Bio Pharma Dive
SEPTEMBER 8, 2022
Fuller data from Alnylam’s APOLLO-B trial confirm the success reported by the company last month, but won’t end a debate on the degree of benefit offered by its drug.
Pharmaceutical Technology
SEPTEMBER 5, 2022
Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.
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AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 7, 2022
If you’ve ever had a urinary tract infection (UTI) before, you know what a pain it can be. Not just because of the physical pains it causes, but because it can also be such a pain to go to the doctor, provide a urine sample, and wait for your results. Skip advert UTIs are extremely […].
World of DTC Marketing
SEPTEMBER 7, 2022
Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Biogen’s failure should be a warning to other pharma companies. They relied so much on a new drug that they tried to market a product with bad science behind it.
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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
SEPTEMBER 8, 2022
Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.
Pharmaceutical Technology
SEPTEMBER 8, 2022
Roche has signed a definitive merger agreement for the acquisition of US-based biopharmaceutical company Good Therapeutics for an upfront payment of $250m in cash. Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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
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 5, 2022
Bayer has agreed to make a payment of $40m for settling claims over the alleged violations of the False Claims Act linked to three drugs, Trasylol, Avelox and Baycol, the US Department of Justice said in a press statement. The settlement comes after a former Bayer employee, Laurie Simpson, filed two 'whistleblower' lawsuits against the company. These litigations were filed under the qui tam or whistleblower provisions of the False Claims Act, which facilitate private citizens to file lawsuits ag
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 5, 2022
The latest TikTok trend has us listening to brown noise. According to TikTok, this has multiple benefits including helping you relax and quickly fall into a deep sleep. Getting insufficient sleep, and insomnia are common. Skip advert So it’s no wonder many people are looking for ways to improve their sleep. But can brown noise […].
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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
Worldwide Clinical Trials
SEPTEMBER 7, 2022
The last time I saw my mom alive, I helped her eat dinner while my son colored her a picture. We were outside, due to Covid-19 restrictions. We were lucky to finally see her in person after almost a year of daily FaceTime videos, and window visits. Of course, none of us knew it would be our last visit. She died on April 3, 2021. My mom was one of the six million Americans living with Alzheimer’s Disease.
Bio Pharma Dive
SEPTEMBER 8, 2022
Updated data released ahead of the ESMO medical conference suggest Relay’s medicine could be more effective than others like it in treating a type of bile duct cancer.
Pharmaceutical Technology
SEPTEMBER 7, 2022
Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. A recombinant replication-deficient adenovirus vectored vaccine, iNCOVACC has a prefusion stabilised spike protein and is claimed to be the first intranasal vaccine globally to obtain primary two-dose schedule approvals.
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 […].
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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.
Rethinking Clinical Trials
SEPTEMBER 7, 2022
Dr. Steven Joffe. In this Friday’s PCT Grand Rounds, Dr. Steve Joffe will kick off our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials, with a keynote presentation, “Building an Academic Learning Health System: Why Is It So Hard?” The Grand Rounds session will be held on Friday, September 9, 2022, at 1:00 pm eastern.
Bio Pharma Dive
SEPTEMBER 8, 2022
The biotech, which has lost nearly all of its value since going public in 2020, reached a deal to sell a drug it tested in sickle cell disease to Cardurion Pharmaceuticals, a richly funded startup focused on cardiovascular research.
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.
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 […].
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
NPR Health - Shots
SEPTEMBER 8, 2022
Millions of New Yorkers embraced an "all in this together" motto during the pandemic — and many are roasting the city's transit agency over updated signs explaining its newly relaxed masking policy.
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.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 7, 2022
The Maharashtra Food and Drugs Administration (FDA) has set timelines for various regulatory approvals with an aim to make approval process transparent and facilitate ease of doing business. On August 22, 2022, FDA came out with a circular prescribing timeline for various applications. As per the circular, the prescribed timeline for drug manufacturers’ plant layout […].
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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
SEPTEMBER 8, 2022
At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.
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.
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,
NPR Health - Shots
SEPTEMBER 7, 2022
A new study finds numbers far higher than previously thought. India has the greatest number of kids affected. The U.S. has 250,000 kids in this category but lags behind in aid for bereaved families.
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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.
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.
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.
Pharmaceutical Technology
SEPTEMBER 5, 2022
Factors such as increasing access to health information, the introduction of new medical treatments and technologies and the spike in birth rate are increasing the need for payers in the pharmaceutical industry. Payers ensure the delivery of the best possible health outcomes to the patients from their financial plan. Finding the top payers in the pharmaceutical industry.
NPR Health - Shots
SEPTEMBER 7, 2022
Historic flooding and record droughts are stressing water systems across the country, and experts warn that with climate change intensifying the crisis in Jackson, Miss., may be just the beginning.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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