News in Numbers

1,470

There are 1,470 monkeypox cases reported in the US, as per a 14 July Centers for Disease Control and Prevention (CDC) update.

100 million

The US state of California plans to invest $100 million to manufacture low-cost insulin under the CalRx Biosimilar Insulin initiative.

81%

The percentage of children who received three doses of the vaccine against diphtheria, tetanus and pertussis fell 5 percentage points between 2019 and 2021 to 81%, as per the World Health Organization (WHO).

1.27 million

As per a recent WHO report, 4.95 million deaths per year are linked to resistant bacterial infections are associated with nearly, with 1.27 million deaths directly attributed to antimicrobial resistance.

1%

The prevalence of coeliac disease worldwide is between 0.5% and 2%, with an average of 1%, as per the Lancet.

 Approvals

VAXNEUVANCE

The US FDA granted approval for Merck’s (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years. It is the first pneumococcal conjugate vaccine to obtain approval in nearly ten years for this group. 

Source: PHARMACEUTICAL TECHNOLOGY

ROCTAVIAN

The European Medicines Agency recommended granting a conditional approval to BioMarin’s Roctavian, also known as valoctocogene roxaparvovec, to treat patients with severe hemophilia A who do not have factor VIII inhibitors.

Source: Fierce Pharma

NUVAXOVID

The EC has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years.

Source: Pharmaceutical Technology

KRYSTEXXA

More than a decade after Krystexxa's original approval, Horizon Therapeutics is breathing new life into the med by winning an expanded FDA label to improve treatment outcomes for patients with uncontrolled gout.

Source: FIERCE PHARMA

Clinical Trials

CANbridge doses first subject in Phase II biliary atresia trial in China

CANbridge Pharmaceuticals has dosed the first subject in the Phase II EMBARK clinical trial of CAN108 (maralixibat) in biliary atresia (BA) in China. The trial is anticipated to enrol up to 20 subjects in China and 72 patients across the globe.

Source: Clinical Trials Arena

Moleculin reports initial Phase Ia data studying Covid-19 asset

Moleculin Biotech has reported initial data from the second cohort of its Phase Ia clinical trial of WP1122 in healthy subjects to potentially treat Covid-19. According to the overall findings from Cohort 2, the dose was found to be safe and well-tolerated.

Source: Clinical Trials Arena

Clinilabs begins enrolment in Phase I/IIa major depressive disorder trial

Clinilabs Drug Development Corporation has commenced subject enrolment in a Phase I/IIa trial of CYB003 to treat major depressive disorder (MDD). A new psilocybin deuterated analog, CYB003 is being developed by biopharmaceutical company Cybin.

Source: Clinical Trials Arena

DiaMedica Phase II/III acute ischemic stroke trial placed on FDA clinical hold

The US FDA placed DiaMedica Therapeutics’ Phase II/III DM199 clinical trial for treating patients with acute ischemic stroke (AIS). The company halted subject enrolment and submitted three serious adverse event reports to the FDA linked to clinically significant, transient hypotension or low blood pressure.

Source: Clinical Trials Arena

Biohaven enrols first subject in Phase III spinal muscle atrophy trial

Biohaven Pharmaceutical has enrolled the first subject in Phase III RESILIENT clinical trial of taldefgrobep alfa (BMS-986089) in spinal muscle atrophy (SMA). A modified adnectin, taldefgrobep alfa can attach to myostatin (GDF-8).

Source: Clinical Trials Arena

Vera concludes Phase IIb IgA nephropathy trial subject enrolment

Vera Therapeutics has concluded subject enrolment in the Phase IIb ORIGIN clinical trial of atacicept in IgA nephropathy (IgAN) patients. The multinational, randomised, double-blind, placebo-controlled, dose-ranging trial is assessing atacicept’s safety and efficacy in 115 IgAN patients.

Source: Clinical Trials Arena