EU | PharmaShots

The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

July 9, 2020July 9, 2020Tuba Khan

Shots: The EC has signed an agreement to supply Roche’s RoActemra and Merck’s Rebif in 27 EU member states willing to buy the [Read More...]

Novartis, Cosentyx ,secukinumab, Receives, EC, Approval, Axial Spondyloarthritis Spectrum, Marking, Fourth Indication, EU

Novartis’ Cosentyx (secukinumab) Receives EC’s Approval for Axial Spondyloarthritis Spectrum Marking its Fourth Indication in EU

April 29, 2020April 29, 2020Tuba Khan

Shots: The approval is based on P-III PREVENT study involve assessing Cosentyx (150mg, SC with loading dose and 150mg with no loading dose) [Read More...]

Henlius Reports the NMPA’s Acceptance of IND for HLX14 (biosimilar, denosumab)

Henlius HLX02 (Trastuzumab for Injection) Receives EU GMP Certificates

April 23, 2020May 7, 2020Shiwani Sharma

Shots: Henlius has received two EU GMP certificate for drug substance (DS) line and drug product (DP) line for HLX02 (trastuzumab biosimilar) and [Read More...]

Biocad with its Partner ICM Received the Registration Certificate for two of its Biosimilar in EU

March 30, 2020April 9, 2020Shiwani Sharma

The partner received Registration Certificate for its Acellbia (biosimilar, rituximab) and Herticad (biosimilars, trastuzumab) in Bosnia and Herzegovina, countries on the Balkan Peninsula [Read More...]

Fujifilm’s CAD EYE Receives CE Mark to Support the Detection of Colonic Polyp Utilizing AI in the EU

February 28, 2020February 28, 2020Tuba Khan

Shots: Fujifilm’s CAD EYE receives CE mark, backing the real-time detection of colonic polyps during colonoscopy utilizing AI, will be available with software [Read More...]

Sanofi to Establish New Company to Provide Active Pharmaceutical Ingredients in the EU

February 25, 2020February 25, 2020Tuba Khan

Shots: Sanofi to create a standalone company which will combine its API commercial and development activities with six of its API’s production sites [Read More...]

Insights+ Interviews: Views of Dr. Upendra Kaul and Dr. Anish Desai on DIA Medical Device Conference 2020

February 20, 2020February 20, 2020Shiwani Sharma

The Medical Devices Conference will be hosted by DIA India on 21st and 22nd February in collaboration with Medical Technology Association of India [Read More...]

Abbott’s Gallant ICD and CRT-D Device Receives CE Mark in the EU

February 19, 2020February 19, 2020Tuba Khan

Shots: Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices offer patients engagement and remote monitoring via smartphone to patients with [Read More...]

Pfizer’s Vyndaqel (tafamidis, 61mg) Receives EC’s Approval as the First Therapy to Treat Transthyretin Amyloid Cardiomyopathy in the EU

February 18, 2020February 18, 2020Tuba Khan

Shots: The EC approval is based on P-III ATTR-ACT study assessing Vyndaqel (tafamidis meglumine, 20/80mg) vs PBO in patients with ATTR-CM that demonstrated [Read More...]

Zambon Signs a License Agreement with Aquestive to Develop and Commercialize Riluzole Oral Film for Amyotrophic Lateral Sclerosis in EU

November 14, 2019November 14, 2019Tuba Khan

Shots: Aquestive to receive up front, development & commercial milestones and royalties on sales of Riluzole oral film (ROF) in EU. Zambon to [Read More...]