Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara)

Shots: Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025 The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed…

ByDipanshu DixitMarch 7, 2025

NEWS

Johnson & Johnson’s Darzalex (daratumumab) Receives the CHMP’s Positive Opinion for Multiple Myeloma

Shots: The CHMP has recommended Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma pts. Opinion was based on P-III (CEPHEUS) trial, which assessed efficacy & safety in transplant-ineligible or deferred NDMM pts (n=395) not planned for ASCT as initial therapy, in 13 countries across North America, South America and…

ByRidhi RastogiMarch 4, 2025

NEWS

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Shots: Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…

ByDipanshu DixitMarch 3, 2025

TOP 20

Top 20 Biopharma M&A of 2024 by Total Deal Value

Top 20 Biopharma M&A of 2024 by Total Deal Value Shots: Dealmaking in 2024 experienced fluctuations due to regulatory challenges and increasing pressure from the Inflation Reduction Act The highest-value deal of the year was Vertex’s acquisition of Alpine Immune Sciences for $4.9B, followed by Gilead’s acquisition of CymaBay for $4.3B and Lilly’s acquisition of…

ByPrince GiriFebruary 6, 2025

NEWS

Johnson & Johnson Receives the CHMP Positive Opinion on Label Extension to SC Rybrevant for the Treatment of Advanced EGFR-Mutated NSCLC

Shots: The CHMP recommended label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT Opinion was backed by P-III (PALOMA-3) trial, evaluating SC vs…

ByDipanshu DixitFebruary 4, 2025

VIEWPOINTS

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Shots: Johnson & Johnson’s (J&J) Tremfya recently received its third approval from the US FDA, supported by the pivotal QUASAR study, which demonstrated significant remission after one year of treatment in adults with moderately to severely active ulcerative colitis Tremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammation At…

BySaurabh ChaubeyFebruary 3, 2025

NEWS

Johnson & Johnson to Acquire Intra-Cellular Therapies for ~14.6B, Boosting its Neuroscience Portfolio

Shots: J&J entered into a definitive agreement to acquire Intra-Cellular Therapies, incl. its drugs Caplyta & ITI-1284, for a total equity value of ~14.6B (cash + debt), with shareholders receiving $132/share in cash, making the latter private In Dec 2024, the latter filed an sNDA to the US FDA for Caplyta as adj. therapy…

ByDipanshu DixitJanuary 14, 2025

NEWS

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Shots: The CE mark of Thermocool Smarttouch SF Catheter for cardiac arrhythmias was based on SmartfIRE trial in European patients with refractory PAF that depicted 100% acute success rate & first-pass isolation achievement in 96.8% of veins (published in Apr 2024). The Trupulse Generator hardware compatibility is anticipated in H1’25 The company has concluded…

ByRidhi RastogiJanuary 13, 2025

NEWS

Johnson & Johnson Reports the US FDA’s BLA Acceptance of Nipocalimab with Priority Review for Generalized Myasthenia Gravis (gMG)

Shots: The US FDA has accepted & granted priority review to the BLA of nipocalimab for treating patients with antibody positive (anti-AChR, anti-MuSK, anti-LRP4) gMG, based on P-III (Vivacity-MG3) trial. MAA in this indication has been filed with the EMA on Sep 11, 2024 The P-III study assessed safety & efficacy of nipocalimab +…

ByRidhi RastogiJanuary 10, 2025

NEWS

Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC

Shots: The EC has approved Rybrevant + Lazcluze as a 1L treatment of advanced NSCLC harboring EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations. The EC’s decision of lazertinib for the corresponding combination regimen is pending (was granted CHMP’s recommendation last month) Approval was based on P-III (MARIPOSA) trial assessing Rybrevant +…

ByDipanshu DixitDecember 30, 2024

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara)

Johnson & Johnson’s Darzalex (daratumumab) Receives the CHMP’s Positive Opinion for Multiple Myeloma

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Top 20 Biopharma M&A of 2024 by Total Deal Value

Johnson & Johnson Receives the CHMP Positive Opinion on Label Extension to SC Rybrevant for the Treatment of Advanced EGFR-Mutated NSCLC

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Johnson & Johnson to Acquire Intra-Cellular Therapies for ~14.6B, Boosting its Neuroscience Portfolio

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Johnson & Johnson Reports the US FDA’s BLA Acceptance of Nipocalimab with Priority Review for Generalized Myasthenia Gravis (gMG)

Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC

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