Marketing Authorisation Application

Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated Assessment by European Medicines Agency

Retrieved on: 
Friday, February 23, 2024

Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.

Key Points: 
  • Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.
  • COPENHAGEN, Denmark, February 23, 2024 – Bavarian Nordic A/S (OMX: BAVA) (“the Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP, the Company’s investigational chikungunya vaccine.
  • Bavarian Nordic is on track and plans to submit its MAA for CHIKV VLP to the EMA during H1 2024.
  • “We are pleased to receive the accelerated assessment in recognition of our chikungunya vaccine candidate and our efforts to bring this novel product to the market.

Axcelis Announces Shipment of Purion EXE Power Series Implanter to Leading SiC Power Device Chipmaker in Japan

Retrieved on: 
Wednesday, October 18, 2023

BEVERLY, Mass., Oct. 18, 2023 /PRNewswire/ -- Axcelis Technologies, Inc. (Nasdaq: ACLS), a leading supplier of enabling ion implantation solutions for the semiconductor industry, today announced the shipment of the Company's Purion EXE SiC Power Series™ 200mm high energy implanter to a leading SiC power device chipmaker located in Japan. The system will be used in high volume production of SiC power devices for use in automotive applications.

Key Points: 
  • BEVERLY, Mass., Oct. 18, 2023 /PRNewswire/ -- Axcelis Technologies, Inc. (Nasdaq: ACLS), a leading supplier of enabling ion implantation solutions for the semiconductor industry, today announced the shipment of the Company's Purion EXE SiC Power Series™ 200mm high energy implanter to a leading SiC power device chipmaker located in Japan.
  • The system will be used in high volume production of SiC power devices for use in automotive applications.
  • The power device market is at a critical inflection point as chipmakers transition from 150mm to 200mm SiC wafers.
  • We look forward to continuing to expand the Purion platform footprint in Japan and supporting our customers' goals to increase their manufacturing capacity."

Cosmo announces submission of Winlevi® to the European Medicines Agency (EMA)

Retrieved on: 
Tuesday, October 17, 2023

This filing marks a significant milestone in pipeline progression, as approval will open the substantial EU market to already selected, high-standing partners.

Key Points: 
  • This filing marks a significant milestone in pipeline progression, as approval will open the substantial EU market to already selected, high-standing partners.
  • Cosmo has officially submitted the Marketing Authorisation Application (MAA) for its innovative acne treatment clascoterone 1% cream (Winlevi®) to the European Medicine Agency (EMA) through the centralized procedure, aimed at obtaining a single Marketing Authorization for the product in the European Union.
  • The EMA's rigorous evaluation process will assess the product's safety, quality, and efficacy, ultimately determining its suitability for approval within the European market.
  • This submission to the EMA is a pivotal step forward in our mission as well as a testament to our ongoing commitment to innovation.

Amylyx Pharmaceuticals Receives Negative CHMP Opinion on its Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union Following Re-Examination Process

Retrieved on: 
Friday, October 13, 2023

The decision follows the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted in June 2023.

Key Points: 
  • The decision follows the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted in June 2023.
  • Since the medication’s approval with conditions in Canada and full approval in the U.S., thousands of people have been prescribed AMX0035 in North America.
  • PHOENIX is a 48-week, randomized placebo-controlled global Phase 3 clinical trial further evaluating the safety and efficacy of AMX0035 for the treatment of ALS.
  • The CHMP opinion will be forwarded to the European Commission, who will adopt the final decision on this application.

Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate

Retrieved on: 
Thursday, September 7, 2023

Saint-Herblain (France) & New York, September 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.

Key Points: 
  • Saint-Herblain (France) & New York, September 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.
  • Lyme disease continues to spread, representing an important unmet medical need that impacts the lives of many people in the Northern Hemisphere.
  • With each new set of positive data, we come one step closer to potentially bringing this vaccine to both adults and children living in areas where Lyme disease is endemic.”
    The Phase 2 booster results emphasize the vaccine candidate’s potential to provide immunity against Lyme disease in pediatric and adolescent populations.
  • “Protection against Lyme disease is important for anyone who lives or spends time outdoors in areas where Lyme disease is endemic.

