News in Numbers

4

Four pharma industry heavyweights: AstraZeneca, Merck, Pfizer and Teva Pharmaceutical are joining forces with an AI-focused initiative called AION Labs that aims to help fund drug research start-ups.

$500m

Moderna is set to build a $500m vaccine manufacturing facility in Africa capable of producing up to 500 million vaccine doses in the continent each year.

$712

The price that Merck is charging for the US Government for a five-day course of its Covid-19 treatment molnupiravir –a reported40 times the cost it takes to produce the medication.

1.5 million

Deaths from tuberculosis have increased for the first time in more than a decade, totalling more than 1.5 million people in 2020, according to a new report from the World Health Organization.

$450m

Supernus Pharmaceuticals has signed an agreement for the acquisition of Adamas Pharmaceuticals for nearly $450m.

Approvals

Tecentriq (atezolizumab)

The US Food and Drug Administration (FDA) has approved Roche’s Tecentriq (atezolizumab) as adjuvant therapy for treating Stage II-IIIA non-small cell lung cancer adult patients whose tumours express PD-L1≥1%.

Source: Pharmaceutical Technology

Ofev (nintedanib)

The National Institute for Health and Care Excellence (NICE) has recommended Boehringer Ingelheim’s Ofev (nintedanib) for the treatment of adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD).

Source: Pharma Times

Dupixent (dupilumab)

NICE has issued a final appraisal determination recommending Dupixent (dupilumab), as an add-on maintenance treatment for severe asthma.

Source: Pharmafield

TYRVAYA (varenicline solution)

The US FDA has approved Oyster Point Pharma Inc's treatment for dry eye disease, TYRVAYA (varenicline solution) Nasal Spray 0.03 mg, making it the first US-approved nasal spray for the chronic condition.

Source: Reuters

Covaxin

An expert panel on India’s Central Drugs Standard Control Organisation has recommended granting emergency use authorisation to Bharat Biotech’s Covid-19 vaccine, Covaxin, for use in children aged two to 18 years.

Source: Pharmaceutical Technology

Clinical Trials

Positive trial results for Valneva Covid-19 vaccine

The Valneva Covid vaccine that the UK cancelled a 100 million dose order for last month, works well at priming the immune system to fight coronavirus, phase III trial results suggest.

Source: BBC

Emergent commences Phase III trial of single-dose chikungunya vaccine

Emergent BioSolutions has dosed the first subject in the Phase III trial of its single dose investigational chikungunya virus (CHIKV) vaccine candidate, CHIKV VLP.

Source: Clinical Trials Arena

Biogen drug for rare form of ALS fails pivotal study

In the phase III VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance.

Source: Biogen

Immune-Onc doses first patient in Phase I solid tumour treatment trial

The trial will analyse the TTX-080’s safety and efficacy as a single agent and in combination with pembrolizumab or cetuximab.

Source: Clinical Trials Arena

FDA halts Allogene CAR-T trial after safety scare

A phase I trial of Allogene’s of-the-shelf CAR-T for lymphoma has been placed on hold by the FDA, after a “chromosomal abnormality” was seen in a patient receiving the cell therapy.

Source: Pharmaphorum

Roche’s Enspryng lowers disease relapses in phase III NMOSD trials

Roche has reported the latest longer-term efficacy and safety results from two Phase III trials of Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Source: Clinical Trials Arena