European Pharmaceutical Review
NOVEMBER 15, 2023
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq ® (atezolizumab). Roche’s monoclonal antibody cancer immunotherapy was recommended for all indications in which Tecentriq intravenous (IV) has been previously approved, including certain lung, liver, bladder and breast cancer types.
Fierce Pharma
NOVEMBER 15, 2023
In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival. | In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.
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MedCity News
NOVEMBER 16, 2023
Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is now approved in the United Kingdom for treating the blood disorders sickle cell disease and beta thalassemia. It’s the first regulatory approval in the world for a CRISPR-based therapy.
Clarivate
NOVEMBER 15, 2023
Every year, the unveiling of the Highly Cited Researchers list sparks anticipation within the global research community as both researchers and their affiliated institutions or organizations scrutinize the list. Today, we present our 2023 list , recognizing 6,849 individuals from more than 1,300 institutions across 67 countries and regions. These Highly Cited Researchers stand out for their significant and broad influence in various scientific and social science domains, representing a small fra
PharmExec
NOVEMBER 15, 2023
Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.
Fierce Pharma
NOVEMBER 14, 2023
Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K. | Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule capabilities at its site in Sandwich in Kent in the U.K. The move is a consequence of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Copyright Clearance Center
NOVEMBER 16, 2023
November 16, 2023 – Danvers, Mass. – The Women’s Edge , a nonprofit that supports female business leaders, in partnership with The Boston Globe , has announced CCC , a pioneer in voluntary collective licensing, advancing copyright, accelerating knowledge, and powering innovation, was named to its annual Top 100 Women-Led Businesses in Massachusetts list.
PharmaVoice
NOVEMBER 16, 2023
Dr. Paul Moss, a hematology expert in the U.K., conducted a study with AstraZeneca showing the alarming extent to which immunocompromised patients are burdened with COVID-19.
Fierce Pharma
NOVEMBER 17, 2023
The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. | The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer.
MedCity News
NOVEMBER 13, 2023
Just 37% of employees trust their insurer to suggest high-quality care regardless of cost, while 53% trust their employer with their health, according to a survey released by Included Health.
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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.
European Pharmaceutical Review
NOVEMBER 16, 2023
Casgevy (exagamglogene autotemcel), also known as exa-cel, is the first treatment to be licensed that uses CRISPR. It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia.
PharmExec
NOVEMBER 15, 2023
Pharm Exec’s 19th annual report on the trends of the day in drug development examines the surging investment in new treatments and advances for so-called “first-world” conditions, capturing the landscape of five expanding therapeutic areas: weight loss, osteoarthritis, Alzheimer’s disease, COPD, and psychedelics.
Fierce Pharma
NOVEMBER 16, 2023
Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. | Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market.
MedCity News
NOVEMBER 15, 2023
Gilead Sciences is increasing its stake in partner Arcellx and expanding the cell therapy alliance the companies started in 2022. The deal expands the lead partnered program to more cancers and gives Gilead a chance at another Arcellx cell therapy candidate made with different technology.
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Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
European Pharmaceutical Review
NOVEMBER 14, 2023
The Association of the British Pharmaceutical Industry (ABPI) has drawn attention to a new report , which has emphasised the importance of UK advanced manufacturing requiring a long-term strategy to ensure its continued success. This ‘manifesto for growth’, developed by the Manufacturing Five (M5), a coalition of the UK’s leading advanced trade associations, proposed the reforms necessary for the UK to close the gap with global competitors and growth of innovative manufacturing in the country.
Eversana Intouch
NOVEMBER 16, 2023
Last week, Frontiers Health, the premier global digital health innovation event, was held in Rome, Italy. The annual event assembled nearly 1,000 attendees from over 40+ countries across the healthcare ecosystem to learn, network and explore industry challenges, strategic trends and solutions in life sciences and healthcare. While Frontiers Health has always been a flagship event for EVERSANA INTOUCH and our clients to attend each year, this year’s event was significant as we were proud to co-ho
Fierce Pharma
NOVEMBER 16, 2023
Timothy Yap, Ph.D., used to see patients nearing the end of their cancer journey in his phase 1 department at the University of Texas' MD Anderson Cancer Center. | Cancer drugs are getting better thanks to innovation, driven by the data and regulatory forces like Project FrontRunner.
