The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
90%
Pfizer and BioNTech mRNA-based vaccine candidate was found to be more than 90% effective in preventing Covid-19 in clinical trials.
76%
The percentage of patients that don’t trust advice from pharmaceutical companies, according to DrugsDisclosed.com research.
92%
Mere days after Pfizer and BioNTech’s announcement, Russia’s sovereign wealth fund claimed that early data for the country’s Sputnik V Covid vaccine showed 92% effectiveness in trials.
$31m
The US Government has committed $31m to technology and solutions provider Cytiva to help fund Covid-19 vaccine-related components.
€6m
The amount that the EU Horizon 2020 research and innovation programme invested for Covid- 19 related research and drug development in April 2020.
Approvals
Sesquient (fosphenytoin sodium) for Injection
The US Food and Drug Administration (FDA) has approved Sedor Pharmaceuticals’ Sesquient (fosphenytoin sodium for injection), a Captisol-enabled, room-temperature stable formulation of fosphenytoin sodium indicated for the treatment of status epilepticus in adults and children.
Source: Business Wire
Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets
Sebela Pharmaceuticals has received US FDA approval for sodium sulfate, magnesium sulfate and potassium chloride tablets (Sutab) for colonoscopy preparation, as an alternative to liquid-based colonoscopy solutions.
Source: Pharmacy Times
Tacrolimus Capsules
Glenmark Pharmaceuticals Inc has been granted final approval by the US FDA for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf®1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US.
Source: Glenmark Pharma
Bronchitol (mannitol) Inhalation Powder
Chiesi USA, Inc has received US FDA approval for Bronchitol (mannitol) inhalation powder, which is an inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in cystic fibrosis patients 18 years of age and older.
Source: Global Newswire
Clinical Trials
Personalised cancer vaccine clinical trial to expand following promising early results
A recent trial to study safety and effectiveness of a personalised cancer vaccine combined with immunotherapy drug Pembrolizumab will expand after promising preliminary data was presented. Researchers reported data on the first ten patients with head and neck cancer.
Source: ScienceDaily
Novartis’ Ilaris fails in late-stage Covid-19 trial
Novartis’ Ilaris (canakinumab) has failed to produce results in a phase III trial, which tested whether it could improve Covid-19 patients’ survival chances without need for mechanical ventilation. The company is trying to repurpose the drug used in rare inflammatory diseases such as juvenile arthritis for Covid-19, to see if it could relieve the extreme immune reaction that can prove fatal after infection with coronavirus.
Source: Pharmaphorum
Pfizer’s abrocitinib scores another phase III win in atopic dermatitis
Pfizer’s investigational oral Janus kinase 1 inhibitor abrocitinib has scored positive top-line results in a phase III atopic dermatitis trial. The 52-week phase III JADE REGIMEN study investigated abrocitinib in patients aged 12 and older with moderate to severe atopic dermatitis following response to initial open label induction with abrocitinib 200mg.
Source: Pharma Times
AstraZeneca posts positive late-stage trial results for asthma treatment
AstraZeneca has announced positive late-stage trial results for its drug candidate, tezepelumab, for patients with severe, uncontrolled asthma. The FTSE 100 group said phase III trials met the primary endpoint, which is the main result the pharma company was seeking, by combining tezepelumab to the standard of care.
Source: Proactive Investors
Sanofi/Alnylam’s haemophilia drug hits another safety speed-bump
Sanofi’s attempt to take on Roche with a ground-breaking approach to treating haemophilia has hit a setback after the company voluntarily placed its late-stage trials of fitusiran on hold because of safety issues. The news that phase III development has been put on hold was not announced by the French pharma, but in a joint statement from three haemophilia patient groups.
Source: Pharmaphorum
SinoVac gets authorisation to restart Covid-19 vaccine trial in Brazil
Chinese biopharmaceutical firm Sinovac is set to resume the Phase III trial of the Inactivated Covid-19 vaccine, CoronaVaC, after the Brazil National Health Surveillance Agency (Anvisa) authorised its resumption. The move comes after Anvisa suspended the large-scale trial of the Covid-19 vaccine owing to a severe adverse event.
Source: Pharmaceutical Technology
