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Wednesday, December 4, 2019

Dr. Reddy’s launches bortezomib for injection in U.S.

Dr. Reddy’s Laboratories (NYSE:RDY) has launched Bortezomib for Injection 3.5 mg/vial, approved by the FDA for intravenous use only. It is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
The branded version is Takeda Pharmaceutical’s (NYSE:TAK) Velcade, administered IV and subcutaneously.
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CASI Pharma’s CD19 CAR-T clinical trial applications OK’d in China

The China National Medical Product Administration (NMPA) has approved CASI Pharmaceuticals’ (NASDAQ:CASI) clinical trial applications for CNCT19 (CD19 CAR-T) in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL) submitted by its partner Juventas Cell Therapy Ltd.
The Company expects to start enrolling patients in early 2020.
CASI has previously acquired exclusive worldwide commercial rights to CNCT19 from Juventas.
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Lannett up on advancement of Lantus biosimilar

Lannett Company (NYSE:LCI) announces positive results from the first human study evaluating it and alliance partner HEC Group’s insulin glargine, a biosimilar to Sanofi’s (NASDAQ:SNY) top diabetes seller Lantus.
It plans to meet with the FDA in the coming months to clarify a registration path.
Lantus accounted for 60% of Sanofi’s Q3 diabetes sales.
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Bristol-Myers’ Orencia nabs accelerated review status

The FDA designates Bristol-Myers Squibb’s (NYSE:BMY) Orencia (abatacept) a Breakthrough Therapy for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
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EyePoint up on expanded access of Dexycu

EyePoint Pharmaceuticals (NASDAQ:EYPT) has entered into a formal two-year contract with one of the largest integrated delivery systems in the U.S. to offer DEXYCU (dexamethasone intraocular suspension 9%) within its network.
This agreement opens up new distribution channels in California, Washington, Georgia, Colorado and mid-Atlantic states.
Shares are up 12% premarket.
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Omeros’ narsoplimab successful in pivotal HSCT-TMA study

Omeros (NASDAQ:OMER) is up 4% premarket on light volume in response to positive data from a pivotal Phase 2 clinical trial evaluating narsoplimab (OMS721) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (blood clots in tiny blood vessels) (HSCT-TMA), a frequently lethal complication of HSCT.
The study met the primary efficacy endpoint showing that 56% of patients receiving at least one dose of narsoplimab, a MASP-2 inhibitor, achieved complete responder status as did 68% who received narsoplimab for at least four weeks.
It initiated the rolling submission of its U.S. marketing application in October. The data will also support a marketing application in Europe.
No new safety signals were observed.
Management hosted a conference call this morning at 8:30 am ET to discuss the results.
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Ra Pharma commences mid-stage study of zilucoplan in rare type of myopathy

Dosing is underway in a 24-subject Phase 2 clinical trial evaluating Ra Pharmaceuticals’ (NASDAQ:RARX) zilucoplan for the treatment of immune-mediated necrotizing myopathy, a rare type of idiopathic (cause unknown) inflammatory myopathy (muscle fiber dysfunction) characterized by muscle weakness, necrosis (uncontrolled cell death) and elevated creatinine kinase (CK) levels.
The primary endpoint is the change from baseline in CK levels at week 8 versus placebo. The estimated primary completion date is November 2020.
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