Pharmaceuticals News and Research

RSS

Sihuan's Roxatidine passes Chinese SFDA on-site inspection

Sihuan Pharmaceutical Holdings Group Ltd., a leading pharmaceutical company with the largest cardio-cerebral vascular drug franchise in China's prescription market, announced that Roxatidine Acetate Hydrochloride for Injection, Sihuan Pharmaceutical's first-to-market generic drug, recently passed on-site inspection for drug registration conducted by the Chinese State Food and Drug Administration.

25 May 2012

FDA reauthorization bill sails through Senate

Showing unusual bipartisan spirit, the Senate passed a massive FDA user-fee reauthorization bill Thursday designed to prevent drug shortages and speed federal approval of medicines, including lower-cost generic versions.

25 May 2012

European CHMP issues positive opinion to Vertex's KALYDECO for treatment of CF

Vertex Pharmaceuticals Incorporated announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion by consensus recommending the approval of KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

25 May 2012

BBSRC allocates £250M for strategic investment programmes

Minister for Universities and Science, David Willetts, will today announce substantial funding that will ensure the UK's bioscience research base remains globally competitive and at the forefront of meeting the grand challenges faced by society in the coming decades. The announcement will be made by the Minister during a visit to the Babraham Research Campus, near Cambridge, and highlighted again during a major speech at the University of East Anglia in Norwich.

25 May 2012

Takeda signs agreement to acquire Multilab

Takeda Pharmaceutical Company Limited and Multilab Indústria e Comércio de Produtos Farmacêuticos Ltda. today jointly announced that both parties have signed an agreement whereby Takeda Farmacêutica Brasil Ltda., a wholly-owned subsidiary of Takeda, aims to acquire Multilab.

25 May 2012

Cyanobacterium produces compounds that could treat chronic inflammatory conditions

A seaweed considered a threat to the healthy growth of coral reefs in Hawaii may possess the ability to produce substances that could one day treat human diseases, a new study led by scientists at Scripps Institution of Oceanography at UC San Diego has revealed.

25 May 2012

New compound can enhance apoptosis in cancer cells

The BCL-2 protein family plays a large role in determining whether cancer cells survive in response to therapy or undergo a form of cell death known as apoptosis.

25 May 2012

Linagliptin safe and effective for African American patients with type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced Phase 3 study results for linagliptin 5 mg once-daily, which showed significant hemoglobin A1c (HbA1c or A1C) reduction of 0.88 percent compared to 0.24 percent in the placebo group (p=0.0002) at 24 weeks in black or African American adult patients with type 2 diabetes whose blood sugar was not adequately controlled.

25 May 2012

Auxilium, FCB I file suit against Watson over generic Testim

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Gel, 1%. Watson's 1% testosterone gel product is a generic version of Auxilium Pharmaceuticals, Inc.'s Testim 1%.

25 May 2012

Insmed initiates patient screening for ARIKACE phase 2 NTM lung disease trial

Insmed Incorporated, a biopharmaceutical company, today announced that it has begun screening patients for its U.S. phase 2 clinical trial, Treatment with ARIKACE to Realize Greater Efficacy Trial (TARGET-NTM), of ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease.

24 May 2012

Halo Healthcare acquires assets of NeoMatrix

Halo Healthcare, Inc. announces it has acquired the assets of NeoMatrix, LLC and has restructured the Company, including engaging a new CEO and management team, appointing a new Board of Directors, and relaunching the HALO diagnostic device for breast cancer risk assessment.

24 May 2012

USP announces two new standards related to elemental impurities

As part of its ongoing efforts to help ensure the quality of medicines, the U.S. Pharmacopeial Convention (USP) has announced two new standards related to elemental impurities: General Chapters <232> Elemental Impurities-Limits and <233> Elemental Impurities-Procedures. The new standards provide procedures for the detection of selected impurities in drug products based on modern analytical methods, as well as acceptable limits for their presence based on toxicity data and exposure levels.

24 May 2012

APP expands portfolio of injectable critical care products

APP Pharmaceuticals, LLC, a Fresenius Kabi Company, today announced it has acquired three products from Nexus Pharmaceuticals, Inc.

24 May 2012

Bayer submits regorafenib NDA with FDA for treatment of mCRC

Bayer HealthCare announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer.

24 May 2012

Zytoprotec completes PD-protec Phase I/II trial on kidney failure

Zytoprotec, a company developing drugs based on active cytoprotection, today announced the completion of a Phase I/II clinical trial with its lead product, PD-protec.

24 May 2012

EMA accepts MAA filing of Takeda’s alogliptin for type 2 diabetes

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation on the acceptance of the submission of a Marketing Authorization Application, or MAA, from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV, or DPP-4, inhibitor for the treatment of type 2 diabetes.

24 May 2012

Phase I/II clinical trial of novel dialysate completed by Zytoprotec

Zytoprotec, a company developing drugs based on active cytoprotection, today announced the completion of a Phase I/II clinical trial with its lead product, PD-protec™. The product is developed to improve the treatment of patients with kidney failure.

23 May 2012

USPTO issues patent to MicuRx’s MRX-I antibacterial agent

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that the U.S. Patent and Trademark Office (USPTO) issued a composition of matter patent covering its clinical candidate, MRX-I. MRX-I is a novel antibacterial oxazolidinone that targets infections due to multi-drug resistant Gram-positive pathogens.

23 May 2012

Researchers to initiate Crenezumab clinical trial to treat Alzheimer's

After an announcement by federal officials approving clinical trials for the drug Crenezumab, researchers searching for a way to treat Alzheimer's Disease are gearing up for a rare study that will allow them to test a therapy for a genetically predestined disease -- before its onset.

23 May 2012

Panel of HuCAL Anti-Drug Antibodies to be launched by AbD Serotec

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its division for research and diagnostic antibodies, AbD Serotec, will launch a series of novel anti-drug antibodies (ADAs) to strengthen its position as a leading provider of diagnostic reagents.

23 May 2012