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Showing 15 posts of 1442 posts found.

Glyxambi image

Boehringer and Lilly score FDA yes for Glyxambi

February 3, 2015
Sales 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 …

News
affrezza image

Sanofi’s inhalable insulin goes on sale in US

February 3, 2015
Sales and Marketing Afrezza, FDA, Mannkind, Sanofi, US, apidra, diabetes, insulin, type 1, type 2

Sanofi has launched its inhalable insulin Afrezza in the US to control blood sugar in people with type 1 and …

News

FDA fast-tracks Roche lung cancer drug

February 2, 2015
Sales 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. …

News
Shire image

Shire drug approved for binge eating disorder

February 2, 2015
Sales 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 …

News
J&J image

J&J leukaemia drug gets FDA go-ahead

January 30, 2015
Sales 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 …

News
BMS image

BMS wins FDA approval for HIV pill

January 30, 2015
Sales 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 …

News
screen_shot_2015-01-28_at_07

New FDA commissioner for medical products named

January 28, 2015
Manufacturing 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 …

Appointment
Novartis image

Novartis earns EMA and FDA nods for Jakavi and Bexsero

January 26, 2015
Sales 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 …

News
Apple image

FDA to start regulating health wearables

January 22, 2015
Medical 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 …

News
Novartis image

Novartis gets FDA approval for psoriasis drug

January 22, 2015
Sales 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 …

News

Gilead and Strides partner in HIV

January 21, 2015
Research 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 …

News
UCB image

UCB epilepsy drug reaches regulatory bodies

January 21, 2015
Research 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 …

News
FDA image

Regulators ‘more efficient at approving drugs’

January 19, 2015
Research and Development, Sales and Marketing EMA, EMA), FDA, Health Canada, PMDA)., Pharmaceutical and Medical Devices Agency, Swissmedic, TGA, approvals, cirs, reuters

Global regulatory bodies have become faster at approving new drug products more quickly and consistently, according to a new analysis …

News
Viekirax and Exviera image

AbbVie Hep C combo pill ready for Europe

January 16, 2015
Medical Communications AbbVie, Exviera, FDA, HIV, Viekira Pak, Viekirax, harvoni, hep C, sovaldi

The European Commission has approved AbbVie’s Viekirax and Exviera for the treatment of chronic hepatitis C (HCV). Viekirax (ombitasvir/paritaprevir/ritonavir) and …

News
VBLOC image

FDA approves novel obesity device

January 16, 2015
Medical Communications, Sales and Marketing EnteroMedics, FDA, Novo, VBLOC, diabetes, obesity, type 2

The US Food and Drug Administration has shown the green light to US firm EnteroMedics’ new obesity device VBLOC that …

News
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