Waters Launches SEC Columns for Gene Therapy Applications
PharmaTech
AUGUST 3, 2023
Waters XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.
Sat.Jul 29, 2023 - Fri.Aug 04, 2023
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As sales crater, Moderna sees hope in private COVID vaccine market and RSV launch
Fierce Pharma
AUGUST 3, 2023
Even as Moderna chugs through another post-pandemic year, the biotech has raised its COVID-19 vaccine revenue projection in the expectation that it can deliver a strong showing in the private marke | The company raised its forecast for COVID-19 sales to between $6 billion and $8 billion, up from a prior estimate of $5 billion. Elsewhere, an RSV clash with pharma giants nears.
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New HIV drug formulation could transform paediatric administration
European Pharmaceutical Review
AUGUST 4, 2023
A new study published in The Lancet HIV has demonstrated the safety and efficacy of a new dispersible drug formulation of an immediate-release tablet as a human immunodeficiency virus (HIV) treatment for children. The single fixed dose combination (FDC) contains dolutegravir , abacavir and lamivudine. “This is the first FDC containing dolutegravir that can be used for children from 13 to 88 pounds,” explained Kristina Brooks, PharmD, an Assistant Professor in the University of Colorado Skaggs Sc
Sage, Biogen Drug Is Now the First Approved Oral Med for Postpartum Depression
MedCity News
AUGUST 4, 2023
Sage Therapeutics’ Zurzuvae is the biotech’s second FDA approved product for postpartum depression, following the 2019 nod for IV-infused Zulresso. But in a blow to the multi-billion dollar partnership between Sage and Biogen, Zurzuvae did not win an additional approval in major depressive disorder.
AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work
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What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.
Court Limits Arkansas “Harmful” Book Law
Copyright Clearance Center
AUGUST 4, 2023
The post Court Limits Arkansas “Harmful” Book Law appeared first on Copyright Clearance Center.
Novo Nordisk, Eli Lilly face injury lawsuit from user of popular GLP-1 medicines
Fierce Pharma
AUGUST 3, 2023
As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. | A Louisiana woman is suing Novo Nordisk and Eli Lilly, alleging that her use of Ozempic and Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, says that she also has been hospitalized on "several" occasions and that the companies failed to warn patients of “seve
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New European monograph for Cannabis flower adopted
European Pharmaceutical Review
AUGUST 3, 2023
The Danish Medicines Agency (Lægemiddelstyrelsen) has announced the European Pharmacopoeia Commission has adopted a new European monograph, which describes quality requirements for the raw material Cannabis flower. EPC’s new Cannabis flower monograph The new monograph Cannabis flower (Cannabis flower, monograph 3028) will be available next year in January 2024 with publication of the supplement 11.5.
‘A Criminal Justice Approach to a Public Health Problem’: How the Justice System Can Improve SUD Support
MedCity News
AUGUST 3, 2023
There is inadequate substance use disorder support for people who are incarcerated or are leaving incarceration. But there are opportunities to make improvements, experts say.
Bavarian Nordic locks up $120M BARDA deal to replenish US stock of smallpox and mpox vaccine
Fierce Pharma
AUGUST 3, 2023
After coming to the rescue during the mpox outbreak in 2022, vaccine maker Bavarian Nordic has agreed to help replenish U.S. stores of its smallpox/mpox shot. | The U.S. Biomedical Advanced Research and Development Authority is handing Bavarian Nordic a new $120 million contract, primarily to cover the production of new bulk vaccine product.
Generative AI has the potential to revolutionise drug discovery
Pharmaceutical Technology
AUGUST 3, 2023
The impact of artificial intelligence has been profoundly felt in the drug discovery space, with increased interest in AI in recent years.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Pharma Marketing in the Age of AI: A New Era Begins
PharmExec
AUGUST 3, 2023
This podcast companion to our roundtable feature explores the transformative power of AI in pharmaceutical marketing, six months after the arrival of ChatGPT.
Driving for Results: 3 Key Benefits of Telehealth [Sponsored]
MedCity News
AUGUST 3, 2023
Explore the myriad benefits telehealth offers to healthcare providers and patients alike. From enhanced convenience and improved privacy to streamlined workflows and elevated patient satisfaction, find out how telehealth is reshaping the future of healthcare delivery.
Intas analyst poured acid over manufacturing docs, FDA says in scathing warning letter
Fierce Pharma
AUGUST 2, 2023
Intas Pharmaceuticals’ new warning letter from the U.S. FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. | The FDA handed Intas a five-observation write up after inspecting the company’s Sanand, India, production plant from November 22 to December 2, 2022. The company got dinged for lapses in quality control, incomplete lab records, testing shortfalls and more.
MHRA authorises new COVID-19 vaccine
European Pharmaceutical Review
AUGUST 2, 2023
A new COVID-19 vaccine has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). Bimervax is now the ninth vaccine to be authorised by the UK’s independent medicines regulator to treat the virus. MHRA authorisation of Bimervax The COVID-19 vaccine, developed by HIPRA Human Health, combines a part of the SARS-CoV-2 virus spike protein with an adjuvant, according to the MHRA.
Solving time crunch and profile challenges for researchers
Clarivate
AUGUST 2, 2023
How librarians can relieve administrative burdens and drive researcher effectiveness In today’s fast-paced world of research, time has become an increasingly scarce and valuable resource. An independent study commissioned by Ex Libris revealed that “academic researchers face a significant challenge in finding enough time to effectively manage their research activities.
What We Can Learn From Health Systems Around the World
MedCity News
AUGUST 3, 2023
I am a practicing UK general practitioner and in this article, I take a magnifying glass to quality indicators including access, affordability, healthcare inequalities and population health, staffing and equipment, and patient and provider experience to discuss how we can shape up.
