Vertex Pharmaceuticals

Aficamten attracts more interest as Sanofi buys China rights

24 December 2024

Positive Phase III trials results with BMS’ Sotyktu

24 December 2024

FDA approves first generic of Victoza

24 December 2024

RAPT obtains worldwide rights ex-China to Jemincare MAb

24 December 2024

Grifols’ Albutein misses primary Phase III endpoint

23 December 2024

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Company Spotlight

A clinical stage biotechnology company developing biologic therapeutics targeting potent regulators of the innate and adaptive immune systems to re-balance immunity in autoimmune and inflammatory diseases.

Latest News & Features of interest to Vertex Pharmaceuticals

Viatris faces FDA import restrictions at Indian facility

Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024

Aficamten attracts more interest as Sanofi buys China rights

Cytokinetics has sold Sanofi exclusive rights to develop and commercialize aficamten in China. 24 December 2024

Positive Phase III trials results with BMS’ Sotyktu

US pharma major Bristol Myers Squibb has announced positive results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 24 December 2024

FDA approves first generic of Victoza

The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024

RAPT obtains worldwide rights ex-China to Jemincare MAb

USA-based immunology company RAPT Therapeutics has entered into an exclusive license agreement with Shanghai Jemincare Pharmaceutical for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. 24 December 2024

Grifols’ Albutein misses primary Phase III endpoint

Spanish plasma-based medicines maker Grifols has announced disappointing top-line data from its Phase III PRECIOSA clinical trial evaluating the potential of long-term albumin treatment with Grifols Albutein on patients with decompensated cirrhosis and ascites, sending its share down 2.4% to 9.27 euros on Friday. 23 December 2024

FTC orders Teva to delist inhaler patents

The US Court of Appeals for the Federal Circuit on Friday affirmed a lower district court order against Israeli pharmaceutical maker Teva Pharmaceutical Industries requiring its US subsidiary to delist several asthma inhaler patents from the Food and Drug Administration’s (FDA) Orange Book. 23 December 2024

Vertex nabs FDA approval for Alyftrek and Trikafta

US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations. 23 December 2024

The week in pharma: action, reaction and insight – week to December 20

Among significant research news last week, UK drug developer PureTech released positive new Phase IIb data on its deupirfenidone in idiopathic pulmonary fibrosis. France’s Sanofi and Israel-based Teva Pharmaceutical Industries announced encouraging new Phase IIb data for their duvakitug in inflammatory bowel disease. Meanwhile, Vertex Pharmaceuticals released Phase II results for its investigational sciatica treatment suzetrigine that failed to impress. Also of note, AbbVie announced strong Phase III results of tavapadon in early Parkinson’s disease. 22 December 2024

Italfarmaco’s Duvyzat backed by MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Duvyzat (givinostat) to treat Duchenne muscular dystrophy (DMD). 22 December 2024

Latest In Brief for Vertex Pharmaceuticals

BRIEF—EMA re-affirms non-renewal of masitinib and Translarna authorizations

Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024

BRIEF—Theriva gets FDA Rare Pediatric Drug designation for VCN-01

1 August 2024

BRIEF—Zevra’s arimoclomol to face FDA AdCom

15 July 2024

PolTREG’s type-1 diabetes Treg cell therapy PTG-007 demonstrates long-term safety and efficacy

24 June 2024

BRIEF—Teva launches first authorized generic of Victoza in USA

24 June 2024

BRIEF—TGA update on GLP-1 RAs pharmacy compounding changes

24 June 2024