The U.S. Court of Appeals for the Federal Circuit didn’t change a thing in a trio of rulings stemming from Eli Lilly and Co.’s inter partes review challenges of several patents protecting Teva Pharmaceutical Industries Ltd.’s migraine drug, Ajovy (fremanezumab).
The European Commission (EC) is investigating whether Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, illegally delayed the launch and uptake of competitors to its blockbuster multiple sclerosis (MS) drug, Copaxone (glatiramer acetate).
The latest global regulatory news, changes and updates affecting biopharma, including: HIV trial networks streamlined; Grants to advance use of RWD, RWE; GAO, National Academies, report on AI in health care; ICER not sold on roxadustat; Teva, Cephalon latest EC targets; Hungary looks to Russian vaccine.
The latest global regulatory news, changes and updates affecting biopharma, including: Retiring lawmakers urge 340B modernization; How human are ‘human antibodies’?; ANDA suitability MAPP updated; MHRA: Drug interactions possible with COVID-19.
Attributing recent reductions in certain U.S. prescription drug prices to intense congressional scrutiny rather than a biopharma industry commitment to affordability, Rep. John Sarbanes (D-Md.) said Congress must put more guardrails in place and restructure how the industry does business.
Rather than the in-your-face, blame-and-shame show that was expected, the Sept. 30 drug pricing hearing before the U.S. House Oversight Committee was more a reminder of the policy differences between Democrats and Republicans on how best to make prescription drugs more affordable.
The FDA’s bright line between orphan designation and exclusivity was erased, again, Monday for some drugs when the U.S. Court of Appeals for the District of Columbia denied the agency an en banc rehearing of Eagle Pharmaceuticals Inc. v. Alex Azar.
HONG KONG – Tel Aviv-based Teva Pharmaceutical Industries Ltd. has inked an exclusive strategic agreement with Reykjavik, Iceland-based Alvotech hf to commercialize five biosimilar product candidates in the U.S.
HONG KONG – Tel Aviv-based Teva Pharmaceutical Industries Ltd. has inked an exclusive strategic agreement with Reykjavik, Iceland-based Alvotech hf to commercialize five biosimilar product candidates in the U.S.
