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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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NEWS

Alvotech and Teva’s Simlandi (Biosimilar, Humira) Receives the US FDA’s Approval for the Treatment of Multiple Indications 

Shots:  The US FDA has approved Simlandi injection for treating adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa & uveitis as well as juvenile idiopathic arthritis & Crohn's Disease  The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in…
February 23, 2024

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