology
NOVEMBER 11, 2022
AstraZeneca has reported an 11% rise in total revenue to $10.98bn in the third quarter (Q3) 2022 as against $9.87bn in the year-ago quarter. For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In the third quarter of 2022, core earnings per share (EPS) were recorded to be $1.67, signifying a 55% increase while reported EPS was $1.06.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Under FDA pressure, GSK limits use of ovarian cancer drug
Bio Pharma Dive
NOVEMBER 11, 2022
The drugmaker’s decision is the latest fallout from safety concerns that have emerged in testing of so-called PARP inhibitors, resulting in withdrawals by Merck & Co., AstraZeneca and Clovis Oncology.
Pharma’s growth in Africa needs domestic focus and investment
Pharmaceutical Technology
NOVEMBER 11, 2022
Investment in AI-based research and development, and a focus on the major diseases that affect people in Africa could facilitate the domestic pharmaceutical industry’s growth and reduce the dependence on imports, experts said at a recent event. Earlier this week, in a panel on “Pharma in Africa” at the Financial Times Global Pharma and Biotech Summit, various stakeholders delved into ways to advance the pharmaceutical industry on the continent.
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Opinion: Violence against health care workers is on the rise. They deserve protection
STAT News
NOVEMBER 11, 2022
There is no place for violence in civil society. Yet stabbings, shootings, threats and other violent attacks have become frighteningly common, including in America’s hospitals and other health care settings. As leaders of national associations representing hospitals and emergency physicians, we know the intimidation and violence endured by medical professionals every day.
Anxious while awaiting election results? Here are expert tips to help you cope
NPR Health - Shots
NOVEMBER 11, 2022
Kate Sweeny, who studies the psychology of waiting, says it's normal to stress about uncertainty. Her suggestions for coping include changing your mindset, taking action and finding deep distraction.
Study: Popular dietary supplement causes cancer risk, brain metastasis
Medical Xpress
NOVEMBER 11, 2022
While previous studies have linked commercial dietary supplements like nicotinamide riboside (NR), a form of vitamin B3, to benefits related to cardiovascular, metabolic and neurological health, new research from the University of Missouri has found NR could actually increase the risk of serious disease, including developing cancer.
STAT+: Unexpected troubles hit large medical billing firm R1 RCM, part-owned by Ascension
STAT News
NOVEMBER 11, 2022
The stock price of R1 RCM tanked by roughly 50% this week after the large medical billing and collections company reported an unexpected $30 million loss in the third quarter. R1’s revenue fell in part because health insurers have taken longer to pay claims to R1’s hospital and physician clients, and because it’s been more difficult to collect on patient bills.
The New Age of Decentralized Clinical Trials
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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
Probiotic 'backpacks' show promise for treating inflammatory bowel diseases
Medical Xpress
NOVEMBER 11, 2022
Like elite firefighters headed into the wilderness to combat an uncontrolled blaze, probiotic bacteria do a better job quelling gut inflammation when they're equipped with the best gear.
Opinion: Lessons from polio about the need to vaccinate kids against Covid-19
STAT News
NOVEMBER 11, 2022
As pediatricians, epidemiologists, and professors of public health — as well as mothers — we are often asked if we recommend Covid vaccines for children. Those asking are often skeptical about the benefits and make the point that relatively few kids have died from Covid-19. There’s also some institutional confusion: the American Academy of Pediatrics and the Centers for Disease Control and Prevention have urged families to get their children vaccinated, but some
Balloon labor induction safer for babies, researchers find
Medical Xpress
NOVEMBER 11, 2022
Melbourne researchers have found that one of two common methods to induce labor is safer for babies, although both were as safe for the mother and neither led to more cesarean births.
STAT+: Telehealth companies that prescribed controlled substances during the pandemic brace for business to change
STAT News
NOVEMBER 11, 2022
Health tech companies that have taken advantage of the possibility to prescribe controlled substances online during the pandemic may soon find their businesses — and their ability to care for patients — in jeopardy. The public health emergency paved the way for these young companies — whose prescriptions range from ADHD medication to substance use disorder treatment and off-label ketamine for depression — to prescribe medicines without ever seeing a patient in-p
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
How do we experience the pain of other people?
Medical Xpress
NOVEMBER 11, 2022
A new study from the Netherlands Institute for Neuroscience recorded the neurons of human patients to show that the pain of others is directly mapped onto neurons in the insula—a brain region critical for our own emotions.
STAT+: Biogen’s new CEO, clear-eyed about company’s challenges, prepares to take the reins
STAT News
NOVEMBER 11, 2022
Christopher Viehbacher, who will start as Biogen’s CEO on Monday , knows that running Biogen may be one of the toughest jobs in the pharmaceutical industry. But he said in an exclusive interview with STAT that after years of working as an investor, and coaching and mentoring other executives, he missed being on the playing field himself. “I’m not the type of guy to go run something that is smoothly running,” Viehbacher said.
COVID sniffer dogs' real-life feasibility study is successful
Medical Xpress
NOVEMBER 11, 2022
Research led by University of Veterinary Medicine Hannover (TiHo), in cooperation with Hannover Medical School (MHH), Robert Koch Institute, Hannover Concerts, ProEvent Hannover and AWiAS Aviation Services GmbH, examined whether trained corona detection dogs can be used in everyday life.
STAT+: Up and down the ladder: The latest comings and goings
STAT News
NOVEMBER 11, 2022
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
The New Age of Decentralized Clinical Trials
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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.
