Published: Mar 01, 2021
LES ULIS, France (BUSINESS WIRE) Regulatory News:
LFB today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted for filing the Marketing Authorization Application for eptacog beta, a recombinant coagulation Factor VIIa (rFVIIa).
The application includes data from three prospective phase 3 clinical trials (PERSEPT
1, PERSEPT
2, and PERSEPT
3) assessing the efficacy and safety of eptacog beta in the treatment of bleeding episodes in children and adults with congenital haemophilia A or B with inhibitors and for the prevention of bleeding in those patients undergoing surgery or invasive procedures. The final outcome from the EMA review is expected by mid-2022.
FibroGen Reports Fourth Quarter and Full Year 2020 Financial Results apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.
Zai Lab Announces Financial Results for Second-half and Full-year 2020
March 01, 2021 07:00 ET | Source: Zai Lab Limited Zai Lab Limited Company to Host Conference Call and Webcast Today at 8:00 a.m. ET
SHANGHAI and SAN FRANCISCO, March 01, 2021 (GLOBE NEWSWIRE) Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today reported financial results for the second half and full year of 2020, along with corporate updates.
“2020 was another year of great accomplishment for Zai Lab,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “We successfully launched ZEJULA for both second-line and first-line ovarian cancer and Optune for glioblastoma in China. We submitted NDAs and were granted priority reviews by China’s National Medical Products Administration (NMPA) for both QINLOCK for advanced gastrointestinal stromal tumors (GIST) and NUZYRA for community-acquire
Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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NEWTON, Mass., March 1, 2021 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Compensation Committee of Karyopharm s Board of Directors granted stock options to purchase an aggregate of 93,600 shares of Karyopharm s common stock to 11 newly-hired employees, with a grant date of February 26, 2021. The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).
Each of the stock options has an exercise price of $13.82 per share, the closing price of Karyopharm s common stock on February 26, 2021. Each stock option vests over four years, with 25% of the total number of shares underlying the stock option vesting on the one-yea
EMA Accepts Pfizer s MAA For 20-valent Pneumococcal Conjugate Vaccine Candidate For Adults
NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) said the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults 18 years of age and older. The epidemiology of pneumococcal serotypes causing disease has been changing due to the success of pneumococcal conjugate vaccines targeting pediatric and adult populations. In many countries across Europe and around the world, more than half of all cases of invasive pneumococcal disease in older adults are due to the 20 serotypes covered in 20vPnC, including seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that are not included in any currently licensed pneumococcal conjugate vaccine, said Kathrin U. Jansen, Senior Vice President and Head of Vaccine Re