MedCity News
NOVEMBER 20, 2023
Multiple studies have shown no correlation between R&D costs and the launch price of new drugs though that is an argument often used by drugmakers to prevent a cap on pricing. Still, one way to keep costs low, is for organizations to leverage health technology like AI and improve formulary compliance.
Fierce Pharma
NOVEMBER 30, 2023
With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.
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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
Pharmaceutical Technology
NOVEMBER 21, 2023
Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.
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.
pharmaphorum
NOVEMBER 30, 2023
AbbVie has moved to shore up its pipeline following the loss of patent protection for its top-selling drug with a $10.1 billion deal to buy ImmunoGen and its marketed ovarian cancer drug.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Fierce Pharma
NOVEMBER 28, 2023
In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.
European Pharmaceutical Review
NOVEMBER 24, 2023
Amgen’s new immunotherapeutic agent Tarlatamab has been shown in a Phase II trial to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer patients. The international DeLLphi-301study was investigated as a new anti-cancer treatment option for patients previously considered to be beyond treatment. Results from the trial were published in the New England Journal of Medicine.
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.
Pharmaceutical Technology
NOVEMBER 24, 2023
Epidiolex has been approved as an adjunct therapy for seizures associated with three rare forms of epilepsy in patients aged two and older.
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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.
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.
MedCity News
NOVEMBER 26, 2023
At RSNA 2023, AI startup Hoppr announced that it teamed up with AWS to launch a new foundation model. The product, named Grace, is a B2B model designed to help application developers build better AI solutions for the medical imaging field — and to build them more quickly.
Fierce Pharma
NOVEMBER 21, 2023
With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.
European Pharmaceutical Review
NOVEMBER 21, 2023
Phase III trials of a low carbon version of GSK’s metered dose inhaler, Ventolin (salbutamol), using a next generation, lower carbon propellant, are set to start in 2024. The pharma company stated that if successful, it has the potential to reduce greenhouse gas emissions from use of the inhaler by approximately 90 percent. According to GSK, thirty-five million patients with respiratory conditions globally relying on its metered dose inhaler.
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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
PM360
NOVEMBER 27, 2023
Quality in software is a multifaceted concept, closely tied to both conformance to requirements and fit for purpose. In the life sciences industry, where software permeates everything from the drug discovery process to pharmaceutical supply chain management, the need for rigorous fit-for-purpose evaluations has never been more critical. As pharmaceutical regulations increasingly intersect with software development standards, the traditional approach to Computer System Verification (CSV) is falli
pharmaphorum
NOVEMBER 30, 2023
FDA chief scientist Namandjé Bumpus has been named as principal deputy commissioner, replacing long-serving Janet Woodcock when she steps down early next year. Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency.
Medgadget
NOVEMBER 9, 2023
A team at the University of Technology Sydney has developed an assistive technology for blind people and those with low vision. The system consists of glasses that can view their surroundings through an on-board camera, appraise the objects nearby using computer vision technology, and then play a sound that provides a cue for the wearer as to their surroundings.
MedCity News
NOVEMBER 7, 2023
The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.
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.
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.
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.
PharmExec
NOVEMBER 29, 2023
The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.
PM360
NOVEMBER 27, 2023
This is the second article in a three-part series examining the commercial dynamics surrounding combination therapy in oncology across the U.S. and Europe. In this article, we investigate strategies that manufacturers could consider to optimize pricing and access opportunities for their combinations in today’s environment. (You can find part one here.
pharmaphorum
NOVEMBER 29, 2023
Japan’s medicines regulator has approved the first vaccine based on self-assembling RNA, a spin on the mRNA technology used in current shots, which is designed to deliver greater efficacy with a lower dose.
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.
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.
European Pharmaceutical Review
NOVEMBER 9, 2023
Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders. In July 2023, MyMD Pharmaceuticals released results from its Phase II study in sarcopenia evaluating potential of MYMD-1 ® , its first-in-class oral TNF-α inhibitor.
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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
Pharmaceutical Technology
NOVEMBER 22, 2023
The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.
PharmExec
NOVEMBER 8, 2023
Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.
pharmaphorum
NOVEMBER 27, 2023
EVERSANA’s alliance with Amazon Web Services (AWS) on the application of generative artificial intelligence (genAI) to the pharma sector has borne its first fruit – a new tool to tackle the time-consuming and error-prone task of getting medical and regulatory content approvals.
MedCity News
NOVEMBER 19, 2023
There is a huge opportunity for specialties to play a critical role in complementing primary care and tertiary care by transforming into a sustainable model that is preventive, boundaryless, and one that empowers patients and caregivers.
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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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