The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
€2.7m
The French drug manufacturer Laboratoires Servier has been fined €2.7m (£2.3m) for concealing potentially fatal side effects of the widely prescribed drug Mediator.
$24.8bn
GlobaldData forecasts that Pfizer/BioNTech’s vaccine will achieve record-breaking sales of $24.8bn by 2021.
2.4 million
The Czech Republic wants to buy around 2.4 million doses of the AstraZeneca/Oxford University vaccine ditched by Denmark, which has said it will stop using it because of concerns about rare blood clotting side effects.
5
An injection, known as PHESGO, which cuts the amount of time breast cancer patients spend in hospital from two and a half hours to as little as five minutes is being rolled out across the country by NHS England.
3 million
The number of diagnosed prevalent cases of Parkinson’s disease is on track to reach 3 million by 2029 in the 7MM, according to GlobalData research.
Approvals
NEXTSTELLIS
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the novel combined oral contraceptive NEXTSTELLIS (3 mg drospirenone and 14.2 mg of estetrol tablets).
Source: Pharmaceutical Technology
Tysabri
The UK Medicines and Healthcare products Regulatory Agency has approved a new subcutaneous formulation for Biogen’s multiple sclerosis treatment Tysabri.
Source: MS Trust
TECFIDERA
China’s National Medical Products Administration has approved Biogen’s TECFIDERA (dimethyl fumarate) for the treatment of relapsing multiple sclerosis.
Source: Yahoo finance
nivolumab
The European Commission has approved Bristol Myers Squibb’s drug nivolumab in combination with cabozantinib as a treatment for patients with advanced renal cell carcinoma.
Source: Market Watch
Sputnik V
India has granted emergency use authorisation for Russia’s Sputnik V vaccine, becoming the 60th country to approve the vaccine.
Source: CNBC
Clinical Trials
PTC’s Evrysdi improves motor function and survival in infants with SMA
Results from Part 2 of the PTC Therapeutics’ FIREFISH trial of Evrysdi reportedly demonstrated that infants with type 1 spinal muscular atrophy continued to show improvements in survival and key motor milestones after two years of treatment.
Source: PTC Therapeutics
Ideaya doses first patient in solid tumour treatment trial
Ideaya Biosciences has announced first-patient-in (FPI) in Phase I clinical trial of methionine adenosyltransferase 2a inhibitor IDE397 for treating methylthioadenosine phosphorylase deletion solid tumours.
Source: Clinical Trials Arena
Romark’s investigational Covid-19 drug lowers disease progression in trial
Romark has reported that initial results from a Phase III clinical trial of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets, 300mg) showed reduced disease progression in mild or moderate Covid-19 patients.
Source: Romark
GSK to halt two cancer trials of investigational ICOS agonist
GlaxoSmithKline (GSK) has decided to stop the enrolment of patients in Phase II INDUCE-3 trial of feladilimab for PD-L1 positive recurrent locally advanced or metastatic head and neck squamous cell carcinoma treatment.
Source: Clinical Trials Arena
Oxford University expands Com-COV2 dose-mixing study with Novavax’s Covid-19 vaccine
The University of Oxford has expanded the Comparing Covid-19 Vaccine Schedule Combinations – Stage 2 (Com-COV2) study to include the Novavax and Moderna vaccines for the disease treatment.
Source: Pharmaceutical Technology
Rigel’s fostamatinib meets primary endpoint in Covid-19 clinical trial
Rigel Pharmaceuticals has reported that the Phase II clinical trial of its oral spleen tyrosine kinase inhibitor fostamatinib in treating hospitalised Covid-19 patients met the primary endpoint of safety.
Source: Rigel
