Bio Pharma Dive
JANUARY 9, 2023
An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the agency’s docket through the end of March.
Pharmaceutical Technology
JANUARY 9, 2023
Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials.
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Bio Pharma Dive
JANUARY 9, 2023
Drug price reforms and regulatory scrutiny present challenges for large drugmakers, although successes in Alzheimer’s and obesity have brought new opportunities, too.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 9, 2023
Sometimes what’s good for your heart is also good for your brain. A recent study of US adults over 50 found that those who owned a pet for more than five years scored better on cognitive memory tests than those living without interspecies housemates. The findings from the University of Michigan suggest the ‘pet effect‘ […].
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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
JANUARY 9, 2023
The CRISPR-focused biotech will lay off 20% of its workforce, stop development of two eye disease treatments and end some early-stage cell therapy research.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 9, 2023
The Department of Biotechnology (DBT) will shortly be opening its electronic project management information system (eProMIS) to accept proposals from eligible researchers under its Chronic and Lifestyle Disease Programme. The Programne supports research on chronic diseases with major thrust on metabolic disorders. It aims to support basic, clinical, translational and interdisciplinary research in focused high […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 9, 2023
Italian pharmaceutical company Chiesi Farmaceutici has signed a definitive agreement to acquire Amryt Pharma in a total deal valued at up to $1.48bn. The Boards of Directors of both companies have unanimously approved the transaction. Under the deal, Amryt shareholders will receive $14.50 per American Depositary Share (ADS) cash upfront, along with Contingent Value Rights (CVR) of up to an additional $2.50 per ADS based on the achievement of certain milestones related to the company’s Filsuvez.
Bio Pharma Dive
JANUARY 9, 2023
Marcus Delatte discusses how and why he focuses his expertise on counseling smaller companies and mentoring the next generation of technical experts.
Pharmaceutical Technology
JANUARY 9, 2023
AbbVie has entered a global collaboration and option agreement with Immunome to discover new antibody-target pairs for cancer treatment. The multi-year collaboration will use Immunome’s Discovery Engine to discover up to ten new antibody pairs arising from three specified types of tumours. Under the deal, AbbVie will have the option to buy global rights for the antibodies.
Bio Pharma Dive
JANUARY 9, 2023
Tech overload is among the greatest challenges sites have when they take on new clinical trials and the average clinical research center has to manage multiple platforms daily.
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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
STAT News
JANUARY 9, 2023
SAN FRANCISCO – U.S. Food and Drug Administration commissioner Robert Califf doesn’t disagree with the basic findings of a congressional investigation into the agency’s role in the controversial approval of Aduhelm, Biogen’s first Alzheimer’s drug. He just wishes the report’s tone had been different. “There were no surprises in the report,” Califf told STAT’s Matt Herper during a Monday night event hosted by STAT during the J.P
Bio Pharma Dive
JANUARY 9, 2023
The biotech and partner Takeda also announced a Phase 3 study of the RNA medicine that is longer than anticipated, pushing out analysts’ timelines.
STAT News
JANUARY 9, 2023
Senior-focused primary care providers Oak Street Health and Agilon Health used their stage time at the J.P. Morgan Healthcare Conference in San Francisco on Monday to talk up their ambitious growth plans in the coming year. Both Oak Street and Agilon’s business models are centered around the Medicare Advantage program, the private form of Medicare for people over 65.
Bio Pharma Dive
JANUARY 9, 2023
The longtime company head is retiring after a trying year for the COVID-19 vaccine developer. John Jacobs, most recently CEO at Harmony Biosciences, will succeed him.
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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
JANUARY 9, 2023
Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases. In the summer of 2022, at least 70 children in Gambia died from kidney failure after using cough medicine made by India-based Maiden Pharmaceuticals that contained ethylen
Bio Pharma Dive
JANUARY 9, 2023
The longtime congressman and “Medicare for All” proponent will soon assume leadership of the Senate HELP committee, giving him sway in one of the nation’s most broadly influential health policy forums.
pharmaphorum
JANUARY 9, 2023
Novartis’ programme providing free access to its spinal muscular atrophy (SMA) gene therapy Zolgensma is being scaled back to a dozen countries worldwide, according to the company. First introduced in 2020, the global Managed Access Programme (gMAP) has provided Zolgensma (onasemnogene abeparvovec) free of charge to nearly 300 children with the genetic disorder across 36 countries where the therapy has not yet received approval or in which no formal access pathway exists.
