Latest News in the pharma Industry

Policy & Regulation

FDA warns Pfizer company about cGMP violations associated with the manufacture of EpiPen

FDA warns Pfizer company about cGMP violations associated with the manufacture of EpiPen

10 Sep 2017

Warning letter cites Meridian Medical Technologies' failure to thoroughly investigate multiple serious component and product failures of EpiPen products.

Read more 
Research reveals costly implementation is the biggest barrier to serialization compliance

Research reveals costly implementation is the biggest barrier to serialization compliance

7 Sep 2017

The time it takes to develop a solution has been gravely underestimated by a large part of the industry.

Read more 
Novo Nordisk settles US federal investigation of marketing practices

Novo Nordisk settles US federal investigation of marketing practices

7 Sep 2017

In connection with the $60 million settlement, the company has also resolved several private whistle-blower cases related to the government's investigation.

Read more 
Life-extending pancreatic cancer medicine recommended by NICE in final guidance

Life-extending pancreatic cancer medicine recommended by NICE in final guidance

6 Sep 2017

The pivotal Phase III study demonstrated that treatment with Abraxane in combination with gemcitabine can offer patients a median overall survival improvement of 1.8 months.

Read more 
Takeda disappointed as NICE issue second negative draft decision for ixazomib

Takeda disappointed as NICE issue second negative draft decision for ixazomib

5 Sep 2017

Company says it is determined to work collaboratively to find a solution.

Read more 
Bayer submits BLA in the for BAY94-9027 – a long-acting factor VIII for the treatment of hemophilia A

Bayer submits BLA in the for BAY94-9027 – a long-acting factor VIII for the treatment of hemophilia A

3 Sep 2017

Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals.

Read more 
FDA approves Pfizer's Mylotarg for treatment of AML

FDA approves Pfizer's Mylotarg for treatment of AML

1 Sep 2017

Only approved antibody-drug conjugate for newly diagnosed and relapsed or refractory CD33-positive AML.

Read more 
Lilly to file baricitinib resubmission to FDA before end of January 2018

Lilly to file baricitinib resubmission to FDA before end of January 2018

30 Aug 2017

Resubmission package will include new safety and efficacy data.

Read more 
Novartis receives first ever FDA approval for a CAR-T cell therapy

Novartis receives first ever FDA approval for a CAR-T cell therapy

30 Aug 2017

Kymriah approvaed for children and young adults with B-cell ALL that is refractory or has relapsed at least twice.

Read more 
FDA approves new antibacterial drug

FDA approves new antibacterial drug

30 Aug 2017

First carbapenem-based combination product – combination of meropenem with a new class of beta-lactamase inhibitor.

Read more 
Acordia's NDA generates Refusal to File letter from FDA

Acordia's NDA generates Refusal to File letter from FDA

29 Aug 2017

FDA cites two manufacturing concerns.

Read more 
Biogen’s adalimumab biosimilar referencing Humira, is approved in the EU

Biogen’s adalimumab biosimilar referencing Humira, is approved in the EU

28 Aug 2017

Biogen becomes the first company with approved biosimilars for the three most prescribed anti-TNF biologic treatments in Europe.

Read more