Bio Pharma Dive
JUNE 2, 2023
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.
Pharmaceutical Technology
JUNE 2, 2023
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
JUNE 2, 2023
A drug the company acquired from AstraZeneca and developed for gram-negative infections — a growing public health threat — could be headed for a regulatory review later this year.
Pharmaceutical Technology
JUNE 2, 2023
In a bit to challenge the market dominance of AbbVie’s Humira (adalimumab), the online pharmacy Cost Plus Drugs, owned by billionaire Mark Cuban has announced a plan to market Coherus Biosciences’ biosimilar Yusimry (adalimumab-aqvh), Cost Plus Drugs will be offering Yusimry at $569 per unit, excluding shipping and dispensing charges. According to GlobalData’s drug pricing database, this would be 84% cheaper than a 40mg pre-filled syringe of Humira ($3,461), as per a 1 June announcement.
Advertisement
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.
Fierce Pharma
JUNE 2, 2023
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.
Pharmaceutical Technology
JUNE 2, 2023
San Francisco-based biotech Eikon Therapeutics has made waves in the bay after managing to raise $106m in its Series C funding round. This latest cash injection will be used to fund and support a range of acquisitions intended to diversify their development pipeline, which were announced alongside the fundraise, as per a 1 June announcement. The company acquired the global rights to develop and commercialise clinical-stage Toll-like receptor 7 and 8 (TLR7/8) agonist immunomodulators from the Edi
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 2, 2023
AB Science has secured a Canadian patent for its lead compound masitinib to treat amyotrophic lateral sclerosis (ALS), a fatal motor neuron disorder. The company stated that Canada’s patent office has issued a notice of allowance (NOA) for a patent relating to methods to treat ALS using the therapy. The patent offers protection until 2037 and completes the intellectual property (IP) coverage for ALS across all important geographic areas where the therapy can be marketed, including the US,
Intouch Solutions
JUNE 2, 2023
Recently, Justin Chase, Executive Vice President of Media, EVERSANA INTOUCH, was interviewed by Maria Fontanazza, director of content for PharmaLive and Med Ad News. They talked about trends in social media, about how to build relationships with patients and HCPs across platforms, and about AI’s effects, coming from the agency’s nine years of experience using AI for clients.
Pharmaceutical Technology
JUNE 2, 2023
The European Commission (EC) and Pfizer/BioNTech have agreed to amend their current supply contract to deliver Covid-19 vaccines to the EU. The original contract, signed in May 2021, required the EU to purchase 900 million doses from Pfizer/BioNTech, with an option for an additional 900 million, by the end of 2023. Since demand significantly decreased after the contract was signed, at least 50% of the first 900 million doses were never delivered, leaving many member states with large financial l
Pharma Times
JUNE 2, 2023
BI-1910 is now the second of the company's anti-tumour necrosis factor receptor 2 programmes to enter clinical development - News - PharmaTimes
Advertisement
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 2, 2023
Kicking off this year’s American Society of Clinical Oncology’s (ASCO) conference, Novartis has released data supporting the use of its CDK4/6 inhibitor Kisqali (ribociclib) as an adjuvant treatment for a group of early-stage breast cancer patients. Data from Novartis ’ Phase III NATALEE trial show that adding Kisqali to endocrine therapy lowered the risk of cancer recurrence by 25% in patients with hormone receptor-positive (HR+)/HER2- early-stage breast cancer (EBC).
Cloudbyz
JUNE 2, 2023
Electronic Data Capture (EDC) has revolutionized clinical research and pharmaceutical drug development. However, adopting this system requires a significant financial commitment. This blog post delves into the financial implications of implementing an EDC system, including the initial costs, long-term savings, and the return on investment. Initial Costs The initial costs of implementing an EDC system can be substantial, encompassing both direct and indirect expenses.
Pharmaceutical Technology
JUNE 2, 2023
The Centers for Medicare and Medicaid Services’ (CMS) Administrator Chiquita Brooks-LaSure announced that Eisai’s Leqembi (lecanemab) will be covered under Medicare Part B, contingent on clinicians’ and hospitals’ participation in a nationwide, CMS-facilitated registry to track outcomes. Broader coverage will begin on the day of the drug’s traditional approval, when it comes through, and CMS’ proposed method will aim to collect more real-world evidence on the drug’s use, as per the 1 June statem
Fierce Pharma
JUNE 2, 2023
As Bristol Myers Squibb braces for increasing generic competition this decade, the company is counting on its newer medicines to drive growth. | As Bristol's top-sellers creep toward the patent cliff, new launch Camzyos has picked up a key endorsement in England.
Advertisement
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 2, 2023
China’s National Medical Products Administration (NMPA) has granted regulatory approval to Amarin’s commercial partner EddingPharm (EDDING) for Vascepa (icosapent ethyl). Vascepa has been approved as an adjunct to diet to cut the levels of triglyceride in adult patients suffering from severe hypertriglyceridemia (≥500mg/dL). EDDING is now working towards securing National Reimbursement Drug Listing (NRDL) for Vascepa in China, with plans to launch it commercially by the end of this year.
