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WilmerHale
Pessimism surrounding the Federal Reserve's interest rate hikes, combined with subdued business and consumer confidence as well as geopolitical concerns...
Jones Day
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with several notable changes.
Exponent
Agency recommends methods for virus detection and clearance for biotechnology manufacturers and products derived from animal or human cell lines...
Exponent
Food and Drug Administration draft guidance for metallic and calcium phosphate coatings on orthopedic devices is now open for comments...
Goodwin Procter LLP
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....
Goodwin Procter LLP
Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.
Goodwin Procter LLP
As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. ("Regeneron") filed a motion seeking to establish a multi-district litigation ("MDL")...
Fenwick
The BIOSECURE Act would prevent companies from using government contracts, grants, or loans to procure certain Chinese technology.
Exponent
Food and Drug Administration's proposal will classify pre-amendment wound dressings and wound washes as Class II or III devices...
Hyman, Phelps, & McNamara
FDA recently issued a draft guidance, Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (link), which describes information...
Venable LLP
On March 13, 2024, Merck Sharp & Dohme, LLC ("Merck") filed four additional IPRs challenging The Johns Hopkins University ("JHU") patents covering methods of treatment using pembrolizumab...
Exponent
New draft guidance describes factors for determining when evidence generated from real-world data may be used to support FDA decisions on medical devices .
Exponent
A series of town halls will support the medical device industry by sharing the current sterilization landscape, including alternatives to ethylene oxide.
Crowley Law LLC
Great news for prevention of respiratory syncytial virus ("RSV") infections! Here's a quick summary of the article...
Fenwick
As antitrust regulators more aggressively wade into M&A transactions, breakup fees have become a valuable tool for allocating risk.
Lowenstein Sandler
The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology...
Goodwin Procter LLP
Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria...
Duane Morris LLP
On January 31, 2024, the U.S. Food and Drug Administration issued a final rule that will promote consistency in the regulation of medical devices and will harmonize the regulatory framework ...
J A Kemp LLP
In attempting to reduce both the causes and effects of climate change, innovation and technology are frequently held up as solutions which may allow us to keep pace...
Goodwin Procter LLP
On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis...
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