Latest News in the pharma Industry

Policy & Regulation

EC approves the first and only immuno-oncology combination, BMS's Opdivo + Yervoy Regimen, for treatment of advanced melanoma

EC approves the first and only immuno-oncology combination, BMS's Opdivo + Yervoy Regimen, for treatment of advanced melanoma

11 May 2016

Approval allows for the marketing of the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in all 28 Member States of the EU.

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FDA grants Priority Review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma

FDA grants Priority Review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma

8 May 2016

Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication.

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Endo announces US District Court ruling upholding Opana ER intellectual property

Endo announces US District Court ruling upholding Opana ER intellectual property

3 May 2016

The ruling confirms the Court's prior injunction against the manufacture or sale of the generic version of non-crush-resistant Opana ER.

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BASF welcomes EU approval for zinc oxide

BASF welcomes EU approval for zinc oxide

2 May 2016

After BASF’s Tinosorb A2B, Z-Cote is the second nano UV filter to be approved for use in cosmetics in Europe.

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Allergan receives FDA approval of Crestor

Allergan receives FDA approval of Crestor

2 May 2016

First company to launch a generic version of Crestor to customers in the US.

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FDA approves ACADIA Pharmaceuticals’ Nuplazid (pimavanserin)

FDA approves ACADIA Pharmaceuticals’ Nuplazid (pimavanserin)

1 May 2016

The first drug approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

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Biogen and AbbVie receive Positive Opinion from the CHMP on Zinbryta for treatment of MS

Biogen and AbbVie receive Positive Opinion from the CHMP on Zinbryta for treatment of MS

29 Apr 2016

Positive benefit-risk profile of Zinbryta supported by large head-to-head Phase III DECIDE study.

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Novartis receives three FDA Breakthrough Therapy Designations for Ilaris to treat rare types of Periodic Fever Syndromes

Novartis receives three FDA Breakthrough Therapy Designations for Ilaris to treat rare types of Periodic Fever Syndromes

28 Apr 2016

Subject to approvals, Ilaris will likely be first FDA-approved treatment for TRAPS and HIDS/MKD, and an important alternative treatment for patients with FMF.

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Fresenius Kabi issues voluntary nationwide recall of Sensorcaine-MPF (bupivacaine HCl) Injection

Fresenius Kabi issues voluntary nationwide recall of Sensorcaine-MPF (bupivacaine HCl) Injection

26 Apr 2016

Visible particulate matter — glass — observed by the company of reserve samples.

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BMS's Opdivo receives Breakthrough Therapy Designation from FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck

BMS's Opdivo receives Breakthrough Therapy Designation from FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck

25 Apr 2016

Designation signals the urgent need for new treatment approaches in recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based therapy.

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Shire Submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets

Shire Submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets

15 Apr 2016

New formulation, in adherence with approved indications, intended for children, adolescents and adults with difficulty swallowing or opening capsules.

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AbbVie receives FDA accelerated approval of Venclexta (venetoclax) tablets

AbbVie receives FDA accelerated approval of Venclexta (venetoclax) tablets

13 Apr 2016

The first BCL-2 inhibitor in relapsed/refractory chronic lymphocytic leukemia patients with 17p deletion.

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