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Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
Sangamo Therapeutics, Inc. . the leader in therapeutic genome editing, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-318, a genome editing product candidate for the treatment of Mucopolysaccharidosis Type I (MPS I), a rare lysosomal storage disorder. Orphan drug designations are granted to drugs and biologics intended to treat rare diseases. The designation provides incentives to advance development of rare disease drugs and for commercialization of those drugs that progress to approval.
RedHill Biopharma Ltd. announced that RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of Nontuberculous Mycobacteria (NTM) infections. The QIDP designation was granted under the FDA's Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections.
Icagen, a drug discovery services and products provider, has announced an agreement with Japan-based drug discovery sales specialist On Target Co., Ltd, granting the right to broker Icagen's products and services in the important territory. The agreement is expected to facilitate the ability of Japanese researchers to access Icagen's expansive portfolio of drug discovery offerings, including Icagen's rich historic expertise in ion channel services and cell lines, transporter investigation and assay services, high throughput screening, computational chemistry, and management of integrated drug discovery Target-to-Lead projects.
New research has found concussions accelerate Alzheimer's disease-related brain atrophy and cognitive decline in people who are at genetic risk for the condition.
The findings, which appear in the journal Brain, show promise for detecting the influence of concussion on neurodegeneration.
The Scripps Research Institute (TSRI), a leading non-profit biomedical research institute, announced a research collaboration and license agreement with Pfizer Inc. to pioneer new DNA-encoded library (DEL) technology, including new synthetic chemistry for the creation of next-generation DELs, a potentially transformative technology for early stage drug discovery research.
The National Cancer Institute (NCI) launched a new drug formulary (the "NCI Formulary") that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.
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The NCI Formulary is a public-private partnership between NCI, part of the National Institutes of Health, and pharmaceutical and biotechnology companies. It is also one of NCI's efforts in support of the Cancer Moonshot, answering Vice President Biden's call for greater collaboration and faster development of new therapies for patients. The availability of agents through the NCI Formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process--sometimes up to 18 months--that has been required for investigators to access such agents on their own.
"The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner," said NCI Acting Director Douglas Lowy, M.D. "Rather than spending time negotiating agreements, investigators will be able to focus on the important research that can ultimately lead to improved cancer care."
The NCI Formulary launched today with fifteen targeted agents from six pharmaceutical companies:
"The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients," said James Doroshow, M.D., NCI Deputy Director for Clinical and Translational Research. "It represents a new drug development paradigm that will enhance the efficiency with which new treatments are discovered."
The establishment of the NCI Formulary will enable NCI to act as an intermediary between investigators at NCI-designated Cancer Centers and participating pharmaceutical companies, facilitating and streamlining the arrangements for access to and use of pharmaceutical agents. Following company approval, investigators will be able to obtain agents from the available formulary list and test them in new preclinical or clinical studies, including combination studies of formulary agents from different companies.
The NCI Formulary leverages lessons learned through NCI's Cancer Therapy Evaluation Program (CTEP) and the NCI-MATCH trial, a study in which targeted agents from different companies are being tested alone or in combination in patients with genetic mutations that are targeted by these drugs. As the use of genomic sequencing data becomes more common in selecting cancer therapies, requests for access to multiple targeted agents for the conduct of clinical trials are becoming more common.
"We are very pleased that several additional pharmaceutical companies have already pledged a willingness to participate and are in various stages of negotiation with NCI," said Dr. Doroshow, who is also director of NCI's Division of Cancer Treatment and Diagnosis. "By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary."
CTEP staff continue to discuss the NCI Formulary with pharmaceutical companies to make additional proprietary agents available for studies initiated by investigators at NCI-designated Cancer Centers.
The Formulary will complement NIH's plans for another new public-private partnership in oncology, the Partnership to Accelerate Cancer Therapies (PACT). Through PACT, the NIH, U.S. Food and Drug Administration, biopharmaceutical groups in the private sector, foundations, and cancer advocacy organizations will come together to support new research projects to accelerate progress in cancer research as part of the Cancer Moonshot. PACT research will center on the identification and validation of biomarkers of response and resistance to cancer therapies, with special emphasis on immunotherapies. PACT will also establish a platform for selecting and testing combination therapies. PACT is expected to launch in 2017.
Heightened activity in the amygdala - a region of the brain involved in stress - is associated with a greater risk of heart disease and stroke, according to a study published in The Lancet that provides new insights into the possible mechanism by which stress can lead to cardiovascular disease in humans.
OmniActive Health Technologies Ltd. announced that it has acquired 85 per cent stake, and has entered into definitive agreements to acquire the balance stake, in Bangalore-based leading health and nutrition active natural ingredients player Indfrag Ltd (Indfrag). The acquisition includes all products related to Indfrag’s Food and Nutrition business.
This is in line with OmniActive’s programme to create global partnerships which help expand the portfolio of high quality authenticated ingredients for the dietary supplement and functional food industries.
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company, announced results from AbbVie’s phase 3 CERTAIN-1 study of 8 weeks of treatment with AbbVie’s investigational, pan-genotypic, ribavirin (RBV)-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis. Top-line results from the study demonstrated 99 per cent (n=105/106) of patients without cirrhosis, who represent the majority of HCV patients, and without the Y93H variant, achieved sustained virologic response at 12 weeks after treatment (SVR12). The one patient who did not reach SVR12 in this intent to treat (ITT) population was lost to follow-up. All 23 patients with the Y93H variant were assigned to the G/P arm of this comparator study, and 100% achieved SVR12.
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