The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
$300m
Bausch has agreed to pay $300m to settle a 2019 antitrust lawsuit that claimed the drugmaker paid off its generic rivals to delay market entry.
12-15
England is set to offer children aged 12 to 15-years-old a first dose of the Pfizer/BioNTech Covid-19 vaccine.
13.5%
Pompe disease market to reach $1.95bn in 2030, growing at an impressive compound annual growth rate of 13.5%.
€1.4bn
The UK has terminated a €1.4bn agreement with France-based biotech company Valneva for the supply of at least 100 million doses of Covid-19 vaccine.
114,000
The number of diagnosed incident cases of HER2+/HR+ breast cancer is set to reach 114,000 in 2030, according to GlobalData.
Approvals
Sotorasib
Patients in England are set to benefit from Sotorasib after the drug was proven to halt growth of tumours for seven months.
Source: The Guardian
Ultomiris (ravulizumab)
The EU has granted expanded approval to AstraZeneca division Alexion’s Ultomiris (ravulizumab) for use in children and adolescents with paroxysmal nocturnal haemoglobinuria.
Source: Pharmaceutical Technology
Invega Hafyera
The US Food and Drug Administration (FDA) has approved Janssen Pharmaceutical’s long-acting atypical antipsychotic, Invega Hafyera (six-month paliperidone palmitate) to treat adults with schizophrenia.
Source: Janssen
Pfizer gets first approval, in UK, for Xeljanz follow-up Cibinqo
Pfizer has claimed its first regulatory approval worldwide for Cibinqo, its JAK inhibitor for atopic dermatitis, from the UK’s Medicines and Healthcare products Regulatory Agency.
Source: Pharmaphorum
Dihydroergotamine mesylat
The US FDA has approved dihydroergotamine mesylate for the treatment of adults with acute migraine with or without aura, according to a press release from the drug’s manufacturer.
Source: Healio
Clinical Trials
NHS launches world first trial for new cancer test
NHS England has begun a large-scale trial of a new blood test that can detect more than 50 types of cancer before the appearance of symptoms.
Source: NHS England
Entos to commence Phase II Covid-19 vaccine trial in South Africa
Entos Pharmaceuticals has obtained approval from the South African Health Products Regulatory Authority to commence a Phase II clinical trial of its Covid-19 vaccine candidate, Covigenix VAX-001, in the country.
Source: Pharmaceutical Technology
Senhwa doses first subject in trial of Pidnarulex for solid tumours
Senhwa Biosciences has dosed the first subject in a clinical trial of Pidnarulex as a potential treatment for solid tumours with homologous recombination gene mutations.
Source: Clinical Trials Arena
AstraZeneca chalks up double win for novel combo of asthma rescue inhaler
Two large trials have hit their goals showing that PT027, a fixed-dose combo of short-acting beta2-agonist albuterol and inhaled corticosteroid budesonide, could help asthma patients better than its individual components alone.
Source: Fierce Pharma
EnGeneIC initiates Phase I trial of nanocellular anti-Covid-19 vaccine
EnGeneIC has initiated dosing in Phase I clinical trial of its first-ever nanocellular technology-based anti-Covid-19 vaccine in healthy adults.
Source: Pharmaceutical Technology
AIVITA finds personalised Covid-19 vaccine generates immune response
AIVITA Biomedical has reported data from Phase II clinical trial of its anti-SARS-CoV-2 Vaccine Enabling Kit. In 96% of participants, vaccination led to an enhanced immune memory response against the Covid-19 virus.
Source: Clinical Trials Arena
