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Global

The latest news from the global pharmaceutical industry

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Merck’s Keytruda with chemoradiotherapy approved by FDA as treatment for cervical cancer
Merck’s Keytruda with chemoradiotherapy approved by FDA as treatment for cervical cancer

Merck has announced that the FDA has approved Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of figo (international federation of gynecology and obstetrics) 2014 stage iii-iva cervical cancer.

7 February 2024Global
J&J’s Balversa approved by FDA for bladder cancer treatment
J&J’s Balversa approved by FDA for bladder cancer treatment

Johnson & Johnson (J&J) has announced that the FDA has approved a supplemental new drug application for Balversa (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 genetic alterations whose disease has progressed on or after one prior treatment.

7 February 2024Global
AstraZeneca and Ionis’s Wainua approved by FDA
AstraZeneca and Ionis’s Wainua approved by FDA

AstraZeneca and Ionis have announced that the FDA has approved Wainua (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (haattr-pn or attrv-pn) in adult patients.

7 February 2024Global
FDA approves Calliditas Therapeutics’ Tarpeyo to reduce loss of kidney function
FDA approves Calliditas Therapeutics’ Tarpeyo to reduce loss of kidney function

Calliditas Therapeutics has announced that the FDA has approved Tarpeyo (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobin a nephropathy at risk of disease progression.

7 February 2024Global
New data shared for Leqembi as Alzheimer’s treatment
New data shared for Leqembi as Alzheimer’s treatment

Eisai and Biogen have announced that Eisai has shared new data for Leqembi (lecanemab-irmb) 100mg/ml injection for intravenous use at the 16th annual clinical trials on Alzheimer’s disease conference in Boston, US on 24-27 October 2023.

24 November 2023Global
Boan Biotech enrols first patient for Nivolumab phase 3 trial in China
Boan Biotech enrols first patient for Nivolumab phase 3 trial in China

Boan Biotech has announced that the first patient has been enrolled in its phase 3 trial of its nivolumab injection (ba1104) in china.

24 November 2023Global
Merck’s Keytruda approved by FDA for gastric cancer treatment
Merck’s Keytruda approved by FDA for gastric cancer treatment

Merck, known as MSD outside of the US, has announced that the FDA has approved Keytruda in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic her2-negative gastric or gastroesophageal junction adenocarcinoma.

24 November 2023Global
BMS’s Augtyro approved by FDA for lung cancer treatment
BMS’s Augtyro approved by FDA for lung cancer treatment

Bristol Myers Squibb has announced that the FDA has approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ros1-positive non-small cell lung cancer.

24 November 2023Global
FDA approves Eli Lilly’s Zepbound for chronic weight management
FDA approves Eli Lilly’s Zepbound for chronic weight management

Eli Lilly has announced that the FDA has approved Zepbound (tirzepatide) injection for chronic weight management, indicated for patients who are obese or overweight and have weight-related medical problems such as hypertension, dyslipidaemia, type 2 diabetes mellitus, obstructive sleep apnoea or cardiovascular disease.

24 November 2023Global
Janssen and Sanofi partner for E. coli vaccine programme
Janssen and Sanofi partner for E. coli vaccine programme

Janssen Pharmaceuticals, a Johnson & Johnson company, has announced a development and commercialisation agreement with Sanofi for Janssen’s extraintestinal pathogenic escherichia coli investigational vaccine programme.

1 November 2023Global
Sun Pharma’s NDA for deuruxolitinib accepted by FDA
Sun Pharma’s NDA for deuruxolitinib accepted by FDA

India-based pharma company Sun Pharmaceutical Industries has announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for deuruxolitinib for the treatment of adults with moderate-to-severe alopecia areata.

1 November 2023Global
FDA accepts Regeneron and Sanofi’s sBLA for Dupixent for priority review
FDA accepts Regeneron and Sanofi’s sBLA for Dupixent for priority review

Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has accepted their supplemental biologics license application for Dupixent (dupilumab) for the treatment of children between one and 11 years old with eosinophilic oesophagitis (EOE).

1 November 2023Global