EMA
EMA’s CHMP recommends new dosing schedule for Opdivo in melanoma
September 25, 2019Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, CHMP, EMA, melanoma, opdivo, pharma
Bristol-Myers Squibb has revealed that its blockbuster immunotherapy drug Opdivo (nivolumab) has secured recommendation from the EMA’s Committee for Medicinal …
Celltrion’s subcutaneous infliximab biosimilar secures CHMP recommendation
September 24, 2019Manufacturing and Production, Sales and Marketing EMA, EU, Europe, biosimilar, celltrion, infliximab, pharma
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous …
Roche’s Tecentriq combo becomes first EU-approved immunotherapy for triple-negative breast cancer
August 30, 2019Medical Communications, Sales and Marketing EMA, Europe, Roche, breast cancer, pharma, tecentriq
Roche has announced the approval of Tecentriq (atezolizumab), in combination with Celgene’s chemotherapy drug Abraxane (nab paclitaxel), by the European …
FDA steps up 2018 drug approvals by 11% on previous year
August 1, 2019Sales and Marketing EMA, FDA, drug approvals, pharma
The FDA continues to excel in the ground it covers as it emerges that the total number of new drug …
GW Pharma’s cannabis-based Epidyolex edges closer to EU approval with positive CHMP opinion in epilepsy
July 26, 2019Medical Communications, Sales and Marketing EMA, Epidiolex, Europe, GW Pharma, cannabis, epilepsy
UK-based biotech GW Pharmaceuticals has announced that its cannabidiol oral solution Epidyolex has secured recommendation from the European Medicines Agency’s …
Top Ten most popular articles on Pharmafile.com this week!
July 19, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AMAL Therapeutics, Alzheimer's Ebola, Amgen, AstraZeneca, EMA, FDA, Novartis, pharma
On 12 July news broke that Novartis, Amgen and Banner’s Alzheimer’s Institute were discontinuing a trial into investigational compound CNP520 …
FDA and EMA fully implement mutual recognition agreement between US and EU
July 15, 2019Sales and Marketing EMA, FDA, GMP, Slovakia, mra, mutual recognition, pharma
The FDA has recognised Slovakia’s ability to carry out inspections of manufacturing facilties. The recognition of Slovakia marks the full …
AstraZeneca’s Farxiga fails to get FDA approval for patients with Type 1 diabetes
July 15, 2019Sales and Marketing AstraZeneca, EMA, FDA, US, diabetes, farxiga
The FDA had said it will not approve AstraZeneca’s diabetes drug Farxiga for use as a supplement to insulin in …
Janssen secures two positive CHMP opinions for Imbruvica label expansions
July 1, 2019Sales and Marketing CHMP, EMA, Europe, Janssen, imbruvica, pharma
Janssen’s Imbruvica (ibrutinib) has racked up two positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human …
Top Ten most popular articles on Pharmafile.com this week!
June 7, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Biogen, EMA, Janssen, Orkambi, Pfizer
It was revealed this week that Pfizer suppressed findings that their anti-inflammatory Enbrel reduced the risk of Alzheimer’s by 64%. …
Use of Genzyme’s MS drug Lemtrada restricted under ongoing EMA safety review
April 16, 2019Manufacturing and Production, Sales and Marketing EMA, Genzyme, Lemtrada, multiple sclerosis, pharma
The EMA has launched a review into Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab) after reports emerged of treatment-related safety issues …
CHMP recommendation for bluebird bio’s gene therapy in β-thalassaemia
April 1, 2019Research and Development, Sales and Marketing Bluebird Bio, CHMP, EMA, Zynteglo, gene therapy, β-thalassaemia
Massachusetts-based bluebird bio has taken a significant leap forward in its pursuit of regulatory authorisation for its first gene therapy, …
AstraZeneca scores accelerated approval in US and Europe for respiratory syncytial virus drug
February 5, 2019Manufacturing and Production, Research and Development, Sales and Marketing AstraZeneca, EMA, FDA, MEDI8897, pharma, respiratory syncytial virus
It’s a double victory for AstraZeneca as the company announced its F monoclonal antibody MEDI8897 has been granted accelerated review …
EMA rejects Lilly’s Lartruvo in soft tissue cancer following trial failure
January 24, 2019Sales and Marketing Cancer, EMA, Eli Lilly, Lartruvo, pharma
Eli Lilly has been dealt a blow as the European Medicines Agency announced its recommendation for soft tissue cancer patients …
EMA approves more new active substances in 2018, but total recommendations fall
January 14, 2019Sales and Marketing EMA, EU, Europe, drug approvals, pahrma
2018 was a strong year for European approvals according to the EMA; the regulator has recently released its Human medicines …
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