FDA Law Blog: Biosimilars
MARCH 18, 2025
Specifically, the Court focused on the purpose: to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications. The Court thus explained that interpreting the patent in 35 U.S.C.
Pharmacy Times
JUNE 23, 2025
From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. As of January 1, 2023, CMS has begun issuing unique J-codes to 505(b)(2) drugs dating back to 2003. “In In 2022, based upon a complaint filed by a pharmaceutical company, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said.
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Express Pharma
DECEMBER 19, 2024
Between 1935 and 2003, the world saw the introduction of 14 new classes of antibiotics. This creates little financial incentive for pharmaceutical companies to invest in antibiotic research. The role of pharmaceutical companies Pharmaceutical companies are at the forefront of combating AMR.
Pharma Mirror
OCTOBER 4, 2021
Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation. In 2003 the Human Genome Project provided the first atlas.
Express Pharma
JUNE 27, 2023
Announcing Gagandeep’s appointment, Mohammed Tawil, Regional Managing Director and Head of Human Pharma for India, Middle East, Turkey, and Africa at Boehringer Ingelheim said, “Since inception in 2003, our focus on improving patient outcomes in India remains steadfast.
pharmaphorum
NOVEMBER 18, 2020
Excellere Partners, a US-based private equity firm focused on partnering with entrepreneurs and management teams in emerging growth companies, will exit its investment in Two Labs following a four-year partnership. Two Labs helps pharmaceutical companies develop and execute customised launch strategies for products.
European Pharmaceutical Review
DECEMBER 21, 2022
“As the contribution of costs of organic chemicals used as feedstock to the operating expenditures is small, the pharmaceutical companies can spearhead and guide the transition.” Design of a Continuous Solvent Recovery System for End-to-End Integrated Continuous Manufacturing of Pharmaceuticals.
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