Clinical Intelligence

Endo Pharmaceuticals to remove OPANA from the market

Friday, July 7, 2017

Endo International plc continues to believe in the safety, efficacy, and favorable benefit-risk profile of OPANA® ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse.  Nevertheless, after careful consideration and consultation with the FDA following the FDA’s June 2017 withdrawal request, the Company has decided to voluntarily remove OPANA® ER from the market. As a result, the Company expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017 to write-off the remaining net book value of its OPANA® ER intangible asset. Reported net sales of OPANA® ER were $158.9 million for full-year 2016 and $35.7 million for first quarter 2017.

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Novartis receives approval in the EU for Cosentyx label update

Friday, July 7, 2017

Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis. The label update includes 52 week data from the CLEAR study demonstrating the long-term superiority of Cosentyx versus Stelara® *(ustekinumab) in psoriasis [1],[2]. The updated label also includes use of Cosentyx to treat moderate-to-severe scalp psoriasis[1] – one of the most difficult-to-treat forms of psoriasis[3], which affects approximately 60 million people worldwide[4],[5]. The updated label is based on the proven efficacy and consistent safety profile of Cosentyx[1].

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Proteostasis Therapeutics files IND for PTI-808, cystic fibrosis potentiator

Monday, July 3, 2017

Proteostasis Therapeutics, a biopharmaceutical company developing small molecule therapeutics to treat diseases caused by dysfunctional protein processing such as cystic fibrosis (CF), announced that the company has filed an Investigational New Drug (IND) application with the FDA for PTI-808, its cystic fibrosis transmembrane conductance regulator (CFTR) potentiator. Proteostasis plans to initiate a phase I study of PTI-808 in healthy volunteers in July.

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The CenterWatch Monthly Industry Snapshot, July 2017

Monday, July 3, 2017

Healthcare stakeholders recognize that there is a clear, ethical rationale to support patient engagement in clinical trials. Setting standards that describe how patient engagement is achieved will lead to research findings that are more pertinent to patients’ concerns and dilemmas.1 However, as there are limited comparative analytic studies to recommend a particular method that improves understanding of patients’ concerns and enables comparisons of the methods employed, it is unclear how to best engage patients and how to measure the success of engagement.

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Cara receives Breakthrough Therapy Designation for I.V. CR845 for UP CKD

Wednesday, June 28, 2017

Cara Therapeutics, a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, announced that the FDA has granted Breakthrough Therapy designation to I.V. CR845 for the treatment of moderate-to-severe uremic pruritus (UP) in chronic kidney disease (CKD) patients undergoing hemodialysis.

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ImmunoGen presents data from IMGN779 study in acute myeloid leukemia

Monday, June 26, 2017

ImmunoGen, a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, presented data from the ongoing phase I study evaluating single agent IMGN779 in patients with relapsed or refractory adult acute myeloid leukemia (AML) whose tumors express CD33. The first-in-human data demonstrate the safety and tolerability of IMGN779 across seven dose levels, with no dose limiting toxicities (DLTs), as well as evidence of dose-dependent biological and anti-leukemia activity.

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