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BioWorld Science

June 4, 2018

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FDA grants orphan drug designation to GBC-0905 for the treatment FSHD

vTv Therapeutics licenses PDE4 inhibitor program to Newsoara Biopharma

Tegsedi receives positive opinion in Europe

Kyowa Hakko Kirin initiated phase III trial of bardoxolone methyl for diabetic kidney disease

Bardoxolone methyl receives orphan drug designation in Europe for the treatment of Alport syndrome

Circassia submits NDA for Duaklir and sNDA for Tudorza to the FDA

Celsius Therapeutics gains rights to Harbour Antibodies' antibody discovery platform

Rxulti receives positive opinion in Europe for the treatment of schizophrenia in adults

Exondys receives negative CHMP opinion

First clinical data for the IDH1/2 inhibitor AG-881 in solid tumors

Aimovig receives positive CHMP opinion for the prevention of migraine

Neural stem cells delivering chimeric orthopoxvirus created to treat ovarian cancer

Kyushu University patents EGFR inhibitors

Bruton tyrosine kinase inhibitors divulged by Daewoong Pharmaceutical

Vanderbilt University synthesizes new mGlu4 receptor positive allosteric modulators

Fully human antibody cocktail shows postexposure protection against lethal Ebola virus in primates

U.S. orphan designation granted to Alnylam Pharmaceuticals siRNA therapy for amyloidosis

FDA approves Olumiant 2 mg for moderate to severe rheumatoid arthritis

Taiwan Liposome submits IND for phase I/II trial of TLC-178 in pediatric rhabdomyosarcoma

EMA CHMP recommends approval of Sandoz adalimumab biosimilar

FDA approves Consensi for osteoarthritis pain and hypertension

Novartis completes divestment of joint venture to GSK

First phase I data presented for LOXO-292 in RET-altered cancers

EMA committee recommends approval of Translarna for younger children with DMD

EMA committee backs approval of trastuzumab biosimilar Trazimera