Drugging RNA with pills: small molecules for a big frontier
Bio Pharma Dive
SEPTEMBER 6, 2022
A handful of startups have formed in recent years with plans to target RNA with small molecules. Many have caught the attention of big drugmakers.
Tue.Sep 06, 2022
294 
US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma
Pharmaceutical Technology
SEPTEMBER 6, 2022
The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin. This approach aids the therapy to be activated mainly in the tumour, sparing healthy tissue from exposure.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Sarepta to restart Duchenne drug study after FDA lifts hold
Bio Pharma Dive
SEPTEMBER 6, 2022
The biotech will expand patient monitoring in response to a previously reported serious adverse reaction that had led the FDA in June to suspend testing.
Scientists Just Found a New Kind of Synapse Hiding in The Brains of Mice
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 6, 2022
A previously unknown type of synapse appears to have been hiding in strange, hair-like appendages that can be found on the surfaces of neurons, new research reveals. A study in mice suggests that structures called primary cilia play a role in neuronal signaling; specifically, they act as a shortcut for transmitting signals directly into the […].
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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
Iveric readies eye drug for FDA following study success
Bio Pharma Dive
SEPTEMBER 6, 2022
The drug slowed eye lesion growth in people with geographic atrophy, positioning it to become the second treatment for the disease to reach the FDA.
Leading pharmaceutical logistics and pharma supply chain companies
Pharmaceutical Technology
SEPTEMBER 6, 2022
The pharmaceutical supply chain is a global and complex network that includes a wide range of stakeholders such as pharmaceutical manufacturers, wholesale distributors, and pharmacy benefit managers (PBM), to ensure efficient and timely delivery of medications to the patients. Hospitals, clinics, pharmacies, wholesalers of medical products and other health centres are catered by pharmaceutical logistics that include handling activities such as procurement, warehousing, and inventory management,
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Business optimism improved in August 2022: Poll
Pharmaceutical Technology
SEPTEMBER 6, 2022
Business optimism improved in August 2022 compared to July 2022, according to an ongoing poll by Verdict, despite businesses expressing concern over inflation, particularly in raw materials and energy costs. Verdict has been conducting the poll to study the trends in business optimism during COVID-19 as reflected by the views of companies on their future growth prospects amid the pandemic.
New Drugs Bill should ensure obligation from buyers to purchase only certified medical devices: AiMeD
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 6, 2022
The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry […].
UK pharma industry IT recruitment activity rises 3.3% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
The UK’s pharma industry registered a 3.3% rise in IT hiring activity in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring is decreased by 1.6% in August 2022 when compared with July 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 4.27% share in August 2022, recording an increase of 0.13% over the last three-month average share.
Pfizer isn’t sharing Covid vaccines with researchers for next-gen studies
STAT News
SEPTEMBER 6, 2022
WASHINGTON — Researchers studying next-generation vaccines to fight an evolving Covid-19 threat are running into problems getting existing vaccines to use in their research. Because Pfizer and Moderna hold the patents for the current vaccines, researchers would likely have to get the companies’ permission to use them for research into products like nasal or pan-coronavirus vaccines.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Switzerland’s pharma industry IT recruitment activity drops 2.3% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
Switzerland’s pharma industry registered a 2.3% drop in IT hiring activity in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring is decreased by 1.62% in August 2022 when compared with July 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 2.74% share in August 2022, recording a decrease of 0.53% over the last three-month average share.
Google debuts a new AI tool in the global fight against tuberculosis
STAT News
SEPTEMBER 6, 2022
Tuberculosis kills 1.4 million people every year, primarily in places where poverty and deprivation conspire to make people uniquely vulnerable, and unable to get lifesaving care in time. Google is now joining a global fight to snuff out the disease, using AI to automate its detection — and expedite treatment — in communities where physicians are in short supply.
US pharma industry IT recruitment activity drops 1.4% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
The US’s pharma industry registered a 1.4% drop in IT hiring activity in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring increased by 2.81% in August 2022 when compared with July 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 1.84% share in August 2022, recording a decrease of 0.05% over the last three-month average share.
Opinion: Open access to research can close gaps for people with disabilities
STAT News
SEPTEMBER 6, 2022
In a long-overdue move, the federal Office of Science and Technology Policy has issued guidance on making federally supported research and publications available to all without delay or embargo. This remarkable announcement about open access has the potential to remove information barriers that have long held back social and scientific progress. Even with immediate open access to research results, however, people with disabilities face unique barriers to information access.
Roles and Responsibilities of Specialized Clinical Supply Experts
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.
AstraZeneca’s IT hiring activity declines 5.4% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
UK-based company AstraZeneca’s IT hiring declined 5.4% in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 8.49% in August 2022 when compared with July 2022. IT jobs claimed an 8.47% share in the company’s total hiring activity in August 2022, and recorded a 0.24% growth over the last three-month average share.
NICE says no to Lynparza in prostate cancer, creating UK access divide
pharmaphorum
SEPTEMBER 6, 2022
NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an agreement on price with the drugmaker. The health technology assessment (HTA) authority said that the PARP inhibitor “is not cost-effective at its current price” as a treatment for BRCA-positive prostate cancer that has spread to other parts of the body and relapsed after prior hormonal therapy.
Bayer’s IT hiring activity rises 0.9% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
Germany-based company Bayer’s IT hiring rose 0.9% in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 1.03% in August 2022 when compared with July 2022. IT jobs claimed a 6.29% share in the company’s total hiring activity in August 2022, and recorded a 0.14% growth over the last three-month average share.
