Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain

Shots: The FDA has approved Journavx (50mg; BID) to treat moderate-to-severe acute pain in adults JOURNAVX is an oral, non-opioid pain signal inhibitor that selectively targets NaV1.8 relative to other NaV channels The company is also testing suzetrigine for peripheral neuropathic pain (PNP), with ongoing P-III trial for diabetic neuropathy and plans for…

ByDipanshu DixitJanuary 30, 2025

News

The US FDA Approves Vertex’s Alyftrek for the Treatment of Cystic Fibrosis

Shots: The US FDA has approved Alyftrek (QD, CFTR modulator) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one F508del mutation or another CFTR gene mutation. Submissions are under review in the EU, UK, Canada, Switzerland, Australia & New Zealand Approval was supported by pivotal P-III CF program involving >1,000 patients across…

ByDipanshu DixitDecember 20, 2024

INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2024

Shots: The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9B This quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…

BySenior EditorJuly 2, 2024

INSIGHTS+

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

Shots: The EMA approved 3 BLA while 6 New Chemical Entities with 1 recommendation and 1 acceptance in November 2023, leading to treatments for patients and advances in the healthcare industry In November 2023, the major highlighted drugs were Vyjuvek to Treat Dystrophic Epidermolysis Bullosa (DEB) and Vyvgart with Halozyme’s Enhanze for the treatment of…

BySenior EditorDecember 29, 2023

INSIGHTS+

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

Shots: The EMA approved 8 New Chemical Entity (NCE) and 3 Biologic Drugs in April 2023, leading to treatments for patients and advances in the healthcare industry In April 2023, the major highlights drugs were Rinvoq’s Approval for active Crohn's Disease, Opzelura for non-segmental vitiligo with facial involvement in adults and adolescents PharmaShots has compiled…

BySenior EditorMay 25, 2023

INSIGHTS+

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

Shots: The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2022

The second quarter of 2022 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, AstraZeneca’s Farxiga (dapagliflozin) meet its primary endpoints for heart failure with a preserved ejection fraction Starting with the latest acquisitions, Pfizer acquire Biohaven for ~$11.6B, GSK acquire Affinivax for ~$3.3B. The second quarter of the year…

BySenior EditorJune 30, 2022

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2021

The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B,…

BySenior EditorSeptember 30, 2021

INSIGHTS+

Insights+: The US FDA New Drug Approvals in September and October 2019

The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year's record of approvals. However, there is a significant…

BySenior EditorNovember 15, 2019

Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain

The US FDA Approves Vertex’s Alyftrek for the Treatment of Cystic Fibrosis

PharmaShots’ Key Highlights of Second Quarter 2024

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

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

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

PharmaShots’ Key Highlights of Second Quarter 2022

PharmaShots’ Key Highlights of Third Quarter 2021

Insights+: The US FDA New Drug Approvals in September and October 2019

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