World of DTC Marketing

SEPTEMBER 6, 2021

SUMMARY: Those working in pharma know that ageism exists, especially in the sales force. Pharma has been purging older employees for some time, and when you reach the magic age of 50+, you’re going to be pushed to take “early retirement.” My workstation while at Lilly was right next to the sales training center. Some of the trainees looked like they were right out of school, but they all had one thing in common; they were young and great-looking.

Pharma Companies 219

Pharma Companies Sales Branding Marketing 219

Pharma Mirror

SEPTEMBER 6, 2021

TOKYO, TANAKA Kikinzoku Kogyo K.K. (Head office: Chiyoda-ku, Tokyo; Representative Director & CEO: Koichiro Tanaka), which is a subsidiary of TANAKA Holdings Co., Ltd. and operates the TANAKA Precious Metals manufacturing business, announced today that TANAKA made an equity contribution to Ambix Life Science Fund I, L.P., a medical device venture fund managed by Ambix Venture Management, LLC, a U.S.

Life Science 130

Life Science Business Development Manufacturing Development 130

pharmaphorum

SEPTEMBER 6, 2021

UK researchers have used artificial intelligence (AI) to develop a way to identify patients with heart failure who would benefit from treatment with beta blockers, by interrogating data from nine landmark clinical trials. The study applied machine learning to trial data involving 15,659 patients who were being treated for heart failure with reduced ejection fraction (HFrEF), a form of heart failure where the left side of the heart isn’t able to pump blood effectively around the body.

Drugs 145

Drugs Trials Clinical Trials Clinical Trials 145

Pharma Times

SEPTEMBER 6, 2021

UK’s chief medical officers will now provide ‘further advice’ on COVID-19 vaccination in this age group

Vaccination 149

Vaccination Vaccine 149

Advertisement

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

Clinical Research

XTalks

SEPTEMBER 6, 2021

Nestlé has announced the launch of the largest R+D Accelerator that provides a platform for startups, students and Nestlé intrapreneurs to quickly bring innovation to the market. The Accelerator will be in Lausanne, Switzerland, at Nestlé’s fundamental research center. . All internal and external teams will have access to Nestlé’s facilities, including science, technology and business expertise.

Production 104

Production Packaging Packaging Marketing 104

BioSpace

SEPTEMBER 6, 2021

The analysis showed tezepelumab achieved an 86% reduction in the annualized asthma exacerbation rate with patients having nasal polyps, and 52% in patients not having nasal polyps.

87

87

BioSpace

SEPTEMBER 6, 2021

Galt's decision was based on lessons offered by the pandemic, along with research showing an increase in productivity and creativity brought about by the 4-day workweek model.

Production 96

Production Research 96

pharmaphorum

SEPTEMBER 6, 2021

Mallinckrodt looks like it could join Purdue Pharma in reaching a settlement in its bankruptcy proceedings related to opioid litigation, after years of legal wrangling. The Ireland-headquartered drugmaker filed for bankruptcy last year, after proposing a $1.6 billion payout to settle lawsuits claiming that its marketing of opioid painkillers helped to fuel an epidemic in addiction that has claimed hundreds of thousands of lives in the US alone.

Marketing 98

Marketing Drugs Sales 98

BioSpace

SEPTEMBER 6, 2021

Exelixis is mourning the loss of two veteran executives—Dr. Gisela M. Schwab, president, Product Development and Medical Affairs and CMO, and Jon Berndt, senior VP of Sales.

Sales 92

Sales Production Development 92

BioPharma Reporter

SEPTEMBER 6, 2021

Pfizer has launched a phase 3 trial for its investigational vaccine against respiratory syncytial virus (RSV) in adults aged 60+.

Vaccination 98

Vaccination Vaccine Trials Development 98

Advertisement

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

BioSpace

SEPTEMBER 6, 2021

Boston-based Ginkgo Bioworks has been having a banner year and doesn’t show any signs of stopping with its recent string of collaboration announcements.

93

93

pharmaphorum

SEPTEMBER 6, 2021

BioMarin Pharma has had another setback in its gene therapy development programme, announcing this morning that the FDA has placed a phase 1/2 trial of its candidate for phenylketonuria (PKU) on hold while it investigates a safety signal. The biotech said that the US regulator ordered the pause on the study after liver tumours were seen in mice given the therapy in preclinical testing.

Gene Therapy 80

Gene Therapy Gene Genetic Disease DNA 80

Pharma Times

SEPTEMBER 6, 2021

Expert Medicals – one of the largest PCR travel test providers in the UK this summer – has received a ‘high number of complaints’

76

76

Delveinsight

SEPTEMBER 6, 2021

Phenylketonuria is an inherited disorder characterized by the absence or deficiency of an enzyme called phenylalanine hydroxylase (PAH), responsible for processing the amino acid phenylalanine. The condition affects one in 13,500 to 19,000 newborns in the United States, says NORD. DelveInsight’s Phenylketonuria epidemiological analysis demonstrated a prevalence of 49,887 in the 7MM (the US, EU5 and Japan) in 2020, which is expected to increase further in the coming next decade.

Marketing 72

Marketing Gene Therapy Gene Clinical Trials 72

Advertisement

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.

