Medical Tidbits,Transplanted nerve cells survive a quarter of a century in a Parkinson’s disease patient

clinical trials for cancer

In the late 1980s and over the 1990s, researchers at Lund University in Sweden pioneered the transplantation of new nerve cells into the brains of patients with Parkinson’s disease. The outcomes proved for the first time that transplanted nerve cells can survive and function in the diseased human brain. Some patients showed marked improvement after the transplantation while others showed moderate or no relief of symptoms. A small number of patients suffered unwanted side-effects in the form of involuntary movements read more

First patients enter Peptonic Medical AB’s clinical phase 2b study

Stockholm 3rd  May 2016. – Peptonic Medical AB (publ) -– a company developing pharmaceuticals based on oxytocin – today announced that the first patients have been randomised in to its phase 2b clinical study. The aim of the study is to investigate the effect of Peptonic Medical’s product candidate Vagitocin® on vaginal atrophy in menopausal and post-menopausal women read more

FDA Grants Priority Review For Amgen’s Supplemental Biologics License Application For BLINCYTO® (Blinatumomab)

Acceptance Reinforces Significant Unmet Need for Difficult-to-Treat Type of Pediatric Acute Lymphoblastic Leukemia

PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome‑negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).  read more

Boston Scientific Announces U.S. FDA Approval of Navigation-Enabled Ablation Catheters

PRNewswire/ — Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for two catheters that can be used with the Rhythmia™ Mapping System. The IntellaNav™ XP and the IntellaNav MiFi™ XP navigation-enabled ablation catheters – designed to map and ablate – were approved to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart. These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market. Along with the immediate launch of the catheters, the company is also releasing a software enhancement for the Rhythmia Mapping System. read more

Allergan Presents New Data at the American Urological Association Meeting in San Diego

PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company today announced that it has presentations in overactive bladder, nocturia and ulcerative interstitial cystitis at the upcoming American Urological Association (AUA) annual meeting in San Diego, California, May 6-10.  read more

Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication – FDA Warns About New Impulse-control Problems

FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized. read more

Epizyme Announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Mesothelioma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that the U.S. Food and Drug Administration has accepted the company’s Investigational New Drug (IND) application for tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function. In the third quarter of this year, the company plans to initiate a phase 2 study in patients with mesothelioma. read more

Colorcon Announces New Film Coating Manufacturing Plant in Brazil

Colorcon Inc. is pleased to announce its investment in a new film coating manufacturing plant in Indaiatuba – São Paulo State, Brazil, supporting the continued growth of the pharmaceutical industry in South America. The construction is scheduled for completion by October 2016 with the production of commercial scale product scheduled for January 2017. Strategically located, the site will produce GMP film coating products for the pharmaceutical and nutritional markets in South America, including Argentina, Brazil, Chile, Paraguay and Uruguay.  read more

MOLOGEN to present next generation of TLR9 agonists at ASGCT 2016

The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) will present pre-clinical data on its EnanDIM® technology, a new family of TLR9 agonists and so-called Immune Surveillance Reactivators (ISR), at the 19th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in Washington, U.S. (4-7 May, 2016). read more

Ligand Acquires Portfolio of Synthetic Royalty and Milestone Rights from CorMatrix® Cardiovascular for $17.5 Million

SAN DIEGO–(BUSINESS WIRE)–Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces the acquisition of economic rights to multiple programs owned by CorMatrix®. Ligand will pay $17.5 million and in return will receive a portion of revenue (synthetic royalty) from CorMatrix’s existing marketed products and will have the right to receive future synthetic royalties from potential future products. CorMatrix’s products are medical devices that are designed to permit the development and regrowth of human tissue. This transaction will be immediately accretive to Ligand and represents Ligand’s entry into the field of medical devices read more

 

 

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