Pharma News

The National Human Rights Commission on Friday issued notices to the commerce and health ministries over reports that India has reassured the US-India Business Council to take a restrained approach in handing out licences to produce cheaper versions of drugs patented with the American firms.

The British Medical Journal (BMJ) in its latest issue has called for radical reforms of the Medical Council of India (MCI) which, it said, failed to oversee quality and integrity in health services in the country.

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.

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.