Shots:The EC has approved label extension of Evrysdi (5mg oral tablet) for pts with spinal muscular atrophy (SMA)Approval was based on P-I study assessing Evrysdi 5mg tablet vs oral solution, showing bioequivalence with comparable efficacy & safety; data was presented at SMA Europe 2024Evrysdi, an SMN2 splicing modifier, treats SMA caused by…
Shots:Roche has reported P-III (IMforte) trial data of Tecentriq + lurbinectedin as 1L maintenance therapy for ES-SCLC pts (≥18yrs)Trial assessed the regimen vs Tecentriq monotx. in ES-SCLC pts, where 660 pts received induction therapy with Tecentriq + CT (4 x 21-day cycles) & 483 pts without progression were then randomized to maintenance with…
Top 20 Diagnostics Companies of 2025 Shots: Driven by continuous innovation and enhanced precision, the diagnostic industry is advancing rapidly, transforming the way healthcare is delivered In 2025, the global diagnostic testing market is valued at approximately $207.96B in 2025 and is projected to grow to around $272.9B by 2034, reflecting a CAGR of 3%.…
Shots:The CHMP has recommended Itovebi + Ibrance & fulvestrant as a 1L therapy for adults with PIK3CA-mutated, HR+/HER2- locally advanced or metastatic breast cancer recurring on or within 12mos. of adj. endocrine therapy, based on the P-III (INAVO120) trialTrial (n=325) assessed the regimen vs PBO + Ibrance & fulvestrant, improved PFS (1EP) by…
Shots:The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR)Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading…
Shots: Following the launch of Idacio (adalimumab) Citrate-free, Fresenius Kabi Canada has launched Tyenne (IV/SC), a biosimilar version of Actemra (tocilizumab) from Roche, now available in Canada Tyenne (IL-6 receptor blocker) is approved to treat inflammatory and immune conditions such as rheumatoid arthritis (RA), giant cell arteritis (GCA), Polyarticular juvenile idiopathic arthritis (pJIA), and systemic…
Shots: In the Biopharma industry, navigating M&A and licensing deals is challenging due to strict antitrust laws and shifting regulations. When these pressures create significant risks, nullifying or restructuring existing agreements can be the most rational and strategic response In 2024, the termination of the $4.45B deal between Adaptimmune and Genentech became a major talking…
Shots:Japan's MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 AbsApproval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…
Shots:Roche has launched its Elecsys PRO-C3 test, developed with Nordic Bioscience to evaluate the severity of liver fibrosis in pts showing signs of metabolic dysfunction–associated steatotic liver disease Elecsys PRO-C3 test requires a single assay & in combination with ADAPT formula (incl. PRO-C3 levels, platelet count, age, & diabetes status) provides clear assessment of…
Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

