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AbbVie's venetoclax granted FDA Breakthrough Therapy Designation for CLL patients with 17p deletion

AbbVie today announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

6 May 2015

Cipher strengthens Canadian dermatology portfolio with acquisition of Vaniqa, Actikerall

Cipher Pharmaceuticals Inc. today announced it has strengthened its Canadian dermatology portfolio by acquiring the Canadian rights to Vaniqa and Actikerall from Almirall S. A., a Spanish pharmaceutical company. Both products have been approved by Health Canada.

6 May 2015

Oncolytics' REOLYSIN granted FDA Orphan Drug Designation for treatment of gastric cancers

Oncolytics Biotech Inc., a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration has granted an Orphan Drug Designation (ODD) for its lead product candidate, REOLYSIN, for the treatment of gastric cancers.

6 May 2015

Transition Therapeutics acquires worldwide rights from Lilly to develop, commercialize TT701

Transition Therapeutics Inc. today announced its wholly-owned subsidiary, Transition Therapeutics Ireland Limited, has exclusively licensed worldwide rights to a novel small molecule drug candidate ("TT701") from Eli Lilly and Company.

6 May 2015

Weston Park Hospital offers two cutting-edge treatments for rare cancer tumours, prostate cancer

TWO cutting-edge cancer treatments using targeted radioactive therapy injections to destroy cancer cells are now being offered to patients with rare neuroendocrine tumours and patients with prostate cancer at Weston Park Hospital.

6 May 2015

Johns Hopkins researchers develop new strategies to treat depression in children, adolescents

A multidisciplinary team of Johns Hopkins researchers has developed two new strategies to treat depression in young people using the selective serotonin reuptake inhibitor (SSRI) class of medications. These strategies, published May 5 in the journal Translational Psychiatry, incorporate a new understanding of how to mitigate the risk of suicide while on SSRI treatment.

6 May 2015

Protein Sciences, CTH@H to provide Flublok vaccine to home health and hospice agencies in Connecticut

Protein Sciences Corporation, along with The Connecticut Association for Healthcare at Home, announced a new partnership today that will bring Flublok influenza vaccine to home health and hospice agencies across the state. As a new affinity partner of CTH@H, Protein Sciences will make Flublok available to CTH@H member agencies for the 2015/16 flu season.

5 May 2015

Mylan releases generic version of Seasonale Tablets in the U.S.

Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale Tablets. Mylan's partner Famy Care Ltd. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

5 May 2015

CMC Biologics to supply bulk drug substance for Emergent BioSolutions' IXINITY

CMC Biologics, Inc., a global CMO dedicated to process development and production of biopharmaceuticals for clinical and commercial use, today announced that it will supply bulk drug substance for Emergent BioSolutions' recently FDA-approved product, IXINITY® [coagulation factor IX (recombinant)].

5 May 2015

TxCell presents preclinical efficacy and tolerability data for Col-Treg at 2015 ARVO Annual Meeting

TxCell SA, a biotechnology company developing innovative, personalized T-cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, today announces that activity and tolerance data for its second lead product Col-Treg were presented through a poster presentation at the 2015 ARVO Annual Meeting, May 3-7, 2015, in Denver, Colorado, US.

5 May 2015

Findings provide glimmer of hope for treating diffuse intrinsic pontine gliomas

Using brain tumor samples collected from children in the United States and Europe, an international team of scientists found that the drug panobinostat and similar gene regulating drugs may be effective at treating diffuse intrinsic pontine gliomas (DIPG), an aggressive and lethal form of pediatric cancer.

5 May 2015

IQWiG finds minor added benefit of dulaglutide in combination with short-acting insulin for type 2 diabetes

Since 2014 dulaglutide has been approved alone or in combination with other drugs for the treatment of adults with type 2 diabetes. The German Institute for Quality and Efficiency in Health Care examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapies.

5 May 2015

Researchers identify multiple types of resistance to new targeted lung cancer drug

After identifying three different types of resistance to a promising investigational lung cancer drug in a phase 1 trial, a team of researchers led by Dana-Farber Cancer Institute scientists say new targeted inhibitors and combinations are urgently needed to stay ahead of tumors' constant and varied molecular shape-shifting.

5 May 2015

University of Adelaide research shows that doping decreases athletes' performances

Doping is damaging the image of sport without benefitting athletes' results, according to University of Adelaide research.