As RSV vaccine clash kicks off, GSK sues Pfizer for patent infringement
Fierce Pharma
AUGUST 2, 2023
In the latest clash of the vaccine titans, GSK is locking horns with Pfizer over claims the company’s competing respiratory syncytial virus (RSV) shot Abrysvo treads on patents belonging to its own | GSK says Pfizer’s vaccine RSV vaccine Abrysvo—approved in late May—infringes four patents related to its RSV antigen shot Arexvy, which itself snagged a green light in the U.S. earlier that same month.
Accelerating biomanufacturing with automated PAT systems
European Pharmaceutical Review
AUGUST 2, 2023
Research published in Biotechnology and Bioengineering has demonstrated two innovative, automatic, online, real-time sample acquisition and preparation systems for in-process monitoring, control, and release of biopharmaceuticals. The proposed autonomous process analytical technology (PAT) platform comprises of a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) for use in the laboratory as an off-line analytical system and on the manufacturing flo
How Machine Learning Drives Clinical Trial Efficiency
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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.
FDA warns of reduced efficacy for oral birth control pill Tydemy
Pharmaceutical Technology
AUGUST 2, 2023
Two lots of Lupin’s Tydemy have been recalled due to a decrease in ascorbic acid levels leading to reduced effectiveness.
Signify Health Unveils Chronic Kidney Disease Evaluation
MedCity News
AUGUST 3, 2023
Home care company Signify Health announced Tuesday that it added an in-home kidney health evaluation to its platform. Based on the results of the evaluation, the company can refer patients to their primary care physician or a specialist if they’re in need of further treatment.
In 'advanced' settlement talks, Teva sets aside $200M to resolve US price-fixing probe
Fierce Pharma
AUGUST 2, 2023
Teva has long maintained its innocence in the face of a far-reaching price-fixing indictment by the U.S. Department of Justice (DOJ). | Teva has long maintained its innocence in the face of a far-reaching price-fixing indictment by the U.S. Department of Justice. Now, the company is earmarking a sizable chunk of cash in an attempt to put the charges to bed.
New Alzheimer’s treatments are the tip of the iceberg in a long-stymied area of medicine
PharmaVoice
AUGUST 3, 2023
A smaller player in the Alzheimer’s space, Prothena is approaching the next phase of treatments, including prevention and clinical trial evolution.
How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales
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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten
BioNTech acquires tech company InstaDeep for $549m
Pharmaceutical Technology
AUGUST 1, 2023
BioNTech has acquired all the remaining shares of technology company InstaDeep in a deal valued at €500m ($549m) in cash.
Novartis Pays Ionis $60M to Expand Alliance on a Hot Target for Cardio Drugs
MedCity News
AUGUST 3, 2023
Novartis and Ionis, already partners in cardiovascular disease R&D, are expanding their alliance to see if they can develop a next-generation therapy offering efficacy and dosing advantages. But competitors are already in the mix with programs addressing the same cardiovascular disease target.
As COVID revenues disappoint, once-high-flying Pfizer looks at possible cost cuts
Fierce Pharma
AUGUST 1, 2023
As COVID-19 revenues ebb and flow—but mostly ebb—Pfizer is eyeing the cost-cutting shears. | Paxlovid generated just $143 million in worldwide sales for the second quarter, while mRNA vaccine Comirnaty brought home $1.4 billion. Against that backdrop, Pfizer reported total second quarter revenues of $12.7 billion, down a whopping 53% operationally from the same period last year.
New immuno-oncology treatment approved for endometrial cancer
European Pharmaceutical Review
AUGUST 1, 2023
The only immuno- oncology treatment approved as frontline therapy for mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), primary advanced or recurrent endometrial cancer in combination with chemotherapy, is now authorised in the US. Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the US Food and Drug Administration (FDA).
How to Stay Competitive in the Evolving State of Martech
Advertiser: ZoomInfo
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
A pharma banking on the success of past blockbusters
PharmaVoice
JULY 31, 2023
180 Life Sciences is on a mission to see if the anti-TNF technology that produced a blockbuster could work for a range of other conditions.
Labor Department Sues UnitedHealth Group Over ‘Thousands’ of Claims Denials
MedCity News
AUGUST 2, 2023
The Labor Department recently sued UnitedHealth Group subsidiary UMR, alleging that it wrongfully denied claims for emergency room services and urinary drug screenings since 2015. UMR did not determine the medical necessity of the claims, denying them “based solely on diagnosis codes and not applying a prudent layperson standard,” according to the complaint.
Bristol Myers, AstraZeneca settle PD-1, CTLA-4 cancer immunotherapy patent suits for $510M
Fierce Pharma
AUGUST 1, 2023
Bristol Myers Squibb and AstraZeneca have quickly resolved patent infringement lawsuits around their blockbuster cancer immunotherapies. | Bristol Myers Squibb and AstraZeneca have quickly resolved patent infringement lawsuits around their blockbuster PD-1/L1 and CTLA-4 cancer immunotherapies.
Innovation passport designation awarded to Pfizer and Arvinas
European Pharmaceutical Review
AUGUST 1, 2023
Arvinas, Inc. and Pfizer Inc. have been awarded an Innovation Passport for vepdegestrant (ARV-471), an investigational PROTAC ® ER degrader, as a treatment for oestrogen receptor (ER)+/ human epidermal growth factor receptor (HER)2- locally-advanced breast cancer or metastatic breast cancer. The award was jointly granted by the UK Innovative Licensing and Access Pathway Steering Group, which consists of the All Wales Therapeutics and Toxicology Centre (AWTTC), the Medicines and Healthcare produc
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