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- Read more about QT VASCULAR Receives FDA 510(K) Clearance For CHOCOLATE XD™
QT Vascular Ltd., together with its subsidiaries, a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced it has received 510(k) clearance from the US Food and Drug Administration (“FDA”) for the sale and distribution of the Chocolate XD™ PTCA catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.
- Read more about Sanofi, Boehringer Ingelheim Swap Animal Health & Consumer Healthcare Businesses
Sanofi and Boehringer Ingelheim announced the signing of contracts to secure the strategic transaction initiated in December 2015 which consists of an exchange of Sanofi’s animal health business (“Merial”) and Boehringer Ingelheim’s consumer healthcare (CHC) business. This step marks a major milestone before closing of the transaction which is expected by year-end 2016 and remains subject to approval by all regulatory authorities in different territories. The integration of Boehringer Ingelheim’s Consumer Healthcare (CHC) business into Sanofi and Merial into Boehringer Ingelheim would start after closing.
- Read more about U.S. FDA grant Bristol-Myers Squibb’s Opdivo Breakthrough Therapy Designation
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen. As part of the Breakthrough Therapy Designation submission, the Company shared for the FDA’s review results from Phase 2 study CA209-275 and other supportive data investigating Opdivo in these previously treated bladder cancer patients.
- Read more about DCGI granted siRNA Drug Trial
Biocon and its partner, Quark Pharmaceuticals, have received approval from the Drug Controller General of India (DCGI) to proceed with the study, the first ever clinical trial of a siRNA therapy in India.
- Read more about ASLAN Pharma Receives Second FDA Orphan Drug Designation For VARLITINIB (ASLAN001)
ASLAN Pharmaceuticals announced the designation as an Orphan drug of its pan-HER inhibitor varlitinib (ASLAN001) by the US Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for gastric cancer. Varlitinib previously received Orphan Drug Designation for cholangiocarcinoma in August 2015.
- Read more about CHMP issue positive opinion for marketing authorization of Teva’s CINQAERO
Teva Pharmaceutical Industries Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for CINQAERO® (reslizumab), a humanized interleukin 5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
- Read more about CHMP issued negative opinion for Genmab’s Arzerra for treatment of patients with relapsed CLL
Genmab announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the use of Arzerra® (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL). The Marketing Authorization Application (MAA) was submitted by Novartis in July 2015 under the ofatumumab collaboration between Novartis and Genmab.

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- Read more about Supernus receives US patent covering Oxtellar XR
Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company, announced the issuance on June 21, 2016 of a seventh patent (number 9,370,525) by the United States Patent and Trademark Office (USPTO) covering Oxtellar XR, its novel once-daily extended-release oxcarbazepine product. The patent provides protection for the product with expiration that is no earlier than 2027.
- Read more about Mycobacterium in olive oil for cancer treatment
Researchers at the Universitat Autònoma de Barcelona (UAB) with the collaboration of the Institute for Bioengineering of Catalonia (IBEC), led by the professor of the UAB Department of Genetics and Microbiology Esther Julián, announced one year ago that the cells of the Mycobacterium brumae offer an improved alternative to current bladder cancer treatments such as BCG (an immunotherapy based on the Mycobacterium bovis), which can cause infections.
- Read more about Development of drugs for local treatment of oral conditions
the 94th General Session & Exhibition of the International Association for Dental Research, researcher W. Peter Holbrook, University of Iceland, will present a study titled "Development of Drugs for Local Treatment of Oral Conditions." The IADR General Session is being held in conjunction with the 3rd Meeting of the IADR Asia Pacific Region and the 35th Annual Meeting of the IADR Korean Division.