Welcome to the seventh issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice.
Iowa Governor Kim Reynolds signed Senate File 383 into law, placing new restrictions on pharmacy benefit...more
7/1/2025
/ Children's Health Insurance Program (CHIP) ,
Constitutional Challenges ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
Medicaid ,
Medicare ,
Medicare Advantage ,
New Legislation ,
OIG ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
State and Local Government
Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and...more
6/4/2025
/ Amgen ,
Biosimilars ,
European Commission ,
FDA Approval ,
Generic Drugs ,
Korea ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Approval ,
Samsung Bioepis
This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee...more
Welcome to the third issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
3/30/2025
/ Affordable Care Act ,
Annual Reports ,
Caremark claim ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Prosecution ,
CVS ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Price Transparency ,
Proposed Rules ,
Trump Administration
Last week, we reported Celltrion’s U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar of Janssen’s STELARA® (ustekinumab). According to Celltrion, STEQEYMA® is being sold at a wholesale acquisition cost (WAC) list...more
The JP Morgan Healthcare Conference (“JPM”) “is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology...more
1/14/2025
/ Biologics ,
Biosimilars ,
Biotechnology ,
Healthcare ,
Investment ,
Investors ,
Life Sciences ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Professional Conferences
Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 -
On December 4, 2024, Duality Biologics (“DualityBio”), a clinical-stage biotech company focusing on...more
Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a Chinese hamster ovary (“CHO”)...more
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more
8/29/2024
/ Biologics ,
Biosimilars ,
BPCIA ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular
Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint (1-24-cv-00816) on July 12 against Alnylam Pharmaceutical Inc. (“Alnylam”) in the U.S. District Court for the District of Delaware, alleging incorrect inventorship of...more
Earlier this month, FDA approved Boehringer Ingelheim’s high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab). CYLTEZO was first approved in the US in...more
On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after...more
In honor of Women’s History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR or “molecular scissors”. By sharing...more
On December 19, a German court invalidated CureVac’s messenger RNA technology patent, EP 1 857 122 B1, in a lawsuit brought by CureVac against its rival BioNTech...more
According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that...more
Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint on November 13 against CureVac in the U.S. District Court for the Eastern District of Virginia, alleging incorrect inventorship of four U.S. Patents related to...more
On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA. Denosumab is indicated for bone metastasis from various forms of cancer and for the...more
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA)...more
Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences...more
As we previously reported, in December 2022, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) had completed acquisition of the global biosimilars business of its long-term partner Viatris, Inc. This week Biocon announced...more
Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter (“CRL”) for its aflibercept 8 mg BLA for the treatment of patients with wet age-related macular degeneration,...more
Last Friday, Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in...more
On March 1, Eli Lilly was the first to announce U.S. list price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less...more
This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, epithelial...more
As we previously reported, Mylan recently filed three IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept, the active ingredient in Regeneron’s Eylea...more