Fierce Pharma

OCTOBER 3, 2023

Four months after GSK settled a key case in California over its heartburn medication Zantac, AstraZeneca is following suit, agreeing to resolve personal injury claims over its heartburn drugs Nexiu | Four months after GSK settled a key case in California over its heartburn medication Zantac, AstraZeneca is following suit, agreeing to resolve personal injury claims over its heartburn drugs Nexium and Prilosec.

Medical 275

Medical 275

PM360

OCTOBER 3, 2023

PM360 has announced the winners of its 15 th annual Trailblazer Awards. Established in 2009, the Trailblazer Awards recognize and honor outstanding companies, marketers, marketing teams, brand managers, and initiatives that have demonstrated innovation and achieved incredible results in the life sciences. In total, PM360 recognized 73 winners across eight overall categories: Companies of the Year, CEOs of the Year, Products of the Year, Marketer of the Year, Marketing Team of the Year, Lifetime

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Education Marketing Media Management 122

Fierce Pharma

OCTOBER 3, 2023

As Galderma attempts to round out its injectable aesthetics portfolio with approvals to resolve crow’s feet and frown lines, the FDA spotted a few manufacturing wrinkles in its RelabotulinumtoxinA | The agency spotted issues relating to chemistry, manufacturing and controls (CMC) processes in the company's application for its liquid botulinum toxin type A.

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Manufacturing FDA 263

MedCity News

OCTOBER 3, 2023

Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.

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FDA Biopharma Pharma 118

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Fierce Pharma

OCTOBER 3, 2023

After a confirmatory trial flop this past summer, Takeda is calling it quits on its targeted non-small cell lung cancer (NSCLC) drug Exkivity. | Takeda will work with the FDA to chart a voluntary withdrawal of Exkivity in the U.S., where the drug is approved for certain adult lung cancer patients whose disease has progressed on or after platinum-based chemotherapy.

FDA 225

FDA Patients 225

Copyright Clearance Center

OCTOBER 3, 2023

October 3, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing and leading information solutions provider to organizations around the world, will host a Town Hall via LinkedIn Live on “AI, Licensing, and the Path Forward” on Thursday, 12 October, 10:00 EDT/15:00 BST/16:00 CEST. CCC’s Vice President, General Counsel Catherine Zaller Rowland and a panel of legal experts including Prof.

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Training Media Leads Marketing 118

MedCity News

OCTOBER 3, 2023

Acquiring Point Biopharma gives Eli Lilly a pipeline of radiopharmaceuticals, including one for prostate cancer that could rival Novartis’s Pluvicto. The deal comes ahead of an expected Phase 3 data readout for that Point therapeutic candidate.

Biopharma 117

Biopharma Pharma 117

Fierce Pharma

OCTOBER 3, 2023

After being denied in its second attempt to resolve talc lawsuits through a bankruptcy ploy, Johnson & Johnson is doubling down on another tactic it has used to negate some of the 30,000-plus c | A New Jersey appeals court has vanquished a $223 million jury award to four plaintiffs who claimed asbestos in Johnson & Johnson's iconic baby powder caused their cancer.

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MedCity News

OCTOBER 3, 2023

A new survey shows that women want more comprehensive medical support, solutions that treat their specific health concerns, access to a doctor who identifies the root cause of their symptoms and better care management services.

Doctors 114

Doctors Management Medical 114

European Pharmaceutical Review

OCTOBER 3, 2023

A paper published in Regulatory Toxicology and Pharmacology has proposed a consistent, health protective read-across methodology for extractables and leachables (E&Ls). The Extractables Leachables Safety Information Exchange (ELSIE) ’s safety team developed the methodology for generating permitted daily exposures (PDEs) for E&Ls. Current challenges in extractables and leachable studies According to the paper, a challenge for E&L read-across is that most toxicology data is from the or

Pharmacology 96

Pharmacology Safety Pharmaceutical 96

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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

OCTOBER 3, 2023

Solera Health recently launched HALO, a platform that allows payers and employers to manage both Solera point solution partners and non-Solera point solutions in one place.

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Management 112

PharmaVoice

OCTOBER 3, 2023

Not every unicorn company lives up to its $1 billion promise. Here are four worth watching.

