Pharma News

Takeda Pharmaceutical Company Limited has announced that Inisync Combination Tablets, a fixed-dose combination of Nesina (generic name: alogliptin benzoate) and metformin hydrochloride (hereinafter metformin), is now available in Japan for the treatment of type 2 diabetes.

PhaseRx, Inc., a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, announced that its lead candidate, PRX-OTC, which is being developed for the treatment of ornithine transcarbamylase deficiency (OTCD), has received orphan drug designation by the US Food and Drug Administration (FDA).

EMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab. This review relates to avelumab's proposed use in patients with metastatic Merkel cell carcinoma (MCC), based on tumor response results from the JAVELIN Merkel 200 trial. Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody and could be the first treatment indicated for metastatic MCC in the US, if approved. MCC is a rare and aggressive skin cancer, which impacts approximately 2,500 Americans a year.

ARIAD Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has granted Iclusig® (ponatinib) full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved in December 2012 under the FDA’s accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drug’s clinical benefit. The therapy was granted the FDA’s orphan drug designation because it is intended to treat a rare disease or condition.

International Society for Pharmacoeconomics and Outcomes Research ISPOR India –Andhra Pradesh Regional Chapter in association with Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapuramu, Andhra Pradesh; Rural Development Trust (RDT) Hospital, Anantapuramu, Andhra Pradesh and Indian Pharmaceutical Association (IPA) Anantapuramu Local Branch organized One Day National Symposium on “Innovations in Pharmacovigilance for ensuring Drug Safety and ensuring Life” on 24th November 2016 (Thursday)  at A.C auditorium, Rural Development Trust (RDT) Hospital, Anantapuramu, Andhra Pradesh.

Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapuramu, Andhra Pradesh in association with Priyadarshini Institute of Pharmaceutical Education and Research, Guntur. Andhra Pradesh organized a Two Days National Workshop on Advances in Pharmacy Practice: Series of Educational and Training Module by faculties of Division of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education and Research (RIPER).  The workshop drew around 60 Pharm. D students, which focussed on Patient care and the role of Pharmacists in healthcare system on policy and practice perspective.

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Sun Pharma announced the execution of definitive agreements by its wholly owned subsidiary, for the acquisition of 85.1% of JSC Biosintez, a Russian pharmaceutical company engaged in manufacture and marketing of pharmaceutical products in Russia and CIS region. The equity consideration for the 85.1% stake is US$ 24 million. Sun Pharma would also assume a debt of approximately US$ 36 million as part of this transaction.

Proteros biostructures GmbH announced that the company has entered into a second research agreement with Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, USA (known as MSD outside the US and Canada). The new collaboration is aimed at developing small molecule compounds against an additional epigenetic target for the potential treatment of various cancers.

Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Xultophy® 100/3.6. Xultophy® 100/3.6 is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).

Janssen-Cilag International NV announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which has been shown to play a key role in the development of immune-mediated inflammatory diseases.