On January 8, the European Medicine Agency (EMA) accepted Amgen and UCB’s submission...
- Novaliq’s NovaTears+Omega-3 represents the first-in-class omega-3-containing eye drop for evaporative dry eye
- Varubi IV’s second-try FDA approval provides CINV patients with a new option
- The future of orphan drugs in Europe
- Innovative trial design: where regulators and payers divide
- Ignyta’s Entrectinib is a game-changer for NTRK/ROS1/ALK fusion-positive solid tumors
Amgen/UCB’s bone-forming agent, Evenity, accepted for review by EMA
On January 8, the European Medicine Agency (EMA) accepted Amgen and UCB’s submission for review for use of Evenity (romosozumab), a novel anabolic agent for the treatment of postmenopausal women and men with osteoporosis.
Duaklir Genuair for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Duaklir Genuair (aclidinium bromide / formoterol fumarate) is an inhalation powder indicated as a maintenance bronchodilator treatment for chronic obstructive pulmonary disease (COPD).
Prevalence of POAG in Japan Dwarfed by Other Markets
The total prevalence of primary open-angle glaucoma (POAG) is substantially lower in Japan when compared with other markets. In most of the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan), the age-standardized prevalence of POAG is at least 1.29% in men 40 years and older and 1.39% in women 40 years and older. However, the age-standardized prevalence of POAG in this age group in Japan is 0.27% in men and 0.15% in women. Figure 1 shows the age-standardized total prevalence of POAG in men and women ages 40 years and older in the 7MM in 2016.
Diagnosed Prevalent Cases of Chronic Kidney Disease Set to Increase Globally
The burden of chronic kidney disease (CKD) in the seven major markets (7MM: US, 5EU [France, Germany, Italy, Spain, UK], and Japan) is expected to grow between 2016 and 2026. GlobalData epidemiologists forecast an increase in the number of diagnosed prevalent cases of CKD, most notably in the 5EU and the US. Figure 1 presents the expected changes in the 7MM from 2016 to 2026.
China’s Growth in Partnership Deals with Pipeline Drugs
Partnership deals that involve drugs in pipeline stage have shown a gradual increase of 8% for the US over the last 5 years. The US still remains to dominate the market, however partnership deals with drugs in pipeline stage for China has also shown a significant increase of 5% from 2013 to 2017.
Portola’s Bevyxxa Will Soon Secure a Critical Market Position in the VTE Space
Portola Pharmaceuticals announced on December 19th that the FDA approved the company’s Prior Approval Supplement (PAS) for Bevyxxa (betrixaban) earlier than it was originally scheduled and therefore the commercial launch will initiate in early January.
ViiV’s Juluca Becomes First Two-Drug, NRTI-Free Regimen to Receive Licensure for HIV
In late November, the FDA approved ViiV Healthcare’s Juluca (dolutegravir + rilpivirine) for the treatment of adults infected with human immunodeficiency virus (HIV), specifically as a maintenance therapy for those with virologically suppressed HIV-1 infections.
Syndros, the First FDA-Approved Liquid Dronabinol, Launched After Long Journey
Insys Therapeutics commercially launched Syndros (dronabinol oral solution) on July 31, 2017, becoming the first marketed, FDA-approved liquid dronabinol. The agent was FDA-approved in July 2016 for chemotherapy-induced nausea and vomiting (CINV) patients who have not responded to conventional antiemetic therapies, and for treating anorexia associated with weight loss in acquired immune deficiency syndrome (AIDS) patients.
Novaliq’s NovaTears+Omega-3 represents the first-in-class omega-3-containing eye drop for evaporative dry eye
Novaliq announced NovaTears+Omega-3, the first omega-3-containing eye drop registered in Europe for the enhanced treatment of the signs and symptoms of evaporative dry eye (EDE), early this month.
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