European Medicines Agency

DGAP-News: CO.DON AG: CO.DON nominated by US magazine 'MedTech Outlook' for 'TOP 10 Orthopedic Solution Providers in Europe 2019'

Thursday, November 21, 2019 - 3:13pm

Berlin/Teltow, 21 November 2019 - CO.DON AG has been nominated in the November issue of MedTech Outlook magazine for the "TOP 10 Orthopedic Solution Providers in Europe - 2019", making it one of the ten leading companies in Europe in terms of its advanced and innovative solutions for orthopaedic applications.

Key Points: 
  • Berlin/Teltow, 21 November 2019 - CO.DON AG has been nominated in the November issue of MedTech Outlook magazine for the "TOP 10 Orthopedic Solution Providers in Europe - 2019", making it one of the ten leading companies in Europe in terms of its advanced and innovative solutions for orthopaedic applications.
  • CO.DON is one of the leading specialists in cell cultivation and produces autologous cell therapies for the regenerative treatment of articular cartilage defects.
  • CO.DON's method is currently used in over 200 clinics in Germany and more than 14,500 patients have already been treated.
  • In July 2017 CO.DON AG received central EU marketing authorisation for this product from the European Medicines Agency (EMA).

Aerie Pharmaceuticals Receives European Commission Approval for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%

Thursday, November 21, 2019 - 11:30am

The marketing authorisation application (MAA) for Rhokiinsa was accepted for review by the European Medicines Agency (EMA) in October 2018.

Key Points: 
  • The marketing authorisation application (MAA) for Rhokiinsa was accepted for review by the European Medicines Agency (EMA) in October 2018.
  • Aerie received a positive scientific opinion recommending approval of the Rhokiinsa MAA from the EMAs Committee for Medicinal Products for Human Use (CHMP) in September 2019.
  • In the interim, we look forward to our Rocklatan, known as Roclanda in Europe, Mercury 3 data expected by mid-2020.
  • The marketing authorisation is valid in all 28 countries of the European Union, plus Iceland, Norway and Liechtenstein.

Tarsius Pharma Announces Granting of Orphan Drug Designation for TRS by the European Medicines Agency

Tuesday, November 19, 2019 - 3:00pm

TEL AVIV,Israel, Nov. 19, 2019 /PRNewswire/ --Tarsius Pharma today announced that the European Medicines Agency (EMA), the European equivalent of the FDA, approved the designation of orphan drug for its TRS for treatment of non-infectious uveitis and has acknowledged the clinically relevant advantage for TRS in non-infectious uveitis patients with glaucoma not eligible for corticosteroid treatment.

Key Points: 
  • TEL AVIV,Israel, Nov. 19, 2019 /PRNewswire/ --Tarsius Pharma today announced that the European Medicines Agency (EMA), the European equivalent of the FDA, approved the designation of orphan drug for its TRS for treatment of non-infectious uveitis and has acknowledged the clinically relevant advantage for TRS in non-infectious uveitis patients with glaucoma not eligible for corticosteroid treatment.
  • Orphan drug designations facilitate development ofdrugs for rare diseases.
  • The TRS Platform Technology has the potential to effectively treat a broad array of autoimmune and inflammatory ocular diseases.
  • Tarsius Pharma was established in 2016and is focused on developing TRS, a breakthrough, bio-inspired platform technology for the treatment of blinding ocular diseases.

European Medicines Agency Grants PRIME Designation to Danicopan for Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients Who Are Not Adequately Responding to a C5 Inhibitor

Tuesday, November 19, 2019 - 12:30pm

We are very pleased that the European Medicines Agency has granted PRIME designation for danicopan, our lead oral factor D inhibitor, said Dr. Kevin P. Malobisky, Senior Vice President Regulatory Affairs, Quality & Compliance.

Key Points: 
  • We are very pleased that the European Medicines Agency has granted PRIME designation for danicopan, our lead oral factor D inhibitor, said Dr. Kevin P. Malobisky, Senior Vice President Regulatory Affairs, Quality & Compliance.
  • The EMAs decision further highlights the unmet medical need for PNH patients who are suboptimal responders to a C5 inhibitor, the current standard of care.
  • To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.
  • Danicopan (ACH-4471) has previously received orphan drug designation and Breakthrough Therapy designation from the U.S. Food & Drug Administration (FDA) for the treatment of PNH, and orphan status from the European Medicines Agency.

