News in Numbers

10,000%

The UK’s competition watchdog has imposed fines totalling more than £260m on pharmaceutical companies after an investigation found that they increased the price of a life-saving steroid treatment by more than 10,000%.

2

Two brands of contraceptive pill containing synthetic progesterone – Hana and Lovima – will soon be available without a prescription in the UK.

£20m

The UK NHS has announced plans to invest £20m to fast-track measures for rapid cancer diagnosis, in a bid to get more people checked for cancer.

$345m

Pfizer is set to pay $345mto settle antitrust allegations over its partnership on the epinephrine injection EpiPen.

200

Researchers from the University of Cambridge’s Milner Therapeutics Institute and Gurdon Institute have reportedly identified 200 approved drugs predicted to work against Covid-19.

Approvals

Rezurock (belumosudil)

The US Food and Drug Administration (FDA) has approved Kadmon Holdings’ kinase inhibitor Rezurock (belumosudil) for the treatment of patients with chronic graft-versus-host disease.

Source: Kadmon

Kerendia (finerenone)

The US FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks and hospitalisation for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

Source: FDA

Imfinzi (durvalumab)

AstraZeneca’s Imfinzi (durvalumab) has been approved in China for the first-line treatment of adult patients with extensive-stage small-cell lung cancer, in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin).

Source: Pharma Web

VAXNEUVANC (Pneumococcal 15-valent Conjugate Vaccine) 

The US FDA has approved VAXNEUVANC for active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

Source: Merck

Tecentriq

The UK Medicines and Healthcare product Regulatory Agency has issued a positive opinion on tepotinib as a treatment for adult non-small cell lung cancer patients whose tumours have METex14 skipping alteration.

Source: Pharmaphorum

Clinical Trials

Huge study supporting ivermectin as Covid treatment withdrawn over ethical concerns

The preprint endorsing ivermectin as a coronavirus therapy has been widely cited, but independent researchers find glaring discrepancies in the data.

Source: The Guardian

New clinical trial aims to improve diagnosis, treatment and rehabilitation of long Covid

A major new consortium led by University College London Hospitals NHS Foundation Trust and University College London has been awarded £6.8m by the National Institute of Health Research to conduct the largest clinical study of long Covid over the next two years.

Source: University College London Hospital

ImmunityBio receives approval to trial Covid-19 vaccine in South Africa

ImmunityBio has received approval from the South Africa Health Products Regulatory Authority to assess its dual-antigen T-cell vaccine for Covid-19 in Phase I/II/III South Africa Sisonke T-Cell Universal Boost clinical trial.

Source: Clinical Trials Arena

BioNTech/Pfizer plan to trial Delta variant vaccine in August

Pfizer and BioNTech are preparing to start clinical trials next month on a version of their Covid-19 vaccine targeting the Delta variant amid fears that existing jabs will offer less protection against the strain spreading across much of the world.

Source: Financial Times

GSK’s daprodustat shows positive data for anaemia in Phase III ASCEND trials

GlaxoSmithKline (GSK) has reported positive headline data gathered from five clinical trials of the Phase III ASCEND programme of daprodustat to treat anaemia in chronic kidney disease patients.

Source: Clinical Trials Arena

Mesoblast’s Covid-19 therapy improves survival rate in ARDS trial 

Mesoblast has reported that its therapy, remestemcel-L, enhanced survival outcomes in ventilator-dependent Covid-19 patients suffering from moderate/severe acute respiratory distress syndrome (ARDS) in a trial.

Source: Clinical Trials Arena