Chiesi, Protalix Receive Positive CHMP Opinion For Pegunigalsidase Alfa To Treat Fabry Disease

RTTNews | 899 dias atrás
Chiesi, Protalix Receive Positive CHMP Opinion For Pegunigalsidase Alfa To Treat Fabry Disease

(RTTNews) - Protalix BioTherapeutics, Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of the Chiesi Group, announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX-102 (pegunigalsidase alfa), the first and only pegylated enzyme for the treatment of adult patients with Fabry disease.

PRX-102 is a novel recombinant human a-Galactosidase-A (a-Gal-A) enzyme being investigated as an enzyme replacement therapy (ERT) for the treatment of Fabry disease.

The positive CHMP opinion was based on a marketing authorization application (MAA) that includes positive data from a comprehensive set of preclinical, clinical and manufacturing studies evaluating PRX-102.

The CHMP opinion is now referred for final action to the European Commission (EC). A final EC decision on the MAA is expected in the beginning of May 2023.

Etiquetas: PLX
read more
European Economic News Preview: UK Unemployment Data Due

European Economic News Preview: UK Unemployment Data Due

Unemployment from the UK and economic confidence from Germany are the top economic news due on Tuesday. At 2.00 am ET, the Office for National Statistics publishes UK unemployment data. The jobless rate is forecast to remain unchanged at 4.7 percent in the second quarter. At 3.00 am ET, retail sales figures are due from Turkey.
RTTNews | 19 minutos atrás
Australian Market Trims Early Gains In Mid-market

Australian Market Trims Early Gains In Mid-market

The Australian stock market is trimming its early gains in mid-market trading on Tuesday, but extending the gains in the previous session, despite the broadly negative cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving above the 8,850 level to fresh all-time high, with gains in financial and energy stocks partially offset by weakness in mining and technology stocks.
RTTNews | 1 h 55 min atrás
Asian Markets Trade Mostly Higher

Asian Markets Trade Mostly Higher

Asian stock markets are trading mostly higher on Tuesday, despite the broadly negative cues from Wall Street overnight, with the Australian and the Japanese markets hitting record all-time highs, as the U.S. and China agreed to extend their tariff truce for another 90 days. Optimism about the US Fed cutting interest rate at its next meeting is also aiding market sentiment.
RTTNews | 2 h 34 min atrás
Sensex, Nifty Set For Muted Open On Mixed Global Cues

Sensex, Nifty Set For Muted Open On Mixed Global Cues

Indian shares are seen opening flat to slightly lower on Tuesday after rising sharply in the previous session as the announcement of a meeting between Russian President Vladimir Putin and U.S. President Donald Trump has fueled expectations of a potential end to sanctions limiting supply of Russian oil to other markets.
RTTNews | 3 h 5 min atrás
Japanese Market Sharply Higher; Up 2%

Japanese Market Sharply Higher; Up 2%

The Japanese stock market is trading sharply higher on Tuesday, extending the gains in the previous five sessions, despite the broadly negative cues from Wall Street overnight, with the Nikkei 225 surging over 2 percent near the 42,700 level to record all-time highs, with gains across all sectors led by index heavyweights, technology and financial stocks.
RTTNews | 3 h 59 min atrás