Bio Pharma Dive
SEPTEMBER 9, 2022
Comments by Billy Dunn, head of the FDA’s neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine, which is in the final stages of regulatory review.
Pharmaceutical Technology
SEPTEMBER 9, 2022
US-based biotech company Gatehouse Bio is extending its collaboration with AstraZeneca for developing RNA therapeutics to treat heart failure with preserved ejection fraction (HFpEF). Initially, the companies partnered to identify new targets for respiratory and cardiovascular diseases using Gatehouse Bio’s artificial intelligence (AI)-powered platform in December 2019.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
SEPTEMBER 9, 2022
A high-dose form of Eylea, administered less frequently, matched the original in late-stage testing, an important step in the company’s plan to defend its bestseller against competition.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 9, 2022
The most effective way for people with diabetes to deliver insulin is also incredibly intrusive. Millions around the world must inject the crucial hormone underneath their skin several times a day to keep their glucose levels in balance. Skip advert For years, scientists have looked for an easier, cheaper, more convenient, and less wasteful alternative […].
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
Bio Pharma Dive
SEPTEMBER 9, 2022
David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters.
Pharma Mirror
SEPTEMBER 9, 2022
Cambridge, UK: STORM Therapeutics Ltd. (STORM), the biotechnology company discovering and developing novel small molecule therapies targeting RNA modification enzymes for oncology and other diseases, today announced the appointment of Dr. Gerald (Jerry) McMahon as President and Chief Executive Officer and Board Director. Dr. McMahon brings with him more than 30 years of biotechnology leadership, scientific innovation, creative deal-making, and financing experience with a broad disease-area exper
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
SEPTEMBER 9, 2022
“I really believe this is why God gave us two arms — one for the flu shot and the other one for the Covid shot.” — Ashish Jha, White House Covid coordinator, Sept. 6, 2022. As the promotional push to get people vaccinated with one of the updated, bivalent Covid vaccines heats up, federal health authorities are urging Americans to consider getting their Covid shot and their flu shot at the same time.
NPR Health - Shots
SEPTEMBER 9, 2022
If the proposed amendment doesn't hit any further roadblocks, voters in Michigan will be able to decide whether to protect abortion rights in the state constitution this November.
STAT News
SEPTEMBER 9, 2022
Pregnancy is risky, and Naima Joseph sees the perils firsthand every day. For some patients, it might be a cardiac injury, their heart issues worsened by having to pump enough blood for two. For others, it might be a uterine infection, or a hemorrhage, or a case of pre-eclampsia. These are the complications we tend to imagine when we think of America’s maternal mortality crisis: Underlying chronic disease, insufficient access to care, cellular cascades gone wrong.
pharmaphorum
SEPTEMBER 9, 2022
Digital health specialist Kry has teamed up with pharma group Novo Nordisk on the development of resources that can help people with obesity manage their condition and adhere to treatment. The partners anticipate that the digital obesity programme will launch later this autumn in Sweden, ahead of a broader rollout in other European markets before the end of the year.
Advertisement
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
SEPTEMBER 9, 2022
Norman Rockwell’s 1939 painting “When the Doctor Treats Your Child” depicts a family doctor with a stethoscope around his neck scribbling a prescription in front of three children, one sitting on his mother’s lap. The painting evokes the health care covenant: one doctor responsible for the family as well as for the community, whose professional ethics required unfaltering dedication to their patient’s well-being.
XTalks
SEPTEMBER 9, 2022
This week, Magnus Medical’s SAINT Neuromodulation System received 510(k) clearance from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults who did not have satisfactory improvement from past antidepressant medications in their current episode. The California-based medical device company develops brain stimulation technology to treat neuropsychiatric disorders.
STAT News
SEPTEMBER 9, 2022
In an unusual turn of events, an appeals panel ruled that the U.K.’s cost effectiveness watchdog agency acted unfairly and exceeded its authority by failing to thoroughly explain why it declined to recommend a Johnson & Johnson medicine called Spravato for combating treatment-resistant depression. Specifically, the panel determined that the National Institute for Health and Care Excellence did not thoroughly convey its views on how uncertainties in the evidence that are “inhere
pharmaphorum
SEPTEMBER 9, 2022
As one of the world’s biggest contributors to climate change, pharma is morally obliged to adapt its processes and operations – and doing so will open up new opportunities for growth. Pharma’s reliance on global supply chains and its need for vast quantities of water make it particularly vulnerable to climate change. But preparing to adapt to the phenomenon presents an opportunity as well as a challenge.
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.
