Latest News in the pharma Industry

Policy & Regulation

FDA accepts for review Ironwood and Allergan's sNDA for 72 mcg linaclotide in CIC

FDA accepts for review Ironwood and Allergan's sNDA for 72 mcg linaclotide in CIC

9 Jun 2016

The FDA Prescription Drug User Fee Act target action date is expected to occur in early 2017.

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FDA targets unlawful internet sales of illegal prescription medicines during international operation Pangea IX

FDA targets unlawful internet sales of illegal prescription medicines during international operation Pangea IX

9 Jun 2016

FDA has requested the suspension of 4,402 websites and has issued warning letters to the operators of 53 websites illegally offering unapproved and misbranded prescription drug products for sale to US consumers.

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FDA approves once-daily Jentadueto XR Tablets for adults with type 2 diabetes

FDA approves once-daily Jentadueto XR Tablets for adults with type 2 diabetes

31 May 2016

New formulation of medicines that helps lower blood sugar in type 2 diabetes can be taken once a day.

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Flixabi, Biogen’s infliximab biosimilar referencing Remicade, approved in the EU

Flixabi, Biogen’s infliximab biosimilar referencing Remicade, approved in the EU

30 May 2016

Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU.

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Merck receives positive CHMP opinion for Zepatier (elbasvir and grazoprevir) in the EU

Merck receives positive CHMP opinion for Zepatier (elbasvir and grazoprevir) in the EU

30 May 2016

Product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.

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Amgen receives positive CHMP opinion to extend indication of Kyprolis for the treatment of relapsed multiple myeloma

Amgen receives positive CHMP opinion to extend indication of Kyprolis for the treatment of relapsed multiple myeloma

30 May 2016

Pivotal head-to-head ENDEAVOR study shows Kyprolis plus dexamethasone doubled progression-free survival compared to Velcade (Bortezomib) and dexamethasone.

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DCGI gives limited approval to market FIRST Allogeneic cell therapy product in India

DCGI gives limited approval to market FIRST Allogeneic cell therapy product in India

30 May 2016

Stempeutics puts India on the 'World map of Regenerative Medicine'.

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BioPharma Services USA awarded a 5 Year, $20 million contract with the FDA

BioPharma Services USA awarded a 5 Year, $20 million contract with the FDA

22 May 2016

The contract is to conduct in vivo studies of generic drug products in human subjects from 2016 through to 2021.

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Pfizer announces EMA Acceptance for Review of MAA for Trumenba

Pfizer announces EMA Acceptance for Review of MAA for Trumenba

22 May 2016

The acceptance marks the beginning of the regulatory review process for this vaccine in the EU.

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Rx-360 summary of FDA draft guidance on use of comparability protocols for CMC post-approval changes

Rx-360 summary of FDA draft guidance on use of comparability protocols for CMC post-approval changes

22 May 2016

Guidance is intended to establish a framework to promote continuous improvement in the manufacturing of quality products.

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FDA grants Genentech’s cancer immunotherapy Tecentriq Accelerated Approval for people with a specific type of advanced bladder cancer

FDA grants Genentech’s cancer immunotherapy Tecentriq Accelerated Approval for people with a specific type of advanced bladder cancer

18 May 2016

First and only anti-PDL1 cancer immunotherapy approved by the FDA.

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Martindale Pharma expands European commercial activities to include France

Martindale Pharma expands European commercial activities to include France

18 May 2016

Launch of early access programme for Noyada, first novel oral liquid formulation of Captopril targeting paediatric cardiovascular conditions and type 1 diabetic nephropathy.

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