Pharma Update 12-20-21
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.
Mergers, Acquisitions, Funding, IPOs, Partnerships, Collaborations
BioSapien Closes $1.8M Seed Round Led by SOSV & Hikma Ventures
BioSapien (@BioSapienInc), a biotech company has announced it has raised $1.8M in seed round funding led by global venture capital investor SOSV. Co-investors in the round include Hikma Ventures, Microventures, Infinity Capital Ventures, JPIN VCATS, Side Door Ventures, and other high-net worth angels and investors (Additional investors listed below*).
Pfizer to Acquire Arena Pharmaceuticals
Pfizer Inc. (@pfizer) and Arena Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Pfizer will acquire Arena Pharmaceuticals, Inc., a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases.
COVID Updates
Here are several actions we’ve taken in our ongoing response to the #COVID19 pandemic. https://t.co/ev7mmpOTNZ pic.twitter.com/40XlWX4pwO
— U.S. FDA (@US_FDA) December 17, 2021
IntelyCare Sets New Industry Standard for Nurse Credentialing With Launch of Credential Passport
IntelyCare (@intelycare), a digital staffing platform for nursing professionals seeking per diem positions, announced the availability of the IntelyCare Credential Passport, a new tool that allows nurses to securely maintain and access their required documentation for credentialing in a single, easily accessible location. Touting the most rigorous credentialing process in the healthcare staffing industry, IntelyCare fully credentials staff as part of an onboarding process that requires applicants to upload their work license, Tuberculosis test, physical exam, CPR certification, COVID vaccination documentation, I-9 verification, and state-specific documents – which requires contacting a multitude of organizations to authenticate credentials.
PreciseMDX and Freedom Medical Group Partner to Provide On-Site and Remote COVID-19 Testing
PreciseMDX, a company in transformative digital health experiences, and Freedom Medical Group, a proven national service and equipment supplier, announced a strategic partnership that will provide seamless on-site and remote testing for healthcare providers, employers and event organizers. Through this collaboration, PreciseMDX will provide the digital health platform for patients to easily track and access lab results while Freedom Medical Group provides the clinical staff for organizations and enterprises to facilitate testing.
Moderna, Amgen among biotech heavyweights pulling out of JPM conference over Covid concerns
STAT reports that some of the biggest names in biotechnology, including Amgen, Moderna, and Sarepta Therapeutics, have pulled out of the upcoming J.P. Morgan Healthcare Conference in San Francisco due to safety and travel concerns related to the Covid-19 pandemic, according to people close to the companies. Additional biopharma companies are weighing whether to do the same.
FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns
FDA revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.
FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
FDA issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
GPOPlus+ Announces the Launch of AntigenTests.com, a Project of HealthGPO
GPO Plus, Inc. (@GPOPlus), a publicly traded company of diversified industry-specific Group Purchasing Organizations (GPOs), announced the official launch of AntigenTests.com, a project of HealthGPO. HealthGPO is a Group Purchasing Organization for the Healthcare industry with operations and facilities located throughout the United States.
Moderna says preliminary data show that a booster dose of its COVID-19 vaccine should offer protection against the rapidly spreading omicron variant. https://t.co/BNcKZ8ocCU
— The Associated Press (@AP) December 20, 2021
FDA Approvals in the News
Curebase Technology Key to metaMe Health’s FDA Clearance of Regulora
Curebase (@CurebaseDCT), a company committed to democratizing access to clinical studies, is pleased to have served as the technology partner for metaMe Health’s Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated with irritable bowel syndrome (IBS) in adults. Digital therapies, like Regulora, are a rapidly expanding area of healthcare that require new a new approach to clinical research.
Implicity Receives FDA Clearance for AI-Powered ECG Analyzer for Implantable Loop Recorders
Implicity (@ImplicityHealth) a company in remote patient monitoring and cardiac data management solutions, announced FDA clearance for a novel medical algorithm that analyzes ECG data from Implantable Loop Recorders (ILRs). The newly 510(k) cleared ILR ECG Analyzer is an algorithm based on artificial intelligence, representing a breakthrough innovation in the cardiology sector.
News & Noted
Solving the U.S. drug pricing crisis starts with a crucial confirmation hearing by STAT – The Senate began its confirmation hearing last week for President Biden’s nominee to head the U.S. Patent and Trademark Office (USPTO), intellectual property attorney Kathi Vidal. While this is one of the more obscure U.S. agencies, it is pivotal in influencing the U.S. health system — from global vaccine equity to the country’s drug pricing crisis.
Resources
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.
Upcoming Events
The 26th Annual ARC Industry Forum Accelerating Industrial Digital Transformation and Sustainability
What: The 26th Annual ARC Industry Forum Accelerating Industrial Digital Transformation and Sustainability
When: February 14 – 17, 2021
Where: Renaissance Orlando at SeaWorld
Register here.
Your mandate is transformation. The target is much better business outcomes. Join us at the 26th Annual ARC Industry Forum to speed up your progress with strategies and stories from the digital front lines.