STAT News
SEPTEMBER 9, 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. Our agenda is decidedly modest. We plan to catch up on some reading, putter about the castle, and promenade with the official mascot. And what about you? This remains a fine time of year to enjoy the great outdoors — beaches, lakes, and mountain trails are beckoning.
pharmaphorum
SEPTEMBER 9, 2022
The pandemic forced clinical trial sponsors to change their processes, with a more technology-driven approach and, according to a new study by Medidata, the sector is now “stronger than ever” as a result. The study , based on interviews conducted earlier this year with 400 clinical trial executives from the UK, France, Germany, and Switzerland, found that more than a third (37%) ranked better outcomes of trials within the top three areas of improvement since COVID-19 emerged.
STAT News
SEPTEMBER 9, 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. ( Editor’s note: Our regular feature that focuses on a newly hired executive will return next week).
Pharma Times
SEPTEMBER 9, 2022
Company is introducing abiraterone film-coated tablets for treating metastatic prostate cancer
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.
NPR Health - Shots
SEPTEMBER 9, 2022
The latest generation of hard hats are designed to cushion the brain during an impact by absorbing forces that cause the head to spin.
Drug Channels
SEPTEMBER 9, 2022
Today’s guest post comes from Kristina Crockett, Vice President of Product Management at CoverMyMeds. Kristina discusses the affordability challenges that patients face in our complex and confusing healthcare system. She then explains how data and technology can help payers, manufacturers, and providers improve medication access. To learn more about CoverMyMeds’ comprehensive affordability solutions, download Overcoming Medication Affordability Challenges with Patient-Centered Solutions.
NPR Health - Shots
SEPTEMBER 9, 2022
A new report from the Centers for Disease Control and Prevention finds that a disproportionate number of people who are contracting monkeypox in the U.S. are also HIV-positive.
Pharma Times
SEPTEMBER 9, 2022
Research showed significant improvements in signs and symptoms of prurigo nodularis
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.
Advarra
SEPTEMBER 9, 2022
A well-trained, effective, and efficient team is key to a successful clinical trial. Especially in the post-COVID world of changing work modalities, implementing a training program can seem more confusing than ever. The forced exodus to all-virtual environments opened the door to more flexibility in developing and delivering training. With the changed landscape, training now has the potential for greater effectiveness and efficiency.
Pharma Times
SEPTEMBER 9, 2022
Get started on your entry for these prestigious awards now – the deadline is 16 September 2022
pharmaphorum
SEPTEMBER 9, 2022
The experienced executive will expand our cross-functional omnichannel, data and analytics, and technology offerings, developing effective solutions to meet our clients’ evolving needs. Geoff Thorne has joined Fishawack Health (FH) as our new Chief Technology Officer. He will focus on refining our technology and strategy offerings to solve complex challenges for our biopharmaceutical, medical technology, and wellness clients.
Pharma Times
SEPTEMBER 9, 2022
You can still submit your entry before the imminent 16 September 2022 deadline – but hurry!
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.
Drug Discovery World
SEPTEMBER 9, 2022
A new genetically engineered herpes virus has delivered a one-two punch against advanced cancers in initial findings from a Phase I trial. Researchers have found that RP2 – a modified version of the herpes simplex virus – showed signs of effectiveness in a quarter of patients with a range of advanced cancers. Patients on the trial had cancers including skin, oesophageal and head and neck cancer and had exhausted other treatments, including by failing to respond to checkpoint inhibitor immunother
pharmaphorum
SEPTEMBER 9, 2022
A higher dose of Regeneron and Bayer’s Eylea given every three or four months has shown efficacy in a pair of clinical trials, in a big boost for the multibillion-dollar product. The two studies – in wet age-related macular degeneration (AMD) and diabetic macular oedema (DME) – showed the 12- and 16-week Eylea (aflibercept) regimens were non-inferior to the currently approved 8-week dosing, reducing the number of injections into the eye needed by patients with the sight-robbing diseases.
Drug Discovery World
SEPTEMBER 9, 2022
News round-up for 5-9 September by DDW Digital Content Editor Diana Spencer. Cancer research has been making headlines over the last seven days in the build-up to the European Society for Medical Oncology (ESMO) Congress 2022. Notably, it was a mixed week for PARP inhibitor olaparib, which was approved by regulator the MHRA for patients with early-stage breast cancer, but rejected by NICE for use on the NHS in metastatic prostate cancer.
pharmaphorum
SEPTEMBER 9, 2022
Prospects for Gilead Sciences’ Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer continue to improve as data from the TROPiCs-02 trial strengthen, but the jury is still out on what that might mean for the drug commercially. At this year’s ASCO congress, news that Trodelvy (sacituzumab govitecan) failed to have a significant impact on overall survival (OS) in this form of breast cancer weighed heavily on Gilead, as the Trop2-targeting antibody-drug conjugat
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.
338 
Let's personalize your content