Thu.Jun 01, 2023

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Coherus sets steep discount for Humira copycat, plans direct sales

Bio Pharma Dive

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.

Sales 299
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UK’s NICE recommends Pfizer’s rimegepant to treat migraine

Pharmaceutical Technology

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Pfizer ’s rimegepant (Vydura) to prevent migraine attacks.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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Medicare keeps limits on Alzheimer’s drug coverage, but loosens policy

Bio Pharma Dive

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.

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AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

Pharmaceutical Technology

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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Startup Eikon, led by Merck vets, buys drugs from three biotechs and banks another $106M

Bio Pharma Dive

The California biotech, led by Roger Perlmutter and other former Merck executives, has now raised nearly $775 million since its launch two years ago.

Drugs 177
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New UK intracellular drug delivery centre to support RNA development

Pharmaceutical Technology

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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Algernon announces acceptance of Repirinast patent application in Japan

Pharmaceutical Technology

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.

Branding 147
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AstraZeneca abandons experimental bowel disease drug

Bio Pharma Dive

The drugmaker cited testing delays and an evolving “competitive landscape” in its decision to discontinue development of its IL-23 inhibitor brazikumab.

Drugs 141
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Pneumagen raises £8 million for further study of intranasal antiviral

Pharmaceutical Technology

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.

In-Vitro 130
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Bayer launches precision health unit in latest digital health venture

Bio Pharma Dive

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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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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USPTO grants Notice of Allowance for Tenax Therapeutics’ oral levosimendan

Pharmaceutical Technology

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.

Drugs 130
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ASCO: Merck bills Keytruda, used around surgery, as new standard in 'messy' early lung cancer realm

Fierce Pharma

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.

Doctors 113
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Negative FDA AdCom vote for Intercept’s obeticholic acid in NASH

Pharmaceutical Technology

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).

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FDA approves ANDA of 20mg generic Nitisinone capsules

Pharma Times

Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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InDex Pharmaceuticals signs licence deal with Viatris for cobitolimod

Pharmaceutical Technology

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.

Sales 130
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Lonza to acquire Synaffix to strengthen ADC development

Pharma Times

Synaffix’s technology platform is intended to enhance and extend Lonza’s integrated ADC services - News - PharmaTimes

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FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

Pharmaceutical Technology

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.

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AZ, Merck's Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote

Fierce Pharma

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.

Drugs 106
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The New Age of Decentralized Clinical Trials

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.

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Univar Solutions to Expand ICL’s Plant-Based Protein Offerings

XTalks

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.

Protein 98
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Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

Fierce Pharma

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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Three trends in the antibody-drug conjugate (ADC) market 

Drug Discovery World

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 Sandoz prepares to spin off from Novartis, the company sets sights on new crosstown headquarters

Fierce Pharma

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.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Amplifying the rare disease experience: A Q&A with Rare Patient Voice

Antidote

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.

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The Drug Discount Ecosystem’s “Mission Critical”

Drug Channels

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.

Drugs 89
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Salesforce Platform Capabilities

Cloudbyz

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.

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Innovation in Heart Disease: A Deep Dive

Pharmaceutical Commerce

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.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Fierce Pharma Asia—Sun’s Taro buyout, Eli Lilly’s XtalPi collab, Yuhan’s cancer candidate

Fierce Pharma

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.

Drugs 58
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New patent expiration for Paratek Pharms drug NUZYRA

Drug Patent Watch

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.

Drugs 52
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Mastering Sensory Research: Techniques, Best Practices, and Future Directions

Cloudbyz

As consumers, we are constantly engaging with the world through our senses. It’s the taste of our morning coffee, the smell of a new car, the texture of a soft sweater, the vibrant colors of fresh produce, or the soothing sound of rain on the roof. These sensory experiences significantly shape our interactions, preferences, and purchasing decisions regarding consumer goods.

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New patent for Sk Life drug XCOPRI

Drug Patent Watch

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.

Drugs 52
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.