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Biocon,Bayer and Regeneron
NEWS

Biocon Enters into an Exclusive License Agreement with Bayer and Regeneron for the Commercialization of Yesafili (biosimilar, aflibercept) into the Canadian Market 

Shots:  Biocon, Bayer & Regeneron have signed an agreement to commercialize and distribute Yesafili, the biosimilar version of Eylea (aflibercept) Injections across Canada   Under the terms of the agreement, Biocon has set Jul 1, 2025, as the launch date for Yesafili (2mg NDS for vials and prefilled syringes). Earlier in Mar 2023, Health Canada approved…
March 4, 2024

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Formosa Pharmaceuticals
NEWS

Formosa Pharmaceuticals Receives the US FDA’s Approval for Clobetasol Propionate to Treat Post-Operative Inflammation and Pain Following Ocular Surgery 

Shots:  The US FDA has approved Formosa’s clobetasol propionate ophthalmic suspension 0.05% (APP13007) to treat post-operative inflammation & pain following ocular surgery  Sosei Heptares will receive a payment of $2.5M from Formosa on achieving the milestone as per the agreement signed b/w them  APP13007 was initially developed by Activus Pharma (subsidiary of Sosei) using its…
March 4, 2024

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Samsung Bioepis
NEWS

Samsung Bioepis Signs a Collaboration Agreement with Samil Pharma to Co-Commercialize SB15 (biosimilar, aflibercept) for the Treatment of Ophthalmologic Conditions

Shots:   Samsung Bioepis entered into a collaborative agreement with Samil Pharmaceuticals to co-commercialize SB15, a biosimilar version for Eylea (aflibercept) for the treatment of wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) across Korea   Earlier in Jun 2022, both companies had collaborated to jointly commercialize Amelivu, a biosimilar version of Lucentis for the…
March 1, 2024

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Allecra Therapeutics
NEWS

The US FDA Approves Allecra Therapeutics’ Exblifep for the Treatment of Complicated Urinary Tract Infections (cUTIs) 

Shots:  The US FDA has granted approval to the company’s Exblifep for the treatment of complicated urinary tract infections (incl. pyelonephritis) patients (18yrs. & above) along with a 5-yr. marketing exclusivity extension until 2032  The approval was based on clinical data that showed the effectiveness of Exblifep against antimicrobial resistance in gram –ve bacteria, especially…
February 27, 2024

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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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Celltrion
NEWS

Celltrion Reports the MAA Submission to the MFDS Korea for CT-P47 (biosimilar, tocilizumab) to Treat Various Indications  

Shots:   The submission was based on the results from the P-III clinical trials evaluating the equivalence & similarity of CT-P47 vs Actemra (tocilizumab) in patients (n=471) with rheumatoid arthritis (RA)   Moreover, based on these results the company also expects to accelerate its marketing authorization application across Canada & other countries. The company expects to receive…
February 24, 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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