Latest News in the pharma Industry

Policy & Regulation

Hikma statement on generic Advair Diskus

Hikma statement on generic Advair Diskus

18 Aug 2017

Company been able to clarify and resolve a number of the questions raised by the FDA.

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Shire submits lifitegrast MAA for treatment of dry eye disease in Europe

Shire submits lifitegrast MAA for treatment of dry eye disease in Europe

15 Aug 2017

Lifitegrast, if approved, would be the first and only new class treatment to address the signs and symptoms of dry eye disease in adults in Europe.

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FDA removes clinical hold on CEL-SCI’s Phase III head & neck cancer trial

FDA removes clinical hold on CEL-SCI’s Phase III head & neck cancer trial

14 Aug 2017

The last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago.

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FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with AML

FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with AML

13 Aug 2017

Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AML.

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NICE recommends Erbitux in combination with chemotherapy for the treatment of head and neck cancer

NICE recommends Erbitux in combination with chemotherapy for the treatment of head and neck cancer

9 Aug 2017

Decision secures access to Erbitux for new patients in England with oral cavity tumours.

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Mylan receives tentative approval for TLD under PEPFAR

Mylan receives tentative approval for "TLD" under PEPFAR

7 Aug 2017

Mylan's TLD is the first fixed-dose combination of its kind to be offered to patients being treated for HIV/AIDS.

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Insanitary conditions bring Isomeric Pharmacy Solutions to a halt

Insanitary conditions bring Isomeric Pharmacy Solutions to a halt

6 Aug 2017

Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions.

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AbbVie's Mavyret receives FDA approval for the treatment of chronic hepatitis C

AbbVie's Mavyret receives FDA approval for the treatment of chronic hepatitis C

6 Aug 2017

FDA approval is supported by an overall 98% cure rate in patients who received the recommended duration of treatment .

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NICE approves Abraxane for pancreatic cancer

NICE approves Abraxane for pancreatic cancer

6 Aug 2017

Life-extending pancreatic cancer medicine to be made available immediately on the NHS.

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FDA grants Genentech’s Alecensa Priority Review

FDA grants Genentech’s Alecensa Priority Review

3 Aug 2017

Designation given for initial treatment of people with ALK-positive lung cancer.

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BMS receives FDA approval for Opdivo Injection for metastatic colorectal cancer

BMS receives FDA approval for Opdivo Injection for metastatic colorectal cancer

3 Aug 2017

Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% among patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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Amgen submits sBLA for Prolia in glucocorticoid-induced osteoporosis

Amgen submits sBLA for Prolia in glucocorticoid-induced osteoporosis

31 Jul 2017

Results from the Phase III study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate.

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