Drug Approval | 01 September 2021
Zymo Research receives CE Mark for new Covid-19 SafeCollect kits
Self-collection devices designed for ease of use and safety
Self-collection devices designed for ease of use and safety
JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies for moderate to severe atopic dermatitis
Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data. The global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine
The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumours, and evaluate the anti-tumour efficacy of ICP-723 on NTRK fusion-positive cancers
The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit
This is Enzene Biosciences third biosimilar to be approved
Textiles treated with the technology have also been proven to deactivate viruses, including SARS-CoV-2 (the virus that causes COVID-19).
When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke
Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options
Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The clinical research organisation located in Hyderabad is a USFDA inspected facility
New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
The company to receive upfront and milestone payments, in addition to royalties
Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease
The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment
New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US
Enoxaparin Sodium Injection, USP is used for prophylaxis of Deep Vein Thrombosis (DVT) in patients undergoing abdominal, hip or knee replacement surgery, and also for the treatment of acute DVT
The company's discovery services support a wide range of global innovator companies from start-ups to large pharma companies, across a diverse set of therapeutic areas including oncology, CNS, antivirals, and inflammation among others
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