The US District Court for the District of Columbia handed the FDA a rare court win on Monday after Ipsen sued the agency, arguing that the FDA erred in its decision to regulate its blockbuster somatostatin agonist Somatuline Depot (lanreotide) as a drug, rather than a biologic.
DUBLIN, Ireland, and Boston MA, December 5, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce the European Commission (EC) approval of Mycapssa® in the European Union (EU) for the maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is already approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.
Ipsen (Euronext: IPN; ADR: IPSEY) announced today it will invest in a new state-of-the-art electronic autoinjector for Somatuline® Autogel® / Somatuline® Depot (lanreotide), to deliver further innovation in the class with the aim of improving administration and the injection experience for patients. The new device will be made in collaboration with Phillips-Medisize, global leaders in drug-delivery design, development and manufacturing solutions, and will be accompanied by enhanced investment in Ipsen’s Signes manufacturing site in France. This step further builds on Ipsen’s 20 years’ experience with Somatuline Autogel / Somatuline Depot, with today’s announcement marking the fourth generation of devices for its administration.
PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) published today new data from seven abstracts to be presented at the hybrid-setting 19th Annual European Neuroendocrine Tumor Society (ENETS) Conference, 10-11 March 2022, in Barcelona, Spain. Presentations include data from the PRESTO 2 and HomeLAN surveys which demonstrated patient-reported benefits when administering Somatuline® Autogel®/Somatuline® Depot (lanreotide). These include fewer patients reporting experiencing injection-site pain and high levels of injection experience satisfaction when participating in patient support programs (PSP), respectively.
Cipla yesterday said it has received approval from the US health nregulator to market the Lanreotide injection, used for the treatment of nacromegaly and gastroenteropancreatic neuroendocrine tumors, in the nAmerican market.
Cipla and its subsidiary Cipla USA Inc., have received the final approval for Lanreotide injection from the United States Food and Drug Administration (USFDA).
PARIS--(BUSINESS WIRE)--Ipsen (Euronext: IPN; ADR: IPSEY) announced today a total of 9 abstracts presenting new data with a focus in NETs.1-10 These include data from the Phase II CLARINET FORTE study and data on the use of independent administration of lanreotide autogel to be presented at the ENETS Conference, taking place virtually 25-27 February 2021.1-3
Ipsen (Euronext: IPN; ADR: IPSEY) today announced the release of first efficacy and safety data from the CLARINET FORTE study, with the abstract to be presented as a mini-oral presentation at the 2020 European Society for Medical Oncology (ESMO) Congress, taking place virtually from 19-21 September 2020. The prospective single-arm, open-label, exploratory, international Phase II study investigated the efficacy and safety of increasing the dose frequency of Somatuline® Autogel® (lanreotide) in patients with pancreatic or midgut NETs with centrally-assessed progression within the last two years while on a standard lanreotide regimen for ?24 weeks. An extension of progression-free survival (PFS) rates and encouraging disease-control rates (DCR) were recorded in both tumor types, with no new safety signals.
Increasing the dose frequency of lanreotidefrom monthly to bi-monthly achieved a progression-free survival of 8.3 months in patients with progressive midgut neuroendocrine tumors (NETs) and 5.6 months in patients with progressive pancreatic NETs
Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced the commercial launch and availability of MYCAPSSA® (octreotide) capsules in the United States for patients with acromegaly. MYCAPSSA, the first and only oral somatostatin analog (SSA), was approved by the U.S. Food and Drug Administration (FDA) on June 26, 2020 for the long-term maintenance treatment of patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide.