Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Shots: The EC has approved Darzalex SC (daratumumab) for the treatment of adults with high‑risk smouldering multiple myeloma (SMM) Approval was based on the P-III (AQUILA) study data assessing Darzalex SC monotx. vs active monitoring in high-risk SMM pts (n=390) At a mFU of 65.2mos., trial showed improved PFS, with 63.1% vs 40.8% pts alive…

ByRidhi RastogiJuly 24, 2025

NEWS

DARZALEX (Daratumumab) Receives Positive CHMP Opinion for High-Risk Smouldering Multiple Myeloma

Shots: Janssen-Cilag (Johnson & Johnson) announced that the CHMP of the EMA has recommended approving DARZALEX (daratumumab) SC as the first therapy for adults with high‑risk smouldering multiple myeloma (SMM) The CHMP’s recommendation is based on the P-III (AQUILA) study data evaluating efficacy and safety of fixed-duration monotx. daratumumab SC compared with active monitoring (N=390)…

ByPrince GiriJune 24, 2025

NEWS

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3)

Shots: NANOBIOTIX & Janssen have amended their 2023 collaboration to develop & commercialize JNJ-1900 (NBTXR3), adjusting the deal value from $2.7B to $2.6B As per the revision, NANOBIOTIX will receive ~$1.77B in milestones related to cisplatin-ineligible HNSCC & inoperable stage 3 NSCLC, with ~$165M in milestones for China, South Korea, Singapore, & Thailand. J&J will cover…

ByRidhi RastogiMarch 18, 2025

NEWS

Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC)

Shots: The CHMP has granted a positive opinion to Balversa monotx. (QD, oral) to treat inoperable mUC adults with susceptible FGFR3 mutations & previously treated with at least 1L of therapy with PD-1/PD-L1 inhibitor The opinion was based on the arm 1 of P-III (THOR) trial assessing the safety & efficacy of erdafitinib (n=136) vs…

ByDipanshu DixitJune 28, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots: The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis PharmaShots has compiled a list of a…

BySaurabh ChaubeyJanuary 23, 2024

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2023

Shots: Third quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, Biogen acquired Reata Pharmaceuticals for ~$7.3B and Danaher acquired Abcam for ~$5.7B The third quarter of the year also showcases multiple clinical trial results which include Janssen reported P-IIb…

BySenior EditorOctober 2, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in August 2023

Shots: The EMA approved 5 New Chemical Entity (NCE) and 6 Biologic Drugs in August 2023, leading to treatments for patients and advances in the healthcare industry In August 2023, the major highlight drugs were Aquipta (atogepant) approved for the preventive treatment of migraine in adults & Opdivo (nivolumab) as an adjuvant treatment for completely…

BySenior EditorSeptember 28, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in August 2023

Shots: The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023 In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…

BySenior EditorSeptember 20, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in July 2023

Shots: The EMA approved 9 New Chemical Entity (NCE) and 5 Biologic Drugs in July 2023, leading to treatments for patients and advances in the healthcare industry In July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancer PharmaShots has compiled a list…

BySenior EditorAugust 24, 2023

INSIGHTS+

Disease of the Month- Juvenile Arthritis

Shots: To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research Continuing the series for the disease of the month, PharmaShots brings this month a summary of Juvenile arthritis, an autoimmune inflammatory disease July is observed…

BySenior EditorJuly 13, 2023

Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

DARZALEX (Daratumumab) Receives Positive CHMP Opinion for High-Risk Smouldering Multiple Myeloma

NANOBIOTIX and Janssen Amend Partnership to Develop and Commercialize JNJ-1900 (NBTXR3)

Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC)

Insights+: EMA Marketing Authorization of New Drugs in December 2023

PharmaShots’ Key Highlights of Third Quarter 2023

Insights+: EMA Marketing Authorization of New Drugs in August 2023

Insights+: EMA Marketing Authorization of New Drugs in July 2023

Disease of the Month- Juvenile Arthritis

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