Pharma Update 10-25-21
According to Statusta, by year end 2020, the total global pharmaceutical market was valued at about $1.27 trillion. A significant increase from 2001 when it was valued at $390 billion. The pharmaceutical market plays a key role in how people get medications and what people pay for medication. At the intersection of healthcare, pharma, and technology, here are current news and announcements.
Today, we took action to expand the use of a booster dose for #COVID19 vaccines in eligible populations. We’re amending the EUAs for the vaccines to allow for the use of a single booster dose: ⬇️ ⬇️ https://t.co/IIp42eOkJ7 pic.twitter.com/U3c1z3ZWRF
— U.S. FDA (@US_FDA) October 20, 2021
Many unvaccinated people are not opposed to getting a shot. The challenge is trying to get it to them.
The Washington Post reports that Barriers to getting the shot and information about the vaccines have hindered the “unvaccinated but willing,” who account for approximately 10 percent of the American population, according to a report last month by the Department of Health and Human Services.
Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
The FDA took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose.
FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment
FDA is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.
Major FDA authorization: This will allow for significant expansion in availability of rapid, easy to use at home tests for Covid. Supply ready to go. These authorizations represent a major new policy effort by FDA to make tests for infectious disease accessible for consumer use. https://t.co/vdApj1D3G2
— Scott Gottlieb, MD (@ScottGottliebMD) October 5, 2021
Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that Merck has submitted an Emergency Use Authorization (EUA) application to FDA for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
Mergers, Acquisitions, Funding, IPOs, Partnerships, Collaborations
VisualDx Announces Collaboration with Janssen to Pilot New API and Bring Equitable AI to the Point of Care
VisualDx (@visualdx), a company in web-based clinical decision support (CDS), announced that it has entered into an agreement with Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson. Through this collaboration, the Research & Development data science team at Janssen will leverage the VisualDx application programming interface (API) as a beta partner and the new interface will enable provider organization and other healthcare technology companies to bring VisualDx’s industry-defining CDS into third-party applications to enhance diagnostic accuracy and improve health outcomes, particularly for traditionally marginalized patient populations. This agreement was facilitated by Johnson & Johnson Innovation.
Artificial Intelligence in Pharma Market Set for Explosive Growth
The global Artificial Intelligence (AI) in pharma market reached a value of nearly $699.3 million in 2020, having increased at a Compound Annual Growth Rate (CAGR) of 31.8 per cent since 2015, according to the recent report from The Business Research Company. The market is expected to grow from $699.3 million in 2020 to $2,895.5 million in 2025 and reach $9,142.7 million in 2030.
Supernus Pharmaceuticals to Acquire Adamas Pharmaceuticals Strengthening its CNS Product Portfolio
Supernus Pharmaceuticals, Inc. and Adamas Pharmaceuticals, Inc., announced a definitive agreement for Supernus to acquire Adamas through a tender offer for $8.10 per share in cash (or an aggregate of approximately $400 million), payable at closing plus two non-tradable contingent value rights (CVR) collectively worth up to $1.00 per share in cash (or an aggregate of approximately $50 million), for a total consideration of $9.10 per share in cash (or an aggregate of approximately $450 million).
FDA Approvals in the News
FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
FDA approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.
News & Noted
AI in pharma market set for explosive growth: Report
Express Pharma reports that the use of artificial intelligence is growing rapidly in the pharma industry and is being driven by the complex drug development process. AI can help pharmaceutical companies improve clinical trials, enable predictive power in the research and development process, and elevate manufacturing.
Quris Closes Critical Drug Development Gaps With New Clinical Prediction AI Platform
Quris, an artificial intelligence (AI) innovator disrupting the pharmaceutical arena, launched the first clinical prediction AI platform to predict which drug candidates will safely work in humans – dramatically improving efficacy and cutting drug development costs.
Comprehensive Medication Management Proves Its Value By Karen Blum, Pharmacy Practice News – CMM is a patient-centered approach to optimizing medication use and improving patient health outcomes that is delivered by a clinical pharmacist working in collaboration with the patient and other care providers. It is much more comprehensive than medication reconciliation, said McKenzie Robillard, PharmD, BCACP, the director of clinical pharmacy for Community Care Physicians in Latham, N.Y.
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
- Approvals of FDA-Regulated Products
- Consumer Updates
- Drug Supply Chain Security Act (DSCSA)
Who We Read
GTMRx Institute’s Blog
BARDA Industry Day is our annual conference, held to increase awareness of U.S. government medical countermeasure priorities, interact with BARDA and ASPR staff, and network with public and private sector colleagues working in the health security space. During BARDA Industry Day 2020, the one-day virtual event attracted 1300+ attendees, featured BARDA program goals and funding updates, expert presentations from government and industry partners, 13 interactive breakout sessions, and two Lightning Talk sessions showcasing 20 exciting technologies.