Global

Global

The latest news from the global pharmaceutical industry

Contaminated cough syrup leads to WHO Medical Product AlertContaminated cough syrup leads to WHO Medical Product Alert
Contaminated cough syrup leads to WHO Medical Product Alert

The WHO has shared a medical product alert for an additional contaminated cough syrup medicine identified in Africa.

Aug 24, 2023 Global
New open innovation hub opened by Astellas for tumour microenvironment researchNew open innovation hub opened by Astellas for tumour microenvironment research
New open innovation hub opened by Astellas for tumour microenvironment research

Astellas Pharma and Mitsui Fudosan have announced that Astellas plans to establish a tumour microenvironment (TME) open innovation hub, intended to open in October 2023.

Aug 24, 2023 Global
Jemperli by GSK approved to treat endometrial cancerJemperli by GSK approved to treat endometrial cancer
Jemperli by GSK approved to treat endometrial cancer

GSK has announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (DMMR) or microsatellite instability-high (MSI-H).

Aug 24, 2023 Global
Alzheimer’s disease drug Leqembi given full approval by FDAAlzheimer’s disease drug Leqembi given full approval by FDA
Alzheimer’s disease drug Leqembi given full approval by FDA

Japanese Eisai and US-based biotechnology company Biogen have announced that the FDA has given their Alzheimer’s disease drug Leqembi (lecanemab-irmb) full approval through the approval of a supplemental biologics license application.

Aug 24, 2023 Global
First over the counter contraceptive pill approved by FDAFirst over the counter contraceptive pill approved by FDA
First over the counter contraceptive pill approved by FDA

FDA has announced that it has approved the Opill (norgestrel) tablet for non-prescription use to prevent pregnancy.

Aug 24, 2023 Global
FDA approves first cellular therapy for treatment of patients with type 1 diabetesFDA approves first cellular therapy for treatment of patients with type 1 diabetes
FDA approves first cellular therapy for treatment of patients with type 1 diabetes

The FDA has announced that it has approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of adult patients with type 1 diabetes.

Aug 24, 2023 Global
FDA approves first oral antiviral to treat adult patients with COVID-19FDA approves first oral antiviral to treat adult patients with COVID-19
FDA approves first oral antiviral to treat adult patients with COVID-19

The US Food and Drug Administration (FDA) has announced that it has approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of adult patients with mild-to-moderate COVID-19 if they are at high risk for progression to severe COVID-19, including hospitalisation or death.

Jul 2, 2023 Global
FDA relaxes blood donation regulations for MSMFDA relaxes blood donation regulations for MSM
FDA relaxes blood donation regulations for MSM

The US Food and Drug Administration (FDA) has released updated guidance for blood donation, which relaxes the rules for donations from men who have sex with men (MSM).

Jul 2, 2023 Global
More infections from contaminated eyedrops in US increase death tollMore infections from contaminated eyedrops in US increase death toll
More infections from contaminated eyedrops in US increase death toll

The US centers for disease control and prevention (CDC) have released updated data regarding contaminated eyedrops. As of may 2023, 81 patients in 18 states have tested positive for VIM-GES-CRPA, a rare strain of drug-resistant pseudomonas aeruginosa.

Jul 2, 2023 Global
GSK receives FDA file acceptance for Jemperli plus chemotherapy for treating endometrial cancerGSK receives FDA file acceptance for Jemperli plus chemotherapy for treating endometrial cancer
GSK receives FDA file acceptance for Jemperli plus chemotherapy for treating endometrial cancer

GSK has announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (SBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (DMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.

Jul 2, 2023 Global
FDA approves Pfizer’s RSV vaccine for older adultsFDA approves Pfizer’s RSV vaccine for older adults
FDA approves Pfizer’s RSV vaccine for older adults

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has approved its respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 60 years or older.

Jul 2, 2023 Global
Bristol Myers Squibb’s NDA accepted by FDABristol Myers Squibb’s NDA accepted by FDA
Bristol Myers Squibb’s NDA accepted by FDA

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its new drug application (NDA) has been accepted by the US Food and Drug Administration (FDA) for its ros1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) treatment repotrectinib.

Jul 2, 2023 Global