ACUC

AcuCort signs its first commercial agreement for the company's drug Zeqmelit™

Retrieved on: 
Thursday, November 24, 2022

The agreement gives Kamada the exclusive right to the marketing and sales as well as the distribution of AcuCort's drug Zeqmelit for, among other things, the treatment of acute allergy on the Israeli market.

Key Points: 
  • The agreement gives Kamada the exclusive right to the marketing and sales as well as the distribution of AcuCort's drug Zeqmelit for, among other things, the treatment of acute allergy on the Israeli market.
  • Under the terms of the agreement, Kamada is responsible for the commercialization of Zeqmelit in Israel and has the exclusive right to marketing, sales, and distribution of the drug in this market.
  • The agreement is a historic and commercial milestone for AcuCort.
  • It is also a confirmation that AcuCort's innovative drug Zeqmelit is commercially interesting and attracts partners," says Jonas Jnmark, CEO of AcuCort AB.

AcuCort is granted SME status by the European Medicines Agency, EMA

Retrieved on: 
Monday, June 27, 2022

STOCKHOLM, June 27, 2022 /PRNewswire/ --AcuCort AB (publ) (Spotlight Stock Market: ACUC) announces that the European Medicines Agency, EMA, has decided that the company meets the requirements for SME status in accordance with current EU regulations.

Key Points: 
  • STOCKHOLM, June 27, 2022 /PRNewswire/ --AcuCort AB (publ) (Spotlight Stock Market: ACUC) announces that the European Medicines Agency, EMA, has decided that the company meets the requirements for SME status in accordance with current EU regulations.
  • The positive decision entails certain administrative and financial benefits for AcuCort in future applications for market approval for the company's pharmaceutical product ISICORT within the EU.
  • During the spring, AcuCort applied to EMA aiming to qualify the company in the category micro, small or medium-sized enterprise (SME) laid down in Regulation (EC) No 2049/2005.
  • "It is very gratifying that the European Medicines Agency has granted AcuCort SME status in the EU.

AcuCort is exempted from the application fee by the U.S. Food and Drug Administration

Retrieved on: 
Tuesday, March 1, 2022

The positive decision means that AcuCort is exempted from paying an application fee of USD 1.6 million provided that the application is submitted no later than the last day of February 2023.

Key Points: 
  • The positive decision means that AcuCort is exempted from paying an application fee of USD 1.6 million provided that the application is submitted no later than the last day of February 2023.
  • In the fall of 2021, AcuCort filed an application for a fee waiver, which the FDA has now granted.
  • It is very gratifying that the FDA has granted AcuCort an exemption from paying the registration application fee forISICORT in the U.S.
  • The application fee is a large cost for a company like AcuCort and FDA's decision is therefore an important and extremely positive news.

AcuCort is exempted from the application fee by the U.S. Food and Drug Administration

Retrieved on: 
Tuesday, March 1, 2022

The positive decision means that AcuCort is exempted from paying an application fee of USD 1.6 million provided that the application is submitted no later than the last day of February 2023.

Key Points: 
  • The positive decision means that AcuCort is exempted from paying an application fee of USD 1.6 million provided that the application is submitted no later than the last day of February 2023.
  • In the fall of 2021, AcuCort filed an application for a fee waiver, which the FDA has now granted.
  • It is very gratifying that the FDA has granted AcuCort an exemption from paying the registration application fee forISICORT in the U.S.
  • The application fee is a large cost for a company like AcuCort and FDA's decision is therefore an important and extremely positive news.

Global Diving Suits Market (2021 to 2027) - Featuring Billabong, Dive Rite and H2Odyssey Among Others - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 26, 2021

The diving suits market is anticipated to grow at a CAGR of 4.5% during the forecast period.

Key Points: 
  • The diving suits market is anticipated to grow at a CAGR of 4.5% during the forecast period.
  • The increasing interest in diving in the young generation has resulted in the establishment of several diving centers, where people learn professional diving with certification from various diving associations.
  • Diving associations and diving centers work hand in hand, wherein diving associations are the organization, which include certification in cave diving, commercial diving, recreational diving, technical diving, and freediving.
  • These diving suits include wet, dry, and semi-dry diving suits.