Ascendis Pharma Reports Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, September 5, 2023

Remain on track for European Commission decision on Marketing Authorisation Application (MAA) for TransCon PTH during the fourth quarter of 2023.

Key Points: 
  • Remain on track for European Commission decision on Marketing Authorisation Application (MAA) for TransCon PTH during the fourth quarter of 2023.
  • Ended the second quarter of 2023 with cash, cash equivalents, and marketable securities totaling €431.1 million.
  • Total revenue for the second quarter of 2023 was €47.4 million compared to €6.2 million during the same period in 2022.
  • Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its second quarter 2023 financial results.

Italfarmaco Group Receives EMA Validation of Marketing Authorization Application for Givinostat in Duchenne Muscular Dystrophy

Retrieved on: 
Tuesday, September 5, 2023

Italfarmaco Group announced today that its Marketing Authorization Application (MAA) for Givinostat as a potential treatment for Duchenne Muscular Dystrophy (DMD) has been submitted to the European Medicine Agency (EMA) and that the EMA has started its regulatory review process.

Key Points: 
  • Italfarmaco Group announced today that its Marketing Authorization Application (MAA) for Givinostat as a potential treatment for Duchenne Muscular Dystrophy (DMD) has been submitted to the European Medicine Agency (EMA) and that the EMA has started its regulatory review process.
  • The MAA submission to the EMA follows Italfarmaco Group's New Drug Application (NDA) submission for Givinostat to the U.S. Food and Drug Administration (FDA), which has granted priority review for Givinostat as announced in June this year .
  • “The Phase 3 evaluation of Givinostat demonstrated that it can slow DMD progression in boys six years and older.
  • If approved, Givinostat could greatly benefit younger and older DMD patients by preserving their motor skills and muscle strength,” said Paolo Bettica, MD, PhD, Chief Medical Officer at Italfarmaco Group.

Amylyx Pharmaceuticals Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the second quarter ended June 30, 2023.
  • Net product revenue for the three months ended June 30, 2023 was $98.2 million, compared to net product revenue of $71.4 million for the three months ended March 31, 2023.
  • Financial Results for the Second Quarter Ended June 30, 2023
    For the three months ended June 30, 2023, net product revenue was $98.2 million, and cost of sales were $5.6 million.
  • Cash, cash equivalents, and short-term investments were $357.3 million at June 30, 2023, compared to $345.7 million at March 31, 2023.

EMA Accepts MAA for DMB-3115 of Dong-A ST, a Stelara Biosimilar

Retrieved on: 
Monday, July 17, 2023

Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).

Key Points: 
  • Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).
  • Accord , a wholly owned subsidiary of Intas Pharmaceuticals Ltd, submitted the MAA to EMA on June 23rd, and the EMA accepted the MMA submission on July 14th in CET.
  • The MAA submission is based on the results of an extensive analytical similarity assessment of DMB-3115 with that US and EU-sourced STELARA using current ‘state-of-the-art’ methods.
  • The MAA submission also comprised the results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326).

InflaRx Announces Commercial Launch of Gohibic (vilobelimab) in the U.S. for the Treatment of Critically Ill COVID-19 Patients

Retrieved on: 
Wednesday, June 21, 2023

Gohibic is currently the only drug directed against the complement factor C5a that is authorized for the treatment of certain critically ill COVID-19 patients.

Key Points: 
  • Gohibic is currently the only drug directed against the complement factor C5a that is authorized for the treatment of certain critically ill COVID-19 patients.
  • InflaRx is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic.
  • Dr. Thomas Taapken, Chief Financial Officer of InflaRx, commented: “We have built an excellent core commercial team to support the launch and distribution to U.S. hospitals.
  • The Company will provide updates on the status of regulatory submissions in the U.S. and elsewhere once available.