Pharmaceutical Technology

JANUARY 8, 2023

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Approaches like bronchodilator inhalers focus on treating both asthma and chronic obstructive pulmonary disease (COPD).

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NPR Health - Shots

JANUARY 8, 2023

The public school district in Seattle has filed a novel lawsuit against TikTok, Instagram, Facebook, YouTube and Snapchat, seeking to hold them accountable for a mental health crisis among youth.

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pharmaphorum

JANUARY 8, 2023

Before the main event at JP Morgan 2023 even kicks off, we’re checking out the Sachs Associates Neuroscience Innovation Forum on Sunday. Speakers from Lilly, Boehringer Ingelheim, Takeda, and many more pharma firms big and small will present on key trends and developments in one of the most exciting areas of pharmaceutical and digital innovation. We’ll also wander over to the UC Davis Health Future & Health CEO Summit a little later this afternoon.

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Development 118

NPR Health - Shots

JANUARY 8, 2023

Photographer Lori Grinker struggled to get along with her mother all of her life. When she moved in with her to help with her failing health, old wounds melted away.

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Nurses 132

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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

Medical Xpress

JANUARY 8, 2023

There is no better time than the start of the New Year to adopt some wellness resolutions. The first thing you can start doing today to boost your immunity and improve your wellness in 2023? Save money and ditch the multivitamins.

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STAT News

JANUARY 8, 2023

Day One Biopharmaceuticals said Sunday that a targeted therapy shrank tumors by at least 50% in a majority of children with the most common form of pediatric brain cancer, setting up a potential approval in a rare disease long overlooked by drugmakers.  The new data expand on earlier results released last year from 22 patients. Of the 69 pediatric low-grade glioma patients now evaluated, 44, or 64%, saw their tumors dwindle to less than half their original size, including three patients who

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Drugs 105

STAT News

JANUARY 8, 2023

Hospitals, health insurers, and other provider-related companies are returning in person to the J.P. Morgan Healthcare Conference for the first time since the coronavirus upended the health care economy. But the more things have changed since then, the more they have stayed the same. Health care gobbled up 18.3% of the U.S. economy by the end of 2021, according to the latest data from federal actuaries.

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Medical Xpress

JANUARY 8, 2023

Patients might be happier with their care when their physician trained with the specialist they're referred to, a new study suggests.

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Doctors Doctor 105

STAT News

JANUARY 8, 2023

For years, BioMarin CEO Jean-Jacques “J.J.” Bienaime has been saying that Roctavian — the company’s gene therapy to treat hemophilia A — could be the biggest product the biotech firm has ever launched. Based on a meeting with STAT Sunday, his hopes don’t seem to have dimmed a bit despite the regulatory delays the product has faced in the U.S.

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Medical Xpress

JANUARY 8, 2023

A new Alzheimer's drug is hitting the market—the first with clear-cut evidence that it can slow, by several months, the mind-robbing disease.

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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

STAT News

JANUARY 8, 2023

SAN FRANCISCO — What should be a triumphant return to the global biotech industry’s biggest annual event, “JPM Week,” after a two-year hiatus is turning as gloomy as Bay Area weather, with industry executives forecasting economic troubles in the year ahead. STAT asked more than 100 biotech and pharma executives, investors, and other insiders how they’re feeling about the state of the sector heading into 2023 and on the eve of the J.P.

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Medical Xpress

JANUARY 8, 2023

Having a "dry January," or giving up alcohol for the first month of the year, is a trend.

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NPR Health - Shots

JANUARY 8, 2023

Dr. Paradi Mirmirani tells us about COVID-19 and hair loss, and NPR's Ayesha Rascoe speaks to hair stylist Rebecca Haehnle about what people can do to style thinning hair.

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JAMA Internal Medicine

JANUARY 8, 2023

This case report describes a patient in their 50s with hypertension, chronic obstructive pulmonary disease, heavy alcohol use, and tobacco use who presented to the emergency department with a 2-month history of nausea and vomiting.

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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

NPR Health - Shots

JANUARY 8, 2023

NPR's Ayesha Rascoe speaks to Child Trends researcher Jennifer Manlove about the significant decline in teenage pregnancies in the United States.

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Research 79

JAMA Internal Medicine

JANUARY 8, 2023

This cohort study assesses the association of adherence to 4 healthy eating scores with total and cause-specific mortality among women from the Nurses’ Health Study and men from the Health Professionals Follow-Up Study.

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Nurses 76

NPR Health - Shots

JANUARY 8, 2023

The Respiratory Syncytial Virus - or RSV - surge has peaked, and the flu appears to be receding. But COVID rates are up again, driven by holiday gatherings and an even more transmissible variant.

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BioSpace

JANUARY 8, 2023

Under a consent order agreement announced Friday, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, allaying the FTC’s primary concerns.

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Production 52

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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

NPR Health - Shots

JANUARY 8, 2023

Popular tourist sites around the world are preparing for a surge in Chinese tourists now that China has loosened its COVID-related border restrictions.

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BioSpace

JANUARY 8, 2023

The vaccine was effective against previous COVID-19 variants but lacked efficacy against new ones, the company announced Thursday, leaving the booster no commercially viable options.

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Drug Patent Watch

JANUARY 8, 2023

Annual Drug Patent Expirations for OZURDEX Ozurdex is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are seven patents protecting…. The post New patent expiration for Allergan drug OZURDEX appeared first on DrugPatentWatch - Make Better Decisions.

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BioSpace

JANUARY 8, 2023

The antibody-drug conjugate will be pitted against chemotherapy in a heavily treated breast cancer subpopulation, with hopes of challenging AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu.

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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

Drug Patent Watch

JANUARY 8, 2023

This chart shows the drugs with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long…. The post Which drugs have the most supplementary protection certificates? appeared first on DrugPatentWatch - Make Better Decisions.

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BioSpace

JANUARY 8, 2023

After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.

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FDA Law Blog

JANUARY 8, 2023

By Larry K. Houck — In October, when pardoning those federally convicted of cannabis possession, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” See President Biden Gives the Green Light for Significant Marijuana Reform, October 10, 2022.

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BioSpace

JANUARY 8, 2023

$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject Medicare price negotiations; Sage Therapeutics axes 40% of staff.

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Drugs 40

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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 Patent Watch

JANUARY 8, 2023

Brimonidine tartrate is the generic ingredient in nine branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Akorn, Apotex, Bausch And Lomb, Indoco, Sandoz Inc, Somerset Theraps Llc, Teva…. The post New tentative approval for Slayback Pharma drug brimonidine tartrate appeared first on DrugPatentWatch - Make Better Decisions.

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BioSpace

JANUARY 8, 2023

Two Democratic senators on Thursday sent a letter to the companies’ CEOs informing them that they have until Sept. 15 to disclose the application processes for their insulin assistance programs.

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