Pharma Update 9-20-21
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.
— U.S. FDA (@US_FDA) September 17, 2021
Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals
FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals. Today’s action does not apply to people who are not immunocompromised.
Steps the FDA will take to ensure the safety and efficacy of these products for children
FDA released statement that they Will Follow The Science On COVID-19 Vaccines For Young Children
Epitome Risk Offers Neutralizing Antibody Test Developed for At-Home Use
Epitome Risk Solutions (@EpitomeRisk) is pleased to announce that another new analysis shows that your neutralizing antibody numbers are the key to understanding how the COVID vaccine worked for you.
Mergers, Acquisitions, Funding, IPOs, Partnerships, Collaborations
FSD Pharma Announces Definitive Agreement to Acquire Lucid Psycheceuticals
FSD Pharma Inc. (@fsdpharma), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions in legal psychedelics and medical cannabis, announced it has entered a definitive agreement to acquire 100% of the issued and outstanding shares Lucid Psycheceuticals Inc. (“Lucid”), a Canadian-based specialty psychedelic pharmaceutical company focused on the development of therapies to treat critical neurodegenerative diseases, for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock (the “Transaction”), as further described below.
AbCellera Acquires TetraGenetics, Enhancing Capabilities to Generate Antibodies Against High-Value Targets
AbCellera, a technology company with a centralized operating system for next-generation antibody discovery, announced it has acquired TetraGenetics, Inc. (TetraGenetics), a biotechnology company with a proprietary platform for generating recombinant human ion channels and other transmembrane proteins, in an all-cash transaction that includes an upfront payment, the potential for payments based on the achievement of technical milestones, and additional development and commercial milestone payments related to successfully developed therapeutics.
Roche signs definitive share purchase agreement with long-term partner TIB Molbiol to expand PCR-test portfolio in the fight against new infectious diseases
Roche announced that it has signed a definitive share purchase agreement to acquire 100% of the outstanding shares of the TIB Molbiol Group. Closing of the transaction is subject to customary conditions and is expected in the fourth quarter of 2021.
US to buy $1.4M additional doses of Regeneron’s COVID-19 therapy
Regeneron Pharmaceuticals Inc announced the US government will buy $1.4M additional doses of its COVID-19 antibody cocktail, REGEN-COV. The company, which completed its contract with the U.S. government of supplying 1.5 million doses in the second quarter, said it would supply the additional doses by Jan. 31 at a cost of $2,100 per dose. That values the latest contract at $2.94 billion.
FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation
FDA announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level. This reorganization will advance the agency’s information technology transformation with improved data and IT competencies that improve agency operations to support the public health mission.
FDA Approvals in the News
FDA Orphan Drug Approval: Octapharma’s Octagam® 10% Receives 7 Years of Market Exclusivity for Adult Dermatomyositis
Octapharma USA announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has awarded seven years of marketing exclusivity for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis (DM).
Intelivation Technologies received FDA approval for the Advantage-C™ PEEK Cervical Interbody Fusion device
Intelivation Technologies, a medical device company with a growing product portfolio announced that they have achieved FDA 510(k) Clearance of the Advantage-C™ PEEK Cervical Interbody Fusion device.
News & Noted
INTEGRA Automated ASSIST PLUS Pipetting Solutions Assist Antibiotic Development
INTEGRA (@INTEGRApipette) is aiding scientists in the vital task of tackling antibiotic resistance by providing the liquid handling tools to help increase throughput and reproducibility in drug development workflows. The company’s ASSIST PLUS pipetting robot, and VIAFLO 96, VIAFLO 384 and MINI 96 handheld electronic pipettes, meet the needs of early phase drug discovery by offering high throughput processing of routine pipetting tasks – such as serial dilutions and plate inoculation – without compromising on precision and reproducibility.
ESMO 2021: An enhanced virtual experience
September 16 – 21: The ESMO Congress is the most influential oncology platform designed in Europe for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. Follow #ESMO21
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.