Latest News in the pharma Industry

Policy & Regulation

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Rx-360 summary of FDA draft guidance on use of comparability protocols for CMC post-approval changes

Rx-360 summary of FDA draft guidance on use of comparability protocols for CMC post-approval changes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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Upcoming PDUFA and ANDA approval dates could catalyse Innovus Pharma and Lipocine

Upcoming PDUFA and ANDA approval dates could catalyse Innovus Pharma and Lipocine

16 May 2016

Investors may want to keep a close eye on both of these companies as key FDA response dates approach and PDUFA and ANDA decisions could serve as key catalysts for the stock price.

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Alprolix (rFIXFc) approved in the EU for the treatment of haemophilia B

Alprolix (rFIXFc) approved in the EU for the treatment of haemophilia B

15 May 2016

First Fc fusion therapy approved for haemophilia B in the EU to provide extended protection against bleeds.

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BMS and AbbVie announce EC approval of Empliciti for the treatment of multiple myeloma in adults who have received at least one prior therapy

BMS and AbbVie announce EC approval of Empliciti for the treatment of multiple myeloma in adults who have received at least one prior therapy

12 May 2016

First and only immunostimulatory antibody approved in the European Union for multiple myeloma.

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Pharmaceutical distribution supply chain pilot projects — FDA request for information

Pharmaceutical distribution supply chain pilot projects — FDA request for information

12 May 2016

The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.

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