Bio Pharma Dive
OCTOBER 1, 2022
The resubmission has been long awaited after BioMarin’s original application was unexpectedly rejected by the FDA two years ago. The company expects a decision around the middle of next year.
Pharmaceutical Technology
OCTOBER 1, 2022
The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). Indicated for use as a monotherapy or along with currently approved therapies, Relyvrio can be administered orally by mixing a packet in eight ounces of water.
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Bio Pharma Dive
OCTOBER 1, 2022
The list price is slightly lower than another ALS therapy approved five years ago, but well above what one drug cost watchdog believes to be reasonable given its purported benefit.
Pharma Mirror
OCTOBER 1, 2022
Nanjing (China) and Barcelona (Spain), a global biopharmaceutical company focused on skin health, and Simcere Pharmaceutical Group（2096.HK), an innovation and R&D-driven pharmaceutical company; today announced that they have entered into an exclusive licensing agreement for Simcere’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278.
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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
OCTOBER 1, 2022
A newly published report by the HHS inspector general found that a substantial number of drugs given an accelerated approval by the FDA still haven’t proven whether they help patients.
Pharma Mirror
OCTOBER 1, 2022
ROCKVILLE, Md., Sept. 28, 2022 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Clinical Edge. Clinical Edge trains and certifies visual function examiners at investigator sites conducting Phase I to IV ophthalmic clinical trials.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
OCTOBER 1, 2022
The Hague, Support for pharmacists to provide services to people with chronic respiratory diseases — namely asthma and chronic obstructive pulmonary disease — is available in the form of two new resources published by the International Pharmaceutical Federation (FIP) today. These are: “Chronic respiratory diseases — A handbook for pharmacists”; and “Knowledge and skills reference guide for professional development in chronic respiratory diseases”.
Bio Pharma Dive
OCTOBER 1, 2022
The Swiss company said it would suffer irreparable harm if generics for the multiple sclerosis drug were allowed to enter the market before the higher court reviews the merits of its case.
Pharmaceutical Technology
OCTOBER 1, 2022
Ventus Therapeutics and Novo Nordisk have signed an exclusive global licence agreement for the development and commercialisation of candidates from the former’s peripherally-restricted NLRP3 inhibitors portfolio. The alliance will merge the lead NLRP3 inhibitor programme of Ventus with the deep capabilities of Novo Nordisk across cardiometabolic ailments.
Bio Pharma Dive
OCTOBER 1, 2022
The “Evolution and Innovation in Oncology Therapeutics Development” podcast series explores the role of multi-biomarkers in precision oncology.
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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
NPR Health - Shots
OCTOBER 1, 2022
In 2014, it was hard to miss the ALS Ice Bucket Challenge that set out to raise money to fund research for the disease. And it paid off. A new treatment was funded by $2.2 million of the funds raised.
Pharma Times
OCTOBER 1, 2022
Data further supports the continued development of FLU-v as a broad-spectrum influenza vaccine
NPR Health - Shots
OCTOBER 1, 2022
Some flu experts are urging many people to get their shots earlier than usual this year because of the potential for an early, possibly severe flu season. But what's the best timing for you?
STAT News
OCTOBER 1, 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. And here is our regular feature in which we highlight a different person each week.
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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.
NPR Health - Shots
OCTOBER 1, 2022
U.S. overdose deaths have exceeded 100,000 a year, yet few hospitals are equipped to treat patients with addiction. A new kind of treatment team connect patients with help before they're discharged.
STAT News
OCTOBER 1, 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 still shaping up, to be honest. We do, however, hope to find time to catch up on our reading, have a listening party with Mrs. Pharmalot, and, of course, promenade with our official mascot.
Pharma Times
OCTOBER 1, 2022
The research involves patients with advanced solid malignancies on tumour-directed therapy
pharmaphorum
OCTOBER 1, 2022
With Frontiers Health 2022 mere weeks away, we continue to interview members of the steering committee, gaining insight into what to expect from Milan. In this latest coverage, pharmaphorum speaks with Eugene Borukhovich. Formerly global head of digital health at Bayer, these days Borukhovich is travelling the entrepreneurial path, co-founder and COO of YourCoach.Health, together with his wife, Marina, who is also herself a health coach.
