Latest News in the pharma Industry

Policy & Regulation

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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
EC approves the first and only immuno-oncology combination, BMS's Opdivo + Yervoy Regimen, for treatment of advanced melanoma

EC approves the first and only immuno-oncology combination, BMS's Opdivo + Yervoy Regimen, for treatment of advanced melanoma

11 May 2016

Approval allows for the marketing of the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in all 28 Member States of the EU.

Read more 
FDA grants Priority Review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma

FDA grants Priority Review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma

8 May 2016

Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication.

Read more 
Endo announces US District Court ruling upholding Opana ER intellectual property

Endo announces US District Court ruling upholding Opana ER intellectual property

3 May 2016

The ruling confirms the Court's prior injunction against the manufacture or sale of the generic version of non-crush-resistant Opana ER.

Read more 
BASF welcomes EU approval for zinc oxide

BASF welcomes EU approval for zinc oxide

2 May 2016

After BASF’s Tinosorb A2B, Z-Cote is the second nano UV filter to be approved for use in cosmetics in Europe.

Read more 
Allergan receives FDA approval of Crestor

Allergan receives FDA approval of Crestor

2 May 2016

First company to launch a generic version of Crestor to customers in the US.

Read more 
FDA approves ACADIA Pharmaceuticals’ Nuplazid (pimavanserin)

FDA approves ACADIA Pharmaceuticals’ Nuplazid (pimavanserin)

1 May 2016

The first drug approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Read more