MedCity News
NOVEMBER 16, 2023
In reality, the healthcare sector is, in many ways, the ideal place for AI to be used. After all, it’s one of the few industries with access to a treasure trove of precisely the kind of high-quality data with which AI operates best.
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.
European Pharmaceutical Review
NOVEMBER 16, 2023
While Europe has historically been a pioneer in the adoption of biosimilars, a new report by the global initiative Act4Biosimilars has revealed differences country by country, including disparities between Eastern and Western Europe. This is based on research from a report published in April this year by IQVIA. [Act4Biosimilars’ Regional Deep Dive Report Europe] noted that biosimilar adoption levels vary significantly across Europe” Act4Biosimilars shared that their Deep Dive Report
PharmExec
NOVEMBER 16, 2023
Emerging technologies like digital twins offer supply chain efficiency solutions, allowing the industry to integrate sustainable practices while ensuring patient safety.
Fierce Pharma
NOVEMBER 17, 2023
Amid a corporate review of AstraZeneca’s global manufacturing and supply network, the company’s Indian subsidiary is planning to close up shop at the “beating heart” of its India operations in Bang | AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing. AZ plans to find a buyer who can also serve as a contract manufacturer for the drugs produced there.
MedCity News
NOVEMBER 13, 2023
New KFF focus groups revealed that some thought the process of renewing Medicaid coverage during the unwinding of the continuous enrollment provision was simple. Others, however, faced challenges with communication from state Medicaid agencies, and some weren’t aware their coverage had been terminated.
European Pharmaceutical Review
NOVEMBER 13, 2023
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for GSK’s momelotinib, recommending marketing approval. The Committee deemed it beneficial as a treatment for disease-related splenomegaly (enlarged spleen) or symptoms in adults with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor n
PM360
NOVEMBER 12, 2023
PM360 asked Ivy Cohen, President and CEO, Ivy Cohen Corporate Communications, about the place she just can’t stop returning to. Ivy and her mother join in to choose the finale winner. My Odyssey: For the past seven years (with a couple year COVID gap), my husband, mother, and I attend Amateur Night at The Apollo—The Grand Finale on the night before Thanksgiving.
Fierce Pharma
NOVEMBER 15, 2023
If you’re curious about the pitfalls of CAR-T drug commercialization, look no further than Bristol Myers Squibb’s Abecma partner 2seventy bio. | After reporting a sizable revenue decline for its BMS-parntered multiple myeloma cell therapy in 2023’s third quarter, 2seventy stands out as a prime example of the dangers of scaling up a process before suffering lower-than-expected demand, one group of analysts contends.
MedCity News
NOVEMBER 16, 2023
Medical science has made significant strides in the development of advanced treatments over the past decade. However, the majority of FDA-approved treatments for Alzheimer’s focus on the management of symptoms or delayed progression of the disease.
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European Pharmaceutical Review
NOVEMBER 14, 2023
Outsourcing regulatory activities in pharma Here, EPR’s Editor explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities. Accelerating drug development for simple and complex drug programmes Quotient Sciences leverages more than 30 years of drug development expertise to support small molecule and synthetic peptide drug programmes, in both simple drug programmes as well as complex cases where specialised formulation e
PharmExec
NOVEMBER 14, 2023
Novo Nordisk said it will continue providing Levemir vials and the Levemir FlexPen for diabetes control while supplies last, until the full product discontinuation at the end of 2024.
Fierce Pharma
NOVEMBER 16, 2023
Micron nets nearly $24M from Gates Foundation to pioneer needle-free vaccine tech in low- and middle-income countries fkansteiner Thu, 11/16/2023 - 11:08
MedCity News
NOVEMBER 17, 2023
Automation can be a powerful tool to bring together all the pieces needed to provide optimal care that can be scattered across various systems and apps. Whether it’s to exchange patient data quickly and easily, identify communities in need of programs to address food inequity, or reduce no-shows by sending automatic reminders, using the right technology is an essential tool for achieving better patient care.
Advertiser: ZoomInfo
In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.
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