Drug approvals in Europe| EMA drug approvals | 2023 |European Commission News| iPharmaCenter
European Commission (EC) has granted conditional marketing authorization for AbbVie's Tepkinly (epcoritamab) as a standalone treatment...
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CHMP Positive Opinions | EMA Drug Approvals | European Commission | 2023 | iPharmaCenter
JULY 2023 CHMP POSITIVE OPINIONS The EMA's CHMP gave a positive opinion for ViiV Healthcare's cabotegravir, marking a significant...
Medicines and Healthcare products Regulatory Agency | News | 2023 Approvals | iPharmaCenter
Eisai and Biogen have jointly announced the submission of a Marketing Authorization Application (MAA) for lecanemab, an investigational...
2022 | CHMP Positive Opinions | EMA Drug Approvals | European Commission | Pharma | News
DECEMBER 2022 CHMP POSITIVE OPINIONS CSL's gene therapy, Hemgenix, received a positive CHMP opinion for treating Hemophilia B. The CHMP...
Drug approvals in Europe| EMA drug approvals in 2022 |European Commission News| iPharmaCenter
December 21, 2022 EMA approved Lynparza, Zytiga, and prednisone or prednisolone combination for metastatic castration-resistant prostate...
France healthcare News | HAS Sante | COVID 19 | Drug approvals | iPharmaCenter
December 08, 2022 Sanofi/GSK's and Novavax's COVID-19 vaccine received a favorable opinion from HAS as a booster dose vaccine. HAS...
COVID19 drug updates | FDA EMA approved COVID19 drugs
Oct 6, 2022 Merck and Ridgeback announced that molnupiravir has no efficacy in vaccinated adults. Merck and Ridgeback announced two...
Opdualag was approved for unresectable/metastatic melanoma | LAG-3 inhibitors | Mode of action
Bristol Myers Squibb announced that the European Commission had approved Opdualag (nivolumab and relatlimab) for treating advanced...
European Commission approved Scemblix for chronic myeloid leukemia | iPharmaCenter
European Commission has approved Scemblix (asciminib) for treating adult patients with Philadelphia chromosome-positive chronic myeloid...
Roche’s Polivy was approved as first-line therapy for patients with DLBCL.
Roche has announced that the European Commission approved Polivy (polatuzumab vedotin) in combination with rituximab plus...
Germany HTA News | IQWIG and G-BA assessment news | Germany Pharma News
December 2021 IQWIG says Rinvoq has added benefit at higher doses, but with safety issues IQWIG has assessed the benefit assessment of...
European Commission approved Roche's and Celltrion's monoclonal antibodies for COVID19
Ronapreve (casirivimab / imdevimab) approved for treating and preventing COVID19 in adults and adolescents Celltrion's Regkirona...
European Commission approved Benlysta for active lupus nephritis
GlaxoSmithKline announced that it received approval for expanded use of Benlysta (belimumab) for lupus nephritis in Europe. The drug is...
France COVID-19 Updates | COVID-19 News in Europe
HAS recommended the user of mRNA vaccines for a population already administered with AstraZeneca vaccine AstraZeneca’s COVID19 vaccine...
GSK’s Jemperli received approval in Europe and the US for endometrial cancer
GSK has announced that the US FDA has approved Jemperli (dostarlimab), a programmed death receptor-1 (PD-1) for endometrial cancer. The...
England patients to benefit from Phesgo, 5-minute breast cancer treatment from Roche
NHS England recommended the use of Roche's Phesgo (pertuzumab/trastuzumab) for treating HER2-positive breast cancer. HER2-positive breast...
CHMP Opinions | EMA drug approvals
March 2021 CHMP Positive Opinion Verastem’s Copiktra (duvelisib) received CHMP positive opinion for treating CLL and FL CHMP gave a...
Novartis and BeiGene collaboration strengthens the Swiss drugmaker's oncology portfolio
Novartis entered a strategic collaboration with BeiGene to license tislelizumab; to market in major markets outside China, including...
Biogen initiated Phase 4 trial to determine the efficacy of Spinraza in Zolgensma treated patients
Biogen has announced that the first patient with spinal muscular atrophy (SMA) has been treated with Spinraza (nusinersen), who were...
Kite’s CAR-Tcell therapy received approval in Europe for relapsed or refractory mantle cell lymphoma
Kite announced that it received conditional approval in Europe for Tecartus (brexucabtagene autoleucel). Tecartus is a chimeric antigen...
European Commission to purchase 200 million doses of Johnson and Johnson's COVID 19 vaccine
Johnson and Johnson announced that the European Commission had approved an Advance Purchase Agreement, according to which the European...
