Big Molecule Watch

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On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure.  According to Lotus’ press release, the long-term strategic partnership gives Lotus exclusive rights to market darbepoetin alfa in Taiwan and South East Asian markets. This is the…
On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented that it had ceased and abandoned development and/or clinical trials of JHL 1101 (rituximab), JHL 1921 and JHL 1922 (dornase alfa), JHL 1149 (bevacizumab),…
On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications: Adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy; Pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy; Reducing signs and symptoms, inhibiting the progression of structural damage of…
IP Litigation Partner and BMW editor, Bill James will be part of the Pre-Suit Exchanges and the BCPIA Tango discussion panel at the Summit on Biosimilars & Innovator Biologics presented by the American Conference Institute, Sept 23 -24. To register please click here. The post Upcoming Speaking Engagement – 11th Summit On Biosimilars & Innovator Biologics appeared first on Big Molecule Watch.…
In late August, MIT announced that a group of MIT researchers led by Kripa Varanasi published a paper describing a low-cost technology for administering biological drug formulations otherwise too viscous to be injected using conventional medical syringes.  The system utilizes a syringe having an inner barrel containing viscous drug fluid and an outer barrel containing a thin coating of lubricant capable of reducing injection force by up to seven times.  In the announcement, Dr. Varanasi…
As biosimilars begin to gain traction in the U.S. pharmaceutical market, the distinct labeling requirements applicable to them are likely to affect product liability litigation in this area, raising implications that are potentially distinct from those applicable to biologics and to small-molecule, generic drugs write Products Litigation and Counseling lawyers Glenn S. Kerner, Nilda M. Isidro and IP Litigation lawyer and BMW editor, Alison Siedor. Read the For the Defense byline here.…
Samsung Bioepis announced positive results yesterday from its exploratory analyses of the Phase 3 study of its biosimilar product, AYBINTIO (bevacizumab).  The study compared AYBINTIO’s efficacy to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).  According to Vice President and Team Lead of Medical & Lifecycle Safety Seongwon Han, the results “reinforce equivalent clinical efficacy between AYBINTIO and reference bevacizumab.”  The study enrolled 665 patients, 337 of whom received…
During the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) meeting this July, the CHMP recommended the approval of two biologics and one biosimilar: GlaxoSmithKline’s Blenrep (belantamab mafodotin), for treatment of relapsed and refractory multiple myeloma Novartis’ Adakveo (crizanlizumab), for prevention of vaso-occlusive crises in patients with sickle cell disease Centus Biotherapeutics’ Equidacent (bevacizumab), for treatment of colon or rectum carcinoma; breast cancer; non-small cell lung cancer; renal cell cancer; epithelial ovarian, fallopian…
On August 25, 2020, the Association for Accessible Medicines filed a new Complaint challenging California’s Assembly Bill 824 (“AB 824”).  Enacted in October 2019 and in effect as of January 1, 2020, AB 824 imposes a presumption of anticompetitive effect on certain agreements that involve generic or biosimilar manufacturers and that resolve patent infringement claims in connection with the sale of pharmaceutical products. Specifically, Section 134002(a)(1) of the Act provides that “an agreement resolving or…
In its second quarter earnings release, Junshi Biosciences announced that its product candidate JS016 was approved to conduct a Phase 1 clinical trial in China. The trial is a randomized, double-blind, placebo-controlled study to evaluate the tolerability and safety of single-dose intravenous infusion of JS106 in healthy subjects. According to Junshi, this study is the world’s first novel coronavirus neutralizing antibody clinical trial conducted in healthy subjects, and Junshi plans to enroll a total…