W
ith the next marketing approval the year 2021 gets off to a promising start for PAION, and we congratulate Hana Pharm on this achievement, said Dr. Jim Phillips, CEO of PAION AG.
With the recently started construction of their own production plant for BYFAVO
TM, our partner continues to invest in the success of BYFAVO
TM and we are looking forward to the upcoming market launch.
Dr. Younha Lee, CEO of Hana Pharm, announced:
We are thrilled to announce BYFAVO
TM approval in South Korea and sincerely thankful for the rewarding partnership with PAION since 2013. Today s approval allows us to leverage Hana Pharm s significant development and commercialization expertise in anesthesiology in South Korea. We will be accelerating the remaining process towards product launch in South Korea and also the regulatory and commercial partnering progress in Singapore, Thailand, Vietnam, Indonesia, the Philippines and Malaysia this year.
DGAP-Ad-hoc: PAION AG / Key word(s): Regulatory Approval
PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM (BYFAVO) IN GENERAL ANESTHESIA IN SOUTH KOREA
07-Jan-2021 / 11:14 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
PAION AG: HANA PHARM RECEIVES MARKET APPROVAL FOR REMIMAZOLAM (BYFAVO
TM) IN GENERAL ANESTHESIA IN SOUTH KOREA
Aachen (Germany), 07 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces that Hana Pharm, remimazolam licensee for South Korea, today informed PAION that South Korea s Ministry of Food and Drug Safety (MFDS) has approved the New Drug Application (NDA) for BYFAVO
Published: Dec 30, 2020 By Alex Keown
Shares of
Protalix Biotherapeutics were up nearly 7% in premarket trading after the company announced its
Phase III BRIDGE study met key objectives in treating Fabry Disease. The announcement followed previous topline data from the study released in May.
The study assessed PRX-102 (pegunigalsidase alfa), a plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A product candidate in Fabry patients who switched from treatment with agalsidase alfa. After the switch from agalsidase alfa to PRX-102, researchers noted substantial improvement in patients’ renal function as measured by mean annualized estimated Glomerular Filtration Rate. In May, the company announced positive topline results for the BRIDGE study.
Hot Penny Stocks For Your Year-End Watch List
Are you ringing in the New Year with penny stocks? If you havenât any cheap stocks on your watch list yet, you might want to take a second look. This week has been red hot for stocks under $5 and no, it isnât because of COVID. Well, some catalysts have stemmed from pandemic-related headlines. But, for the most part, countless penny stocks have surged thanks to their own momentum and headlines. For instance, we discussed Bionano Genomics Inc. (BNGO Stock Report) this quarter and most recently, earlier this week.
Something we discuss frequently is following sector and industry trends to find âthe rising tideâ. This saying suggests that a broader trend can help catapult momentum for stocks. In this case, biotech stocks have been hot. In the case of BNGO stock, it was benefiting from a series of headlines relating to its Saphyr system. This is the companyâs platform designed for diagnostics and therapeutic data ana
TMCnet News
Sorrento Announces the Submission of a Marketing Authorization Application to COFEPRIS (Mexico) for COVI-STIX™ Rapid Detection Test of SARS-CoV-2 Viral Antigen
[December 30, 2020]
Sorrento Announces the Submission of a Marketing Authorization Application to COFEPRIS (Mexico) for COVI-STIX™ Rapid Detection Test of SARS-CoV-2 Viral Antigen
SAN DIEGO, Dec. 30, 2020 (GLOBE NEWSWIRE) Sorrento Therapeutics, Inc. (Nasdaq: SRNE, Sorrento ) today announced that a Marketing Authorization Application has been submitted by its agents in Mexico to Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the health regulatory authority for Mexico, for its COVI-STIX rapid diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients, Inmunoensayo de flujo lateral para la detección cualitativa de la proteÃna nucleocápside del SARS-CoV-2 .