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The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Pfizer ’s rimegepant (Vydura) to prevent migraine attacks.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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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.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 1, 2023
Sanofi has announced that its anti-CD40L antibody frexalimab demonstrated significantly reduced disease activity in a Phase II trial of patients with relapsing multiple sclerosis (RMS). The Phase II trial (NCT03732820) was a double-blind, placebo-controlled study that enrolled 129 patients with RMS who were randomised to receive two different doses of frexalimab or placebo over the course of 12 weeks.
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
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 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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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
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.
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
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
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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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.
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).
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
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.
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.
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.
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.
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.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
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.
Cloudbyz
JUNE 1, 2023
Salesforce’s Force.com is a comprehensive Platform as a Service (PaaS) that allows developers to build and deploy custom applications that run on Salesforce’s infrastructure. Force.com is designed to simplify the development, delivery, and management of applications and services. Configurable Workflow Engine Salesforce Workflow Automation is a robust feature that allows businesses to automate standard internal procedures and business processes.
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.
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.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
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.
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.
Fierce Pharma
JUNE 1, 2023
In this episode of the "The Top Line," Fierce’s Anastassia Gliadkovskaya talks with Autumn Ehnow, vice president of Medicines360, a nonprofit pharma with a mission to produce and sell affordable me | This week on "The Top Line," we discuss the need to democratize access to medications like emergency contraception, plus Elizabeth Holmes, the state of Alzheimer's research, and the rest of the week's headlines.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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