Industry News

Gilead Sciences, Inc. and Nimbus Therapeutics, LLC announced that the companies have signed a definitive agreement under which Gilead will acquire Nimbus Apollo, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time.

Pfizer Inc. announced that the Phase 3 SPIRE-AI (AutoInjector) trial of the investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) bococizumab administered with a pre-filled pen met its co-primary endpoints: percent change from baseline in low-density lipoprotein cholesterol (LDL-C) reduction at 12 weeks compared to placebo and proportion of patients successfully operating the pre-filled pen. The SPIRE-AI trial is the second study completed of the six SPIRE Phase 3 lipid-lowering studies, and we expect it will be part of the potential regulatory filing for bococizumab.

Corbus Pharmaceuticals Holdings Inc. announced that a protocol amendment has been added to one of the Company's existing Investigational New Drug ("IND") Application with the U.S. Food and Drug Administration ("FDA") for a Phase 2 clinical trial of Resunab in systemic lupus erythematosus ("SLE").

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the conditional approval of Pandemic Live Attenuated Influenza Vaccine (P/LAIV). P/LAIV is indicated for the prevention of influenza in an officially declared pandemic in children and adolescents from 12 months to less than 18 years of age.

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo)  announced that the company has filed an application for the manufacture and sales in Japan of hydromorphone hydrochloride oral formulation (extended-release and immediate-release formulations), a narcotic analgesic.

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Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a Positive Opinion recommending marketing authorisation in the European Union for the medicinal product TREVICTA® (paliperidone palmitate a 3 monthly injection) for the maintenance treatment of schizophrenia. If approved, this 3 monthly injection will allow patients to maintain an optimal level of treatment in their blood with fewer administrations, compared to currently available antipsychotic treatments, and therefore may improve outcomes for patients, carers and HCPs.1 A 1 monthly formulation of paliperidone palmitate (XEPLION®) is approved for the maintenance treatment of schizophrenia in Europe.

AstraZeneca confirmed that the American College of Cardiology (ACC) and American Heart Association (AHA) have released a treatment guideline on the duration of dual antiplatelet therapy (DAPT). Brilinta (ticagrelor) is now preferred over clopidogrel for the management of patients with acute coronary syndrome (ACS) who have received a coronary stent and in non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) patients treated with medical therapy alone (Class IIa LoE: B-R). This update is the first time the ACC/AHA has recommended Brilinta over clopidogrel for patients who have experienced an ST-elevation myocardial infarction (STEMI).

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced that Phase 3 clinical trials for AMG 162 (hereafter, denosumab), a gene recombinant drug for patients with rheumatoid arthritis, has achieved a major objective.

Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that it is discontinuing the Phase 3 development program for fulranumab in osteoarthritis pain. This decision was based on strategic portfolio prioritization and was not based on any emerging safety concerns from the Phase 3 clinical studies with fulranumab.