Pharma Update 6-28-21
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.
Policy
Biden Administration Recommends Policy Changes to Secure U.S. Pharmaceutical Supply Chain
The White House, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the U.S. Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains. Led by FDA and ASPR, the White House report and its recommendations have been accepted by President Biden.
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry
June 2021 FDA issues final guidance intended to aid trading partners3,4 (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined at section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21)) and terminating notifications.
Product Identifiers under the Drug Supply Chain Security Act – Questions and Answers
June 2021 FDA issues final guidance intended to address anticipated questions regarding product identifiers that are required under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), for packages and homogenous cases of certain drug products. , , , Section 582(b)(2) and (e)(2) require manufacturers and repackagers, respectively, to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction in(to) commerce beginning November 27, 2017, and November 27, 2018, respectively.
FDA Approvals in the News
Alzheimer’s Association Welcomes FDA Approval of Aducanumab
On behalf of those impacted by Alzheimer’s disease, the Alzheimer’s Association (@alzassociation) enthusiastically welcomes the historic FDA approval of aducanumab (Biogen/Eisai) for treatment of Alzheimer’s disease.
Lilly to seek accelerated FDA approval for Alzheimer’s drug this year
Eli Lilly and Co (@LillyPad) said it will seek accelerated approval from the U.S. health regulator this year for its Alzheimer’s candidate, weeks after a rival drug from Biogen Inc won the agency’s endorsement using the same regulatory pathway.
Mergers & Acquisitions
FTC Announces Multilateral Working Group to Build a New Approach to Pharmaceutical Mergers
Agency joins forces with Canadian Competition Bureau, European Commission Directorate General for Competition, United Kingdom’s Competition and Markets Authority, U.S. Department of Justice, and Offices of State Attorneys General.
Algorics Announces Acquisition Of Domain Clinical Data Sciences
Algorics (@Algorics), a provider of biostatistics and programming solutions for the pharmaceutical and biotechnology industry, announced the acquisition of Domain Clinical Data Sciences “DCDS”, a clinical data services organisation based in India.
COVID Updates
Affinity Empowering Launches “Operation Expanded Testing” on Behalf of Clinical Enterprise, Inc., in Agreement with U.S. Government to Increase COVID-19 Testing
Affinity Empowering, Inc., a provider of the most sophisticated and secure occupational, behavioral, and direct-to-consumer health services, announced the launch of Operation Expanded Testing, a program to increase COVID-19 testing capabilities throughout congregate settings including K-8 schools and summer school programs, correctional facilities, homeless shelters, and select, non-profit community centers.
GetMyDNA Receives EUA for Retail and Bulk Purchase of COVID-19 Test Home Collection Kit
As summer travel ramps up and employees return to work, COVID-19 testing and reporting just got easier with GetMyDNA’s (@get_my_dna) DTC test kit, which is now available not only online, but also for bulk orders and retail purchase. GetMyDNA’s easy to read report is delivered the same day the lab receives the sample 99% of the time, providing the perfect solution for fast, reliable gold standard PCR COVID-19 testing. All samples are processed in CLIA Certified and CAP Accredited full-service laboratory, Gravity Diagnostics.
News & Noted
Pandemic proves importance of pharmaceutical innovation
From The Hill – If there is one big lesson learned from the COVID pandemic, it is the importance of innovation in this country. We have seen clothing manufacturers making face masks, alcohol producers making hand sanitizer and companies like GM manufacturing ventilators. All of which are examples of American ingenuity in the face of crisis. But there is another example that is undeserving of the bad rep it sometimes receives — pharmaceutical innovation.
DCAT Week 2021 to take on industry education, innovation
From Outsourcing-Pharma.com – The annual event (scheduled July 12-16 online) will feature educational sessions, presentations, and networking opportunities for drug manufacturing pros.
The annual Drug, Chemical, and Associated Technologies Association gathering, known more familiarly as DCAT Week, will take place online realm (rather than its traditional home of New York City) July 12-16. While the virtual venue might be new, the opportunity for industry professionals to gather and share ideas and innovations is once again on the table.
Paying For Revolutionary New Drug Therapies Is A Good Problem To Have
From Forbes – We are in the midst of an incredible transformation of American medicine away from merely managing chronic illnesses and towards a new generation of drugs that actually cure formerly fatal diseases. This reality may constitute the most important development in society this century.
Thousands of Jobs in Pharma, Biotech, Clinical Research, Life Sciences, Medical Devices in Europe and Australia – Upload Your CV Now! https://t.co/DeLT1krXJg#jobs #hiringnow, #pharmajobs #clinicalresearchjobs #biotechjobs #pharmiweb pic.twitter.com/r6eaWWNwTD
— Pharma News (@pharminews) June 27, 2021
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.
