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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Manufacturing FDA Pharmaceutical 238

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 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.

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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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Medicine Patients Manufacturing Healthcare 98

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Distribution

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.

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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

MedCity News

AUGUST 2, 2023

Allurion Technologies has commercialized a gastric balloon in the form of a pill that patients swallow. But the weight loss platform from the now NYSE-listed company also include AI-driven software that provides insights about a patient’s progress, technology with the potential for use alongside obesity drugs.

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Patients Biopharma Medical 94

Fierce Pharma

AUGUST 2, 2023

Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen | Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen.

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FDA 183

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

Manufacturing 94

Manufacturing Management Competition Leads 94

Fierce Pharma

AUGUST 2, 2023

During a first-quarter earnings call, as CEO Chris Viehbacher talked of his plan to return Biogen to growth, he said the company needed to figure out the best way to manage its biosimilar business | During a first-quarter earnings call, Biogen CEO Chris Viehbacher said the company needed to figure out the best way to manage its biosimilar business and determine who might be its “best owner.

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Management Sales 182

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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

MedCity News

AUGUST 2, 2023

Horizon Healthcare Services’ 2.5 million commercial members now have access to Resilience Lab clinicians. The mental health provider matches patients with therapists based on their unique needs and offers in-person care and online care.

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Healthcare Healthcare Patients 90

Fierce Pharma

AUGUST 2, 2023

With sales stagnating for its lone approved product, Xopvio, Karyopharm Therapeutics has reduced its workforce by 20%, the company said.

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Sales 179

MedCity News

AUGUST 2, 2023

In 2022, per Gallup, 38 percent of Americans (a record high) deferred healthcare because of cost. To tackle the issue of patients scaling back care because of cost concerns, we need solutions that address care costs from multiple angles. Here are three trends that should inform the development of such solutions.

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Healthcare Healthcare Patients 87

Fierce Pharma

AUGUST 2, 2023

The U.K.’s cost-effectiveness watchdog has tossed cold water on CSL Behring and uniQure’s pricey new hemophilia B gene therapy Hemgenix. | The National Institute for Health and Care Excellence rejected CSL's pricey gene therapy in draft guidance after finding doubts about the drug's long-term benefits. The agency will come to a final decision this fall.

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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

Pharmaceutical Technology

AUGUST 2, 2023

Tyra Biosciences has received orphan drug designation (ODD) from the US FDA for TYRA-300 to treat achondroplasia, a common form of dwarfism.

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FDA 97

Fierce Pharma

AUGUST 2, 2023

With a new growth strategy on tap and two recent launches in its pocket, Teva appears to be entering a new chapter on better financial footing. | The company brought the slow-release schizophrenia med Uzedy and an extended-release version of Austedo to the market this quarter. After reporting second-quarter results, Teva narrowed its full-year revenue outlook to a new range of $15 billion to $15.4 billion.

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Marketing 130

MedCity News

AUGUST 2, 2023

A new startup named Uptiv Health launched to make infusion care more accessible and enjoyable for patients. The company, which was built at Redesign Health, is launching its flagship infusion center later this month in the Detroit area.

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Patients 79

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.

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FDA Leads 98

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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

Medgadget

AUGUST 2, 2023

Scientists at Queen Mary University of London have developed an artificial muscle that can change from soft to hard in response to a voltage change. The technology aims to mimic human muscles in both its movements and in its ability to sense forces and deformation. The muscle is made using carbon nanotubes that have been coated with silicone to form a cathode that can also sense forces, and an anode made from a soft metal mesh, forming an actuation layer between the anode and cathode.

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Medical 78

PharmaTimes

AUGUST 2, 2023

The University of Strathclyde, the NHS and New York University join forces to increase knowledge - News - PharmaTimes

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Pharmaceutical Technology

AUGUST 2, 2023

Pfizer has posted a reported net income of $2.36bn for Q2 2023, a drop of 77% from nearly $10bn in the same quarter of 2022.

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PharmaTech

AUGUST 2, 2023

A comprehensive understanding of what makes mRNA vaccines tick is crucial in charting the future of the market.

Marketing 96

Marketing 96

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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.

Specialization

Medgadget

AUGUST 2, 2023

Researchers at Northwestern University have developed a cardiac monitoring device that is intended for use in patients who have suffered a cardiac event. The soft and flexible patch can be affixed to the outside of the heart during a routine procedure, but does not require a second procedure to remove the device later, as it is fully biodegradable. The patch is transparent, and so should allow clinicians to image the heart as normal, while the microelectrode array within it helps to monitor hear

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Electronics Doctors Patients 72

Pharmaceutical Commerce

AUGUST 2, 2023

CDMO’s Taoyuan City plant is set to provide customers with products ranging from emulsions to gels.

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Manufacturing Pharmaceutical 97

PharmExec

AUGUST 2, 2023

Webinar Date/Time: Thursday, September 28th, 2023 at 10am EDT | 7am PDT | 3pm BST | 4pm CEST

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MedCity News

AUGUST 2, 2023

Drug manufacturers can’t wave a magic wand and streamline government drug discount programs.

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Manufacturing Government Biopharma 93

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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

Leads

Medgadget

AUGUST 2, 2023

Researchers at the Terasaki Institute for Biomedical Innovation in California have developed an implantable sponge that can monitor for signs of a hemorrhage, and then help to control bleeding once it has occurred. The researchers used silk fibroin, a protein produced by the Bombyx mori silkworm, to create the sponge, and took advantage of its biodegradation and anti-inflammatory properties to create a porous and highly absorbent shape-memory sponge.

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Management Leads Medicine 65

PharmaTimes

AUGUST 2, 2023

The deal covers 13 brands across six therapeutic areas, mainly focused on pain treatment - News - PharmaTimes

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PharmaTech

AUGUST 2, 2023

mRNA may be a modality whose chief advances are yet to come.

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InCrowd

AUGUST 2, 2023

“Sadness is but a wall between two gardens.” —Kahlil Gibran As I noted in my last article, a self-assessment provides clarity for both your particular risks and unique solutions for burnout. Along with standard acts of nourishment, it is pivotal to align your values and use your strengths to recapture your inner vitality. My journey was long. Though I work in mental health (and unfortunately maybe even because of this) my self-assessment, insights, and interventions were hard-won.

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Healthcare Healthcare Medicine Consulting 52

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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.

Management