CEO of Novartis pledges to speed data integrity disclosures
Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.
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Fast Track designation granted to fosmanogepix for seven indications
Both the intravenous and oral formulations of the antifungal candidate, fosmanogepix, have been granted Fast Track designation by the FDA.
Microrobot could be used to deliver hyperthermia treatment to cancers
A team has developed a microrobot that is effective at targeting specific areas, so could be used in hyperthermia therapies when treating cancers.
Alternative viral delivery of gene therapy developed
New nanocapsules are a promising platform for many types of gene therapies due to their small size and superior stability.
Federal judge enters consent decree against drug distributors
Two Tennessee companies have been prevented from distributing drugs after a complaint they were supplying unapproved medications.
First treatment for patients with rare lung disease approved
The FDA has approved the first treatment for interstitial lung disease associated with systemic sclerosis or scleroderma.
Fosaprepitant and Decitabine generics receive FDA approval
Generic treatments for blood/bone marrow disorders and acute nausea and vomiting associated with chemotherapy have gained FDA approval.
EMA to review Picato after rise in skin cancer cases
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
EC approves expanded use of ustekinumab for ulcerative colitis
The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.
Korean pharma company alleged to have conducted trials on employees
Ahngook Pharmaceuticals reportedly held clinical trials on its employees without their consent, leading to the arrest of the company president.
Respiratory virus vaccine receives breakthrough therapy designation
The FDA has awarded a breakthrough therapy designation to an investigational prophylactic vaccine to treat respiratory syncytial virus in seniors.
Purdue Pharma prepares for bankruptcy ahead of opioid crisis trial
A report has found that the rejection of a settlement offer from Purdue has led to the company arranging to file for bankruptcy.
China grants Tagrisso (osimertinib) marketing authorisation
Following positive clinical trials, the Tagrisso drug has been given marketing authorisation in China for treatment of NSCLC.
Drug delivery improved through mesoporous materials
A new study on DOX as a model drug has potential applications in the drug delivery field for better control drug release.
Pharma reputation worst among other industries in US
An annual report has found that the pharmaceutical sector is the lowest regarded industry among US citizens.
