Sat.May 27, 2023 - Fri.Jun 02, 2023

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Lowering Sodium Levels: A New Perspective for Cognitive Health

XTalks

Warnings against high sodium intake, particularly table salt, have been consistently issued by the World Health Organization (WHO) and numerous health-promoting organizations. Now, there’s a fresh perspective from a new study that highlights not only the effects of high sodium on hypertension, but also its correlation with emotional and cognitive impairment.

Protein 111
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Biohaven sends latest drug to FDA, despite past trial setback

Bio Pharma Dive

The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

Trials 317
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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

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May 31, 2023: PROACT Xa Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. John Alexander In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern. PROACT Xa was a prospective, randomized clinical trial conducted to determine whether apixaban was noninferior to warfarin in preventing valve thrombosis or valve-related thromboembolism in patients w

Trials 130
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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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Meeting Global Demands for Viral Vector-based Vaccines

Pharma Mirror

In the face of increasing global health challenges, the development and production of vaccines have become paramount. One critical aspect is the ability to scale up manufacturing processes to meet the growing demand for viral vector-based vaccines. In this article, we will explore the efforts being made by innovative biotechnology companies to develop scalable and cost-effective manufacturing methods.

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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.

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More Trending

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ASCO: Novartis pressures Lilly with Kisqali, targeting $3B opportunity in early breast cancer

Fierce Pharma

Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.

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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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Amylyx’s ALS drug could face rejection in Europe

Bio Pharma Dive

The biotech said a committee advising the European Medicines Agency is “trending” toward issuing a negative opinion of its drug Relyvrio, which was approved in the U.S. last year.

Drugs 299
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US companies drive 2023 drug launches positioned for blockbuster success by 2028

Pharmaceutical Technology

According to GlobalData’s Looking Ahead to 2023 – the Future of Pharma report, five drugs set for approval in 2023 are projected to attain blockbuster status or near-blockbuster status by 2028 with US company dominance. Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut.

Drugs 264
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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.

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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.

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NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks

Pharma Times

The final draft guidance recommends rimegepant for adults who have at least four migraine attacks per month, but less than 15 - News - PharmaTimes

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Novartis drug helps stop breast cancer’s return in large study

Bio Pharma Dive

Treatment with Kisqali reduced the risk of disease recurrence when used after surgery, potentially positioning Novartis to win a similar adjuvant approval as Lilly’s rival therapy Verzenio.

Drugs 294
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EC approves Briumvi to treat relapsing forms of multiple sclerosis

Pharmaceutical Technology

The European Commission (EC) has approved TG Therapeutics’ Briumvi (ublituximab-xiiy) to treat relapsing forms of multiple sclerosis (RMS) in adult patients. Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody.

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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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FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Fierce Pharma

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

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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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Pfizer says hemophilia drug succeeded in Phase 3 study

Bio Pharma Dive

The drug, called marstacimab, outperformed factor treatment in the study, and wasn’t associated with the kind of safety signals that have dogged other medicines in its class.

Drugs 269
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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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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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ASCO: AstraZeneca guns for wider ovarian cancer market with Imfinzi-Lynparza combo. Will the FDA buy the plan?

Fierce Pharma

Lynparza may be the most popular PARP inhibitor, but a use restriction in ovarian cancer has been a thorn in AstraZeneca’s side. | AstraZeneca is bringing on Imfinzi to potentially help Lynparza reach a broader ovarian cancer population. But the lack of evidence for contribution from Imfinzi and a regulatory concern over the use of PARP inhibitors outside BRCA-mutant tumors could make it hard for AstraZeneca to win over the FDA.

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BioInvent receives Investigational New Drug approval for monoclonal antibody BI-1910

Pharma Times

BI-1910 is now the second of the company's anti-tumour necrosis factor receptor 2 programmes to enter clinical development - News - PharmaTimes

Antibody 117
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FDA pauses PepGen’s plans to test muscle disease drug

Bio Pharma Dive

The company’s experimental treatment for myotonic dystrophy became the latest neuromuscular disease therapy to face a regulatory roadblock before the start of human testing.

Drugs 258
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Lexicon gets FDA approval for Inpefa to treat heart failure

Pharmaceutical Technology

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). It is intended to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure.

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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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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 103
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Intensive Blood Pressure Management in Hospitalized Older Adults

JAMA Internal Medicine

This cohort study examines the association of intensive treatment of elevated blood pressure in hospitalized older adults with in-hospital clinical outcomes.

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Pfizer’s RSV vaccine wins FDA approval in older adults

Bio Pharma Dive

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

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Stealth and Pharmanovia partner for commercialisation of elamipretide

Pharmaceutical Technology

Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.

Licensing 245
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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit

Fierce Pharma

Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit zbecker Tue, 05/30/2023 - 10:24

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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.

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Sanofi drug, acquired from a startup, shows early potential in MS

Bio Pharma Dive

The medicine, licensed from biotech ImmuNext in 2017, is one of two later-stage MS drug prospects in the French drugmaker’s portfolio.

Licensing 269
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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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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.