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BeiGene
NEWS

BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC) 

Shots:   The MAA was based on the evaluation of NSCLC patients (n=1,499) in 3 P-III studies incl. (RATIONALE 307) for Tevimbra + carboplatin + paclitaxel/nab-paclitaxel vs CT (1L treatment for sq. NSCLC), (RATIONALE 304) for Tevimbra + pemetrexed + platinum-containing CT vs CT (1L treatment for non-sq. NSCLC) & (RATIONALE 303) for Tevimbra vs CT…
February 27, 2024

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Merck new
NEWS

Merck’s Keytruda (pembrolizumab) in Combination with Chemotherapy Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer  

Shots:   The company received the positive opinion based on the results from the P-III (KEYNOTE-671) clinical trial evaluating neoadjuvant Keytruda + platinum-containing CT followed by adjuvant Keytruda monotx. vs neoadjuvant PBO in patients with resectable NSCLC at high risk of recurrence  The study met its dual 1EP by demonstrating a statistically significant & clinically meaningful…
February 26, 2024

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Astrazeneca
NEWS

AstraZeneca’s Voydeya Receives CHMP’s Recommendation for Treating Paroxysmal Nocturnal Haemoglobinuria (PNH) with Residual Haemolytic Anaemia

Shots:   The CHMP has recommended Voydeya as an add-on therapy to SoC for treating PNH adult patients with residual haemolytic anaemia  The recommendation was based on the P-III (ALPHA) study investigating the safety & efficacy of Voydeya as an add-on therapy to Ultomiris or Soliris (SoC) for treating PNH patients with extravascular haemolysis (EVH)  The…
February 26, 2024

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Vertex Pharmaceuticals
NEWS

Vertex Receives CHMP’s Positive Opinion for Kalydeco as a Treatment of Cystic Fibrosis in Infants  

Shots:   The company received the CHMP’s positive opinion for the label expansion of Kalydeco (Ivacaftor) to include the treatment of infants (aged 1mos.-4mos.) with cystic fibrosis with specific mutations in the CFTR gene (R117H/G551D/G1244E/G1349D/G178R/G551S/S1251N/S1255P/S549N/S549R)  Kalydeco has been approved by the EU for the treatment of cystic fibrosis patients aged ≥4mos. with specific CFTR gene mutations …
February 23, 2024

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NEWS

CSL Vifor and Travere Therapeutics’ Filspari (sparsentan) Gains CHMP’s Positive Opinion to Treat IgA Nephropathy  

Shots:   The CHMP has granted positive opinion to CSL (exclusive commercialization rights holder in the EU, Australia & New Zealand) & Travere’s sparsentan for its conditional approval to treat primary IgAN with a urine protein excretion >1.0 g/day. EC’s decision is anticipated in Q2’24  The opinion was supported by the P-III (PROTECT) trial investigating the…
February 23, 2024

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NEWS

Biogen’s Qalsody (tofersen) Receives CHMP’s Positive Opinion for the Treatment of Amyotrophic Lateral Sclerosis (ALS) 

Shots:   The opinion was based on the results from the P-III (VALOR) trial evaluating the safety & efficacy of Qalsody (100mg) vs PBO in ALS patients (n=108) associated with SOD1 mutations. The 1EPs of the study include changes in ALSFRS-R total score from baseline to wk.28 & 2EPs includes change in total cerebrospinal fluid SOD1…
February 23, 2024

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Pfizer New
NEWS

Pfizer’s Velsipity (etrasimod) Receives the European Commission’s Approval for the Treatment of Severely Active Ulcerative Colitis 

Shots:   The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma   Patients in the trial have previously received 1-3 prior lines of therapy,…
February 19, 2024

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Sandoz
NEWS

Sandoz Introduces Tyruko (Biosimilar, Tysabri) for Multiple Sclerosis in Germany 

Shots :  Sandoz has introduced Tyruko (natalizumab), biosimilar of Tysabri for the treatment of r/r multiple sclerosis (RRMS), in Germany which will be available from Feb 1   Polpharma Biologics is responsible for the development, manufacturing and supply of Tyruko while Sandoz holds its commercialization rights in all markets as per a global commercialization agreement signed…
January 31, 2024

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Astellas
NEWS

Astellas Receives the EMA’s Validation on Type II Variation Application for Padcev (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) to Treat Advance Bladder Cancer

Shots The application was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study were OS & PFS whereas the 2EPs were ORR, DoR & safety The results depicted that the study met its…
January 29, 2024

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Takeda
NEWS

Takeda Reports EC’s Approval of Hyqvia as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Shots Takeda’s Hyqvia has been approved as maintenance therapy for treating chronic inflammatory demyelinating polyneuropathy (CIDP) on stable IVIG therapy valid throughout the EU plus Iceland, Liechtenstein, Norway & Northern Ireland The approval is based on the results from the P-III (ADVANCE-CIDP 1) study assessing Hyqvia’s safety and efficacy as a maintenance therapy to…
January 29, 2024

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