pharma news

Apr 12, 2017

Malaysia calls for phase 4 Dengvaxia study before considering full approval Already struggling to meet initial expectations, Sanofi Pasteur's dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia’s National Pharmaceutical ...

Mar 28, 2017

Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival,...

Mar 07, 2017

NPPA slams pharma giants for overcharging The price regulator in the pharmaceutical industry, National Pharmaceutical Price Authority (NPPA) has discovered that the leading Pharma companies are overcharging customers for abundantly prevalent drugs in the market. NPPA has alleged that the listed 634 drugs are being s...

Feb 21, 2017

USFDA warns Bengaluru-based Resonance Labs of manufacturing norms violations US health regulator USFDA has red-flagged significant deviations from manufacturing norms at the Bengaluru-based API facility of Resonance Laboratories, including failure to have adequate cleaning procedures to prevent contamination of prod...

Jan 31, 2017

AstraZeneca announces availability of Saxa / Dapa FDC in UK UK-based AstraZeneca has announced the availability of Qtern for adult patients with type 2 diabetes in the country. Quern is a fixed dose combination of saxagliptin and dapagliflozin. The tablet received marketing authorization from the European Commission...

Dec 21, 2016

For Inflectra launch, Pfizer uses 'hybrid model' to home in on HCPs Pfizer hit the market with Inflectra, a biosimilar of Johnson & Johnson's Remicade. And with the launch came not only the beginning of a new class of copycats, but a new way to go to market. Each biosimilar, even versions of the same biologic—wh...

Dec 06, 2016

Glaxo replaces ViiV Healthcare chief as executive shuffle continues The executive exodus at GlaxoSmithKline is continuing—and so is the rise of women to the company’s top ranks. The British pharma giant announced that Dominique Limet, head of HIV unit ViiV Healthcare, would step down at the end of March 2017—the sam...

Nov 08, 2016

Fresenius Kabi introduced Bivalirudin for Injection Fresenius Kabi announced that it has introduced Bivalirudin for Injection in the United States, which is an anticoagulant, and a generic alternative to Angiomax. Fresenius Kabi’s Bivalirudin was approved by the U.S. Food and Drug Administration in October. The U.S....