5 May 2015

Makindus' MI-100 granted EMA orphan drug designation for treatment of Stargardt's Disease

Makindus, Inc. a specialty pharmaceutical development company focused on ophthalmology announced today that the European Medicines Agency has granted orphan drug designation for their lead candidate, MI-100, for the treatment of Stargardt's Disease.

4 May 2015

High Throughput ChIP-seq Assay for Genome-wide Protein-DNA Analysis

Chromatrap®, a business unit of Porvair Sciences, has published a new application note that describes how Chromatrap® ChIP-seq assays now enable unbiased, genome-wide understanding of protein-DNA regulatory networks...

From Chromatrap® - Porvair Sciences Ltd 30 Apr 2015

Texas Biomed scientists awarded NIH grant to develop potential HPV-based HIV vaccine

Scientists at Texas Biomedical Research Institute have begun work on a nearly $3.4 million study funded by the National Institutes of Health over the next four years to create an attenuated, or weakened, virus that is a hybrid of the papilloma virus and the human immunodeficiency virus, with the potential to jumpstart a body's immune response to develop antibodies against both viruses.

30 Apr 2015

New research-based pharmaceutical industry report provides insights on how to slow down antimicrobial resistance (AMR) and boost antibiotic R&D

Eleven IFPMA member companies are involved in the development of new antibiotics. There are currently 34 antibacterial compounds in development (19 molecules and 15 vaccines). Eight compounds are undergoing the final stages of demonstrating their efficacy, quality, and safety (phase 3 clinical trials)...

30 Apr 2015

FDA grants tentative approval to Amerigen's ANDA for generic version of Toviaz

Amerigen Pharmaceuticals Limited today announced that the U.S. Food and Drug Administration has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Toviaz (Fesoterodine Fumarate Extended-release Tablets, 4mg and 8mg).

30 Apr 2015

Research provides insights into the ability of FL118 to overcome treatment resistance

The latest research from the team that discovered the novel anticancer agent FL118 highlights distinctive characteristics of this small-molecule compound and provides insights into its ability to overcome the persistent problem of treatment resistance. In findings reported in Molecular Cancer, Fengzhi Li, PhD, of Roswell Park Cancer Institute, and colleagues provide new evidence that FL118 may be more effective than two structurally similar injectable drugs and, additionally, may be effective as an oral agent.

30 Apr 2015

Pharmaceutical News

AbbVie's venetoclax granted FDA Breakthrough Therapy Designation for CLL patients with 17p deletion

Cipher strengthens Canadian dermatology portfolio with acquisition of Vaniqa, Actikerall

Oncolytics' REOLYSIN granted FDA Orphan Drug Designation for treatment of gastric cancers

Transition Therapeutics acquires worldwide rights from Lilly to develop, commercialize TT701

Weston Park Hospital offers two cutting-edge treatments for rare cancer tumours, prostate cancer

Johns Hopkins researchers develop new strategies to treat depression in children, adolescents

Protein Sciences, CTH@H to provide Flublok vaccine to home health and hospice agencies in Connecticut

Mylan releases generic version of Seasonale Tablets in the U.S.

CMC Biologics to supply bulk drug substance for Emergent BioSolutions' IXINITY

TxCell presents preclinical efficacy and tolerability data for Col-Treg at 2015 ARVO Annual Meeting

Findings provide glimmer of hope for treating diffuse intrinsic pontine gliomas

IQWiG finds minor added benefit of dulaglutide in combination with short-acting insulin for type 2 diabetes

Researchers identify multiple types of resistance to new targeted lung cancer drug

University of Adelaide research shows that doping decreases athletes' performances

Makindus' MI-100 granted EMA orphan drug designation for treatment of Stargardt's Disease

High Throughput ChIP-seq Assay for Genome-wide Protein-DNA Analysis

Texas Biomed scientists awarded NIH grant to develop potential HPV-based HIV vaccine

New research-based pharmaceutical industry report provides insights on how to slow down antimicrobial resistance (AMR) and boost antibiotic R&D

FDA grants tentative approval to Amerigen's ANDA for generic version of Toviaz

Research provides insights into the ability of FL118 to overcome treatment resistance

How GLP‑1 Agonists Are Shaping the Future of Obesity Treatment With Dr Bryony Henderson

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

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