European Medicines Agency

Ascendis Pharma A/S Receives Positive Opinion from the Paediatric Committee of the European Medicines Agency on the Agreement of a Paediatric Investigation Plan

Monday, July 6, 2020 - 2:25pm

As planned, we will move forward with our marketing application submission in Europe this quarter, said Dana Pizzuti, M.D., Ascendis Pharmas Senior Vice President of Development Operations.

Key Points: 
  • As planned, we will move forward with our marketing application submission in Europe this quarter, said Dana Pizzuti, M.D., Ascendis Pharmas Senior Vice President of Development Operations.
  • The Paediatric Committee (PDCO) is the European Medicines Agency's (EMA) scientific committee responsible for activities on medicines for children and to support the development of such medicines in the European Union by providing scientific expertise and defining paediatric needs.
  • A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children.
  • Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group.

The European Commission has Granted Orphan Medicinal Product Designation in the EU for MIV-818

Friday, July 3, 2020 - 6:39am

STOCKHOLM, July 3, 2020 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) today announced that the European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.

Key Points: 
  • STOCKHOLM, July 3, 2020 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) today announced that the European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
  • Orphan Medicinal Product designation provides certain regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10 000 persons in the European Union.
  • This designation can give access to several incentives, including protocol assistance, the EU centralized authorization procedure and reduced regulatory fees and a potential for a 10-year market exclusivity in the EU.
  • HCC represents the fifth most common cancer worldwide but is a rare disease in Europe and the US.

Pfenex Announces Positive European CHMP Opinion for PF708 (EU Brand Name: Livogiva™) and New Partnership in Latin America, and Provides CRM197 Business Update

Friday, June 26, 2020 - 7:05pm

Theramex, the European commercialization partner for Pfenex and Adalvo (formerly Alvogen B2B), received a positive opinion for PF708 (branded in Europe as Livogiva) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Key Points: 
  • Theramex, the European commercialization partner for Pfenex and Adalvo (formerly Alvogen B2B), received a positive opinion for PF708 (branded in Europe as Livogiva) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
  • In order to address this incorrect information, Pfenex asked the NYSE to temporarily halt trading in Pfenexs stock.
  • The CHMPs recommendation will now be considered by the European Commission, which typically issues a decision within 67 days of CHMPs recommendation.
  • Pfenex also uses its Pfenex Expression Technology platform to produce CRM197, a diphtheria toxoid carrier protein for use in prophylactic and therapeutic vaccines.

Samsung Bioepis Receives Positive CHMP Opinion for AYBINTIO® (Bevacizumab)

Friday, June 26, 2020 - 12:12pm

INCHEON, Korea, June 26, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AYBINTIO, a biosimilar candidate referencing Avastini (bevacizumab).

Key Points: 
  • INCHEON, Korea, June 26, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AYBINTIO, a biosimilar candidate referencing Avastini (bevacizumab).
  • The CHMPs positive opinion will now be reviewed by the European Commission (EC) to decide on granting marketing authorization for AYBINTIO.
  • We are delighted by our progress in expanding patient access to high-quality biopharmaceuticals, said Hee Kyung Kim, Senior Vice President, Clinical Science and Regulatory Affairs at Samsung Bioepis.
  • Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company.

Philogen Received Combination Pack Approval for Nidlegy

Wednesday, June 24, 2020 - 8:00am

NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an application for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004.

Key Points: 
  • NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an application for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004.
  • "We are extremely pleased to record EMA's agreement to our strategy for the marketing of NidlegyTM as a combination pack that was considered by CHMP 'indispensable for public health reasons,'" commented Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen.
  • Philogen is a Swiss-Italian clinical-stage company engaged in the discovery and development of novel pharmaceutical and biopharmaceutical products.
  • Philogen is headquartered in Siena, Italy, and has research activities at its subsidiary company Philochem in Zrich, Switzerland.

Philogen Received Combination Pack Approval for Nidlegy

Wednesday, June 24, 2020 - 8:00am

NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an application for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004.

Key Points: 
  • NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an application for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004.
  • "We are extremely pleased to record EMA's agreement to our strategy for the marketing of NidlegyTM as a combination pack that was considered by CHMP 'indispensable for public health reasons,'" commented Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen.
  • Philogen is a Swiss-Italian clinical-stage company engaged in the discovery and development of novel pharmaceutical and biopharmaceutical products.
  • Philogen is headquartered in Siena, Italy, and has research activities at its subsidiary company Philochem in Zrich, Switzerland.

Novartis Cosentyx receives FDA approval for new indication to treat active non-radiographic axial spondyloarthritis

Wednesday, June 17, 2020 - 3:20am

"This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis."

Key Points: 
  • "This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis."
  • In April 2020, Novartis received European Medicines Agency approval of Cosentyx for the treatment of nr-axSpA15.
  • The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection.
  • Novartis Cosentyx gains fourth indication in EU with first-in-class approval in axial spondyloarthritis spectrum.

BrainStorm Granted SME Status by the European Medicines Agency

Monday, June 15, 2020 - 2:00pm

NEW YORK, June 15, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc.(NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agencys (EMA) Micro, Small and Medium-Sized Enterprise (SME) office .

Key Points: 
  • NEW YORK, June 15, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc.(NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agencys (EMA) Micro, Small and Medium-Sized Enterprise (SME) office .
  • Brainstorm is also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data.
  • EMA is facilitating pathways such as PRIME designation that enables critical medicines for major unmet medical need like NurOwn to reach patients earlier.
  • BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS).

Aldeyra Therapeutics Receives Orphan Medicinal Product Designation from the European Commission for ADX-2191 Retinal Disease Program

Monday, June 15, 2020 - 1:00pm

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that ADX-2191 has been designated an orphan medicinal product by the European Commission for the treatment of retinal detachment.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that ADX-2191 has been designated an orphan medicinal product by the European Commission for the treatment of retinal detachment.
  • The Commissions broad orphan medicinal product designation, covering the treatment of retinal detachment, is an important step in advancing the clinical development of ADX-2191 in the European Union, stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.
  • The Commissions decision follows a positive opinion on Aldeyras application for orphan medicinal product designation from the European Medicines Agencys Committee for Orphan Medicinal Products.
  • ADX-2191 previously was granted orphan drug status and fast track designation by the U.S. Food and Drug Administration for the prevention of PVR.

Polyneuron’s PN-1007 Receives U.S. FDA Orphan Drug Designation in Anti-MAG Neuropathy

Friday, June 5, 2020 - 7:00am

Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax credits, FDA user-fee benefits, and seven years of market exclusivity following marketing approval.

Key Points: 
  • Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax credits, FDA user-fee benefits, and seven years of market exclusivity following marketing approval.
  • PN1007 received orphan drug designation from the European Medicines Agency in July 2017.
  • Receiving orphan designation in the U.S. provides additional validation to the development of PN-1007 as a treatment for anti-MAG neuropathy.
  • Polyneuron has obtained orphan drug designation from the U.S. Food and Drug Administration and the European Medicines Agency for PN-1007 in anti-MAG neuropathy.