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MedCity News

OCTOBER 3, 2023

7wireVentures launched its largest fund to date on Tuesday — the closing of the $217 million digital health fund brings the Chicago-based firm’s assets under management to more than $500 million. Two-thirds of the new fund’s capital will be allocated to 7wireVentures’ existing portfolio companies for follow-up investments, and the remaining third will go toward Series B and Series C funding round for companies in which the firm hasn’t yet invested.

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Management 105

Pharmaceutical Technology

OCTOBER 3, 2023

Drug manufacturer Viatris has announced the divestment of a number of businesses owned by the company in a $.37bn deal.

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Manufacturing 98

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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

MedCity News

OCTOBER 3, 2023

San Francisco-based Plenful emerged from stealth on Tuesday. The startup sells a workflow tool that automates manual and administrative workflows for pharmacy technicians. In addition to its launch out of stealth mode, the company also announced that it has closed a $9 million funding round led by Bessemer Venture Partners and signed contracts with more than 20 customers.

Healthcare 101

Healthcare Healthcare 101

PharmaTimes

OCTOBER 3, 2023

The Cancer Hub aims to create a world-leading ecosystem for cancer research - News - PharmaTimes

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Leads 104

PharmExec

OCTOBER 3, 2023

Chandler discusses how life sciences companies are navigating the current climate.

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Pharma 111

Evolve Your Success

OCTOBER 3, 2023

Diagnostic testing sales: where meticulous detail meets the human touch, changing the course of cancer care one relationship at a time. In this special episode for Breast Cancer Awareness Month, Veronica Vasek uncovers the challenges, triumphs, and the vital role that diagnostic sales reps play in the healthcare landscape. Veronica discusses a revolutionary technology for testing and how it’s transforming the way physicians and patients approach cancer treatment.

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Sales Medical sales Physicians Medical 64

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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

Clarify Health

OCTOBER 3, 2023

From shopping to banking to travel, consumers today have everything at their fingertips, with digital technology transforming not only how business is conducted but how people live every day. Despite the rapid adoption of digital technology in other industries, healthcare has been a bit slower to transform. To date, healthcare interactions have been bogged down by poor experiences outside the doctor’s office – long hold times to make an appointment, confusing phone trees, paper forms

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Healthcare Healthcare Patients Side effects 59

pharmaphorum

OCTOBER 3, 2023

Takeda pulls Exkivity in US after failed confirmatory trial Phil.

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95

Prognos Health

OCTOBER 3, 2023

Like many life sciences marketing professionals in the life sciences and pharma industry, I attended Digital Pharma East in Philadelphia recently. It’s three days of learning and leaning in to new methods, new information, and new networking opportunities, and yes, as they say, it is #Fierce.

Pharma 52

Pharma Patients Networking Marketing 52

pharmaphorum

OCTOBER 3, 2023

AZ pays $425m to settle claims heartburn drugs caused harm Phil.

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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

PharmaTech

OCTOBER 3, 2023

The new customized system is designed for fully automated and integrated labeling, orientation, and palletization, and it is expected to streamline the current manual processes, according to the press release.

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Legacy MEDSearch

OCTOBER 3, 2023

ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). The Seraph 100 is a patented blood filter containing a biomimetic surface, similar to that found in the human circulatory system that removes pathogens that could otherwise overwhelm a patient;

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FDA Food and Drug Administration Recruitment Medical 52

PharmaTimes

OCTOBER 3, 2023

NIHR awards £97.

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Pharmacy Times

OCTOBER 3, 2023

Lack of awareness, cultural beliefs, and physician preferences may influence whether minority patients receive palliative care during metastatic breast cancer treatment.

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Patients Physicians 61

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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

pharmaphorum

OCTOBER 3, 2023

Exscientia trims pipeline to focus on top cancer prospects Phil.

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Prospecting 79

Pharmaceutical Commerce

OCTOBER 3, 2023

Company’s branded temperature-controlled container has collaborated with several stakeholders in an effort to simply the cold chain transport process.

Transportation 52

Transportation Pharma 52

Pharmaceutical Technology

OCTOBER 3, 2023

Sanofi has signed an agreement with Janssen Pharmaceuticals for potential first-in-class vaccine against extraintestinal pathogenic E coli.

Pharmaceutical 52

Pharmaceutical 52

Pharmacy Times

OCTOBER 3, 2023

Although respondents reported no impacts on patient safety, workload significantly increased during the COVID-19 pandemic and led to major burnout challenges.

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Safety Patients 59

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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