BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors

Shots: The CHMP has granted positive opinion to repotrectinib for treating ROS1+ advanced NSCLC in adults and NTRK+ advanced solid tumors in patients (≥12yrs.), with the EC’s decision anticipated in Jan 2025 Opinion was based on P-I/II (TRIDENT-1 & CARE) trials, with TRIDENT-1 assessing repotrectinib in advanced solid tumors (NSCLC and tumors with ROS1 &…

ByDipanshu DixitNovember 15, 2024

NEWS

BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia

Shots: The US FDA has granted approval to BMS’ Cobenfy for treating schizophrenia in adults, based on its EMERGENT studies The EMERGENT studies comprised of P-III (EMERGENT-2 & 3) trials, evaluating the safety, efficacy & tolerability of Cobenfy vs PBO in schizophrenic adults for over 5wks., as well as two open-label trials assessing long-term safety…

ByDipanshu DixitSeptember 26, 2024

NEWS

BMS’ Opdivo Plus Cisplatin and Gemcitabine Gain EC’s Approval for Treating Urothelial Carcinoma

Shots: The EC has approved Opdivo + cisplatin & gemcitabine as 1L treatment of unresectable or metastatic urothelial carcinoma (UC) adults, valid across the whole EU along with Iceland, Liechtenstein & Norway, based on the P-III (CheckMate -901) study The P-III (CheckMate -901) study assessed Opdivo + Yervoy or Opdivo + cisplatin & gemcitabine…

ByDipanshu DixitMay 29, 2024

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2023

Shots: The Fourth quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, BMS acquired Mirati Therapeutics for ~$5.8B and AbbVie acquired ImmunoGen for $10.1B The Fourth quarter of the year also showcases multiple clinical trial results from Regeneron’s Two-Year…

BySenior EditorJanuary 16, 2024

INSIGHTS+

New Drug Designations – November 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…

BySenior EditorDecember 27, 2023

INSIGHTS+

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

Shots: The US FDA approved 5 NDAs & 4 BLAs in November 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 109 novel products in 2023 In November 2023, the major highlights drugs were Wezlana (ustekinumab) approved for Multiple Inflammatory Diseases, and Cosentyx (secukinumab) for the Treatment…

BySenior EditorDecember 20, 2023

INSIGHTS+

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

Shots: The US FDA approved 5 NDAs & 9 BLAs in October 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023 In October 2023, the major highlights drugs were Velsipity (Etrasimod) approved for Ulcerative Colitis, and Bimzelx (bimekizumab) for the Treatment of Adults…

BySenior EditorNovember 15, 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

BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors

BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia

BMS’ Opdivo Plus Cisplatin and Gemcitabine Gain EC’s Approval for Treating Urothelial Carcinoma

PharmaShots’ Key Highlights of Fourth Quarter 2023

New Drug Designations – November 2023

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

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

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

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

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