Headwinds loom for pharma web strategy
Dominic Tyer
APRIL 11, 2024
Online changes pose some pressing questions for the industry and demand a new approach to websites and data
Sat.Apr 06, 2024 - Fri.Apr 12, 2024
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Number of ongoing US drug shortages reaches new high, pharmacist group says
Fierce Pharma
APRIL 11, 2024
As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.
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How Can Healthcare Ensure Responsible AI Use?
MedCity News
APRIL 9, 2024
At a recent conference, executives from across the industry shared their thoughts on how the healthcare sector can ensure its use of AI is ethical and responsible. They highlighted the need for collaboration, trust building and pragmatic thinking. The post How Can Healthcare Ensure Responsible AI Use? appeared first on MedCity News.
EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies
PharmaTech
APRIL 12, 2024
The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
NHS trust bids to take license for abandoned gene therapy
pharmaphorum
APRIL 9, 2024
Great Ormond Street Hospital is applying for the license to a gene therapy for rare disease ADA-SCID that was abandoned by a biotech developer on commercial grounds.
AstraZeneca, Daiichi Sankyo's Enhertu wins historic HER2 tumor-agnostic FDA nod
Fierce Pharma
APRIL 8, 2024
With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s (ADC's) reach in the U.S.< | With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s reach in the United States.
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FDA Releases Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
PharmaTech
APRIL 11, 2024
The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.
The 7 Ps of Marketing
Healthcare Success
APRIL 8, 2024
As an engineering undergrad, I took a Marketing 101 class on a lark, seeking to better understand the psychology behind consumer behavior and developing products with a competitive edge. On the first day of class, we learned the fundamental concept of the 4 Ps of marketing. However, today, I like to use an expanded “7 Ps” definition. In any event, this marketing mix remains essential for any successful marketing strategy.
Regeneron hit with DOJ complaint that it hid 'hundreds of millions' in Eylea credit card processing fees from Medicare
Fierce Pharma
APRIL 11, 2024
The U.S. government is accusing Regeneron of deliberately using an unusual method to overcharge Medicare for the company’s popular eye drug Eylea. | The U.S. government is accusing Regeneron of deliberately using an unusual method to overcharge Medicare for the company’s popular eye drug Eylea.
Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem
MedCity News
APRIL 10, 2024
Nurse managers being too busy to train and support their team members is one of the biggest reasons nurses are exiting the healthcare industry, according to a new report. The post Why So Many Nurses Are Fleeing Healthcare — And How Hospitals Can Address The Problem appeared first on MedCity News.
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.
UK calls time-out on post-Brexit rules opposed by industry
pharmaphorum
APRIL 10, 2024
The UK has agreed to delay border checks on products used in life sciences R&D and manufacturing, says industry group BIA.
How Efficient Logistics Can Change the Lives of Rare Disease Patients
Pharmaceutical Commerce
APRIL 10, 2024
If manufacturers cannot ensure safe, cost-effective delivery of treatments for rare diseases, access will remain a challenges for many patients living with these conditions.
Amid corporate restructuring, Novartis plots 680 layoffs in development group
Fierce Pharma
APRIL 9, 2024
Even as Novartis rolls ahead with a global restructuring campaign targeting thousands of job cuts, the Swiss drug giant has blueprinted several hundred layoffs in its development organizational uni | Even as Novartis rolls ahead with a global restructuring campaign targeting thousands of job cuts, the Swiss drug giant has blueprinted several hundred layoffs in its development organizational unit.
Report: How MA Plan Design Affects Utilization, Health Equity
MedCity News
APRIL 8, 2024
A new study found that enrollees with zero-premium MA plans are three times as likely to be non-White compared to other MA enrollees and traditional Medicare enrollees. The post Report: How MA Plan Design Affects Utilization, Health Equity appeared first on MedCity News.
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
Next-gen menopause treatments have blockbuster potential. Can women, doctors and payers be convinced?
PharmaVoice
APRIL 8, 2024
The market is huge, but will companies overcome the triple hurdles of payer hesitance, prescriber reluctance and sluggish consumer demand?
Ed Schoonveld Discusses Drug Pricing in the US and Upcoming Articles
Pharmaceutical Commerce
APRIL 8, 2024
In an interview with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value & Access Advisor, Schoonveld Advisory, offers his thoughts on lower drug prices in the US and provides a sneak peak into future PC features.
FDA advisers back new endpoint for myeloma approvals, paving way for faster introduction of new drugs
Fierce Pharma
APRIL 12, 2024
After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey. | After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey.
Report: Payers Aren’t Providing an Adequate Digital Experience
MedCity News
APRIL 10, 2024
About 32% of health insurance sites and apps “don’t meet the foundational level of functionality and intuitive organization of information,” according to a new J.D. Power report. The post Report: Payers Aren’t Providing an Adequate Digital Experience appeared first on MedCity News.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Unlocking growth: How GenAI can help pharma companies convert new clients
PharmaVoice
APRIL 8, 2024
GenAI is profoundly reshaping various facets of the pharmaceutical industry. Projections indicate that the global GenAI market in pharma will soar to USD 2258.1 million by 2032.
Patent expiration to drive biosimilars market expansion to 2032
European Pharmaceutical Review
APRIL 11, 2024
Expirations of biologic patents has enabled manufacturers to enter the market and offer lower-cost alternatives of these drugs, [which has] resulted in increased competition and price pressure, driving the growth of the biosimilar market” A report published by Towards Healthcare has estimated that the global biosimilar market will value $1,26,019.67 million by 2032, at 17.6 percent CAGR between 2023 and 2032.
FDA commissioner tells lawmakers his agency needs more authority to prevent drug shortages
Fierce Pharma
APRIL 11, 2024
After investigations into the FDA’s response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency’s | FDA Commissioner Robert Califf, M.D., told lawmakers that the agency, as the "referee," needs to be given more authority in order to preemptively halt drug shortages.
Grow Therapy Secures $88M To Expand Mental Health Services
MedCity News
APRIL 11, 2024
Grow Therapy’s $88 million Series C funding round was led by Sequoia Capital. The financing will help the company invest in its team, improve its product and expand its footprint. The post Grow Therapy Secures $88M To Expand Mental Health Services appeared first on MedCity News.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Women want to participate in clinical trials. Lack of flexibility is still a problem.
PharmaVoice
APRIL 8, 2024
Underrepresentation of women in clinical trials affects the resulting drugs that are available down the line. Encouraging more women to partake is a critical step in promoting more equitable healthcare.
Is the pharmaceutical sector realising its potential for sustainable manufacturing?
European Pharmaceutical Review
APRIL 11, 2024
The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available. 1 That’s more than the automotive sector, which released 46.4 megatonnes in the same year, and the increased demand and complexity of medicines since then will only have swollen this figure. 1 Every major pharmaceutical manufact
'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study
Fierce Pharma
APRIL 8, 2024
One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. | Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.
Novartis Pays $150M to Nab a Phase 3-Ready Protein Degrader for Prostate Cancer
MedCity News
APRIL 11, 2024
Novartis gains global rights to an Arvinas protein degrading drug that targets the androgen receptor to treat prostate cancer. The deal also includes a preclinical molecule addressing an androgen receptor variant. The post Novartis Pays $150M to Nab a Phase 3-Ready Protein Degrader for Prostate Cancer appeared first on MedCity News.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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.
Ionis, Arrowhead hail data with triglyceride drugs at ACC
pharmaphorum
APRIL 8, 2024
Drugs from Ionis and Arrowhead Pharma that block apolipoprotein C-III (apoC-III) have shown their value in treating diseases associated with elevated triglyceride levels in two studies presented at the American College of Cardiology annual congress. The two companies are racing to bring their apoC-III inhibitors to market for severe hypertriglyceridaemia (HTG) and ultra-rare disorder familial chylomicronaemia syndrome (FCS).
Women in Leadership: 4 Key Takeaways for the Career Journey
ALULA
APRIL 9, 2024
It’s been somewhat of an annual tradition for me to attend the Women in Leadership panel at the American Manufacturing Summit and share the highlights. This year’s panel discussion brought together five senior leaders: Joy Malinowski from Constellation Brands, Elena Bernado from Hello Fresh, Susanne Lauda from AGCO, Donna Deyo from Paccar, and Angela Reamer from Monin.
FDA swats away Supernus’ Parkinson’s disease infusion pump for 3rd time
Fierce Pharma
APRIL 8, 2024
The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The following year, the agency doled out a complete response letter, dashing Supernus' second try.
Why Hospitals Are Condemning CMS’ Proposed Inpatient Payment Rule
MedCity News
APRIL 12, 2024
CMS released a proposed rule this week that would boost hospitals’ inpatient payment rates by 2.6%. Hospitals groups have swiftly denounced this plan, arguing that this payment update is insufficient and will jeopardize hospitals’ financial stability. The post Why Hospitals Are Condemning CMS’ Proposed Inpatient Payment Rule appeared first on MedCity News.
ABM Evolution: How Top Marketers Are Using Account-Based Strategies
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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