European Commission

Orphan designation: Veliparib Treatment of ovarian cancer, 17/12/2010 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Ovarian cancer, Enzyme, DNA repair, Abbott Laboratories, Survival, Disease, Patient, Committee, Knowledge, DNA, Cancer, Female, Regulation, Laboratory, EMA, IRIS, Ludwigshafen, Woman, PARP, European, COMP, Sponsor, European Commission, Fibroadenoma, Safety, Marketing, Medicine, Pharmaceutical industry

Orphan designation: Veliparib Treatment of ovarian cancer, 17/12/2010 Withdrawn

Key Points: 


Orphan designation: Veliparib Treatment of ovarian cancer, 17/12/2010 Withdrawn

Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Brain, Disease, Coagulation, Patient, Committee, Knowledge, Internal, Regulation, Haemophilia, EMA, IRIS, Joint, Human, Wound healing, European, COMP, Bleeding, Spinal cord, Antibody, Sponsor, European Commission, Immune system, Safety, Factor IX, Blood, Marketing, Haemophilia B, Medicine, Pharmaceutical industry

Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

Key Points: 


Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

CCC, Croatia sign contract for DHC-515 firefighting aircraft

Retrieved on: 
Monday, March 25, 2024
Civil service commission, Canadair, Interior, Government, Export Development Canada, Climate change, De Havilland Canada, DHC, Natural Resources, Purchasing, Sale, Acquisition, Corporate Affairs, River, Janez, Contract management, Air force, Water, Safety, European Commission, Crisis management, Aircraft, Ministry, CCC, De Havilland, Wildfire, Airline

Through CCC’s G2G contract, DHC will provide the DHC-515 aircraft to Croatia, along with spare parts, training, and maintenance support.

Key Points: 
  • Through CCC’s G2G contract, DHC will provide the DHC-515 aircraft to Croatia, along with spare parts, training, and maintenance support.
  • Building on the foundation of the iconic Canadair CL-215 and CL-415 aircraft, the DHC-515 FIREFIGHTER™ is a new purpose-built aerial firefighting aircraft.
  • Currently, Croatia currently operates six CL-415 aircraft and will increase its aerial firefighting program by one-third with the acquisition of these two new DHC-515 aircraft.
  • I congratulate Croatia to sign into reality the first planes of what will form a new generation of European firefighting aerial capacity.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in iRobot Corporation of Class Action Lawsuit and Upcoming Deadlines – IRBT

Retrieved on: 
Saturday, March 23, 2024
Civil service commission, European Economic Area, Amazon, District court, RVC, News, Ext, Acquisition, LLP, IRBT, Bloomberg, POLITICO, Complaint, Amazon (company), IRobot, Person, Workforce, European Commission, Pomerantz, Action Replay, Court, Reuters, FTC

NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against iRobot Corporation (“iRobot” or the “Company”) (NASDAQ: IRBT) and certain officers.

Key Points: 
  • NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against iRobot Corporation (“iRobot” or the “Company”) (NASDAQ: IRBT) and certain officers.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • iRobot designs, builds, and sells robots and home innovation products in the U.S., Europe, the Middle East, Africa, Japan, and internationally.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024
Urinary tract infection, Anaphylaxis, Bronchitis, European Commission, Tendon rupture, Patient, European Medicines Agency, Bempedoic acid, Ezetimibe, Therapy, Citrate synthase, Anemia, Pain, Sinusitis, Abdominal pain, Risk, Gout, Ageing, Committee, ACL, Spasm, EMA, Back pain, ATP, Safety, Fatigue, CHMP, Arthralgia, Angioedema, Tablet, Constipation, Agent handling, Death, Pregnancy, CLEAR, Rash, Kidney, Moyamoya disease, Rupture, Apolipoprotein, Hypercholesterolemia, Hypersensitivity, Health, CVD, Incidence, Diarrhea, Fetus, Esperion Therapeutics, Diet, Upper respiratory tract infection, FDC, Uric acid

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD

Retrieved on: 
Friday, March 22, 2024
Retina, Civil service commission, Committee, EMA, European Medicines Agency, Bevacizumab, European, Outlook, Therapy, European Commission, AMD, Marketing, CHMP, Pharmaceutical industry

Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

Key Points: 
  • Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.
  • “The CHMP positive opinion for ONS-5010/LYTENAVA™ represents a significant milestone for Outlook Therapeutics and advancement in the treatment of wet AMD in the EU.
  • If approved, an initial ten years of market exclusivity in the European Union (EU) is expected for ONS-5010/LYTENAVA™.
  • The CHMP’s positive opinion supports the grant of marketing authorization by the European Commission (EC) for Outlook Therapeutics’ application for ONS-5010.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against iRobot Corporation (IRBT)

Retrieved on: 
Friday, March 22, 2024
Civil service commission, The Wall Street Journal, European Economic Area, Roomba, Amazon, Federal Trade Commission, GPM, Defendant, RVC, News, Acquisition, IRBT, Bloomberg, Suite, Amazon (company), IRobot, Workforce, European Commission, Court

Then, on January 10, 2024, it was reported that Amazon did not offer concessions to the EC regarding concerns about the Merger.

Key Points: 
  • Then, on January 10, 2024, it was reported that Amazon did not offer concessions to the EC regarding concerns about the Merger.
  • On this news, iRobot’s stock price fell $7.33, or 19.8%, to close at $29.75 per share on January 10, 2024.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • Glancy Prongay & Murray LLP, Los Angeles

MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, March 21, 2024
Burn, Tax, Debridement, Patient, EWMA, Bank statement, Eschar, Investment, SAWC, Therapy, Depreciation, European Commission, Phase, BCC, Research, Supplement, Wound, EMA, GMP, HERE, Safety, CMS, BLA, Eastern Time Zone, Food, Bromelain (pharmacology), WBP, Development, PMI, WHS, Adjustment, FDA, BMCI, Forecasting, Symposium, Incidence, BSV, Basal-cell carcinoma, Operating cost, European Wound Management Association, Table, Event, Medicare, Pharmaceutical industry

YAVNE, Israel, March 21, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Revenue: Revenue for the fourth quarter 2023 was $5.3 million, compared to $11.6 million in the fourth quarter of 2022.
  • Research and development expenses in the fourth quarter 2023 were $1.8 million compared to $2.7 million in the fourth quarter of 2022.
  • Selling, general, and administrative expenses in the fourth quarter 2023 were $2.8 million, compared to $3.0 million in the fourth quarter of 2022.
  • Operating Results: Operating loss in the fourth quarter of 2023 was $3.9 million, compared to an operating profit of $2.1 million in the fourth quarter of 2022.

Fennec Pharmaceuticals Reports Full Year and Fourth Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 21, 2024
AYA, Research, Remuneration, Civil service commission, Administration, Conference, Net, Growth, Young adult, Fennec, FENC, Patient, Into, G&A, NCCN, Adolescence, Marketing, MHRA, TSX, European Commission, FDA, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the fiscal year ended December 31, 2023 and provided a business update.

Key Points: 
  • ET ~
    RESEARCH TRIANGLE PARK, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the fiscal year ended December 31, 2023 and provided a business update.
  • PEDMARQSI was granted EU marketing authorization by the European Commission in June 2023, and received UK approval from the MHRA in October 2023.
  • Achieved PEDMARK net product revenue of approximately $9 million and $21 million for the fourth quarter and full year 2023, respectively.
  • Financial Results for the Fourth Quarter and Fiscal Year Ended December 31, 2023
    Net Sales – Net product sales of $21.3 million in fiscal 2023 compared to $1.5 million in 2022.

Fennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand

Retrieved on: 
Monday, March 18, 2024
Civil service commission, Neuroblastoma, Ototoxicity, Partnership, Central nervous system, ANZ, Risk, FENC, Patient, Hepatoblastoma, Neoplasm, Cancer, MHRA, TSX, Hearing loss, European, Cisplatin, Safety, European Commission, Liver, Arnold & Porter, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C. and UXBRIDGE, United Kingdom, March 17, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, and Norgine, a leading European specialist pharmaceutical company, today announced an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI® in Europe, Australia and New Zealand. PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to

Key Points: 
  • Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations in the licensed territories.
  • It is estimated that more than 5,000 pediatric patients annually are eligible for platinum-based chemotherapy in Europe.
  • PEDMARQSI was granted EU marketing authorization by the European Commission in June 2023, and received UK approval from the MHRA in October 2023.
  • The studies compared PEDMARQSI plus cisplatin-based regimens to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients.