Bio Pharma Dive
JUNE 1, 2023
The biotech will price its biosimilar Yusimry at 85% below Humira’s list price when it launches next month, and charge even less if bought through Mark Cuban’s pharmacy.
Pharmaceutical Technology
JUNE 1, 2023
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Pfizer ’s rimegepant (Vydura) to prevent migraine attacks. The therapy has been recommended as an option to prevent episodic migraines in adult patients, who have between four and 15 migraine attacks per month, and where a minimum of three preventive treatments have previously failed.
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Bio Pharma Dive
JUNE 1, 2023
The agency will reimburse Alzheimer’s treatments like Eisai and Biogen’s Leqembi if they receive full FDA approval, but plans to still require data collection via a patient registry.
Pharmaceutical Technology
JUNE 1, 2023
The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). On 31 May, the FDA granted approval based on subgroup analysis of the Phase III PROpel trial (NCT03732820) in patients with BRCA mutations.
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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
JUNE 1, 2023
The California biotech, led by Roger Perlmutter and other former Merck executives, has now raised nearly $775 million since its launch two years ago.
Pharmaceutical Technology
JUNE 1, 2023
A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. The centre will be established by UK-based technology innovation centre CPI, in collaboration with Medicines Discovery Catapult, the University of Strathclyde, the University of Liverpool, and Imperial College London.
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Pharmaceutical Technology
JUNE 1, 2023
Algernon Pharmaceuticals’ patent application for NP-251 (Repirinast) has been accepted by the Japanese Patent Office (JPO) for the treatment of chronic kidney disease (CKD). The company has announced that the JPO has issued a Notice of Allowance for the patent application. The invention is for use in the prophylaxis or therapeutic treatment of renal fibrosis or kidney disease.
Bio Pharma Dive
JUNE 1, 2023
The drugmaker cited testing delays and an evolving “competitive landscape” in its decision to discontinue development of its IL-23 inhibitor brazikumab.
Pharmaceutical Technology
JUNE 1, 2023
Pneumagen has raised £8m ($10 million) for the further development of its intranasal antiviral drug neumifil in Phase II studies for chronic obstructive pulmonary disease (COPD) patients suffering from virus-induced exacerbations. A Phase IIb study of neumifil is currently planned to start in 2024, per the 1 June announcement. According to the company’s website, the Phase IIb is planned to begin in early 2024.
Bio Pharma Dive
JUNE 1, 2023
The pharma company said it will work with startups and other digital health companies as it builds out the consumer-focused business unit.
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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
Pharmaceutical Technology
JUNE 1, 2023
The US Patent and Trademark Office (USPTO) has granted a Notice of Allowance for Tenax Therapeutics’ patent application covering its oral levosimendan, TNX-103, to treat pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). Once granted, the patent will offer intellectual property protection until December 2040 and additional protection to the company in the US.
Fierce Pharma
JUNE 1, 2023
As doctors weigh various immunotherapy strategies for the treatment of early-stage non-small cell lung cancer, Merck & Co. | As doctors navigate the "messy" early-stage non-small cell lung cancer landscape with various immunotherapy approaches, Merck & Co. has now unveiled new data that it hopes can establish Keytruda, used before and after surgery, as a new standard of care.
Pharmaceutical Technology
JUNE 1, 2023
On 19 May, the FDA’s Gastrointestinal Drugs Advisory Committee (GDAC), by a vote of 12 to two, with two abstentions, voted against the FDA’s approval of Intercept Pharmaceuticals’s new drug application (NDA) for obeticholic acid (OCA) 25mg oral tablets, for the treatment of pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).
Fierce Pharma
JUNE 1, 2023
After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit. | The drug is now approved to treat BRCA-mutated metastatic castration-resistant prostate cancer in combination with Johnson & Johnson’s Zytiga and a corticosteroid.
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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.
Pharmaceutical Technology
JUNE 1, 2023
InDex Pharmaceuticals has entered a licence deal with Viatris Pharmaceutical Japan for the development and commercialisation of cobitolimod in Japan to treat ulcerative colitis (UC). Under the terms of the deal, InDex will receive a $10m upfront payment from Viatris Japan for the exclusive commercialisation rights for cobitolimod in the country. The company will also be entitled to receive up to $40m in additional payments linked to development and sales milestones.
