Latest News in the pharma Industry

Policy & Regulation

FDA takes action to protect consumers from potentially dangerous dietary supplements‏

FDA takes action to protect consumers from potentially dangerous dietary supplements‏

19 Nov 2015

Civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.

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Merck and Pfizer receive FDA Breakthrough Therapy Designation for avelumab in metastatic Merkel cell carcinoma

Merck and Pfizer receive FDA Breakthrough Therapy Designation for avelumab in metastatic Merkel cell carcinoma

18 Nov 2015

If approved, avelumab could potentially become the first immunotherapy to treat metastatic MCC.

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FDA accepts for priority review the sBLA for Opdivo in patients with advanced renal cell carcinoma

FDA accepts for priority review the sBLA for Opdivo in patients with advanced renal cell carcinoma

17 Nov 2015

The projected FDA action date is 16 March 2016.

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FDA approves Tagrisso (AZD9291) as treatment for patients with EGFR T790M mutation-positive metastatic NSCLC

FDA approves Tagrisso (AZD9291) as treatment for patients with EGFR T790M mutation-positive metastatic NSCLC

13 Nov 2015

One of fastest development programs - from start of clinical trials to approval in just over two and a half years to meet unmet patient need.

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FDA approves Roche’s Cotellic in combination with Zelboraf in advanced melanoma

FDA approves Roche’s Cotellic in combination with Zelboraf in advanced melanoma

12 Nov 2015

FDA approval underscores the important role of targeted medicines to help people with BRAF V600 mutation-positive advanced melanoma.

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Dr Reddy’s statement on the receipt of Warning Letter from FDA

Dr Reddy’s statement on the receipt of Warning Letter from FDA

11 Nov 2015

Warning letter relates to the company’s API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, and Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.

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Rx-360 summary of FDA guidance

Rx-360 summary of FDA guidance

11 Nov 2015

The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers — Compliance Policy.

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FDA accepts Amgen's NDA for novel intravenous calcimimetic etelcalcetide

FDA accepts Amgen's NDA for novel intravenous calcimimetic etelcalcetide

9 Nov 2015

If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.

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GSK’s Nucala (mepolizumab) receives approval from FDA

GSK’s Nucala (mepolizumab) receives approval from FDA

6 Nov 2015

First anti-IL5 treatment for adults and adolescents with severe asthma with an eosinophilic phenotype.

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FDA requests further data for approval of Epigenomics' blood based colorectal cancer screening test

FDA requests further data for approval of Epigenomics' blood based colorectal cancer screening test

4 Nov 2015

Epigenomics adjusts 2015 outlook after FDA response letter.

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Rx-360 Summary of WHO Guidance on Good Manufacturing Practices - Inspection Report

Rx-360 Summary of WHO Guidance on Good Manufacturing Practices - Inspection Report

4 Nov 2015

Describes general principles and a recommended format for inspection reports for use by organizations performing pharmaceutical inspections.

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Regeneron’s Eylea Injection for the treatment of visual impairment secondary to myopic CNV gains EU approval

Regeneron’s Eylea Injection for the treatment of visual impairment secondary to myopic CNV gains EU approval

1 Nov 2015

Eyela already approved in the EU for neovasular (wet) age-related macular degeneration.

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