News in Numbers

12

The pharmaceutical industry has warned against the UK Government’s controversial decision to 

extend the dosing regimen for the two approved Covid-19 vaccines to 12 weeks.

10

US cost effectiveness watchdog ICER has identified ten examples of substantial price rises for top-selling medicines in 2019.

>50%

Jazz Pharmaceuticals CEO Bruce Cozadd has announced that more than half of the company’s revenue will come from new drugs by 2022.

74%

Irish exports of medical and pharmaceutical products increased 74% in November compared to results from the previous year.

1.25 million

After signing a new supply deal with the US Government, Regeneron is now set to provide up to 1.25 million doses of its antibody cocktail for the treatment of non-hospitalised Covid-19 patients.

Approvals

ZEJULA (niraparib)

National Institute for Health and Care Excellence has recommended GSK’s ZEJULA (niraparib) on the NHS in England for women with advanced high-grade epithelial ovarian cancer, fallopian tube or primary peritoneal cancer.

Source: Pharmafield

Tivicay

The European Commission has granted marketing authorisation for the new formulation of ViiV’s Tivicay. The drug will be made available Europe in a new dispersible tablet form to treat children living with HIV.

Source: Pharmaphorum

Covid-19 Vaccine Moderna

The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for Covid-19 Vaccine Moderna to prevent Covid-19 in people from 18 years of age.

Source: EMA

Gemtesa (vibegron)

The US Food and Drug Administration (FDA) has approved Urovant Sciences’ New Drug Application for once-daily 75 mg Gemtesa (vibegron), for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency in adults.

Source: Healio

Ebanga (Ansuvimab-zykl)

The US FDA has approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children.

Source: FDA

Clinical Trials

Covid: Large trial of new treatment begins in UK

A large-scale trial of a new treatment it is hoped will help stop Covid-19 patients from developing severe illness has begun in the UK. It was developed at Southampton University Hospital and is being produced by the Southampton-based biotech company, Synairgen.

Source: BBC

Celltrion’s Covid-19 drug shows therapeutic efficacy in Phase II trials

South Korean company Celltrion has reported data from Phase II clinical trials confirming that its Covid-19 treatment candidate, Regkirona (CT-P59; regdanvimab), demonstrated better therapeutic efficacy than other antibody treatments.

Source: Clinical Trials Arena

'Anti-Covid pill' could replace jabs as green light is given for clinical trials to begin

IosBio - based in Sussex, England - has found a way to engineer a vaccine that doesn't require an injection, but can be orally administered instead, in a stunning revelation in the fight against coronavirus. In collaboration with Californian firm ImmunityBio, the company is currently testing the technology in clinical trials.

Source: The Irish Post

Sinovac: Brazil results show Chinese vaccine 50.4% effective

A coronavirus vaccine developed by China's Sinovac has been found to be 50.4% effective in Brazilian clinical trials, according to the latest results released by researchers. It shows the vaccine is significantly less effective than previous data suggested - barely over the 50% needed for regulatory approval.

Source: BBC

Study demonstrates efficacy of new treatment for neurofibromatosis type 1-related tumours

Researchers at Children's Hospital of Philadelphia as part of the Neurofibromatosis Clinical Trials Consortium have shown that the drug, cabozantinib, reduces tumor volume and pain in patients with the genetic disorder neurofibromatosis type 1.

Source: EurekAlert!

Sputnik V Covid-19 vaccine meets endpoints in India trial

Dr. Reddy’s Laboratories has announced that the Phase II clinical trial of the Russia’s Covid-19 vaccine Sputnik V met the primary endpoints of safety. Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, Sputnik V is based on human adenoviral vector platform.

Source: Clinical Trials Arena