FDA approves first new ADHD drug in a decade
April 6, 2021Manufacturing and Production ADHD, FDA, paediatric
The FDA have approved the first new drug for the treatment of attention deficit hyperactivity disorder (ADHD) in over a …
Pharmafile.com’s top 10 news stories of the week
April 2, 2021COVID-19, covid 19 news, covid-19 news, news, news roundup, pharma news
In the last week, a number of new COVID-19 developments have emerged; Novavax has delayed 100 million vaccines to the …
EC grants marketing authorisation to Angelini Pharma’s epilepsy treatment
April 1, 2021Angelini Pharma have announced that the European Commission (EC) have granted marketing authorisation for Ontozry (cenobamate) for the treatment of …
New Sanofi Sarclisa treatment for multiple myeloma approved by FDA
April 1, 2021FDA, FDA Approval, Sanofi, Sarclisa, multiple myeloma
Sanofi’s Sarclisa drug has been approved by the FDA in combination with carfilzomib and dexamethasone (Kd) for the treatment of …
Newron announce successful results from schizophrenia study
April 1, 2021schizophrenia
Newron, a biopharmaceutical company focused on novel therapies, have announced the initial results from two short-term exploratory studies assessing the …
BD’s rapid COVID-19 test granted Emergency Use Authorization by FDA
April 1, 2021BD, COVID-19, COVID-19 testing, EUA, FDA
The FDA has granted Emergency Use Authorization (EUA) for Becton, Dickinson and Company’s (BD) rapid antigen test to be used …
NICE recommends Kineret for Still’s disease treatment
April 1, 2021NICE
Sobi has today announced a NICE recommendation of Kineret (anakinra) as a first-line biologic therapeutic option for still’s disease, including …
The Truth Behind the £1.8 Million Drug
March 31, 2021Manufacturing and Production FDA, NHS, NICE
As NICE approves the most expensive drug ever for use by the NHS, Jack Goddard takes a look at drug …
Real-world evidence and clinical research diversity
March 31, 2021Research and Development rwe
Clinical trials are immensely valuable in establishing the safety and effectiveness of a drug in carefully selected participants, but what …
Pharmafile.com’s weekly COVID-19 news round-up
March 31, 2021Research and Development COVID-19, covid 19 news, covid-19 news, covid-19 roundup
The past week has seen plenty of positive COVID-19 news; Starpharma are to start selling their COVID-fighting nose spray in …
Amryt submits NDA to the FDA for Oleogel-S10
March 31, 2021Research and Development FDA
Amryt has today announced the rolling submission of a New Drug Application (NDA) to the FDA for Olegel-S10, potential treatment …
EC approves combination treatment for kidney cancer
March 31, 2021Research and Development Cancer, Europe, oncology
The European Commission (EC) has approved Ipsen’s Cabometyx in combination with Opdivo as a first-line treatment for advanced renal cell …
Celonic to manufacture at least 100 million CureVac COVID-19 jabs
March 31, 2021Research and Development COVID-19, COVID-19 vaccine, CureVac, colonic, vaccine production
Celonic are to manufacture more than 100 million doses of CureVac’s COVID-19 vaccine, with 50 million shots expected to be …
Arecor receives £2.8m grant for rapid insulin product
March 31, 2021Research and Development diabetes, insulin
Arecor has announced today that it has received a £2.8 million grant from Innovate UK, to support the Phase II …
J & J to ship up to 400 million vaccines to Africa
March 30, 2021Manufacturing and Production COVAX, COVID-19, COVID-19 vaccine, Janssen, Johnson & Johnson
Johnson & Johnson has reached an agreement to ship as many as 400 million doses of their COVID-19 vaccine to …
Roche’s SMA treatment Evrysdi approved by European Commission
March 30, 2021Manufacturing and Production EMA, European Commission, PTC Therapeutics, Roche, sma, spinal muscular atrophy
The European Commission has granted marketing authorisation to Roche and PTC Therapeutics’ Evrysdi, for the treatment of patients aged 2 …
Novartis expands targeted radioligand therapy pipeline
March 30, 2021Manufacturing and Production
Novartis has announced today that it has obtained exclusive rights to develop therapeutic applications for a library of fibroblast activation …
GSK to support manufacture of 60m Novavax COVID-19 vaccines
March 30, 2021Manufacturing and Production COVID-19, GSK, UK, Vaccine
GSK has reached an agreement with Novavax and the UK Government Vaccines Taskforce to support the production of up to …
Incyte receives EC approval for Pemazyre
March 30, 2021Manufacturing and Production EU
Incyte have received approval from the European Commission (EC) for Pemazyre (pemigatinib), the first new treatment for adults with locally …
500,000 Moderna COVID-19 vaccines to arrive in UK next month
March 29, 2021Sales and Marketing COVID-19, Moderna, Vaccine
More than 500,000 doses of Moderna’s COVID-19 vaccine are set to arrive in the UK next month, ministers have confirmed. …
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