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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.
NPR Health - Shots
OCTOBER 1, 2022
A controversial new drug for ALS could add months to patients' lives – if it actually works (Image credit: Manuel Balce Ceneta/AP)
Drug Channels
OCTOBER 1, 2022
Today’s guest post comes from Kylie Hall, Director of Product Management at ConnectiveRx. Kylie explains how new ways of harnessing patient data can transform the way pharmaceutical companies interact with patients and providers—and ultimately help improve adherence. Click here to learn about the ConnectiveRx Enterprise Data Platform. Read on for Kylie’s insights.
NPR Health - Shots
OCTOBER 1, 2022
Some have required rescues, while others are hunkered down and depending on generator power as crews begin to sort through the damage.
Drug Channels
OCTOBER 1, 2022
Today’s guest post comes from Kylie Hall, Director of Product Management at ConnectiveRx. Kylie explains how new ways of harnessing patient data can transform the way pharmaceutical companies interact with patients and providers—and ultimately help improve adherence. Click here to learn about the ConnectiveRx Enterprise Data Platform. Read on for Kylie’s insights.
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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.
NPR Health - Shots
OCTOBER 1, 2022
Little green worms are crawling all over the Dallas-Fort Worth area in Texas. Scientists attribute the outbreak of cankerworms, or inchworms, to recent heavy rains.
pharmaphorum
OCTOBER 1, 2022
Intercept Pharma’s hopes of getting its non-alcoholic steatohepatitis (NASH) therapy obeticholic acid (OCA) in the US may have taken another dive, after it flunked a phase 3 trial. Shares in the company lost around 16% of their value after the top-line result of the REVERSE study in patients with compensated NASH-related cirrhosis were announced, as investors tried to work out what the failure will mean for the drug’s prospects.
Drug Discovery World
OCTOBER 1, 2022
Securing life sciences supply chains – where chemistry meets biology and products meet services. Biosynth is at the edge of innovation. With an unrivalled research product portfolio and end-to-end manufacturing services, we are science led and customer focused to solve problems and deliver key reagents across complex chemicals, peptides and key biologics all from one trusted partner.
pharmaphorum
OCTOBER 1, 2022
UK digital health company Babylon has hired Andrew Hine to take charge of its international expansion efforts, as it fights to retain its stock market listing in the US. Andrew Hine via LinkedIn. Formerly partner and head of health for Middle East and North Africa (MENA) at accounting group Ernst & Young, Hine will head up Babylon’s go-to-market team for Europe, Middle East, and Africa (EMEA), as well as Asia.
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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.
Drug Patent Watch
OCTOBER 1, 2022
Annual Drug Patent Expirations for NITHIODOTE Nithiodote is a drug marketed by Hope Pharms and is included in one NDA. It is available from one supplier. There are six patents…. The post New patent for Hope Pharms drug NITHIODOTE appeared first on DrugPatentWatch - Make Better Decisions.
Clinical Trial Podcast
OCTOBER 1, 2022
If you’re a sponsor responsible for outsourcing your clinical trials or someone who is curious about what clinical trial outsourcing entails, you’re in for a treat. Our guest today is Anca Copaescu (CO PAH ES COO), CEO at Strategikon Pharma. Outsourcing a multi-million dollar clinical trial is not as simple as calling a CRO, signing a contract, and spending the money.
Drug Patent Watch
OCTOBER 1, 2022
Annual Drug Patent Expirations for SODIUM+NITRITE Sodium Nitrite is a drug marketed by Hope Pharms and is included in one NDA. It is available from one supplier. There are two…. The post New patent for Hope Pharms drug SODIUM NITRITE appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
OCTOBER 1, 2022
In a dramatic change in fortunes, Novartis has won a major victory in its bid to defend oral multiple sclerosis therapy Gilenya from early generic competition in the US. Things have been looking bleak for the Swiss pharma group since the US Court of Appeals for the Federal Circuit (CAFC) denied its petition to rehear a case on the validity of a patent covering Gilenya (fingolimod) in relapsing-remitting MS.
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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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