Complete response letter sent for two generic products
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
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Pharma bodies confirm signing NDAs for no-deal Brexit plans
The DHSC has confirmed that several pharmaceutical industry bodies have agreed to NDAs regarding plans for a no-deal Brexit.
Drug supplier Aspen to pay NHS £8m after competition probe
The CMA alleges that Aspen broke competition law, prompting the drug supplier to offer a payment and other compensations to the NHS.
New drug for treatment-resistant forms of tuberculosis approved
Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.
Chlamydia vaccine passes safety trial
A first-of-its-kind experimental chlamydia vaccine trial has been found to be safe and able to provoke an immune response.
Imbruvica® granted expanded use from European Commission
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
FDA to deactivate out-of-date drug listings in its database
In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
Letter highlights issues with US drug returns verification requirements
An open letter has underscored the challenges of return failure in the US drug supply chain, especially after the introduction of the Drug Supply Chain Security Act in November.
Voluntary recall issued for lidocaine cream and liquid gel products
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
Ebola clinical trial stopped early due to positive results
An Ebola clinical trial has been stopped early as Regeneron's REGN-EB3 therapy shows superiority to ZMapp in preventing Ebola deaths.
Amgen wins court patent ruling over Sandoz biosimilar
The US District Court has decided in favour of Amgen’s Enbrel, ruling over Sandoz’s Erelzi in a patent conflict.
US court rules in favour of Lilly in Alimta® patent lawsuit
The US District Court has ruled in favour of Eli Lilly in the Alimta patent lawsuit against Dr. Reddy's Laboratories and Hospira, Inc.
FDA grants Orphan Drug Designation to DYN101 treatment
A treatment for Centronuclear Myopathies has received Orphan Drug Designation from the FDA and will begin Phase I/II trials.
Clinical trial reporting is improved by professional medical writers
A new systematic review has shown that the speed and quality of clinical trial reports are improved by professional medical writers.
NICE releases draft guidance for using cannabis-based medicinal products
The NICE and NHS have announced their draft recommendations for the prescribed use of cannabis-based treatments.
