Pharmaceutical Technology

JULY 6, 2022

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

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Marketing Gene Therapy Manufacturing Pharma Companies 324

Bio Pharma Dive

JULY 6, 2022

The decision by U.S. regulators is the latest boost for a company whose shares have climbed more than 30% during the biotech sector’s worst downswing in years.

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Regulation 328

Pharmaceutical Technology

JULY 6, 2022

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in

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Bio Pharma Dive

JULY 6, 2022

The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.

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Regulation Drugs 291

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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

Clinical Research

Pharmaceutical Technology

JULY 6, 2022

Europe was the fastest growing region for data analytics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Europe made up 11.8% of total data analytics jobs - up from 11.1% in the same quarter last year. That was followed by North America, which saw a -0.4 year-on-year percentage point change in data analytics roles.

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Marketing 246

World of DTC Marketing

JULY 6, 2022

Endpoint News reported “Three major drug distributors are off the hook for what may have been a $2.5 billion payment after a federal judge found them not liable for the opioid epidemic in parts of West Virginia, one of the hardest-hit areas of the country. This is beyond outrageous it’s a classic example of abuse of power. Despite distributing more than 51.3 million doses of oxycodone and hydrocodone to pharmacies in Cabell County and the city of Huntington over less than a decade, M

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Pharmacy Doctors Doctor Sales 238

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 6, 2022

We know the brain changes after traumatic injury, and now we have maps from mice showing what that change looks like. A team of scientists has traced connections between nerve cells throughout the entire brain of mice, showing that distant parts of the brain become disconnected after a head injury. The stunning visualizations of brain-wide […].

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Scientist Clinical Trials Clinical Trials Clinical Research 176

Pharmaceutical Technology

JULY 6, 2022

Scientists at the National Institutes of Health (NIH) unit National Institute of Neurological Disorders and Stroke (NINDS) have found that Covid-19-induced immune response could damage the blood vessels of the brain and may lead to short and long-term neurological symptoms. . NINDS team analysed changes in the brain of nine individuals who died following Covid-19 infection.

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Rethinking Clinical Trials

JULY 6, 2022

Respect for persons is a central obligation for the ethical conduct of research with human subjects. Traditionally, clinical trials have primarily relied on informed consent practices to fulfill this ethical obligation. A new article in the Hastings Center Report proposes 8 dimensions for how researchers can meet the ethical obligation of respect for persons in pragmatic clinical trials.

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Trials Clinical Trials Clinical Trials Research 130

Pharmaceutical Technology

JULY 6, 2022

The proportion of pharmaceutical companies hiring for big data related positions rose in June 2022 compared with the equivalent month last year, with 68.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 65.7% of companies who were hiring for big data related jobs a year ago and the same as the figure of 68.4% in May 2022.

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Big Data 162

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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

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 6, 2022

The National Institute of Mental Health and Neuro Sciences (NIMHANS), Department of Integrative Medicine is propelling its efforts towards holistic care combining modern medicine, Ayurveda and Yoga to treat the neurological and mental diseases and disorders. Here three medical experts of allopathy, Ayurveda and Yoga disciplines sit together to formulate a tailor made approach for […].

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Medicine Clinical Trials Clinical Trials Clinical Research 144

Pharmaceutical Technology

JULY 6, 2022

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

Marketing 162

Marketing Gene Therapy Manufacturing Pharma Companies 162

Rethinking Clinical Trials

JULY 6, 2022

Left to right: Dr. Carolyn Bramante, Dr. Thomas Murray, Dr. Jared Huling. In this Friday’s COVID-19 Grand Rounds, Dr. Carolyn Bramante, Dr. Thomas Murray, and Dr. Jared Huling of the University of Minnesota will present “Results From the COVID-OUT Trial, a Phase-3 Trial of Outpatient Treatment for COVID-19 Using Metformin, Ivermectin, and Fluvoxamine.”.

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Trials Clinical Trials Clinical Trials Clinical Research 100

Pharmaceutical Technology

JULY 6, 2022

Business optimism improved in June 2022 compared to May 2022, even amid concerns over rising costs and slowing demand, revealed an analysis of an ongoing poll by Verdict. Verdict has been conducting the poll to study the trends in business optimism during COVID-19 as reflected by the views of companies on their future growth prospects amid the pandemic.

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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.

Clinical Supply

XTalks

JULY 6, 2022

Plant-based e-commerce platform PlantX recently announced a partnership with ice cream brand Dream Pops at its multi-brand pop-up retail initiative in Venice Beach, California. The Pop-up Initiative was launched in April following the successful pilot tenancy program promoting PlantX’s partner brands and now welcomes new brand partners on a two-to-three-month rotational basis.

