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RSS FeedPosted by Michael Wonder on 01 Feb 2020
Highlights from the CHMP 27-30 January 2020 meeting
31 January 2020 - Fifteen new medicines recommended for approval. ...
Posted by Michael Wonder on 31 Jan 2020
UK withdrawal from the EU on 31 January 2020
31 January 2020 - The United Kingdom will formally leave the European Union on 31 January 2020 and will become ...
Posted by Michael Wonder on 31 Jan 2020
Bristol-Myers Squibb withdraws European application of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of advanced non-small cell lung cancer
31 January 2020 - Company committed to first-line lung cancer patients in Europe, U.S. and other markets with planned filing of ...
Posted by Michael Wonder on 31 Jan 2020
Pulmatrix receives fast track designation for Pulmazole for the treatment of asthma-ABPA
30 January 2020 - Pulmatrix today announced that the U.S. FDA has granted fast track designation to PUR1900 (Pulmazole), the ...
Posted by Michael Wonder on 30 Jan 2020
FDA updates prioritization policy for original abbreviated new drug applications, amendments and supplements to maximise impact on public health
30 January 2020 - Today, the U.S. FDA is making critical updates to our policy for prioritising the review of ...
Posted by Michael Wonder on 30 Jan 2020
Aprea Therapeutics receives FDA breakthrough therapy designation for APR-246 in combination with azacitidine for the treatment of myelodysplastic syndromes with a TP53 mutation
30 January 2020 - Aprea Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for APR-246 in combination ...
Posted by Michael Wonder on 30 Jan 2020
ProQR receives rare paediatric disease designation from FDA for QR-421a
30 January 2020 - Designation is for the treatment of patients with retinitis pigmentosa caused by mutations in exon 13 ...
Posted by Michael Wonder on 30 Jan 2020
Corium announces FDA filing acceptance of new drug application for Adlarity (donepezil transdermal system) for the treatment of Alzheimer’s disease
27 January 2020 - Corium today announced that the U.S. FDA has accepted for filing the company’s new drug application ...
Posted by Michael Wonder on 29 Jan 2020
Understanding the rewards of successful drug development — thinking inside the box
30 January 2020 - Risks and rewards change during the life cycle of a drug. In the innovation period, drug companies ...
Posted by Michael Wonder on 29 Jan 2020
European Medicines Agency validates Kite’s marketing application for company’s second CAR T cell therapy
28 January 2020 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma in Europe ...
Posted by Michael Wonder on 29 Jan 2020
Monoferric (ferric derisomaltose) injection is approved by the FDA in the US for the treatment of iron deficiency anaemia
29 January 2020 - Pharmacosmos announces that the FDA has approved Monoferric in the US for the treatment of iron ...
Posted by Michael Wonder on 29 Jan 2020
FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data
29 January 2020 - Interactive tool offers information on ARVs eligible for purchase under the President’s Emergency Plan for AIDS Relief ...
Posted by Michael Wonder on 29 Jan 2020
Documents disclosed to the EMA as part of an MA application process are not presumed to be confidential
28 January 2020 - On 22 January 2020 the CJEU handed down two decisions in which it decided that the ...
Posted by Michael Wonder on 29 Jan 2020
With new rules, FDA aims to spark competition, lower prices for expensive gene therapies
28 January 2020 - The FDA released a slew of gene therapy policies Tuesday aimed at encouraging drug makers to ...
Posted by Michael Wonder on 29 Jan 2020
Janssen announces European Commission approval for expanded use of Erleada (apalutamide) for treatment of patients with metastatic hormone-sensitive prostate cancer
29 January 2020 - Latest approval for apalutamide could benefit a population of more than 100,000 people living with mHSPC across ...