Fibrocell Science, Inc. a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, announced that the remaining two patients in the NC1+ cohort have been dosed in the Phase 1 portion of the Phase 1/2 clinical trial of FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), a devastating genetic skin disease with a high mortality rate. The cohort consists of three patients.
Cell Design Labs, Inc. announced the issuance of U.S. Patent No. 9,670,281, entitled “Binding-triggered transcriptional switches and the methods of use thereof.” This patent, issued to UC San Francisco (UCSF) and exclusively licensed to Cell Design Labs, broadly covers composition of matter for proprietary synNotch™ constructs, cells genetically modified with synNotch receptors and methods for treating diseases.
The Drug Controller General of India (DCGI) on relaxed guidelines for the production of pediatric HIV drugs, whose supply was affected by regulatory issues. The regulator approved the child-friendly and thermally stable pellet formulation of Lopinavir / Ritonavir without feasibility studies, but said it would control post-marketing surveillance.
Zydus Cadila has informed that the USFDA has given final approval to market Mesalamine Delayed- Release Tablets USP, 1.2 g in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda® (mesalamine).
AstraZeneca and its global biologics research and development arm, MedImmune, will present the latest research from the Company’s Cardiovascular and Metabolic Diseases (CVMD) therapy area, including for Farxiga (dapagliflozin) and Bydureon (exenatide extended-release) for injectable suspension, with more than 50 abstracts at the American Diabetes Association’s (ADA) 77th Scientific Sessions in San Diego, USA 9-13 June 2017.
Alkermes plc announced the initiation of ENLIGHTEN-Early, a supportive study in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.
The government of Punjab will establish two 50-bed Ayush hospitals in the state, Health Minister Brahm Mohindra said. Standardized services of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homeopathy would also be provided to patients indoors and outdoors in these hospitals, he added.
Puerto Rico stated that the Zika 2016 epidemic is over, saying that transmission of the virus that can cause birth defects when exposed to pregnant women has fallen
The central government is firm in its plan to introduce an electronic platform to regulate the sale of drugs despite opposition from chemists.
Government of Assam and Tata Trusts, signed a Memorandum of Understanding to provide comprehensive cancer care and ensure affordable quality treatment for cancer patients in the state. Assam is one of the states that has the highest per capita cancer burden in India. The Memorandum of Understanding was signed under the presence of Shri. Himanta Biswa Sarma, Hon’ble Minister of Health and Family Welfare, Government of Assam along with R. Venkataramanan, Managing Trustee, Tata Trusts.