Family caregivers month: How caregivers can be partners in research
Antidote
NOVEMBER 11, 2022
November is designated as National Family Caregivers Month , which is a way to honor over 50 million Americans that provide care and assistance to loved ones. Caregivers play a vital role in the medical journeys of many patients , and they often dedicate their entire lives to maintaining a person’s health and dignity throughout the process.
STAT+: Pharmalittle: Lilly says fake Twitter account offered free insulin; AstraZeneca drops plans for Covid shot in the U.S.
STAT News
NOVEMBER 11, 2022
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. We are still setting our agenda, but for the moment, we expect to promenade with our official mascot, have another listening party with Mrs. Pharmalot and attend the latest installment in our “Let’s-see-them-before-they-go” concert series.
Maintaining masking requirements at Boston Public Schools protected students, staff
Medical Xpress
NOVEMBER 11, 2022
The lifting of masking requirements in school districts outside of Boston in February 2022 was associated with an additional 44.9 COVID-19 cases per 1,000 students and staff in the 15 weeks after the statewide masking policy was rescinded. This represented nearly 12,000 total COVID-19 cases or 30% of all cases in those school districts that unmasked during that time, according to a new study led by Harvard T.H.
Twitter trolls, Musk’s changes tank stocks for Lilly, other insulin makers
pharmaphorum
NOVEMBER 11, 2022
Elon Musk’s Twitter takeover has been nothing of tumultuous, and that tumult hit home for pharma Thursday when an account impersonating Eli Lilly and Company, taking advantage of lax oversight in the new Twitter Blue program, tweeted “We are excited to announce insulin is free now” Insulin is, of course, not free, especially in the United States where a vial of Humalog, Lilly’s insulin product, can cost upwards of $300 and competing products from Sanofi and Novo Nordisk a
Accelerating Clinical Supply Through Integrated Drug Development
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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.
11.3 percent of school students report tobacco product use
Medical Xpress
NOVEMBER 11, 2022
About 11.3 percent of all middle and high school students reported currently using any tobacco product in 2022, with electronic cigarettes the most commonly used product, according to research published in the Nov. 11 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.
Stanford prof pays investors in defunct biotech Nuredis $29m
pharmaphorum
NOVEMBER 11, 2022
A prominent genetics professor at Stanford University in the US has paid $29 million to investors in Nuredis – a biotech that has now been wound up – after a California court found he misrepresented the company to investors. Dr Stanley Cohen was sued by Alafi Capital and the Christopher Alafi Family Trust – the only investors in Nuredis – in 2018. The lawsuit claimed he misled them whist persuading them to invest $20 million in the biotech, set up to develop a candidate therapy for neurodegenera
Neural networks enlist physics-based computations for faster, clearer image restoration
Medical Xpress
NOVEMBER 11, 2022
Fluorescence microscopy allows researchers to study specific structures in complex biological samples. However, the image created using fluorescent probes suffers from blurring and background noise. The latest work from NIBIB researchers and their collaborators introduces several novel image restoration strategies that create sharp images with significantly reduced processing time and computing power.
Spotlight on women in pharma: ?eyda Atadan Memi?, Takeda
pharmaphorum
NOVEMBER 11, 2022
As part of our Women in Pharma series, where we talk to leading figures in the life sciences, we hear from ?eyda Atadan Memi?, recently appointed general manager for Takeda UK and Ireland. Here, she discusses her new role, key steps to a successful career in life sciences, and her plans for the future. What inspired you to pursue a career in the life sciences?
How Machine Learning Drives Clinical Trial Efficiency
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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.
Non-hormonal therapy reduces hot flashes and night sweats in women who have been diagnosed with breast cancer
Medical Xpress
NOVEMBER 11, 2022
A Monash University-led trial of a new drug known as Q-122 therapy significantly reduced the number and severity of hot flashes and night sweats in women who have been diagnosed with breast cancer. It also improved their sleep and had no serious adverse effects.
STAT+: Head of MassBio trade group is out after serving just over a year
STAT News
NOVEMBER 11, 2022
Barely a year after he was named head of the Massachusetts Biotechnology Council, former state Senator Joseph Boncore has been ousted and will be replaced with the trade group’s second-highest executive, according to two members of the nonprofit organization’s board of directors. In response to Globe inquiries, MassBio issued a brief statement saying that Boncore “is resigning as CEO to open a consulting practice and will remain an advisor to MassBio on state and federal iss
Updated rheumatoid arthritis treatment recommendations
Medical Xpress
NOVEMBER 11, 2022
Since their first publication in 2010, the EULAR recommendations for the use of disease-modifying anti-rheumatic treatments (DMARDs) in people with rheumatoid arthritis (RA) have become a most important publication in the field, and their updates are relied upon by many healthcare professionals, professional organizations and other stakeholders to offer an up-to-date and robust analysis on an optimal approach to the application of available treatment options in clinical practice.
Pharma companies team-up to reduce emissions
Drug Discovery World
NOVEMBER 11, 2022
Seven pharmaceutical companies have announced a joint initiative to reduce near-term emissions and help develop net zero health systems. . CEOs from AstraZeneca, GSK, Merck KGaA , Novo Nordisk, Roche, Samsung Biologics and Sanofi announced commitments to tackle climate change through the Sustainable Markets Initiative (SMI) Health Systems Task Force, a public-private partnership launched last year at COP26. .
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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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