News in Numbers

$1.48 billion

Italian pharmaceutical company Chiesi Farmaceutici has signed a definitive agreement to acquire Amryt Pharma in a total deal valued at up to $1.48bn.

37

In 2022, the US FDA approved 37 new drugs that were hitherto not approved or marketed in the US.

$200

Element Biosciences announced that a new throughput-based option for its AVITI System will provide sequencing on a benchtop for $200 a genome.

42

As of 11 January, 42 days or two incubation periods had passed since the last case of Ebola in Uganda, marking the end of the outbreak in the country.

1.73 million

As per the Centers for Disease Control and Prevention, 1.73 million children below the age of 5 have received at least one Covid-19 vaccine dose since June 2022.

 Approvals

LEQEMBI

Eisai and Biogen have received an accelerated approval for their antibody Leqembi (lecanemab-irmb), from the US Food and Drug Administration (FDA) to treat Alzheimer’s disease.

Source: PHARMACEUTICAL TECHNOLOGY

SUNLECA

The US FDA approved Gilead Sciences’ long-acting HIV capsid inhibitor, Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat HIV infections.

Source: PHARMACEUTICAL TECHNOLOGY

TYMLOS

The US FDA has granted approval for Radius Health’s Tymlos (abaloparatide) to boost bone density in men with osteoporosis at increased fracture risk.

Source: Pharmaceutical Technology

VRAYLAR

The US FDA has approved AbbVie’s Vraylar (cariprazine) as an adjunctive treatment to antidepressants to treat adult patients with major depressive disorder (MDD).

Source: Pharmaceutical Technology

KRAZATI

The US FDA has granted accelerated approval for Mirati Therapeutics’ Krazati (adagrasib) as a targeted therapy option to treat KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults.

Source: Pharmaceutical Technology

Clinical Trials

Innovent Biologics begins subject dosing in type 2 diabetes therapy trial

Innovent Biologics has dosed the first participant in the Phase III DREAMS-2 clinical trial of mazdutide (IBI362) for type 2 diabetes in China. The trial will compare the safety and efficacy of mazdutide and dulaglutide in type 2 diabetes patients. 

Source: Clinical Trials Arena

Journey Medical completes subject enrolment in PPR therapy trial

Journey Medical has completed participant enrolment and randomisation in its Phase III clinical trials programme of DFD-29 (minocycline modified release capsules 40mg) to treat papulopustular rosacea (PPR).

Source: Clinical Trials Arena

SciSparc and Soroka Medical Center sign agreement for ASD drug trial

SciSparc and the Soroka University Medical Center Israel have signed an agreement for a clinical trial of drug candidate SCI-210 in patients with autism spectrum disorder. The clinical trial will be carried out in 60 children for 20 weeks.

Source: Clinical Trials Arena

Algernon to begin chronic cough therapy trial in third quarter of 2023

Algernon Pharmaceuticals has unveiled plans to commence a Phase IIb clinical study of NP-120 (Ifenprodil) to treat chronic cough in the third quarter of this year. The randomised trial has been designed to assess NP-120 in approximately 180 participants.

Source: Clinical Trials Arena

Sorrento reports positive data from oral Covid-19 treatment trial

Sorrento Therapeutics has reported positive data from a Phase Ib clinical trial of ovydso (STI-1558), an oral main viral protease (Mpro) inhibitor for Covid-19. STI-1558 was well-tolerated at these doses and no adverse events (AEs) were reported by most of the participants.

Source: Clinical Trials Arena

BioNTech signs deal with UK government for personalised cancer therapies

BioNTech has signed a memorandum of understanding (MoU) with the UK Government to provide personalised mRNA cancer immunotherapies for up to 10,000 patients by 2030. The collaboration is focused on infectious disease vaccines, cancer immunotherapies, and investments

Source: Clinical Trials Arena