Fri.Mar 24, 2023

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GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial

Fierce Pharma

GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial fkansteiner Fri, 03/24/2023 - 10:05

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AI Is at the Intersection of Safety and Equity in Healthcare

MedCity News

Hidden biases, reduced privacy, and over-reliance on non-transparent, decision-making black boxes can cut against democratic values, potentially putting our civil rights at risk. This means that the effective and equitable use of AI will be based on solving inherent ethical, safety, data privacy and cybersecurity challenges.

Safety 132
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Sanofi, Regeneron's Dupixent could hit $20B in peak sales with COPD expansion: analyst

Fierce Pharma

Sanofi, Regeneron's Dupixent could hit $20B in peak sales with COPD expansion: analyst kdunleavy Fri, 03/24/2023 - 07:30

Sales 274
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SXSW 2023: Moving from NFTs to LSD

PM360

Technology evolves fast. Nothing illustrates that better than attending SXSW each year and noticing how much has changed in just 12 months. In 2022, SXSW was all NFTs and metaverse activations and events, and in 2023 they weren’t anywhere to be found. But a lot was shared at this year’s SXSW that had staying power. In place of NFTs, psychedelics were given their own conference track this year.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Brii Bio shelves once-promising COVID antibody combo that stood up to variants

Fierce Pharma

Brii Bio shelves once-promising COVID antibody combo that stood up to variants kdunleavy Fri, 03/24/2023 - 10:07

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Time to pay Daniel O'Day: Gilead chief nabbed nearly $22M after strong showings in HIV, cancer

Fierce Pharma

Time to pay Daniel O'Day: Gilead chief nabbed nearly $22M after strong showings in HIV, cancer fkansteiner Fri, 03/24/2023 - 08:56

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Caregivers Face Financial and Mental Burdens, New Survey Shows

MedCity News

About 28% of Americans consider themselves to be caregivers, and 22% are unpaid, according to a new survey from CVS Health and Harris Poll. These caregivers are facing financial and mental health struggles: 47% said that being a caregiver is a financial burden and 49% said their mental health suffers from being a caregiver.

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With rejection for slow-release Jakafi, FDA sends shockwaves across Incyte's pipeline: analyst

Fierce Pharma

With rejection for slow-release Jakafi, FDA sends shockwaves across Incyte's pipeline: analyst aliu Fri, 03/24/2023 - 10:04

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Cancer Patient-Support Program Uptake is Low: Here’s How to Change That

PM360

Cancer-support programs provide vital assistance to patients and their caregivers as they face one of the toughest times of their lives. Yet while patients are interested in these programs, new survey data suggests they aren’t taking advantage of them. Results from 825 patients diagnosed with or treated for cancer who were surveyed on Phreesia’s PatientInsights platform as they checked in for their doctors’ appointments revealed that few cancer patients are accessing the support resources availa

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Biotech Financing Roundup: Mbiomics, Flare Therapeutics, EpiBiologics & More

MedCity News

Flare Therapeutics, EpiBiologics, and Mbiomics are among the biotech companies that recently unveiled new rounds of financing.

Biopharma 108
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4 Steps to Create an Inclusive Workplace by Overcoming Personal Biases

PM360

Unacknowledged personal biases in the workplace can quickly spiral, leaving employees feeling alienated and disengaged. This has far-reaching implications that can also influence external brand experiences with target stakeholders. In the healthcare industry, this is especially concerning as it can contribute to health disparities and impact progress toward health equity : better health and well-being for all.

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Celebrating Women in Health Care Starts with Reimagining your Workforce

MedCity News

These are challenging times for health care, and particularly for women in health care.

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How to Stay Compliant with State Drug Price Transparency Reporting

PM360

Drug price transparency (DPT) laws have been in effect in several states for a few years now. Starting with Vermont in 2016, more than half of the U.S. states are now collecting pricing data from manufacturers in the hopes it will assist in creating effective policies to reduce drug prices for their constituents. The question of whether this goal will be realized or not remains unanswered for now.

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from OUI Medical, Vital, Cognito Therapeutics and Reveal HealthTech.

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A Firsthand Perspective of Pharma’s Failures with DE&I

PM360

Let’s talk digital transformation! In January, I started my series by identifying five key components of a successful digital transformation. We covered the first one by looking at Organizational Structures , today, let’s dive into the second which is the toughest, not just for pharma, but for the entire country: Diversity, Equity, and Inclusion (DE&I).

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Developing novel therapies for NASH

European Pharmaceutical Review

Following the recent announcement of topline results from 89bio’s Phase IIb trial, ENLIVEN, evaluating FGF21 analogue pegozafermin for nonalcoholic steatohepatitis (NASH), a serious liver condition, EPR spoke with Dr Hank Mansbach, the company’s Chief Medical Officer. NASH currently has no approved treatments. Caused by excess fat, it is referred to as the ‘silent killer’, as most affected individuals don’t exhibit symptoms until liver damage has already occurred.

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Making an Impact During Disease Awareness Days, Weeks, and Months

PM360

Pharma marketers often turn to disease awareness days, weeks, and months to inform campaigns as they strategize for the year ahead. With the sheer number of official awareness days out there, it’s no wonder they’ve become a pillar to a marketer’s early plan development. To the pharma marketing industry, these days and months present a clear opportunity to shed light on a particular condition or therapeutic area.

