Early Alzheimer’s disease treatment meets trial primary endpoints
Aducanumab, an Alzheimer's disease treatment, will be submitted as part of a Biologics License Application after meeting clinical trial primary endpoints.
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FDA sends warning letter to company illegally selling CBD products
A business selling unapproved products containing CBD has been sent a warning letter from the FDA and FTC for making unsubstantiated claims about their therapeutic properties.
FDA approved 1,171 generic drugs in 2019
The FDA has released a statement on their generic drug approvals in FY 2019, revealing a new record high breaking above last year.
Breakthrough therapy for cystic fibrosis approved by FDA
Trikafta is the first approved treatment that is effective for patients 12 years and older with the most common cystic fibrosis mutation.
Teva to supply treatment in settlement agreement on Track 1 opioid case
Teva has agreed to supply opioid medication and make a cash payment in a settlement agreement that removes it from the Track 1 opioid litigation.
Global consortium formed to combat unproven cell banking services
The International Society for Cell and Gene Therapy has created a group to tackle the rising number of commercial cell bank services that are misleading patients.
Mutagenic impurities – a JPAG event
The Joint Pharmaceutical Analysis Group held an event in London, discussing the testing of nitrosamine mutagenic impurities in pharmaceutical products and the next steps for manufacturers to take.
HER2-positive metastatic breast cancer treatment granted Priority Review
Priority Review has been granted for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of HER2-positive metastatic breast cancer.
Sanofi announces voluntary recall of Zantac products
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
Concept discovered for fabricating nanomeshes as drug delivery system
The fight against antibiotic resistance could be improved with the discovery of a concept for fabricating nanomeshes as a drug delivery system.
Seven medicines recommended for approval by EMA
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.
First non-injectable treatment for severe hypoglycaemia recommended
Marketing authorisation in the EU for Baqsimi, the first non-injectable treatment for very low levels of blood sugar, has been recommended by an EMA committee.
First patient enrolled on Phase II trial for cystic fibrosis treatment
A Phase II trial for an inhaled cystic fibrosis drug, intended for adults and adolescents, has enrolled its first patient.
Osteoarthritis therapeutics market to be worth $10.1bn by 2024, says report
A new report has said the osteoarthritis therapeutics market is estimated to grow due to rapid increase in the geriatric and obese population.
New report shows that clinical research improves health of UK economy
A new report has shown that from 2016/17 to 2018/19 clinical research has generated an estimated £8 billion of GVA for the UK.
