News in Numbers

27.8 billion

Amgen announced plans to acquire rare disease drug developer Horizon Therapeutics for $27.8 billion, making it one of the year’s largest deals.

24.8%

Of the tests performed in clinical laboratories nationwide, 24.8% are positive for influenza, as per a 9 December Centers for Disease Control and Prevention update.

2.7%

Global growth is forecast to slow down to 2.7% in 2023, a significant drop from 6% in 2021, as per the International Monetary Fund.

15%

As per a WHO report, bloodstream infections due to resistant E. coli and Salmonella species, and resistant gonorrhoea infections increased by at least 15%, compared to rates in 2017.

16.1 million

As per a December EMA update, 16.1 million doses of the adapted bivalent Comirnaty Covid-19 vaccine have been administered in the EU/EEA

 Approvals

TZIELD

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients.

Source: PHARMACEUTICAL TECHNOLOGY

EMPAVELI

Health Canada has granted approval for Swedish Orphan Biovitrum (Sobi ) affiliate Sobi North America’s Empaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare hematologic ailment.

Source: PHARMACEUTICAL TECHNOLOGY

QDENGA

The European Commission (EC) has granted marketing authorisation for Takeda’s Qdenga, a tetravalent dengue vaccine (TAK-003) to prevent dengue in people aged four years and above.

Source: Pharmaceutical Technology

REBYOTA

The US FDA has granted approval for Ferring Pharmaceuticals ’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above.

Source: Pharmaceutical Technology

Clinical Trials

UCB reports positive data from two hidradenitis suppurativa therapy trials

UCB has reported positive data from the BE HEARD I and BE HEARD II Phase III studies of bimekizumab in moderate to severe hidradenitis suppurativa adult patients. Bimekizumab met the primary endpoint, as well as a key secondary endpoint in both the studies.

Source: Clinical Trials Arena

Sitero and CRIO partner to improve patient safety in trials

Sitero has entered into a strategic partnership with CRIO to remove the administrative burden of clinical research for sites and sponsors, and improve participant safety, experiences, and outcomes. The collaboration will remove the need for redundant, manual, and error-prone activities across the clinical lifecycle.

Source: Clinical Trials Arena

Roche reports positive data from Phase III PNH therapy trial

Roche has reported positive findings from the Phase III COMMODORE 3 clinical trial, in which its antibody crovalimab achieved disease control in paroxysmal nocturnal haemoglobinuria (PNH) patients. Crovalimab’s overall safety data was in line with those already reported with C5 inhibitors and underlying disease.

Source: Clinical Trials Arena

AstraZeneca-Daiichi Sankyo’s therapy shows response in breast cancer trials

AstraZeneca and Daiichi Sankyo have reported updated data from the Phase I TROPION-PanTumor01 clinical trial, where their datopotamab deruxtecan (Dato-DXd) showed to offer encouraging responses in heavily pretreated metastatic triple-negative breast cancer (TNBC) patients.

Source: Clinical Trials Arena

Catalent expands clinical supply facility in China’s FTZ

Catalent has announced the completion of its clinical supply facility expansion in China’s Waigaoqiao Free Trade Zone (FTZ). The two facilities provide optimised supply solutions to sponsors for clinical trials that are being undertaken in China.

Source: Clinical Trials Arena

US FDA grants clearance to commence trials of Sorrento’s mRNA vaccine

The US FDA has granted clearance to Sorrento Therapeutics to commence clinical trials of the messenger ribonucleic acid (mRNA) vaccine STI-1557. The microneedle system, along with an mRNA vaccine candidate, showed enhanced humoral immunity in animal models.

Source: Clinical Trials Arena