Pharma 92
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First mild asthma combination reliever approved in UK

European Pharmaceutical Review

AstraZeneca has announced the first and only dual-combination inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA) treatment for mild asthma has been approved in the UK. The marketing authorisation has been given to budesonide/formoterol (Symbicort Turbohaler 200/6) as a reliever therapy for patients over 12 years old. The combination therapy, delivered as a formulation in a single inhaler contains b udesonide, an inhaled corticosteroid (ICS) and f ormoterol, a long-acting beta2-agoni

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At London Book Fair, Spotlight on Ukraine

Copyright Clearance Center

The post At London Book Fair, Spotlight on Ukraine appeared first on Copyright Clearance Center.

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EMA publishes mid-point regulatory science strategy report

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a report summarising the mid-point achievements of its Regulatory Science Strategy (RSS) to 2025. Initially published in March 2020, the strategy provides a plan for advancing regulatory science over a five-year period. Regulatory science refers to the scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products.

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What would you fix with a ‘magic wand’? Pharma leaders chime in about clinical trials

PharmaVoice

How life science execs would transform clinical trials with a little hocus pocus.

Pharma 98
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Pharma Fix: The quest for the next tuberculosis vaccine

Pharmaceutical Technology

Since the first human administration of the Bacillus Calmette-Guérin vaccine in 1921, no one has been able to successfully follow the vaccine’s path to become the next approved vaccine to tackle tuberculosis (TB). However, as the TB-related death toll remains high, the global need for another vaccine is steadily rising. TB is caused by the bacillus Mycobacterium tuberculosis and is transmitted when infected individuals expel bacteria into the air (e.g., by coughing).

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PAP 2023: A Summary of Unparalleled Strategies to Drive Access and Affordability

Pharmaceutical Commerce

Pharma Commerce offers a synopsis of some of the conference’s events.

Pharma 96
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Comparison of Humira biosimilars in the US and Europe

Pharmaceutical Technology

Biosimilars for AbbVie’s (US) Humira (adalimumab) have finally launched in the US, bringing an end to Humira’s 20-year reign as the best-selling biologic of all time. Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board. Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year.

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Oncology Market Trends to Watch Out For in 2023

Medico Reach

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. As a result, a global approach to healthcare has emerged continually over the years. Even for cancers that are difficult to treat, new treatments and technologies improve patient survival rates. Hence, new oncology market trends will set in as doctors and pharmaceutical companies work towards individualized treatment decisions.

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Macomics signs collaboration deal with Ono Pharmaceutical

Pharma Leaders

Macomics and Ono Pharmaceutical have entered into a global collaboration deal for the discovery and development of macrophage-targeting antibody therapy for cancer. Under the deal terms, Macomics will be responsible for identifying and characterising the antibody candidates against a new target leveraging its Enigmac macrophage drug discovery platform.

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Oncology Market Trends to Watch Out For in 2023

Medico Reach

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. As a result, a global approach to healthcare has emerged continually over the years. Even for cancers that are difficult to treat, new treatments and technologies improve patient survival rates. Hence, new oncology market trends will set in as doctors and pharmaceutical companies work towards individualized treatment decisions.

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Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

Legacy MEDSearch

Ancora Heart, Inc., a company developing a completely transcatheter device-based therapy to address heart failure (HF), announced that patients treated with the investigational AccuCinch ® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart. The 12-month data were presented as part of a late-breaking clinical science session at the Technology and Heart Failure Therapeutics conference (THT 2023) and simultaneously pu

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China’s NMPA grants conditional approval for AstraZeneca’s Calquence

Pharmaceutical Technology

China’s National Medical Products Administration (NMPA) has granted conditional approval for AstraZeneca ’s Calquence (acalabrutinib) to treat mantle cell lymphoma (MCL) in adult patients who have previously received a minimum of one therapy. The regulatory approval marks the first approved indication for Calquence in the country. It is a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor which binds covalently to BTK, and then inhibits its activity.

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2023 PM Society Awards – Winners Announced

PharmaTimes

21GRAMS takes four Golds plus Best in Show AstraZeneca tops the pharma leader board

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Moderna and Generation Bio partner for genetic medicines development

Pharmaceutical Technology

Moderna has entered a strategic partnership with Generation Bio for the development of non-viral genetic medicines. Moderna’s biological and technical expertise will be combined with core technologies of the non-viral genetic medicine platform from Generation Bio. The collaboration aims to expand each company’s platform application through the development of new nucleic acid therapeutics, and to expedite their respective non-viral genetic medicines pipelines.

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EVERSANA® Announces Partnership with ChemoMouthpiece, LLC

PharmExec

The partnership was sealed to support U.S. launch & commercialization of a medical device to help cancer patients manage and treat oral mucositis.

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Takeda set to build $764m manufacturing facility in Japan

Pharmaceutical Technology

Takeda has unveiled plans to invest almost $764m (JPY100bn) to construct a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan. The new facility represents the company’s largest-ever investment in the expansion of manufacturing capacity in the country. It is expected to become the largest facility in Japan and to increase the company’s current plasma manufacturing site capacity in Narita almost five-fold.