Fri.Jun 02, 2023

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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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Pfizer says antibiotic is effective against tough-to-treat infections

Bio Pharma Dive

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.

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AB Science announces Canadian patent for masitinib to treat ALS

Pharmaceutical Technology

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,

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

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The final draft guidance recommends rimegepant for adults who have at least four migraine attacks per month, but less than 15 - News - PharmaTimes

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Revised EU/Pfizer/BioNTech Covid-19 vaccine deal may lead to a Comirnaty monopoly

Pharmaceutical Technology

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

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Novartis touts breast cancer win with “landmark” Kisqali results

Pharmaceutical Technology

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).

HR 130
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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.

Marketing 102
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China’s NMPA approves Vascepa for hypertriglyceridemia

Pharmaceutical Technology

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.

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Engage, Educate, Empower, Equalize: Justin Chase Talks to PharmaLive/Med Ad News

Intouch Solutions

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.

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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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Rentschler Biopharma and Ikarovec partner to expedite new gene therapies

Pharmaceutical Technology

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

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Unpacking the Financial Implications of EDC System Implementation: Initial Costs, Long-term Savings, and ROI

Cloudbyz

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.

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Swiss company Lonza acquires Synaffix to boost ADC offering

Pharmaceutical Technology

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

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Carrying blockbuster sales expectations, BMS' Camyzos picks up early nod from England's NICE

Fierce Pharma

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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Anavex Life Sciences receives US patent for ANAVEX 2-73 (blarcamesine)

Pharmaceutical Technology

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.

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Addressing Rx Affordability

Pharmaceutical Commerce

The Medicare Part D cap in 2025 won’t solve patients’ need for financial assistance.

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PhRMA cries foul on CMS' registry approach for Alzheimer's disease drugs

Fierce Pharma

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.

Drugs 60
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CMS update on Alzheimer's coverage raises questions

pharmaphorum

CMS update on Alzheimer's coverage raises questions Phil.

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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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How to Harmonize and Interpret the Tsunami of Sensor Data in Clinical Trials

Fierce Pharma

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?

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Modern Solutions for Modern Clinical Trials – The Benefits of Mobile EDC Access

Crucial Data Soutions

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.

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Exploring the Phases of Clinical Trials

My Local Study

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.

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Lilly Highlights Verzenio® (abemaciclib) and Jaypirca™ (pirtobrutinib) Data at 2023 ASCO® Annual Meeting

The Pharma Data

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.

HR 52
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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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New patent for Abbvie Endocrine drug LUPRON DEPOT-PED KIT

Drug Patent Watch

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.

Drugs 52
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Gilead and Kite Oncology Demonstrate Growing Hematology Pipeline and Strength of Leading Cell Therapy Portfolio at EHA

The Pharma Data

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

HR 52
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New patent for Amgen Inc drug LUMAKRAS

Drug Patent Watch

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.

Drugs 52
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FDA Approves

The Pharma Data

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.

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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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Clinical Studies Come in All Sizes

My Local Study

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.

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Novartis receives European approval for Cosentyx® as first and only IL-17A inhibitor for hidradenitis suppurativa

The Pharma Data

Novartis receives European approval for Cosentyx® as first and only IL-17A inhibitor for hidradenitis suppurativa Novartis announced today that the European Commission (EC) has approved Cosentyx ® (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS) and an inadequate response to conventional systemic HS therapy 7.

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Open-source lab robot makes bioautomation accessible for all

Drug Discovery World

Lab automation company Opentrons has launched the Opentrons Flex robot. The company says that these are affordable and easy-to-programme liquid-handling lab robots which are designed to level the playing field for labs of all sizes and bring advanced lab automation to more researchers. Fusing advanced robotics with open-source software, the Flex is compatible with AI tools and has near-limitless potential to learn new protocols.

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Sanofi launches 2023 global Employee Stock Purchase Plan  

The Pharma Data

Sanofi launches 2023 global Employee Stock Purchase Plan Sanofi launches Action 2023, its global employee shareholder plan, open to around 86,000 employees in 56 countries. The program builds on plans carried out since 2013 and demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve all employees, across all its territories, in the future development and results of the company.

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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.