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Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST for Prophylaxis of Hereditary Angioedema Attacks
11/27/2017
The submission includes data from two completed trials of RUCONEST for the prophylaxis of HAE attacks: a randomized, double-blind, placebo-controlled trial and an open-label study.
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Sobi Receives Approval From Health Canada for Orfadin (nitisinone) Oral Suspension for the Treatment of HT-1
11/27/2017
Orfadin is the first medicine approved in multiple countries globally for use in combination with dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1).
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Benitec Biopharma Provides Update on OPMD Orphan Disease Program
11/27/2017
In addition, over the past several weeks, the Benitec team has now completed pre-IND and scientific advice meetings with the U.S. FDA, Health Canada and several European agencies.
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European Commission Approves Tremfya (Guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis in the European Union
11/27/2017
The EC approval is based on data from three Phase III clinical studies. The VOYAGE 1 and 2 trials, which compared guselkumab with placebo and HUMIRA.
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Ferring Receives Swiss Approval for Rekovelle, The First Personalised Fertility Treatment Using an Approved Dosing Algorithm
11/27/2017
Nov. 27, 2017 06:00 UTC Ferring Receives Swiss Approval For Rekovelle ® , The First Personalised Fertility Treatment Using an Approved Dosing Algorithm Rekovelle ® provides doctors with an approved, evidence-based, individualised dosing regimen to personalise fertility treatment Approval expands options for fertility patients in Switzerland, providing a new and tailored appr
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MorphoSys Announces That its Licensee Janssen Has Received Approval for Tremfya (Guselkumab) in Europe for the Treatment of Moderate-to-Severe Plaque Psoriasis
11/27/2017
MorphoSys is eligible to receive royalties on net sales of Tremfya.
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Perrigo Announces the Launch of an AB Rated Generic Version of Exalgo 32mg Extended Release Tablets
11/27/2017
Exalgo 32mg extended release tablets C-II is an opioid agonist indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
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VANC Pharmaceuticals Plans to Launch INSTI HIV Test with United Pharma Group on World AIDS Day
11/27/2017
This represents the first time the Canadian public will have direct access to their HIV status within 60 seconds in a community pharmacy, since the program was successfully piloted in July 2014.
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Perrigo Announces the Launch of an AB Rated Generic Version of Mycolog II Cream
11/27/2017
Mycolog II Cream is indicated for the treatment of cutaneous candidiasis.
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New Intelligence Tool Helps Researchers Cope With Immuno-Oncology Boom
11/27/2017
IO Combination Trials Intelligence is part of Hanson Wade's Beacon Targeted Therapies service.
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BASF to Increase Prices for Formic Acid and Propionic Acid in the EMEA Region
11/27/2017
Prices for all other concentrations of Formic Acid will be increased accordingly on a pro rata basis.
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Quadrant Biosciences Release: Salivary microRNA May Predict Duration and Nature of Concussion Symptoms Among Children
11/27/2017
Small molecules in saliva may hold the key to predicting the type and duration of concussion symptoms, according to a study just published in the JAMA.
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NYU Langone Health Release: Removing Chemical Used to Make Teflon-Like Coatings Has Led to Fewer Low Birth Weights and Less Brain Damage
11/27/2017
Scientists behind the research, conducted at NYU School of Medicine, say that studies have long linked the chemicals-famous for keeping food from sticking to pans-with high blood pressure, birth defects, and lower-than-normal birth weights.
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Bio-Tissue Announces Study that Demonstrates Cryopreserved Amniotic Membrane Graft Reduces Recurrence After Pterygium Surgery
11/27/2017
In this retrospective review, 556 eyes representing 535 patients, who had pterygium excision (527 primary, 29 recurrent) were treated with adjunctive cryopreserved amniotic membrane.
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Storm Therapeutics Announces Publication in Nature on RNA Epigenetics by Founder Professor Tony Kouzarides
11/27/2017
The study has found an unexpected new drug target for acute myeloid leukaemia that could open new avenues to develop effective treatments against this potentially lethal disease.
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Orig3n Acquires Interleukin Genetics, a Genetics-Based Personalized Health Company, to Advance the Future of Health Faster
11/27/2017
The automated genotyping lab is fully-licensed for testing in all 50 U.S. states and is capable of processing over one million samples per year.
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Avista Capital Partners to Acquire Express Scripts' Subsidiary United BioSource
11/27/2017
Centerview Partners LLC acted as financial advisor and Bryan Cave LLP acted as legal counsel to Express Scripts.
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Skinvisible Announces Proposed Merger With Quoin Pharma
11/27/2017
Skinvisible announced that it has entered into a non-binding term sheet regarding a proposed merger of Skinvisible with and into Quoin Pharma subject to tax, accounting, legal, regulatory, and other considerations.
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CanniMed Therapeutics Confirms Receipt of Unsolicited Offer From Aurora Cannabis
11/27/2017
Shareholders already have an attractive and accretive acquisition of Newstrike Resources available to them.
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GENFIT: Contributing Significantly to the European LITMUS Initiative on NASH Biomarkers
11/27/2017
LITMUS (The Liver Investigation: Testing Marker Utility in Steatohepatitis) is a European consortium that brings together clinicians and scientists from prominent academic centers across Europe.