Xeris Pharmaceuticals Reports Third Quarter 2019 Financial Results and Highlights

Thursday, November 7, 2019 - 1:00pm

CHICAGO, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced financial results for the third quarter and nine months ended September 30, 2019.

Key Points: 
  • CHICAGO, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced financial results for the third quarter and nine months ended September 30, 2019.
  • Xeris salesforce will begin calling on healthcare professionals with an additional focus on enabling formulary inclusion and patient access.
  • Xeris expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) by the end of 2019 for its ready-to-use liquid stable glucagon.
  • Xeris senior management will participate in a fireside chat at the Jefferies London Healthcare Conference on November 21, 2019 at 8:00 a.m. local time.

Aimmune Therapeutics Announces Third Quarter 2019 Financial Results and Provides Operational Highlights

Wednesday, November 6, 2019 - 9:05pm

Cash, cash equivalents, and investments totaled $200.5 million on September 30, 2019, compared to $303.9 million on December 31, 2018.

Key Points: 
  • Cash, cash equivalents, and investments totaled $200.5 million on September 30, 2019, compared to $303.9 million on December 31, 2018.
  • In connection with this announcement, Aimmune Therapeutics will host a conference call and webcast today at 4:30 p.m.
  • To access a live or recorded webcast of the call, please visit the Investor Relations section of the Aimmune Therapeutics website at www.aimmune.com .
  • The European Medicines Agency (EMA) is reviewing Aimmunes Marketing Authorization Application (MAA) for PALFORZIA, which Aimmune submitted in June 2019.

Vertex Announces European Medicines Agency Marketing Authorization Application Validation for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Triple Combination Treatment in Cystic Fibrosis

Thursday, October 31, 2019 - 11:21am

Vertex Pharmaceuticals (Europe) Limited today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.

Key Points: 
  • Vertex Pharmaceuticals (Europe) Limited today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.
  • In these studies, the triple combination regimen was generally well tolerated.
  • Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.
  • Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

Aimmune Therapeutics to Host Conference Call and Webcast to Discuss Third Quarter 2019 Financial Results and Recent Operational Highlights

Wednesday, October 30, 2019 - 11:00am

ET to discuss its financial results for the quarter ended September 30, 2019, and recent operational highlights.

Key Points: 
  • ET to discuss its financial results for the quarter ended September 30, 2019, and recent operational highlights.
  • To access the live call by phone, dial (877) 497-1438 (domestic) or (262) 558-6296 (international) and enter the passcode 7842939.
  • To access a live or recorded webcast of the call, please visit the Investor Relations section of the Aimmune Therapeutics website at www.aimmune.com .
  • The European Medicines Agency (EMA) is reviewing Aimmunes Marketing Authorization Application (MAA) for PALFORZIA, which Aimmune submitted in June 2019.

FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder

Wednesday, October 30, 2019 - 6:00am

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the companys Biologics License Application (BLA) for satralizumab for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD).

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the companys Biologics License Application (BLA) for satralizumab for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD).
  • The European Medicines Agency (EMA) has also validated the companys Marketing Authorization Application (MAA) for satralizumab, granting it Accelerated Assessment.
  • The FDA decision and the EMAs Committee for Medicinal Products for Human Use (CHMP) recommendation are expected in 2020.
  • A lower rate of infections (including serious infections) was observed in patients treated with satralizumab compared with the placebo group.

Omeros’ Narsoplimab Receives Positive Opinion from European Medicines Agency for Pediatric Investigation Plan Required for MAA Submission

Tuesday, October 29, 2019 - 1:00pm

Omeros Corporation (Nasdaq: OMER) today announced that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has issued a positive opinion for the companys pediatric investigation plan (PIP) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Key Points: 
  • Omeros Corporation (Nasdaq: OMER) today announced that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has issued a positive opinion for the companys pediatric investigation plan (PIP) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
  • Omeros received a deferral for completion of its pediatric plan until after EMA approval of the narsoplimab MAA.
  • In addition to its planned MAA, Omeros recently initiated the rolling submission of its biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab in HSCT-TMA.
  • The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.