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.

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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.

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MedCity News

JULY 30, 2023

As clinical psychologists, we talk about therapy as the gold standard. I’m not saying it isn’t, but if only a minority of people are getting it, we need to broaden our perspective.

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Biopharma 98

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.

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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.

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Networking Medical science Management Leads 98

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.

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Sales 238

PharmExec

JULY 31, 2023

Rebekah Martin, senior VP of reward, inclusion, and talent acquisition at AstraZeneca, discusses ways to address the need for talent in pharma, how pharma can increase more interest in young talent, and how many roles in pharma will require a degree in the coming years in this Pharmaceutical Executive Podcast video.

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Pharma Pharmaceutical 98

Clarivate

AUGUST 2, 2023

Trends point to growing interest by major funding organizations in international collaborative research. Understanding the funding landscape can make bid success more likely. Scientific research is increasingly collaborative. The once siloed approach to research activity has given way to a more interconnected global model, which has enabled a global research network to evolve.

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Competition Networking Management Leads 98

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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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.

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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.

Safety

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.

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PharmaTech

AUGUST 1, 2023

AstraZeneca, via its subsidiary Alexion Pharmaceuticals, will purchase a portfolio of preclinical rare disease gene therapies from Pfizer in a deal worth up to $1 billion.

Pharmaceutical 96

Pharmaceutical 96

Fierce Pharma

JULY 31, 2023

GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. | GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation.

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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.

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Medical 96

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

Competition

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

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Manufacturing Management Competition Leads 94

Medgadget

AUGUST 4, 2023

LUMINELLE , a medtech company based in North Carolina, has developed a suite of endoscopic tools that allow clinicians to perform visually guided gynecological procedures right from their office. At present, the majority of uterine biopsies taken to investigate the cause of abnormal uterine bleeding are taken blind, with no visual guidance at all. This leads to suboptimal outcomes, and the frequent need to repeat the biopsy procedure because the first attempt did not yield an adequate sample.

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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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Medicine Sales Patients 230

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.

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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.

FDA

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.

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Marketing Pharma Pharmaceutical 98

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.

Medicine 98

Medicine 98

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.

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MedCity News

JULY 31, 2023

The average cost of a healthcare data breach is now $10.93 million, up from $10.10 million in 2022, according to a new report. Healthcare has the highest data breach costs of all industries — breaches are second costliest in the financial sector, where the average cost is $5.9 million.

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Healthcare Healthcare 96

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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

Distribution

European Pharmaceutical Review

JULY 31, 2023

The first treatment for children and adolescents who have epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) has been approved in the EU by the European Commission (EC). EC has granted approval of ZTALMY ® (ganaxolone) oral suspension as adjunctive treatment in CDD patients from two to 17 years old. The European regulatory body’s decision “represents a significant milestone” according to Dr Scott Braunstein, Chairman and Chief Executive Off

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Medicine Pharmaceutical Patients FDA 90

Pharmaceutical Technology

AUGUST 4, 2023

Amid one of the worst dengue fever outbreaks in decades, Bangladesh has recorded the highest number of hospitalised cases of the disease in a day.

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Marketing 98

Fierce Pharma

JULY 31, 2023

Johnson & Johnson’s attempt to end its talc litigation with a sweeping $8.9 billion settlement didn’t pass muster at the bankruptcy court, which instead dismissed the company's latest bankruptc | U.S. Bankruptcy Judge Michael Kaplan ruled that J&J's LTL Management subsidiary didn't establish immediate financial distress when it applied for bankruptcy protections.

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Management 228

MedCity News

AUGUST 1, 2023

Last week, the CFO of Universal Health Services stated that the company chooses which patients to treat based on whose insurance plans offer the highest payments. The comments have sparked some media attention, but healthcare finance experts say the practice of cherry-picking patients is nothing new to the industry.

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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.

Safety

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.

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Pharma 98

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.

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Fierce Pharma

JULY 31, 2023

An accelerated approval for a potential growth driver for Takeda is in danger. | Takeda's targeted non-small cell lung med Exkivity has failed in a phase 3 trial in newly diagnosed patients, just days after Johnson & Johnson touted a win for its rival EGFR inhibitor.

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Patients 226

MedCity News

JULY 30, 2023

It’s never a question of whether a hospital will experience downtime — it’s a matter of when. Adopting the right downtime technology means hospitals can cut costs, reduce stress on staff and mitigate risk of cyberattack by automatically encrypting data to HIPAA standards.

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Patients 96

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.

Marketing