Pharmaceutical Commerce
JUNE 2, 2023
The Medicare Part D cap in 2025 won’t solve patients’ need for financial assistance.
Pharmaceutical Technology
JUNE 2, 2023
Rentschler Biopharma has collaborated with Ikarovec for expediting the new gene therapies to treat ophthalmic disease. Under the deal, Rentschler Biopharma’s ATMP facility in Stevenage, UK, will undertake the bioprocess development of adeno-associated virus (AAV) material. The AAV material will be used for the planned pre-clinical testing of the new gene therapy of Ikarovec to treat geographic atrophy, an advanced form of age-related macular degeneration that may result in the progressive and ir
Fierce Pharma
JUNE 2, 2023
The Centers for Medicare and Medicaid Services has said it plans to cover Alzheimer's disease meds with the use of a registry to collect real-world data from physicians. Trade group PhRMA argues the move will "severely restrict" access.
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 2, 2023
Switzerland-based company Lonza has boosted its antibody-drug conjugates (ADCs) offering with the acquisition of Dutch biotechnology company Synaffix for a total consideration of $172m (€160m). The deal includes $107.17m (€100m) of initial financial consideration in cash and an additional $64.3m (€60m) in performance-based consideration. Synaffix is focused on the commercialisation of its clinical-stage technology platform to develop ADCs that offer a range of potential targeted treatments for c
FDA Law Blog
JUNE 2, 2023
By Alan M. Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. It is not our purpose to describe all of the nearly 20 changes proposed in this regulation, but the most noteworthy are described below, roughly in order of i
Pharmaceutical Technology
JUNE 2, 2023
Anavex Life Sciences has secured new US intellectual property compositions patent for its ANAVEX 2-73 (blarcamesine). The patent number 11,661,405 has been issued by the US Patent and Trademark Office (USPTO) and is expected to remain effective until October 2036. This expands the company’s patent coverage for certain ANAVEX 2-73 crystal forms preparation methods, compositions, and uses thereof, which are covered by the US patent number 10,413,519.
Fierce Pharma
JUNE 2, 2023
Author: Mark Matson, Managing Partner, Patient Cloud, Medidata | The surge of wearable sensors is transforming clinical trials for patients, sponsors, and research sites, but how can we optimize all the data obtained to really improve clinical trials and outcomes?
Advertisement
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
pharmaphorum
JUNE 2, 2023
CMS update on Alzheimer's coverage raises questions Phil.
Crucial Data Soutions
JUNE 2, 2023
Clinical trials continue to move closer to patients. Improvements to data collection technologies and processes, a robust high-speed internet infrastructure, The post Modern Solutions for Modern Clinical Trials – The Benefits of Mobile EDC Access appeared first on Crucial Data Solutions.
My Local Study
JUNE 2, 2023
Clinical studies come in all shapes and sizes! From different conditions to varying phases, each study presents its own unique set of variables. Find out more on our blog! The Purpose Clinical Studies Serve Clinical studies are research studies conducted with human volunteers to investigate the effectiveness and safety of medical treatments, procedures, and drugs.
The Pharma Data
JUNE 2, 2023
Lilly Highlights Verzenio® (abemaciclib) and Jaypirca™ (pirtobrutinib) Data at 2023 ASCO® Annual Meeting Eli Lilly and Company (NYSE: LLY) today announced Verzenio ® (abemaciclib; CDK4/6 inhibitor) and Jaypirca™ (pirtobrutinib; non-covalent (reversible) BTK inhibitor) data to be presented at the 2023 ASCO ® Annual Meeting in Chicago, June 2 – 6, 2023.
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 Patent Watch
JUNE 2, 2023
Annual Drug Patent Expirations for LUPRON+DEPOT-PED+KIT Lupron Depot-ped Kit is a drug marketed by Abbvie Endocrine Inc and is included in one NDA. It is available from one supplier. The… The post New patent for Abbvie Endocrine drug LUPRON DEPOT-PED KIT appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JUNE 2, 2023
Gilead and Kite Oncology Demonstrate Growing Hematology Pipeline and Strength of Leading Cell Therapy Portfolio at EHA FOSTER CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present 17 abstracts from its industry-leading cell therapy portfolio and growing blood cancer pipeline at the upcoming 2023 European Hematology Association (EHA) Annual Congress being held in Frankfurt, Germany, June 8-11, and virtual
Drug Patent Watch
JUNE 2, 2023
Annual Drug Patent Expirations for LUMAKRAS Lumakras is a drug marketed by Amgen Inc and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Amgen Inc drug LUMAKRAS appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JUNE 2, 2023
FDA Approves LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) AstraZeneca and Merck (NYSE: MRK),known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S.
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
Expert insights. Personalized for you.
301 
Let's personalize your content