HAS says Gilead's Veklury 'does not improve benefit' for COVID19 patients; EMA to review safety
HAS announced that Gilead has withdrawn the refund request of Veklury (remdesivir) for COVID19 patients. Also read: HEALTHCARE SYSTEM IN...
ESMO 2020
BMS Opdivo for Resected Esophageal or Gastroesophageal Junction Cancer Bristol Myers Squibb has presented the results of Phase 3...
Oxford vaccine trials were paused because of safety concerns; AZ said it’s ‘routine’
AstraZeneca has announced that the randomized clinical trials of AZD1222, a vaccine developed Oxford, has been paused because of the...
European Commission approved GSK’s Blenrep for relapsed and refractory multiple myeloma
GSK has announced that the European Commission has granted approval for Blenrep (belantamab mafodotin) for treating adult patients with...
JULY 2020 CHMP POSITIVE OPINION
ADAKVEO (crizanlizumab) Adakveo received a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) for...
European Commission approved Lynparza for metastatic pancreatic cancer
AstraZeneca and Merck have announced that they have received the approval of Lynparza (Olaparib) for germline BRCA-mutated metastatic...
Gilead’s Veklury received conditional marketing authorization from the European Commission
Gilead Sciences has announced that the European Commission has granted conditional marketing authorization for Veklury (remdesivir) for...
European Commission approved Janssen's Ebola vaccine
Johnson and Johnson announced that the European Commission had approved the Ebola vaccine to prevent the Ebola virus disease. Janssen has...
GSK and Clover Biopharmaceuticals begins COVID-19 vaccine Phase 1 clinical trial
GSK has announced that Clover Biopharmaceuticals initiated the Phase 1 trial of COVID-19 vaccine SCB-2019. The vaccine was given in...
Governments and other organizations raised US$ 8.8 billion at Global Vaccine Summit
The Global Vaccine Summit hosted in the UK was successful in raising US$ 8.8 billion, more than the expected target of US$ 7.4 billion....
#EULAR2020
JANSSEN TREMFYA Janssen has presented new data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2 of Tremfya (guselkumab), in...
Sanofi’s Sarclisa approved in Europe for relapsed and refractory multiple myeloma
Sanofi has announced that the European Commission has approved Sarclisa (isatuximab) for treating adult patients with relapsed and...
Gilead announced the positive Phase 3 trial of remdesivir in COVID-19 patients
Gilead has announced top-line Phase 3 trial results of remdesivir in patients with COVID-19. The drug is indicated in moderate COVID-19...
European Commission approved Zolgensma, activates “Day one” access program
Novartis announced that Zolgensma (onasemnogene abeparvovec) had received conditional approval in Europe for treating patients with...
HAS gave favorable opinion for reimbursing Darzalex for treating multiple myeloma naïve patients
Favorable opinion is given for indicating the drug in newly diagnosed multiple myeloma patients and who are eligible for an autograft of...
EMA allowed compassionate use of remdesivir to patients who were not on mechanical ventilation
European Medicines Agency’s Human Medicines Committee has recommended the use of remdesivir in COVID-19 patients who were not on...
PFIZER AND BIONTECH STARTS THE CLINICAL TRIALS OF COVID-19 VACCINE
Pfizer and BioNTech have announced that the first participant was administered with the vaccine in the Phase ½ trial. The trial was...
Novo Nordisk’s Rybelsus approved by European Union
Novo Nordisk has announced that Rybelsus (oral semaglutide) has been approved for the adult patients suffering with type 2 diabetes by...
NICE recommendation to manage symptoms of COVID-19
NICE issues rapid guidelines to provide recommendations to manage the symptoms. These recommendations are specifically for healthcare...
EMA approved GSK’s Trelegy Ellipta for asthma
GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) announced that they had received the approval of Trelegy Ellipta (fluticasone...
EMA approved Mayzent (siponimod) for secondary progressive multiple sclerosis
Novartis has announced that it has received the EU approval for Mayzent (siponimod) for adult patients with secondary progressive...
European Commission approved AbbVie's Rinvoq (upadacitinib) for adults with moderate to severe RA
• Approval based on Phase 3 SELECT, in which drugs evaluated in 4,400 patients • In five Phase 3 trials, Rinvoq has met all the...
CHMP gave positive opinions for Beovu and Recarbrio
Novartis’ Beovu (brolucizumab) received CHMP positive opinion for the treatment of wet age-related macular degeneration (AMD). Nikos...
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