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FibroGen, Astellas initiate Phase 2 study of ASP1517/FG-4592 for treatment of anemia linked with CKD

Astellas Pharma Inc. (Tokyo:4503) (Astellas) and FibroGen, Inc. (FibroGen) announced today the initiation of a Phase 2 clinical study in Japan of ASP1517/FG-4592 for treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis.

31 Jul 2013

Adocia, Lilly terminate collaboration agreement relating to fast-acting insulin analog

Adocia, a biotechnology company specializing in the development of ‘best-in-class’ medicines from already approved therapeutic proteins, announced today that it had agreed with Eli Lilly and Company not to continue further joint research under the licensing agreement signed in December 2011 relating to use of Adocia's BioChaperone(R) technology for the formulation of fast acting insulin analog formulated with the BioChaperone(R) technology. Consequently, the two companies have terminated the collaboration.

30 Jul 2013

FDA grants orphan-drug designation to Convergence's CNV1014802 for treatment of TN

Convergence Pharmaceuticals Limited, the company focused on the development of novel and high value analgesic medicines for the treatment of chronic pain, is pleased to announce that its novel sodium channel blocker, CNV1014802 ('802), has been granted orphan-drug designation by the US Food and Drug Administration for the treatment of trigeminal neuralgia.

30 Jul 2013

Affymetrix introduces cost-effective, high-throughput Axiom 384HT format for genotyping

Affymetrix, Inc. (NASDAQ: AFFX) announces the introduction of the Axiom® 384HT genotyping format, a breakthrough cost-effective, high-throughput format for genotyping in which 384 samples are simultaneously processed with 384 discrete microarrays in a microplate format analyzing up to 50,000 SNPs per sample.

30 Jul 2013

FDA approves Rebiotix's IND application to begin RBX2660 Phase 2 study for recurrent CDI

Rebiotix Inc. announced today that the U.S. Food and Drug Administration has approved the company's Investigational New Drug application to begin the Phase 2 clinical study of RBX2660 for the treatment of recurrent Clostridium difficile infection.

30 Jul 2013

Prana announces dosing of first patient in PBT2 Phase II trial for Alzheimer’s disease

Prana Biotechnology today announced that the first patient has been dosed in the 12-month open label extension study with Alzheimer’s Disease patients participating in Prana’s Phase 2 IMAGINE trial.

29 Jul 2013

Teva, Lonza decide to discontinue biosimilars collaboration

Teva Pharmaceutical Industries and Lonza Group today announced that following a strategic review of the Teva-Lonza Joint Venture (TL-JV), the companies have decided to discontinue their collaboration for the development, manufacturing and marketing of biosimilars.

25 Jul 2013

FMC acquires all shares of Epax for $345 million

FMC Corporation today announced that it has acquired all of the shares of Epax Nutra Holding III AS (Norway) and Epax UK Holding III AS (United Kingdom) (together, "Epax"), a leading manufacturer of high purity, premium grade Omega-3 fatty acid concentrates that are used in nutraceuticals, pharmaceuticals and food.

24 Jul 2013

Four research teams receive NIH grants to explore use of genome sequencing in medical care

The National Institutes of Health has awarded four grants for up to four years to multidisciplinary research teams to explore the use of genome sequencing in medical care. The awards total approximately $6.7 million in the first year and, if funding remains available, approximately $27 million in total.

24 Jul 2013

NIH study seeks genetic links to answer the 'Why?' of unexplained disorders

Even in the absence of a ready solution, knowing why a child faces physical, emotional and intellectual challenges is helpful to physicians and families. Researchers at the HudsonAlpha Institute for Biotechnology are using high throughput genomic sequencing to meet major diagnostic needs for childhood genetic disorders through a multi-year grant potentially totaling more than $7.6 million from the National Institutes of Health.

24 Jul 2013

Genentech announces that Phase III CLL11 study meets primary endpoint

Genentech, a member of the Roche Group, today announced positive results from the Phase III CLL11 study. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint showing that GA101 plus chlorambucil helped people live significantly longer without their disease worsening (progression-free survival; PFS) compared to Rituxan (rituximab) plus chlorambucil.

24 Jul 2013

Researchers develop PEDV rapid diagnostic test

Mere months after porcine epidemic diarrhea virus (PEDV) was first confirmed in the United States swine population, University of Minnesota researchers have developed a PEDV rapid diagnostic test.

24 Jul 2013

Prana Biotechnology completes PBT2 phase 2 trial in patients with Huntington's disease

Prana Biotechnology today announced the successful completion of Reach2HD, a phase 2 clinical trial in patients with early to mid-stage Huntington disease. The Company expects to announce the results arising from the trial in October.

23 Jul 2013

Array BioPharma announces positive results from ARRY-502 Phase 2 trial for allergic asthma

Array BioPharma Inc. today announced positive results from a placebo-controlled, randomized, double‑blind Phase 2 trial in mild to moderate persistent allergic asthma for ARRY-502, an oral CRTh2 antagonist.

23 Jul 2013

AMRI receives a Form 483 from the FDA for Burlington pharmaceutical manufacturing facility

As previously disclosed, Albany Molecular Research, Inc. ("AMRI" or "the "Company") (NASDAQ: AMRI) received a warning letter, dated August 17, 2010, from the U.S. Food and Drug Administration (FDA) in connection with the FDA's inspection of the Company's pharmaceutical manufacturing facility located in Burlington, Massachusetts.

23 Jul 2013

Biotechnology News and Research

FibroGen, Astellas initiate Phase 2 study of ASP1517/FG-4592 for treatment of anemia linked with CKD

Adocia, Lilly terminate collaboration agreement relating to fast-acting insulin analog

FDA grants orphan-drug designation to Convergence's CNV1014802 for treatment of TN

Affymetrix introduces cost-effective, high-throughput Axiom 384HT format for genotyping

FDA approves Rebiotix's IND application to begin RBX2660 Phase 2 study for recurrent CDI

Prana announces dosing of first patient in PBT2 Phase II trial for Alzheimer’s disease

Teva, Lonza decide to discontinue biosimilars collaboration

FMC acquires all shares of Epax for $345 million

Four research teams receive NIH grants to explore use of genome sequencing in medical care

NIH study seeks genetic links to answer the 'Why?' of unexplained disorders

Genentech announces that Phase III CLL11 study meets primary endpoint

Researchers develop PEDV rapid diagnostic test

Prana Biotechnology completes PBT2 phase 2 trial in patients with Huntington's disease

Array BioPharma announces positive results from ARRY-502 Phase 2 trial for allergic asthma

AMRI receives a Form 483 from the FDA for Burlington pharmaceutical manufacturing facility

Ligand, Azure Biotech sign global license agreement for development of lasofoxifene

Fujikura to exercise option to license Cellmid’s midkine diagnostic technology

BioCryst completes BCX4161 Phase 1 clinical trial for treatment of hereditary angioedema

Experts to focus on health care challenges at U.S. Conference on Rare Diseases and Orphan Products

Research collaboration to tackle multiple sclerosis, motor neurone disease

Event guide: 3rd IMPACCT Real World Evidence Summit Europe eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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