News in Numbers

 32%

In a GlobalData poll, 32% of respondents agreed that the most negative impact of e-pharmacies is an increase in opportunities for drug misuse or abuse.

 100 million

UK Prime Minister Boris Johnson has announced plans to donate at least 100 million surplus Covid-19 vaccine doses within the next year.

 5

A five-month-old child has become the first patient to receive the spinal muscular atrophy treatment Zolgensma on the NHS.

 $5.1bn

The Global Polio Eradication Initiative, a public-private partnership led by national governments and health groups has released a $5.1bn plan to eradicate polio by 2026.

 26%

Approximately 26% of all cell and gene therapies in late-stage clinical development in the US are being developed in the oncology space, according to GlobalData.

Approvals

Aduhelm (aducanumab)

In a landmark ruling, the US Food and Drug Administration (FDA) has granted accelerated approval to Aduhelm (aducanumab) for the treatment of Alzheimer’s.

Source: FDA

Contezolid

China’s National Medical Products Administration has approved MicuRx’s new drug application for contezolid for the treatment of complicated skin and soft tissue infection.

Source: MicuRx

DELYTACT (teserpaturev/G47∆)

Daiichi Sankyo has received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare for DELYTACT, an oncolytic virus, for the treatment of patients with malignant glioma.

Source: Pharmaphorum

Prevnar 20 Injection

The US FDA has approved Pfizer’s pneumococcal Prevnar 20-valent conjugate vaccine for adults ages 18 years or older.

Source: Pfizer 

Tecentriq

Novo Nordisk has received approval from the US FDA for Wegovy (the brand name for once-weekly semaglutide 2.4 mg injection in the US) for chronic weight management. 

Source: Novo Nordisk

Clinical Trials

Novavax’s Covid-19 vaccine shows 90% efficacy in Phase III

Novavax has announced that its Covid-19 vaccine candidate, NVX-CoV2373, demonstrated 90.4% overall efficacy in a Phase III trial conducted across sites in the US and Mexico.

Source: Pharma Times

Biogen’s rare eye disease gene therapy falls short at Phase III

Biogen’s Phase III trial of its gene therapy timrepigene emparvovec did not meet its primary or key secondary endpoints in patients with the rare inherited eye disease choroideremia, the firm has announced.

Source: Clinical Trials Arena

Celltrion’s Covid-19 drug regdanvimab meets Phase III endpoints

South Korean drugmaker Celltrion Inc (068270.KS) has announced positive results for its experimental antibody Covid-19 treatment, which it said was safe and reduced the treatment period by nearly five days in Phase III global clinical trials.

Source: Reuters

Sanofi’s sutimlimab meets primary goal in Phase III CAD trial

Sanofi has reported that its sutimlimab met the primary composite goal in Part A of the Phase III CADENZA trial in patients with cold agglutinin disease (CAD) without a recent blood transfusion history.

Source: Clinical Trials Arena

BMS’ Breyanzi meets primary endpoint in Phase III lymphoma trial

Bristol Myers Squibb (BMS) has reported positive top-line data from the Phase III TRANSFORM clinical trial where Breyanzi (lisocabtagene maraleucel) met the primary endpoint in relapsed or refractory large B-cell lymphoma patients.

Source: BMS

Selva’s Covid-19 drug shows activity against SARS-CoV-2 variants  

Selva Therapeutics has reported that its antiviral drug candidate, SLV213, demonstrated activity against three prominent SARS-CoV-2 variants in a preclinical study.

Source: Clinical Trials Arena