approval
AbbVie and Janssen announce failure of cancer drug Imbruvica in Phase 3 trial
July 12, 2018Research and Development AbbVie, Cancer, FDA, Janssen, approval
AbbVie and Janssen have announced that Imbruvica (ibrutinib) failed to achieve the primary endpoint in a late-stage study assessing its …
Insider interview: NICE discusses its planned ‘fast-track’ appraisal process
December 19, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NHS, NICE, UK, approval
Jenniffer Prescott, associate director of planning, operations and topic selection, answers questions on NICE’s recent plans for a ‘fast-track’ appraisal …
European Commission approves new RA treatment from BMS
September 6, 2016Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, EMA, EU, Orencia, RA, abatacept, approval, rheumatoid arthritis
Bristol-Myers Squibb has received approval from the European Commission for rheumatoid arthritis (RA) treatment Orencia (abatacept), making it the first …
NICE recommends Bayer’s Xofigo for prostate cancer treatment
September 2, 2016Medical Communications, Sales and Marketing Bayer, NICE, approval, prostate cancer, recommendation, xofigo
NICE has issued final draft guidance recommending Bayer’s Xofigo (radium-223 dichloride) for the treatment of prostate cancer. Previously, the drug …
FDA approves Pfizer’s abuse-deterrent opioid painkiller
August 22, 2016Sales and Marketing FDA, Pfizer, abuse deterrent, abuse-deterrent, approval, opioid, troxyca
Pfizer has announced that the US FDA has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the …
EU grants marketing authorisation for Teva’s asthma drug Cinqaero
August 19, 2016Medical Communications, Sales and Marketing EU, Teva, approval, asthma, cinqaero, eosinophilic
The European Commission has granted marketing authorisation for Teva’s Cinqaero (reslizumab), as an odd-on therapy in adult patients with severe …
MSD scores EU approval for Keytruda in lung cancer
August 3, 2016Research and Development, Sales and Marketing EU, MSD, Merck, approval, keytruda, lung cancer
MSD, called Merck in the US and Canada, has announced that the European Commission has approved Keytruda (pembrolizumab) for patients …
Sanofi gets FDA approval for type-2 diabetes treatment Adlyxin
July 28, 2016Research and Development, Sales and Marketing FDA, Lixisenatide, Lyxumia, Sanofi, adlyxin, approval, diabetes, type 2, type-2, zealand
Sanofi has announced that the US Food and Drug Administration (FDA) has approved Adlyxin (lixisenatide), which is a once-daily mealtime …
Pfizer gets approval expansion from FDA for pneumonia vaccine
July 13, 2016Research and Development, Sales and Marketing FDA, Pfizer, Prevnar 13, adults, approval
The US Food and Drug Administration (FDA) has issued an expanded approval for Pfizer’s pneumococcal pneumonia vaccine Prevnar 13 to …
FDA approves Allergan hypertension fixed-dose combo, Byvalson
June 7, 2016Manufacturing and Production, Research and Development, Sales and Marketing Allergan, FDA, US, angiotensin ii, approval, beta blocker, byvalson, hypertension, nebivolol, valsartan
Allergan has announced that the US Food and Drug Administration (FDA) has approved its fixed-dose combination, Byvalson (nebivolol and valsartan), …
Shares at Sarepta Therapeutics jump after FDA delay in drug approval review
May 26, 2016Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, FDA, Sarepta Therapeutics, approval, delay, delayed announcement, muscular dystrophy, sarepta, treatment
Sarepta Therapeutics (NASDAQ: SRPT) has witnessed a sharp rise in the price of its shares after the US Food and …
NICE recommends Jevtana for advanced prostate cancer
May 25, 2016Sales and Marketing Jevtana, NICE, approval, prostate cancer, recommendation
The National Institute for Health and Care Excellence (NICE) has recommended Sanofi Genzyme’s Jevtana (cabazitaxel), in combination with prednisone or …
EU approves Idelvion for haemophilia B treatment
May 13, 2016Medical Communications, Research and Development CSL, EU, Idelvion, approval, haemophilia B
The European Commission has approved Idelvion, coagulation Factor IX (recombinant) for the treatment and prophylaxis of bleeding in patients with …
Multiple myeloma treatment from BMS and AbbVie scores EU approval
May 12, 2016Research and Development, Sales and Marketing AbbVie, BMS, EMA, EU, Empliciti, approval, bristl-myers squibb, elotuzumab, multiple myeloma
Bristol-Myers Squibb (NYSE: BMY) and AbbVie (NYSE: ABBV) have announced that the European Commission has approved Empliciti (elotuzumab) for the …
EU grants approval for Gilead’s HIV treatment Descovy
April 26, 2016Manufacturing and Production, Research and Development EU, HIV, approval, descovy, taf
Gilead Sciences (NASDAQ: GILD) has announced that the fixed-dose combination HIV treatment, Descovy (emtricitabine, tenofovir alafenamide), has been granted marketing …
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