Bio Pharma Dive
APRIL 22, 2022
In a letter to regulators, Biogen said it chose to withdraw its approval filing after discussions with the EMA, which previously found the data supporting Aduhelm to be lacking.
pharmaphorum
APRIL 22, 2022
Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. Shares in the US biotech have fallen sharply after it revealed that the regulator did not accept changes to a phase 3 trial of the drug – called Ampion – that the company put forward in order to make it serve as a confirmatory pivotal study.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
APRIL 22, 2022
Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.
Pharma Times
APRIL 22, 2022
Researchers were able to detect specific combinations of genetic alterations which may hold key to the growth of cancers
Advertisement
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
pharmaphorum
APRIL 22, 2022
Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development. The write-down comes in the wake of problems affecting the Japanese drugmaker’s AT132 gene therapy candidate for rare disease X-linked myotubular myopathy (XLMTM), which was placed on clinical hold by the FDA last year after four patient deaths liked to pos
Pharma Times
APRIL 22, 2022
Infertility is estimated to affect one in seven couples across the UK and can have a profound effect on mental health
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
APRIL 22, 2022
Sanofi held a ground-breaking ceremony for its new vaccine facility in Singapore on April 20. The US$475m site is pegged to become fully operational by Q1 2026.
Scienmag
APRIL 22, 2022
While cancer is a genetic disease, the genetic component is just one piece of the puzzle — and researchers need to consider environmental and metabolic factors as well, according to a research review by a leading expert at the University of Alberta. Credit: Richard Siemens, University of Alberta While cancer is a genetic disease, the […].
Drug Channels
APRIL 22, 2022
This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Click here to see the original post and comments from February 2022. More than four years ago, I warned about the emerging trend of copay accumulators and outlined the costly consequences for patients. The latest data reveal that copay accumulator adjustment programs are now in the word list for a growing share of pharmacy benefit designs.
Scienmag
APRIL 22, 2022
AMES, Iowa – An Iowa State University research team that helped develop a demonstration-scale pyrolyzer capable of sequestering thousands of tons of carbon dioxide a year has received a prestigious milestone award from XPRIZE Carbon Removal, it was announced on Friday. The milestone prize provides $1 million to the carbon removal team at the […].
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
NY Times
APRIL 22, 2022
Once again, a dysfunctional health care system has hindered our pandemic response.
Scienmag
APRIL 22, 2022
LA JOLLA—(April 22, 2022) For years, the brain has been thought of as a biological computer that processes information through traditional circuits, whereby data zips straight from one cell to another. While that model is still accurate, a new study led by Salk Professor Thomas Albright and Staff Scientist Sergei Gepshtein shows that there’s also […].
pharmaphorum
APRIL 22, 2022
In March 2022 , Leela Barham argued that, in light of new highs in the number of non-submissions to UK’s HTA agency, NICE, it was time to ask companies why they choose not to submit. In this piece, she provides an independent view of the reasons companies have given through an anonymous survey conducted by the industry body, the ABPI. ABPI survey. The ABPI surveyed their members in March 2021, including questions relating to terminated appraisals for non-submissions to NICE between 2016 and 2021
Scienmag
APRIL 22, 2022
New research has identified a lesser-known form of ozone playing a big role in heating the Southern Ocean — one of Earth’s main cooling systems. Credit: Liam Quinn New research has identified a lesser-known form of ozone playing a big role in heating the Southern Ocean — one of Earth’s main cooling systems. Ozone is […].
Advertisement
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.
pharmaphorum
APRIL 22, 2022
Sweden’s Vicore Pharma has started a clinical trial of a digital therapeutic (DTx) intended to relieve anxiety in patients with idiopathic pulmonary fibrosis (IPF), a debilitating and progressive respiratory disease with no curative treatment. The COMPANION study will test a cognitive behavioural therapy-based DTx called Almee (formerly VP04) – developed in partnership with digital health company Alex Therapeutics – to see if it can reduce the psychological symptom burden in adults diagnos
Scienmag
APRIL 22, 2022
Don’t be fooled by the name. While 3D printers do print tangible objects (and quite well), how they do the job doesn’t actually happen in 3D, but rather in regular old 2D. Credit: Tracy H. Schloemer and Arynn O. Gallegos Don’t be fooled by the name. While 3D printers do print tangible objects (and quite […].
