Amryt submits NDA to the FDA for Oleogel-S10

March 31, 2021
Research 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, 2021
Research 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, 2021
Research 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, 2021
Research 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, 2021
Manufacturing 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 building

Roche’s SMA treatment Evrysdi approved by European Commission

March 30, 2021
Manufacturing 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, 2021
Manufacturing and Production

Novartis has announced today that it has obtained exclusive rights to develop therapeutic applications for a library of fibroblast activation …

gsk_boronia_australia

GSK to support manufacture of 60m Novavax COVID-19 vaccines

March 30, 2021
Manufacturing 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 …

stock-incyte-01-shutter

Incyte receives EC approval for Pemazyre

March 30, 2021
Manufacturing and Production EU

Incyte have received approval from the European Commission (EC) for Pemazyre (pemigatinib), the first new treatment for adults with locally …

moderna_norwood_plant

500,000 Moderna COVID-19 vaccines to arrive in UK next month

March 29, 2021
Sales 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. …

GSK building

GSK & Vir’s COVID-19 treatment shows 85% efficacy in Phase III trial

March 29, 2021
Sales and Marketing COVID-19, GSK, Phase III trial, covid-19 treatment, vir

GSK and Vir Biotechnology have submitted an Emergency Use Authorization request to the FDA for their VIR-7831 therapy for the …

Janssen’s multiple sclerosis treatment recommended by EMA

March 29, 2021
Sales and Marketing CHMP, EMA, Janssen, Johnson & Johnson, PONVORY, multiple sclerosis

Janssen’s PONVORY therapy for the treatment of adults with relapsing forms of multiple sclerosis (MS) has been recommended by the …

BATM develops molecular diagnostics test for tuberculosis

March 29, 2021
Sales and Marketing TB, testing

BATM have announced that it has developed a new method for the rapid and comprehensive diagnosis of tuberculosis (TB), which …

gaitQ awarded NIHR grant for Parkinson’s wearable tech

March 29, 2021
Sales and Marketing Parkinson's, medical technology

The UK’s National Institute for Health Research (NIHR) has awarded a £135,000 grant to gaitQ, a spin-off from the University …

Top 10 news roundup

Pharmafile.com’s top 10 news stories of the week

March 26, 2021
Medical Communications AstraZeneca vaccine, COVID-19, covid 19 news, covid-19 news, news, news roundup, starpharma

In the last week, a number of new developments have made the news; for COVID-19, Starpharma will begin to sell …

FDA approve Astellas’s Myrbetriq treatment for bladder dysfunction

March 26, 2021
Medical Communications Astellas Pharma, FDA, Ida approval

The FDA have approved a new indication for Astellas Pharma’s Myrbetriq and Myrbetriq Granules to treat neurogenic detrusor overactivity (NDO), …

credit_-_daniel_leal-olivas-afp

Astellas Pharma and Seagen cancer treatment gets MAA acceptance from EMA

March 26, 2021
Medical Communications EMA, oncology

Astellas Pharma and Seagen Inc. have announced that the EMA has accepted their marketing authorisation application (MAA) for enfortumab vedotin, …

Novavax delays 100 million vaccines to the EU

March 26, 2021
Medical Communications COVID-19, EU, Vaccine

Novavax is delaying the signing of a contract to supply COVID-19 vaccines to the EU, as the company warned it …

Pfizer's New York headquarters

Pfizer begins COVID-19 vaccine testing on young children

March 26, 2021
Medical Communications COVID-19, Pfizer, Vaccine

Pfizer have begun testing its COVID-19 vaccine on children under the age of 12, with the trials’ first participants, a …

Starpharma to sell COVID-fighting nose spray in UK

March 25, 2021
COVID-19

Australian biotech company, Starpharma, has announced a deal with LloydsPharmacy to sell its COVID-fighting antiviral nasal spray, Viraleze, in the …

The Gateway to Local Adoption Series

Latest content