Fierce Pharma
SEPTEMBER 11, 2023
Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.
MedCity News
SEPTEMBER 11, 2023
Moderna and Immatics aim to see if the combination of their respective technologies can lead to better cancer treatments spanning multiple therapeutic modalities. Milestone payments to immunotherapy developer Immatics could top $1.7 billion.
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Fierce Pharma
SEPTEMBER 11, 2023
Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.
MedCity News
SEPTEMBER 11, 2023
The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.
Fierce Pharma
SEPTEMBER 11, 2023
Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).
MedCity News
SEPTEMBER 11, 2023
The group of 10 startups in the accelerator have ambitions to improve early detection of lung cancer, eliminate contaminated needles, improve remote monitoring and provide new ways to treat head lice, among other goals.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.
Fierce Pharma
SEPTEMBER 11, 2023
After 10 years of stagnation, a new FDA approval could help more cancer patients become eligible for stem cell transplants. | The FDA approved motixafortide—also known as Aphexda—in tandem with the decades-old colony stimulating factor (CSF) filgrastim to mobilize hematopoietic stem cells for collection and autologous stem cell transplantation (ASCT) in patients with multiple myeloma.
PharmExec
SEPTEMBER 11, 2023
Integrating artificial intelligence and advanced analytics throughout operations offers pharma companies a pathway to offset impending drug patent expirations.
Fierce Pharma
SEPTEMBER 11, 2023
A shortage of attention-deficit/hyperactivity disorder (ADHD) medicines has been ongoing for a year in the U.S. | Supernus is sharing positive results for its nonstimulant ADHD treatment, Qelbree, which was approved for children in 2021. In a poster presented over the weekend at Psych Congress 2023, Qelbree was shown to sharpen the focus of children 6 and older when combined with a stimulant.
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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.
MedCity News
SEPTEMBER 11, 2023
Pumpspotting’s funding round was led by Sincere Corporation and Maine Venture Fund and included participation from Unum Business Ventures and Maine Technology Institute. In total, pumpspotting has raised more than $3.3 million.
Fierce Pharma
SEPTEMBER 11, 2023
Gaurav Marya: Hi everyone. My name is Gaurav Marya. I am the Strategic Business Unit Head and Global Head of Mergers and Acquisitions for Life Sciences at Cognizant. | The adoption of technology and data by biopharma is driving a digital transformation in manufacturing, accelerating the process of bringing molecules from benchside to bedside.
PharmaVoice
SEPTEMBER 11, 2023
After dropping its neuroscience program earlier this year, the clinical-stage oncology company is doubling down on a candidate targeting the MAPK pathway.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Pharmaceutical supply chain partners are trying to create an efficient cold chain system to transport cell and gene therapies.
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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
European Pharmaceutical Review
SEPTEMBER 11, 2023
A new strategy to detect lipopolysaccharide (LPS) in minutes in soluble samples has been developed by Japanese researchers. The platform holds potential in revolutionising how LPS is screened. High-throughput LPS detection of endotoxins was achieved by combining a fluorescent chemosensor with a flow injection analysis (FIA) system and a self-developed dual-wavelength fluorophotometer.
PharmaTimes
SEPTEMBER 11, 2023
Both companies will work to advance the development of novel radiopharmaceuticals - News - PharmaTimes
European Pharmaceutical Review
SEPTEMBER 11, 2023
The Cell and Gene Therapy Catapult (CGT Catapult) is set to improve the process and efficiency of AAV manufacture for gene therapies as part of a two-year project alongside two other organisations. CGT Catapult will partner with contract development and manufacturing organisation (CDMO) Rentschler Biopharma and Refeyn Ltd to improve the process of manufacturing adeno-associated viruses (AAV) through automated and digital process analytical technologies (PAT).
PharmaTimes
SEPTEMBER 11, 2023
The platform will be used to advance the effectiveness of antibiotics - News - PharmaTimes
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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.
European Pharmaceutical Review
SEPTEMBER 11, 2023
Samsung Bioepis Co., Ltd. has entered into an agreement with Sandoz to commercialise SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara ( ustekinumab ). The reference medicine Stelara (ustekinumab) is a monoclonal antibody (mAb) treatment to interleukin (IL)-12/23 indicated for autoimmune disorders including Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
PharmExec
SEPTEMBER 11, 2023
Pharm Exec’s latest selections of notable biopharma brand launches—some with novel preemptive approaches—highlight products that are paving uncharted paths across a diverse disease landscape.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Coherus BioSciences has concluded the acquisition of immuno-oncology (I-O) company Surface Oncology in a deal totalling nearly $66.9m.
The Marketing Advantage
SEPTEMBER 11, 2023
September 11, 2023 One of the most popular sales compensation design types utilized in the life sciences industry is the commission-based design. Commission-based sales compensation plans are the simplest among the four major design types (goal, commission, grid and forced rank) and can be very effective across all stages of the product life cycle. In fact, a commission-based plan is, in most cases, the most effective design type for a product launch.
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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.
Legacy MEDSearch
SEPTEMBER 11, 2023
Zeta Surgical, a surgical robotics and mixed reality company, announced today that the U.S. Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. The Zeta Cranial Navigation System is a mixed-reality navigation system for neurosurgery that provides surgeons with “GPS-like” guidance with millimetric accuracy in real time.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Alexion has entered into a partnership with Verge Genomics to detect new drug targets for rare neurodegenerative and neuromuscular ailments.
PharmaVoice
SEPTEMBER 11, 2023
Bill Sibold has led Sanofi's specialty care business unit for the past six years. He replaces Paul Friedman as head of the NASH drug developer.
Pharmaceutical Technology
SEPTEMBER 11, 2023
The agency has set a PDUFA target action date to June 2024, with no current plans for an advisory meeting in the works.
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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
Pharmacy Times
SEPTEMBER 11, 2023
Although GLP-1 receptor agonists have shown promise in promoting weight loss, they are prescription medications and should be used under the guidance of health care professionals.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Mark Chadwick explains how CSRD, the EU's new ESg reporting regulation, will impact pharmaceutical companies.
Pharmacy Times
SEPTEMBER 11, 2023
FDA grants updated Moderna and Pfizer-BioNTech COVID-19 vaccines with emergency use authorization to target currently circulating variants of the virus.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Grit Biotechnology has secured more than $60m in a Series B funding round to support the development of its pipeline programmes.
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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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