FDA
J&J’s apalutamide scores snap FDA approval in castration-resistant prostate cancer subgroup
February 15, 2018Sales and Marketing Cancer, Erleada, FDA, J&J, JJ, Johsnon & Johnson, apalutamide, pharma, prostate cancer
Johnson & Johnson has announced that its androgen receptor inhibitor apalutamide, now branded as Erleada, has received approval from the …
Top Ten most popular articles on Pharmafile.com this week
February 9, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AI, Allergan, Antibiotics, Avycaz, Elastagen, FDA, GSK, India, J&J, JJ, Nektar Therapeutics, Novartis, Theravance, artificial intelligence, pharma
It’s top ten time again. This week, among our most popular stories was the worrying news that, accoridng to research …
FDA expands J&J Zytiga combo’s indication to include castration-sensitive prostate cancer
February 9, 2018Medical Communications, Sales and Marketing Cancer, FDA, J&J, JJ, Janssen, Johnson & Johnson, Zytiga, pharma
Johnson & Johnson has announced that Zytiga (abiraterone acetate) in combination with prednisone has been awarded FDA approval in the …
New Year, new goals
February 8, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CRUK, Cancer Research UK, Chiesi, EMA, FDA, Genetic Alliance, pharma
With the New Year begun in earnest, Pharmafocus speaks to a range of players in pharma and the life sciences …
Dr Reddy’s hit by yet another recall, of 80,000+ bottles
February 8, 2018Sales and Marketing Dr Reddy's, FDA, biotech, drugs, pharma, pharmaceutical
Dr Reddy’s Laboratories problem with ensuring products reach the market at a quality the FDA deems acceptable is no secret …
FDA approves Gilead’s Biktarvy for HIV as Viiv Healthcare launches patent lawsuit
February 8, 2018Sales and Marketing Biktarvy, FDA, GSK, Gilead, HIV, Pfizer, Shionogi, US, ViiV Healthcare, descovy, pharma
Gilead has announced that its daily single-tablet therapy Biktarvy has received FDA approval for HIV-1 infection.
Novartis tastes own medicine, Advair generic delayed
February 8, 2018Sales and Marketing FDA, Novartis, biotech, drugs, pharma, pharmaceutical
Novartis had not been frontrunner to receive approval for its generic version of GSK’s Advair – lagging behind Mylan’s generic …
Allergan’s Avycaz becomes first FDA-approved gram-negative antibiotic in over 15 years
February 2, 2018Medical Communications, Sales and Marketing Allergan, Avycaz, FDA, pharma, pneumonia
Allergan has announced that the FDA has awarded approval to its fixed-dose combination antibacterial Avycaaz (ceftazidme and avibactam) for the …
FDA halts Bellicum trial over brain disease in participants, shares crash 48%
February 1, 2018Research and Development Bellicum Pharmaceuticals, FDA, encephalopathy, pharma, trial failure
Texas-based clinical-stage company Bellicum Pharmaceuticals has taken a massive stock hit after the FDA put a hold on its trials …
FDA revises methods, after public outrage at testing of monkeys
January 29, 2018Manufacturing and Production, Medical Communications FDA, biotech, drugs, pharma, pharmaceutical
The story broke in September of last year that the FDA was testing nicotine addiction in squirrel monkeys and that …
iQOS heat-not-burn electronic tobacco product doesn’t reduce health risk, FDA says
January 26, 2018Medical Communications, Sales and Marketing FDA, Philip Morris, iQOS, pharma, smoking, tobacco
An advisory panel of the FDA has judged that US tobacco firm Philip Morris International (PMI) has not been able …
Novartis’ CAR T therapy Kymriah scores accelerated approval in both Europe and US
January 17, 2018Research and Development, Sales and Marketing CAR T, CAR-T, EMA, Europe, FDA, Kymriah, Novartis, US, pharma
Following up last year’s ground-breaking news that CAR T therapy Kymriah had become the first such treatment to be approved …
Boehringer’s Gilotrif approved in US for lung cancer with non-resistant EGFRs
January 16, 2018Manufacturing and Production, Sales and Marketing Boehringer Ingelheim, Cancer, FDA, Giltrif, NSCLC, lung cancer
Boehringer Ingelheim is celebrating the FDA’s decision to expand the indication of its lung cancer drug Gilotrif (afatinib) to include …
FDA expands indication of Teva’s Trisenox for acute promyelocytic leukaemia
January 16, 2018Manufacturing and Production, Sales and Marketing FDA, Teva, acute promyelocytic leukaemia, leukaemia, pharma
Teva has announced that its Trisenox (arsenic trioxide) injection has been awarded US approval from the FDA in combination with …
AZ and MSD’s Lynparza becomes first PARP inhibitor approved in US for metastatic breast cancer
January 15, 2018Sales and Marketing AstraZeneca, Cancer, FDA, MSD, breast cancer, lynparza, pharma
The FDA has announced that it has awarded marketing authorisation in the US to Lynparza (olaparib), a poly ADP-ribose polymerase …
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Five Facts about cardiovascular disease