Pharma Times
JUNE 1, 2023
Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine
Pharmaceutical Technology
JUNE 1, 2023
The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. Nitisinone capsules are hydroxy-phenylpyruvate dioxygenase inhibitors which are used as first-line treatment for a rare condition, hereditary tyrosinemia type 1 (HT-1). They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.
Fierce Pharma
JUNE 1, 2023
About a month after GSK won the world's first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. | After winning FDA approvals one month apart, Pfizer and GSK are set to launch competing RSV vaccines this fall.
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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.
Pharma Times
JUNE 1, 2023
Synaffix’s technology platform is intended to enhance and extend Lonza’s integrated ADC services - News - PharmaTimes
Fierce Pharma
JUNE 1, 2023
As Sandoz prepares to spin off from Novartis into its own generics and biosimilars business, the company has settled on a location for its new headquarters. | After spinning off from Novartis later this year, generics and biosimilars giant Sandoz plans to move into its new headquarters by the middle of 2024.
XTalks
JUNE 1, 2023
Univar Solutions , a leading global distributor of ingredients and chemicals, has recently been chosen to distribute ICL’s Rovitaris line of textured plant proteins in North America. With this agreement in place, Univar is strategically positioned to broaden the availability of plant-based protein alternatives for its clientele in the food ingredients sector, primarily in the US and Canada.
Drug Discovery World
JUNE 1, 2023
Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.
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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.
Antidote
JUNE 1, 2023
The Antidote partner network is a key element of our ability to build relationships with patients and increase awareness surrounding medical research. By providing Match, our clinical trial search tool, free of charge , we are able to assist advocacy groups, nonprofits, and more in providing patient-centric clinical trial listings to empower their audiences.
Pharmaceutical Commerce
JUNE 1, 2023
While generics and adherence challenges are keeping drugmakers up at night, breakthroughs in the pipeline coupled with innovative uses of artificial intelligence and machine learning techniques are bringing optimism to the cardiovascular disease space.
Drug Channels
JUNE 1, 2023
Today’s guest post comes from Vishali Amin, Chief of Staff to the Office of the President and Senior Director of Customer Success at Kalderos. Vishali discusses the persistent challenges of duplicate discounts between the 340B Drug Pricing Program and the Medicaid Drug Rebate Program. The Inflation Reduction Act of 2022 will further complicate duplicate discount issues.
Fierce Pharma
JUNE 1, 2023
Sun Pharma picked up Taro Pharmaceutical Industries 16 years after its initial offer. Eli Lilly and XtalPi linked up in a $250 million deal. | Sun Pharma snapped up Taro Pharmaceutical Industries in a $307 million deal after its initial 2007 offer. Eli Lilly and XtalPi linked up in a $250 million collaboration to identify potential drug candidates using the latter's AI technology.
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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
JUNE 1, 2023
Annual Drug Patent Expirations for NUZYRA Nuzyra is a drug marketed by Paratek Pharms Inc and is included in two NDAs. It is available from one supplier. There are ten… The post New patent expiration for Paratek Pharms drug NUZYRA appeared first on DrugPatentWatch - Make Better Decisions.
Intouch Solutions
JUNE 1, 2023
At EVERSANA INTOUCH, we strongly believe in promoting mental health awareness and prioritizing self-care. Throughout the month of May, a variety of events aimed at fostering well-being and improving mental health in recognition of National Mental Health Awareness Month across the U.S. Read on to learn more about the exciting events that were hosted!
Drug Patent Watch
JUNE 1, 2023
Annual Drug Patent Expirations for XCOPRI Xcopri is a drug marketed by Sk Life and is included in one NDA. It is available from one supplier. There is one patent… The post New patent for Sk Life drug XCOPRI appeared first on DrugPatentWatch - Make Better Decisions.
ECRG Media's Clinical Research Podcast
JUNE 1, 2023
Getting Your First Job in Clinical Research Don't forget to Subscribe for new content! Merch: [link] Subscribe: / eliteclinicalrese. Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Educatio
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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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