Fierce Pharma
JANUARY 9, 2023
JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint. esagonowsky. Mon, 01/09/2023 - 09:55.
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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.
pharmaphorum
JANUARY 9, 2023
We’re preparing to start JP Morgan week with a busy day Monday, with day 1 of the Informa Biotech Showcase, including a dedicated mini-event on Cell and Gene Therapy in the morning. Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf. Check below for updates throughout the day.
NPR Health - Shots
JANUARY 9, 2023
Dr. Celine Gounder speaks out against disinformation after her husband Grant Wahl's sudden death was seized on by anti-vaccination conspiracy theorists.
STAT News
JANUARY 9, 2023
Moderna disclosed Monday that it plans to price its Covid-19 vaccine at anywhere from $110 to $130 per dose when the company pivots from a focus on government contracts to commercial distribution efforts. The timing was not disclosed, but the company is holding talks with hospitals, pharmacy chains and pharmacy benefit managers. In setting such a price, Moderna will pursue the same path as Pfizer, which last year also announced plans to charge $110 to $130 a dose this year for its own Covid-19 s
Fierce Pharma
JANUARY 9, 2023
JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023. kdunleavy. Mon, 01/09/2023 - 10:34.
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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
JANUARY 9, 2023
“Living With” explores the contours of life with chronic illness, from the prelude to diagnosis to new patterns of living, to wrestling with big questions about illness and health. Kristin Houlihan, 38, got sick in March 2020 with a virus she assumes was Covid. She wasn’t sick, in a flu-like sense, for long. But then, some symptoms never went away: night sweats, extreme temperature swings after meals.
NPR Health - Shots
JANUARY 9, 2023
Instead of "watchful waiting," the American Academy of Pediatrics now recommends intensive lifestyle and behavior therapy for young kids, and for older children, medication.
STAT News
JANUARY 9, 2023
The surge in telehealth during the pandemic promised to shed light on a crucial question: Does the convenience of telehealth drive up costs when patients make more appointments than they would in-person? The answer stands to shape investments in — and oversight of — the fast-growing field. But three years in, the mountain of telehealth claims data has created a fresh set of questions, and left regulators, insurers, researchers, and health systems with a newfound recognition that vi
NPR Health - Shots
JANUARY 9, 2023
Instead of health insurance, the Rev. Jeff King had signed up for an alternative that left members of the plan to share the costs of health care. That meant lower premiums, but a huge hospital bill.
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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
JANUARY 9, 2023
A new study suggests physician practices acquired by private equity rely more heavily on advanced practice providers like nurse practitioners and physician assistants and experience higher churn compared with their non-private equity owned peers. The researchers used clinician-level and practice acquisition data to study changes in the makeup of clinician workforces at private equity-acquired versus non-private equity-acquired dermatology, ophthalmology, and gastroenterology practices between 20
Medical Xpress
JANUARY 9, 2023
For those who exercise regularly, eating almonds each day might be the ideal new year's resolution. A randomized controlled trial in Frontiers in Nutrition showed that female and male participants who ate 57g almonds daily for one month had more of the beneficial fat 12,13-dihydroxy-9Z-octadecenoic acid (12,13-DiHOME) in their blood immediately after a session of intense exercise than control participants.
STAT News
JANUARY 9, 2023
Children struggling with obesity should be evaluated and treated early and aggressively, including with medications for kids as young as 12 and surgery for those as young as 13, according to new guidelines released Monday. The longstanding practice of “watchful waiting,” or delaying treatment to see whether children and teens outgrow or overcome obesity on their own only worsens the problem that affects more than 14.4 million young people in the U.S.
Medical Xpress
JANUARY 9, 2023
Children struggling with obesity should be evaluated and treated early and aggressively, including with medications for kids as young as 12 and surgery for those as young as 13, according to new guidelines released Monday.
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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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