Latest News in the pharma Industry

Policy & Regulation

Companies warned for selling unapproved opioid cessation products using deceptive claims

Companies warned for selling unapproved opioid cessation products using deceptive claims

26 Jan 2018

The companies have 15 days to respond to the FDA and FTC.

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Shire receives FDA approval for tech transfer of Cinryze

Shire receives FDA approval for tech transfer of Cinryze

24 Jan 2018

Commercial manufacturing of Cinryze drug product in Vienna to begin in the first quarter of 2018.

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Promacta receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia

Promacta receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia

4 Jan 2018

Data supporting designation showed over half of treatment-naïve SAA patients achieved complete response with Promacta when given with standard immunosuppressive therapy, with overall response rate of 85%.

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Novartis Kisqali receives FDA Breakthrough Therapy designation

Novartis Kisqali receives FDA Breakthrough Therapy designation

3 Jan 2018

Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal women who received no prior endocrine therapy for adva...

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Novartis' combination therapy Tafinlar + Mekinist granted FDA Priority Review

Novartis' combination therapy Tafinlar + Mekinist granted FDA Priority Review

1 Jan 2018

If approved, Tafinlar + Mekinist expected to be the first adjuvant targeted therapy combination to demonstrate a significant clinical benefit in patients with a BRAF V600 mutation.

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ANVISA approves Biocon and Mylan's biosimilar Trastuzumab

ANVISA approves Biocon and Mylan's biosimilar Trastuzumab

29 Dec 2017

Libbs will commercialize the product in Brazil under the brand name Zedora.

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FDA approves first generic for Estrace Cream

FDA approves first generic for Estrace Cream

29 Dec 2017

Mylan now offers estradiol in four delivery methods.

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FDA accepts NDA filing for Epidiolex in the treatment of Lennox-Gastaut syndrome and Dravet syndrome

FDA accepts NDA filing for Epidiolex in the treatment of Lennox-Gastaut syndrome and Dravet syndrome

28 Dec 2017

The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is 27 June 2018.

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Novartis drug Tasigna approved by FDA

Novartis drug Tasigna approved by FDA

28 Dec 2017

First and only CML therapy with Treatment-free Remission data in its label.

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MAA submitted to EMA for patisiran for the treatment of hereditary ATTR amyloidosis

MAA submitted to EMA for patisiran for the treatment of hereditary ATTR amyloidosis

27 Dec 2017

Sanofi and Alnylam's patisiran MAA to be reviewed under accelerated assessment.

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FDA approves the only OTC eye drop with low-dose Brimonidine to treat eye redness

FDA approves the only OTC eye drop with low-dose Brimonidine to treat eye redness

27 Dec 2017

Clinical studies showed 95% symptom improvement at one minute and reduced redness for up t 8 hours.

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Allergan acknowledges Appeals Court decision for Combigan

Allergan acknowledges Appeals Court decision for Combigan

27 Dec 2017

Allergan plans to file petitions for rehearing of the appeals court decision and has asserted a new Orange Book patent against Sandoz's generic version of Combigan.

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