Drug Patent Watch
APRIL 22, 2022
Annual Drug Patent Expirations for OXYCONTIN Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from eight suppliers. There are nineteen…. The post New patent for Purdue Pharma drug OXYCONTIN appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 22, 2022
Metasurfaces are artificial array structures consisting of subwavelength unit cells arranged on a specific two-dimensional surface. Dynamic, reconfigurable metasurfaces are an excellent way to manipulate electromagnetic (EM) waves flexibly. Credit: Zhang et al., doi 10.1117/1.AP.4.2.025001. Metasurfaces are artificial array structures consisting of subwavelength unit cells arranged on a specific two-dimensional surface.
Advertisement
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.
Drug Patent Watch
APRIL 22, 2022
Annual Drug Patent Expirations for LEQVIO Leqvio is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are nineteen patents protecting…. The post New patent expiration for Novartis drug LEQVIO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 22, 2022
BIRMINGHAM, Ala. – For more than two decades, University of Alabama at Birmingham researcher Susan Bellis, Ph.D., has studied how the addition of sialic acid to various proteins increases cancer resistance and oncogenicity. Credit: UAB BIRMINGHAM, Ala. – For more than two decades, University of Alabama at Birmingham researcher Susan Bellis, Ph.D., has studied how […].
Drug Patent Watch
APRIL 22, 2022
Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are two…. The post New patent for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 22, 2022
HOUSTON – (April 22, 2022) – Nanotechnology is increasingly important to the development of treatments for cancer. But to succeed, clinicians need to understand it. Credit: Jeff Fitlow/Rice University HOUSTON – (April 22, 2022) – Nanotechnology is increasingly important to the development of treatments for cancer. But to succeed, clinicians need to understand it.
Advertisement
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.
Drug Patent Watch
APRIL 22, 2022
Annual Drug Patent Expirations for LOREEV+XR Loreev Xr is a drug marketed by Almatica and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent for Almatica drug LOREEV XR appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 22, 2022
In a small but multi-institutional study, an artificial intelligence-based system improved providers’ assessments of whether patients with bladder cancer had complete response to chemotherapy before a radical cystectomy (bladder removal surgery). Credit: Justine Ross/Michigan Medicine In a small but multi-institutional study, an artificial intelligence-based system improved providers’ assessments of whether patients with bladder cancer had […].
Drug Patent Watch
APRIL 22, 2022
Annual Drug Patent Expirations for HYSINGLA+ER Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from one supplier. There are…. The post New patent for Purdue Pharma drug HYSINGLA ER appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 22, 2022
A third of healthcare workers took sick leave after being vaccinated against COVID-19, a German study presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Lisbon, Portugal, (23-26 April) has found. A healthy healthcare workforce is vital to cope with COVID-19, as well as with the pandemic’s wider effects on […].
Advertisement
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
APRIL 22, 2022
BioConnection, an independent contract development manufacturing organization (CDMO) based in Oss in The Netherlands has completed a new capital raising round led by the European investment company, Gimv.
Scienmag
APRIL 22, 2022
Using a telecommunications fiber-optic-based sensing system, researchers were able to track the spread of sea ice in near-real-time over a 40-kilometer stretch of the Beaufort Sea north of Alaska. Credit: Sandia National Laboratories Using a telecommunications fiber-optic-based sensing system, researchers were able to track the spread of sea ice in near-real-time over a 40-kilometer stretch […].
BioPharma Reporter
APRIL 22, 2022
The diagnostics and drug development company, Labcorp, is partnering with San Francisco based, Xcell Biosciences, to advance efforts to help clients bring cell and gene therapies to market.
Scienmag
APRIL 22, 2022
East Hanover, NJ. April 22, 2022. Unemployment rose for people with disabilities in March, indicating that more people with disabilities are looking for work, according to today’s National Trends in Disability Employment (nTIDE) COVID Update. While unemployment declined for people without disabilities, they have yet to reach their pre-pandemic levels of employment.
Advertisement
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.
Expert insights. Personalized for you.
158 
Let's personalize your content