Pharma Update 7-26-21
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.
FDA Approvals in the News
Alzheimer’s Association Welcomes Revised Label for Aduhelm
The Alzheimer’s Association (@alzassociation) is pleased with the announcement that the Food and Drug Administration (FDA) has revised the prescribing label for Aduhelm™ (aducanumab). Consistent with the Alzheimer’s Association’s position, the updated label specifies the treatment should be initiated in patients in the disease stage studied in the clinical trials — people with mild cognitive impairment (MCI) or mild dementia stage of disease.
FDA Grants Priority Review for the Biologics License Application for PFIZER-BIONTECH COVID-19 Vaccine
Pfizer-BioNTech announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.
Albireo Announces FDA Approval of Bylvay™ (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
Albireo Pharma, Inc. (@AlbireoPharma), a rare liver disease company developing novel bile acid modulators, announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC).
Merck Announces U.S. FDA Approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes
Merck (@Merck), known as MSD outside the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.
Johnson & Johnson Vision Introduces Veritas Vision System Withfeatures to Address Key Unmet Needs in Cataract Surgery
Johnson & Johnson Vision (@JNJVision), a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies, announced the global availability of the VERITAS Vision System, a next-generation phacoemulsification (phaco) system designed to address three critical areas: patient safety, surgeon efficiency and comfort.
Mergers, Acquisitions, Partnerships, Collaborations
Banjo Health Inc. Announces Partnership with AscellaHealth, LLC
Banjo Health (@BanjoHealth) is excited to announce the signing of a multi-year partnership with AscellaHealth, a global specialty pharmacy and healthcare solutions company, to improve patient care by reducing Prior Authorization (PA) review times through the deployment of Banjo Health’s entire package of AI-powered PA solutions.
PharmStars™ Reveals Leading Pharma Companies as Founding Members
PharmStars, a digital-health accelerator that launched earlier this month, announces its founding pharma members: Boehringer Ingelheim, Eli Lilly and Company, Novo Nordisk, and Takeda.
Lilly Announces Acquisition of Protomer Technologies
Eli Lilly and Company (@LillyPad) announced the acquisition of Protomer Technologies (“Protomer”), a private biotech company. Protomer’s proprietary peptide- and protein-engineering platform is used to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity.
ImmPACT Bio Announces Completion of Merger with Kalthera to Progress Next-Generation CAR T Therapies for the Treatment of Cancer
ImmPACT Bio USA, Inc., a company developing novel cell therapies for treating cancer, announced its merger with Kalthera, Inc., a biotechnology company.
COVID Updates
Coronavirus (COVID-19) Update: July 20, 2021
The U.S. Food and Drug Administration announced actions taken in its ongoing response effort to the COVID-19 pandemic.
CDC Advisory Committee on Immunization Practices
COVID-19 Vaccine Safety Technical (VaST) Work Group provides an update on the latest vaccine information.
News & Noted
RxBenefits Rapidly Expands Team & Leadership Bench to Meet Growing Demand, Adds Executives in Operations and Business Development
RxBenefits (@rxbenefits), the employee benefits industry’s first and only technology-enabled pharmacy benefits optimizer (PBO), announced it has significantly expanded its employee base since the start of the year, including appointing three seasoned industry experts to its leadership team.
FDS Amplicare Awards $25,000 Grant to CPESN Minnesota
FDS Amplicare, Inc. (@FDSRx), a pharmacy software company, announced it is awarding a $25,000 grant to Community Pharmacy Enhanced Services Network (CPESN) Minnesota to help independent pharmacies prepare for opportunities to expand their provider offerings for Medicaid patients.
Amylyx Pharmaceuticals Closes $135M Series C Financing Led by Viking Global Investors to Support Late Stage Development of Lead Product Candidate AMX0035 for the Treatment of ALS
Amylyx Pharmaceuticals, Inc. (@amylyxpharma) announced the closing of an oversubscribed $135 million Series C financing, led by Viking Global Investors, to support the clinical development and potential launch plans for lead product candidate AMX0035, for the potential treatment of ALS, and further research and development in other neurodegenerative diseases.
ImmixBio Announces Confidential Submission of Draft Registration Statement for Proposed Initial Public Offering
Immix Biopharma, Inc. announced that it has confidentially submitted a draft registration statement on Form S-1 with the Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering (“IPO”) of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. The IPO is expected to commence after the SEC completes its review process, subject to market and other conditions.
Pharma and Biotech to Highly Invest in RNA Therapeutics to Expedite Research & Development across the Globe
Frost & Sullivan’s recent analysis, Global RNA Therapeutics: Technology Growth Opportunities, reveals that ribonucleic acid (RNA) therapeutics is poised to gain momentum in the next few years and can potentially be applied to a wide variety of disease interventions.
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
Cambridge Healthtech Institute (@CHI_Healthtech)
What: 13th Annual Next Generation Dx Summit
When: August 24 – 26, 2021
Where: In Person & Virtual, Grand Hyatt Washington, D.C. & Online (EDT)
Hashtag: #NGDx21
Register here.
Next Generation Dx Summit – Since 2009, the diagnostics community has united at Next Generation Dx Summit to discuss trend-setting developments, milestones, challenges and opportunities in the industry. Next Generation Dx Summit provides a venue to advance the science of diagnostics and improve the practice of medicine.
