Latest News in the pharma Industry

Policy & Regulation

Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

21 Dec 2015

As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance and Pharmacovigilance System Master F...

Read more 
FDA Draft Guidance: Safety Assessment for IND Safety Reporting

FDA Draft Guidance: Safety Assessment for IND Safety Reporting

18 Dec 2015

The FDA has published draft guidance for sponsors of investigational new drug application (IND) studies with recommendations for identifying and evaluating important safety information that must be submitted to FDA and all participating investigators u...

Read more 
FDA approves Basaglar (insulin glargine injection), a long-acting insulin treatment

FDA approves Basaglar (insulin glargine injection), a long-acting insulin treatment

17 Dec 2015

Basaglar is the first FDA-approved follow-on insulin glargine treatment.

Read more 
A Practical Guide to Writing Risk Management Plans

A Practical Guide to Writing Risk Management Plans

17 Dec 2015

Research and Markets has announced the addition of the "A Practical Guide to Writing Risk Management Plans (RMPS) (London, UK — 25 January 2016)" conference to their offering.

Read more 
NICE ‘no’ for Opdivo, could deny some lung cancer patients one of the most significant advances in almost 20 years

NICE ‘no’ for Opdivo, could deny some lung cancer patients one of the most significant advances in almost 20 years

15 Dec 2015

The draft decision specifically affects adult patients with locally advanced or metastatic squamous non-small cell lung whose disease has progressed after prior chemotherapy.

Read more 
Rx-360 summary of PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE-009-12)

Rx-360 summary of PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE-009-12)

10 Dec 2015

The Guide covers GMP principles and active substances used as starting materials.

Read more 
FDA approves Kanuma for the treatment of patients with lysosomal acid lipase deficiency

FDA approves Kanuma for the treatment of patients with lysosomal acid lipase deficiency

9 Dec 2015

Kanuma is the first approved treatment in the US for patients suffering from LAL-D, a life-threatening and ultra-rare metabolic disorder.

Read more 
Novo Nordisk files for regulatory approval of faster-acting insulin aspart in the EU for the treatment of type 1 and 2 diabetes

Novo Nordisk files for regulatory approval of faster-acting insulin aspart in the EU for the treatment of type 1 and 2 diabetes

8 Dec 2015

The company intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch.

Read more 
Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea

Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea

7 Dec 2015

Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck

Read more 
Sun Pharma receives FDA approval for generic Gleevec

Sun Pharma receives FDA approval for generic Gleevec

6 Dec 2015

Company eligible for 180-days marketing exclusivity on a first-to-file Para-IV ANDA.

Read more 
Amgen's first biosimilar marketing authorization application submitted to EMA for ABP 501

Amgen's first biosimilar marketing authorization application submitted to EMA for ABP 501

4 Dec 2015

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

Read more 
Baxalta receives CHMP positive opinion for Sanquin to begin production, enhancing global supply of plasma-based therapies

Baxalta receives CHMP positive opinion for Sanquin to begin production, enhancing global supply of plasma-based therapies

4 Dec 2015

Sanquin is now licensed to produce bulk material for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) for the European Union, I...

Read more