Latest News in the pharma Industry

Policy & Regulation

Patent trial and appeal board upholds the validity of Lialda patent

Patent trial and appeal board upholds the validity of Lialda patent

6 Oct 2016

Shire pleased with the decision and will continue to vigorously defend its patents.

Read more 
Theratechnologies to move forward with development of new single vial formulation for Egrifta

Theratechnologies to move forward with development of new single vial formulation for Egrifta

28 Sep 2016

The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta (Tesamorelin for Injection).

Read more 
Biogen completes rolling submission of NDA to FDA for nusinersen as a treatment for spinal muscular atrophy

Biogen completes rolling submission of NDA to FDA for nusinersen as a treatment for spinal muscular atrophy

27 Sep 2016

Submission of Marketing Authorization Application to the EMA planned in the coming weeks.

Read more 
FDA approves Amgen's new biosimilar for multiple inflammatory diseases

FDA approves Amgen's new biosimilar for multiple inflammatory diseases

25 Sep 2016

Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases.

Read more 
Novartis receives three new FDA approvals for the expanded use of Ilaris

Novartis receives three new FDA approvals for the expanded use of Ilaris

23 Sep 2016

Ilaris is the first and only US FDA-approved biologic treatment for patients with TRAPS, HIDS/MKD and FMF disease.

Read more 
FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

22 Sep 2016

Read more 
EMA validates BMS’s type II variation application for Opdivo in advanced form of bladder cancer

EMA validates BMS’s type II variation application for Opdivo in advanced form of bladder cancer

20 Sep 2016

Extends the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

Read more 
FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

19 Sep 2016

Approval given to EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 mg/kg for the treatment of DMD in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.

Read more 
District Court issues ruling in Hatch Waxman Case regarding Shire’s Lialda

District Court issues ruling in Hatch Waxman Case regarding Shire’s Lialda

18 Sep 2016

Shire to consider appeal.

Read more 
Glyxambi approval recommended by CHMP for adults with type 2 diabetes in the EU

Glyxambi approval recommended by CHMP for adults with type 2 diabetes in the EU

18 Sep 2016

Glyxambi is a single tablet that combines Jardiance and Trajenta and has been shown to improve blood sugar control in adults with type 2 diabetes.

Read more 
FDA advisory committees recommend to remove boxed warning in labeling for Pfizer’s smoking cessation therapy, Chantix

FDA advisory committees recommend to remove boxed warning in labeling for Pfizer’s smoking cessation therapy, Chantix

15 Sep 2016

Read more 
Santalis Pharmaceuticals issued patent for the use of sandalwood oil to treat cancers

Santalis Pharmaceuticals issued patent for the use of sandalwood oil to treat cancers

12 Sep 2016

Patent covers East Indian sandalwood oil-containing compositions that can be used to treat a variety of cancers.

Read more