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Branding Cosmetics Production Marketing 105

pharmaphorum

JULY 6, 2022

The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December. The first-in-class drug – which targets CD20 and CD3 – is being assessed by the regulator for relapsed or refractory FL, the most common slow-growing form of non-Hodgkin lymphoma (NHL), after two or more prior systemic therapies.

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Drugs Antibody Trials Genetics 104

ACRP blog

JULY 6, 2022

“The time for pontification is over when it comes to improving diversity in the clinical trial population,” says Reginald Swift, PhD, founder and CEO of Rubix Life Sciences. “Underserved populations needed these therapies yesterday and the next generation requires us to step up,” he adds. While he’s a big fan of diversifying the clinical trial workforce as one way to promote diversity, Swift warns industry must also find new ways to reach out to new, potential trial participants in traditionally

Clinical Trials 101

Clinical Trials Clinical Trials Trials Life Science 101

pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a

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FDA Approval Regulation Medicine Drugs 98

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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

XTalks

JULY 6, 2022

The adoption of decentralized clinical trial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Remote trial monitoring and assessments offer significant benefits to patients and investigators alike and are thus becoming a mainstay option in clinical studies.

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Clinical Trials Clinical Trials Trials Licensing 98

pharmaphorum

JULY 6, 2022

BioNTech has responded to a patent infringement lawsuit filed by fellow German biotech CureVac over its COVID-19 vaccine, saying it will “vigorously” defend itself. CureVac revealed yesterday that had filed suit in the Düsseldorf Regional Court, claiming that mRNA technology used in BioNTech’s Comirnaty vaccine – partnered with Pfizer – infringes its intellectual property.

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Intouch Solutions

JULY 6, 2022

Cartoonist, author, Stanford lecturer, TED presenter, marketer, and cartoonist Tom Fishburne recently spoke to a group at EVERSANA INTOUCH with expertise drawn (pun intended) from his 20-year career as a marketer for brands including HotelTonight, Method Products, Nestle, and General Mills, and his decade-plus of full-time content marketing with his agency Marketoonist.

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Marketing Branding Production Development 98

BioSpace

JULY 6, 2022

Lysogene's Phase II/III trial assessing LYS-SAF302 for the treatment of MPS IIIA, also known as Sanfilippo syndrome type A, revealed positive biomarker data, spurring hope for a potential treatment.

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Gene Therapy Gene Trials 98

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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.

Clinical Supply

Scienmag

JULY 6, 2022

European Molecular Biology Organization (EMBO), an international organisation of more than 1900 life scientists helping to build a European research environment where scientists can achieve their best work, has announced today that it will award the lifetime honour of EMBO Membership to Raquel Oliveira and Carlos Ribeiro in recognition of their outstanding achievements in the […].

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Scientist Research 94

BioSpace

JULY 6, 2022

???????CytomX Therapeutics is discontinuing enrollment in two arms of its three-arm Phase II study of praluzatamab ravtansine in patients with triple-negative breast cancer.

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Scienmag

JULY 6, 2022

A research group of Professor Makoto Tsubota and Specially Appointed Assistant Professor Satoshi Yui, both from the Graduate School of Science and the Nambu Yoichiro Institute of Theoretical and Experimental Physics, Osaka Metropolitan University, in cooperation with their colleagues from Florida State University and Keio University, conducted a systematic numerical study of vortex diffusion in […].

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Research 92

BioSpace

JULY 6, 2022

Portage Biotech announced Wednesday that it has inked an acquisition agreement with New York-based Tarus Therapeutics, adding four new candidates to its pipeline.

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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.

Clinical Trials

Drug Channels

JULY 6, 2022

The boom in copay accumulators and maximizers has radically shifted payers’ views on manufacturers’ copay support programs for specialty drugs. Below, I review a new survey of commercial plan sponsors and contrast the findings to a comparable survey from 2018. As you will see, plan sponsors now perceive manufacturers’ patient assistance programs primarily as a source of funding for their own plans.

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Manufacturing Drugs 93

BioSpace

JULY 6, 2022

Researchers from Osaka University have released details on how they discovered a unique, albeit strange, potential treatment method for cancer - parasitic worms.

Research 101

Research 101

Scienmag

JULY 6, 2022

The thousands of cells in a biological sample are all different and can be analyzed individually, cell by cell. Based on their gene activity, they can be sorted into clusters. But which genes are particularly characteristic of a given cluster, i.e. what are its “marker genes”? A new statistical method called Association Plot facilitates the […].

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Gene Gene Marker 90

BioSpace

JULY 6, 2022

BioSpace caught up with Roland and Ben Buelow of Ancora, and Lightspeed Venture Partners' Galym Imanbayev to talk about the AstraZeneca deal and the company's unique business model.

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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