Industry News

- Read more about Pfizer and Allergan terminates merger of $160 billion
Pfizer Inc. announced that the merger agreement between Pfizer and Allergan plc has been terminated by mutual agreement of the companies. The decision was driven by the actions announced by the U.S. Department of Treasury on April 4, 2016, which the companies concluded qualified as an “Adverse Tax Law Change” under the merger agreement.
- Read more about Corbus pharma announces addition of phase 2 clinical protocol for resunab treatment to FDA IND
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").
- Read more about Astrazeneca pandemic influenza vaccine receives positive CHMP opinion
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.
- Read more about Daiichi Sankyo filed application in Japan for manufacturing and sales approval of Hydromorphone Hydrochloride
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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- Read more about Janssen receives CHMP positive opinion for TREVICTA® recommending approval in EU
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.
- Read more about AstraZeneca brilinta preferred over clopidogrel in updated ACC & AHA guideline in acute coronary syndrome
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).
- Read more about Daiichi Sankyo announces phase 3 clinical trial results for AMG 162 (denosumab)
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.
- Read more about Janssen announces discontinuation of fulranumab phase 3 development program in Osteoarthritis Pain
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.
- Read more about Oculus innovative sciences and lipogrid of sweden announce strategic collaboration
Oculus Innovative Sciences, Inc. announced it has finalized a strategic collaborative agreement with the Lipogrid Company of Sweden to develop multiple topical drug delivery formulations based upon the company's Lipogrid® Technology.
- Read more about FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow
The U.S. Food and Drug Administration approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). This is the first FDA-approved therapy for treatment of severe hepatic VOD, a rare and life-threatening liver condition. Defitelio is marketed by Jazz Pharmaceuticals based in Palo Alto, California.