FDA
Pfizer gets early approval for breast cancer drug
February 4, 2015Sales and Marketing FDA, Pfizer, Xalkori (crizotinib), axitinib, bosulif, bosutinib, femara, ibrance, inlyta, letrozole, palbociclib
The FDA has shown Pfizer’s breast cancer drug Ibrance an early green light to treat patients who are at the …
Merck releases insomnia drug in US
February 4, 2015Sales and Marketing FDA, Merck, belsomra, insomnia, orexin, suvorexant
Merck’s insomnia drug Belsomra is now available in the US to treat patients who have difficulty falling asleep or staying …
Mylan buys into women’s health
February 3, 2015Sales and Marketing Abbott, FDA, India, Mylan, famy care, female, women
Mylan is to acquire a number of women’s healthcare companies from Indian-based Famy Care that will build upon its 2008 …
Boehringer and Lilly score FDA yes for Glyxambi
February 3, 2015Sales and Marketing Boehringer, FDA, Glyxambi, Tradjenta, empagliflozin, jardiance, lilly, linagliptin
The FDA has approved Glyxambi (empagliflozin/linagliptin), which has become the first combination of two diabetes drugs in their different classes …
FDA fast-tracks Roche lung cancer drug
February 2, 2015Sales and Marketing Cancer, FDA, MPDL3280A, Roche, bladder, lung, oncology, pdl1
Roche will be celebrating after its investigational cancer drug MPDL3280A has been fast-tracked by the FDA for the second time. …
Shire drug approved for binge eating disorder
February 2, 2015Sales and Marketing ADHD, FDA, Shire, Vyvanse, binge, eating, lisdexamfetamine dimesylate, obesity
Shire has become the first company to gain FDA approval for a treatment for binge eating disorder (BED) in adults …
J&J leukaemia drug gets FDA go-ahead
January 30, 2015Sales and Marketing FDA, J&J, JJ, Janssen, The US Food and Drug Administration has shown Janssen’s leukaemia drug Imbruvica the green light to treat patients with waldenström’s macroglobulinemia (WM) – a rare indol, Waldenström’s Macroglobulinemia, ibrutinab, imbruvica, johnson
The US Food and Drug Administration has shown Janssen’s leukaemia drug Imbruvica the green light to treat patients with waldenström’s …
BMS wins FDA approval for HIV pill
January 30, 2015Sales and Marketing BMS, Bristol-Myers Squibb, FDA, Gilead, Reyataz, atazanavir, cobicistat), evotaz, tybost
Bristol-Myers Squibb has earned FDA approval for its HIV combination treatment Evotaz. The US drugs regulator gave BMS the go-ahead …
New FDA commissioner for medical products named
January 28, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Robert Califf
US Food and Drug Administration commissioner Margaret Hamburg has appointed industry veteran Dr Robert Califf as the FDA’s deputy commissioner …
Novartis earns EMA and FDA nods for Jakavi and Bexsero
January 26, 2015Sales and Marketing Bexsero, Cancer, EU, FDA, Jakavi, Novartis, US, meningitis, ruxolitinib
Novartis has secured the regulatory go-ahead for two of its drugs, after the EMA recommended Jakavi for a rare blood …
FDA to start regulating health wearables
January 22, 2015Medical Communications, Sales and Marketing Apple, FDA, Samsung, digital, wearables
Any firms making exaggerated health claims of wearable devices face marketplace disappointment following new FDA guidelines. The FDA has released …
Novartis gets FDA approval for psoriasis drug
January 22, 2015Sales and Marketing Cosentyx, European Commission, FDA, Novartis, Secukinumab, psoriasis
The US Food and Drug Administration (FDA) has shown Novartis’ skin condition drug Cosentyx the green light to treat patients …
Gilead and Strides partner in HIV
January 21, 2015Research and Development, Sales and Marketing Cipla, FDA, Gilead, HIV, Ranbaxy, Tenofovir Alafenamide, WHO, strides, taf
Gilead is partnering with India-based pharma firm Strides Arcolab in a licensing agreement to manufacture and distribute an HIV treatment …
UCB epilepsy drug reaches regulatory bodies
January 21, 2015Research and Development, Sales and Marketing EMA, FDA, UCB, brivaracetam, epilepsy
UCB has established regulatory milestones for its investigational antiepileptic drug brivaracetam in Europe and the US. The Food and Drug …
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