Latest News in the pharma Industry

Policy & Regulation

FDA approves Takeda's Ninlaro, the first and only oral proteasome inhibitor to treat multiple myeloma

FDA approves Takeda's Ninlaro, the first and only oral proteasome inhibitor to treat multiple myeloma

24 Nov 2015

Ninlaro provides a new option for patients living with multiple myeloma who have received at least one prior therapy.

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BMS receives FDA approval for Opdivo, the only treatment to deliver significant overall survival in advanced renal cell carcinoma

BMS receives FDA approval for Opdivo, the only treatment to deliver significant overall survival in advanced renal cell carcinoma

24 Nov 2015

Fifth approval for Opdivo in 12 months.

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FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose

FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose

23 Nov 2015

Naloxone in nasal spray form provides important new alternative for family members, first responders.

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Biogen announces Benepali (etanercept) is the first biosimilar of Enbrel to receive a positive opinion from CHMP

Biogen announces Benepali (etanercept) is the first biosimilar of Enbrel to receive a positive opinion from CHMP

20 Nov 2015

Pending EC approval, Biogen would commercialize Benepali in the EU.

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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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