White House signals most people will only need annual Covid booster
STAT News
SEPTEMBER 6, 2022
As part of its push to encourage vaccine-weary Americans to get the updated Covid shot, the White House put forth a new selling point Tuesday: to view it as a first annual shot, akin to the annual flu shot. The messaging from the White House — part of a briefing where health officials outlined the rollout of the new bivalent booster shots authorized last week — reflects another transition point in the country’s fight against the coronavirus.
The New Age of Decentralized Clinical Trials
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.
Eurofins Scientific’s IT hiring activity declines 4.0% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
Luxembourg-based company Eurofins Scientific’s IT hiring declined 4.0% in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 2.3% in August 2022 when compared with July 2022. IT jobs claimed a 5.43% share in the company’s total hiring activity in August 2022, and recorded a 0.49% decline over the last three-month average share.
What happens to patients when telehealth businesses shutter?
STAT News
SEPTEMBER 6, 2022
Buzzy, venture-backed startups and big tech companies that have promised to disrupt health care are indeed doing so — including by shuttering services that early adopter patients may have come to rely on. Following its deal to acquire primary care tech company One Medical , Amazon announced it was ending its own virtual- and in-person health service Amazon Care , which covers 40,000 patients, by the end of the year.
Johnson & Johnson’s IT hiring activity declines 2.7% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
US-based company Johnson & Johnson’s IT hiring declined 2.7% in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 0.86% in August 2022 when compared with July 2022. IT jobs claimed a 4.11% share in the company’s total hiring activity in August 2022, and recorded a 0.06% decline over the last three-month average share.
Opinion: The FDA got it right with hearing aids. Updating Medicare coverage is next
STAT News
SEPTEMBER 6, 2022
“You would really benefit from hearing aids, but they aren’t covered by Medicare and cost around $4,000.” We’ve each said this phrase countless times to patients with hearing loss and are prepared for the reaction that invariably follows: an expression of bewilderment about why a pair of hearing aids may have to be their third largest material purchase in life, after a house and car.
Accelerating Clinical Supply Through Integrated Drug Development
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.
Merck’s IT hiring activity rises 11.5% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
Germany-based company Merck’s IT hiring rose 11.5% in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 1.86% in August 2022 when compared with July 2022. IT jobs claimed an 8.87% share in the company’s total hiring activity in August 2022, and recorded a 1.45% growth over the last three-month average share.
STAT+: Pharma donations to patient charities may violate the ‘spirit’ of anti-kickback laws
STAT News
SEPTEMBER 6, 2022
There is a federal law that prohibits drug companies from directly covering out-of-pocket spending by Medicare beneficiaries. But these companies are allowed to donate to independent charities that provide assistance to patients — and they can earmark donations for a condition treated by their drugs. With this in mind, a group of researchers wanted to know whether the donations are a good investment for the pharmaceutical industry — and they found that, yes, the donations can be pr
Parexel International’s IT hiring activity rises 73.6% in August 2022
Pharmaceutical Technology
SEPTEMBER 6, 2022
US-based company Parexel International’s IT hiring rose 73.6% in August 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 72.59% in August 2022 when compared with July 2022. IT jobs claimed a 13.68% share in the company’s total hiring activity in August 2022, and recorded a 2.3% growth over the last three-month average share.
Whatever happened to the baby shot 3 times in the Kabul maternity hospital bombing?
NPR Health - Shots
SEPTEMBER 6, 2022
The child incurred severe injuries in her right leg in the 2020 attack, which killed 24, including her mother. Complications mean a need for more surgeries. But it seemed impossible in Afghanistan.
How Machine Learning Drives Clinical Trial Efficiency
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.
STAT+: Bayer agrees to $40 million settlement over kickbacks and downplaying drug safety risks
STAT News
SEPTEMBER 6, 2022
After nearly two decades of litigation, Bayer agreed to pay $40 million to settle a pair of whistleblower lawsuits that accused the company of paying kickbacks to doctors and hospitals, as well as marketing two medicines for unapproved uses and downplaying safety risks of two other drugs. One lawsuit alleged that the company deliberately downplayed risks and overstated benefits of Trasylol, which is used to control bleeding in certain heart surgeries.
CGT manufacturing tech innovator expands global footprint and team
BioPharma Reporter
SEPTEMBER 6, 2022
Ori Biotech, a company aiming to bring automated manufacturing to the CGT industry, has been executing its strategic plan following the US$100m it raised in its Series B funding round earlier this year.
STAT+: How a tool to map computer viruses came to power biology research
STAT News
SEPTEMBER 6, 2022
When mathematicians Leland McInnes and John Healy walked into their work’s annual “Big Dig” — a sort of classified hackathon for Canada’s version of the National Security Agency — in 2017, they were not thinking about biology at all. They wanted to find a way to quickly spot the differences between computer viruses.
Konvomep Gets FDA Approval as a New Oral Liquid Formulation Option of Omeprazole
XTalks
SEPTEMBER 6, 2022
Gastric ulcers, also called stomach ulcers, are painful sores on the stomach lining. The most common sign of a gastric ulcer is a discomfort or burning pain in the abdomen, and less common symptoms may include burping, bloating, nausea and other symptoms. Almost 70 percent of all gastric ulcers are caused by a bacterial infection with Helicobacter pylori.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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.
Let's personalize your content