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One of India’s largest sterile Injectables company, Claris Lifesciences Limited (Claris/Company), announced today that it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, wherein the US FDA has concluded that the inspection stands closed and the facility was found to be acceptable.
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes. The fixed-dose combination of saxagliptin and dapagliflozin has the potential to be the first DPP-4i/SGLT-2i combination product approved in Europe.
Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, has licensed to AiVita Biomedical, Inc., the exclusive global rights to its tumour cell/dendritic cell technology for the treatment of ovarian cancer. In return, Caladrius will receive certain development milestone payments as well as royalties on sales of any commercial product. This transaction supports the Caladrius' strategy to monetize non-core assets. Under the license agreement AiVita will assume responsibility for all costs to develop a product using the licensed intellectual property, including the maintenance costs of the associated intellectual property.
Intercept Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic acid(UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is an agonist of the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
Palatin Technologies, Inc. announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/514,472 (the '472 application). The allowed composition of matter claims are to a broad family of melanocortin receptor-1 (MC1r) peptides with potential application in inflammatory disease-related and autoimmune indications.
ProNAi Therapeutics, Inc. announced it has obtained an exclusive license from Carna Biosciences, Inc., Kobe, Japan (JASDAQ: 4572), for worldwide rights to develop and commercialize AS-141, a small molecule kinase inhibitor targeting CDC7.
"Our exclusive license with Carna gives us access to a highly promising asset that was created leveraging Carna's world-class kinase drug discovery expertise. Our team has extensive experience developing oncology drugs and will be focused on the rapid and efficient advancement of this drug candidate," said Dr. Nick Glover, President and CEO of ProNAi. "This agreement, and our focused efforts to identify additional high-quality assets to acquire, reflect our strategy of building a broad and diverse pipeline of targeted oncology drugs that will change people's lives."
Under the terms of the agreement, ProNAi will pay Carna Biosciences an initial upfront payment of USD 0.9 million and aggregate additional potential payments upon achievement of certain developmental, regulatory and commercial milestones of up to USD 270 million. ProNAi will also pay Carna single-digit tiered royalties on the net sales of any product successfully developed.
"ProNAi and Carna Biosciences are fully aligned in our vision of making a meaningful difference for patients with cancer," said Kohichiro Yoshino, PhD, Founder, President and CEO of Carna Biosciences. "We are confident the further development of AS-141 will be well-managed under the stewardship of the ProNAi team."
"We are very excited to work with the highly experienced team at ProNAi to progress AS-141 to the clinic," added Dr. Masaaki Sawa, Chief Scientific Officer of CarnaBio. "AS-141 has demonstrated compelling anti-tumor activity against multiple tumor types in preclinical studies and represents an opportunity for promising clinical development."
"CDC7's role as a key regulator of both DNA replication and DNA damage response make it a compelling emerging target for the treatment of a broad range of tumor types, providing significant commercial potential for the agent," said Dr. Angie You, Chief Business & Strategy Officer and Head of Commercial for ProNAi. "While there is growing interest in targets of this class, we believe we have an opportunity with this potent and selective kinase inhibitor to be first-in-class and highly differentiated."
"Preclinical data and published literature suggest a variety of oncology indications with potential for response to CDC7 inhibitors," added Dr. Barbara Klencke, ProNAi's Chief Development Officer. "Continued preclinical assessment of AS-141 will further inform our clinical development plans and patient selection strategies, with the objective of advancing this drug into the clinic in H2 2017.
AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.
The U.S. Food and Drug Administration (FDA) approved ZINBRYTATM (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS), Biogen and Abbvie announced. Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to two or more therapies indicated for the treatment of multiple sclerosis (MS).
The U.S. Food and Drug Administration approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Axumin is marketed by Blue Earth Diagnostics, Ltd., Oxford, United Kingdom
Braeburn Pharmaceuticals announces that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine delivers buprenorphine continuously for up to six months and should be used as part of a complete treatment program to include counseling and psychosocial support.
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