Clinical Supply

Pharma Times

SEPTEMBER 6, 2021

New government body will be co-led by deputy chief medical officer Jeanelle de Gruchy

104

104

JAMA Internal Medicine

SEPTEMBER 6, 2021

This case report discusses the electrocardiographic findings of a man in his 40s with hypertension who presented to the emergency department after becoming unresponsive during descent on a commercial flight.

76

76

BioSpace

SEPTEMBER 6, 2021

?The collaboration between Spark and NeuExcell opens up access to the latter's proprietary neuro-regenerative gene therapy platform and resources.

Gene Therapy 74

Gene Therapy Gene 74

JAMA Internal Medicine

SEPTEMBER 6, 2021

This individual participant data analysis assesses the cross-sectional and longitudinal associations of baseline thyroid dysfunction with cognitive function and dementia.

75

75

Advertisement

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

BioPharma Reporter

SEPTEMBER 6, 2021

Moderna has submitted data for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of its COVID-19 vaccine.

Vaccination 59

Vaccination Vaccine Medicine Marketing 59

Pharma Times

SEPTEMBER 6, 2021

TSLP blocker reduced exacerbations in patients with severe asthma and comorbid nasal polyps

81

81

BioSpace

SEPTEMBER 6, 2021

Gene therapy clinical trials have been paused due to safety concerns, including the most recent one by BioMarin Pharmaceutical.

Gene Therapy 74

Gene Therapy Gene Clinical Trials Clinical Trials 74

The Pharma Data

SEPTEMBER 6, 2021

Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

Advertisement

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.

Clinical Supply

Scienmag

SEPTEMBER 6, 2021

Adults younger than 45 years who reported recently using cannabis were 2 times more likely to have had a heart attack (myocardial infarction), and this link was stronger in frequent users, according to new research in CMAJ (Canadian Medical Association Journal). VIEW EMBARGOED ARTICLE Credit: CMA Joule Inc. or its licensors Adults younger than 45 years who reported recently using […].

Research 52

Research Medicine 52

The Pharma Data

SEPTEMBER 6, 2021

GSK Consumer Healthcare (GSKCH), the world-leading consumer healthcare business, whose brands include Sensodyne, parodontax, Voltaren and Advil, is contributing to raising sustainability standards in the oral care industry with its first carbon neutral toothbrush. GSKCH, which is due to separate into a new company next year, has found an innovative way to leverage renewable raw materials for high-performance oral care products – helping reduce the use of fossil fuels for virgin plastic.

Packaging 52

Packaging Packaging Branding Production 52

Scienmag

SEPTEMBER 6, 2021

The ongoing climate crisis has already had drastic global impacts. For example, droughts have become critical high-impact hydro-meteorological hazards worldwide. In Europe, the consequences of the climate crisis have been severe, with droughts having caused considerable social, economic, and environmental costs already, especially in the years 2003, 2010, and 2018.

52

52

The Pharma Data

SEPTEMBER 6, 2021

Significant improvement in 24-hour cough counts over placebo after 12 weeks of treatment and with a favorable safety and tolerability profile / Results from PAGANINI Phase IIb dose-finding study presented at the virtual European Respiratory Society (ERS) International Congress 2021 / Currently no treatment approved for refractory chronic cough, a condition affecting one to five percent of people wordwide.

Trials 52

Trials Clinical Trials Clinical Trials Medicine 52

Advertisement

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.

Clinical Trials

FDA Law Blog

SEPTEMBER 6, 2021

By Sara W. Koblitz — Innovators rejoice while generic sponsors mourn: In the wake of the latest in GSK v. Teva decision , the skinny label may be dead. The “skinny label,” also known as a “carve-out” or a “section viii statement,” is a widely-used statutory provision adopted in the Hatch Waxman Amendments that allows generic sponsors to come to market notwithstanding a method-of-use patent covering an aspect of the reference listed drug (RLD) labeling by removing that patent-protected use from t

Generic Drugs 52

Generic Drugs Production Drugs Branding 52

The Pharma Data

SEPTEMBER 6, 2021

First data to be presented from the phase II coopERA Breast Cancer study evaluating neoadjuvant giredestrant treatment for oestrogen receptor (ER)-positive, HER2-negative breast cancer. New data from the phase III IMpower010 study provide further insights into the role of Tecentriq ® ( atezolizumab ) in early-stage non-small cell lung cancer (NSCLC).

Genome 52

Genome Genomics HR Hormones 52

Scienmag

SEPTEMBER 6, 2021

EMBARGOED UNTIL 3 P.M. ET 9/6/21 Credit: Rick Lindroth / UW–Madison EMBARGOED UNTIL 3 P.M. ET 9/6/21 CONTACT: Rick Lindroth, richard.lindroth@wisc.edu; Olivia Cope, oliv.cope@gmail.com. To reach Rick Lindroth before Sept. 6, contact Eric Hamilton at eshamilton@wisc.edu or (608) 263-1986. Study shows how aspen forests maintain the diversity needed to adapt to changing environments MADISON – […].

52

52

pharmaphorum

SEPTEMBER 6, 2021

Bayer has released the data in its phase 2b trial of eliapixant in refractory chronic cough, as it tries to close the gap with Merck & Co’s rival drug gefapixant. The drugmaker said last month that the PAGANINI study hit its main objective, which was to reduce the average cough frequency compared to placebo after 12 weeks of treatment, but saves the data reveal until this week’s European Respiratory Society (ERS) meeting.

Trials 52

Trials Drugs Clinical Trials Clinical Trials 52

Advertisement

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Clinical Trials