Regeneron

TherapeuticsMD bags FDA approval for hormone therapy The FDA has nodded hormone therapy of TherapeuticsMD for hot flashes that are associated with menopause. Bijuva is an oral treatment that contains molecularly identical (bio-identical) versions of the hormones estradiol and progesterone for menopausal women with a...

Regeneron/Sanofi’s PD-1 drug candidate will be tested with ISA’s HPV immunotherapy Regeneron and Sanofi’s PD-1 candidate cemiplimab is paired with Dutch biotech ISA Pharma’s human papillomavirus (HPV) targeting drug for testing. The new drug is competing to become the sixth PD-1/PD-L1 drug on the market. Joined with...

Positive Phase 2 data for Roche’s lymphoma ADC Roche’s antibody-drug conjugate for non-Hodgkin lymphoma polatuzumab has already received breakthrough designation from the USFDA and priority medicine status in the EU, and the expectations for the same are running pretty high. Phase 2 data presented by the company at...

Novartis takes on Regeneron with AMD drug that needs fewer doses than Eylea Last year, U.S. sales of Regeneron’s drug to treat age-related macular degeneration (AMD) came in at $3.3 billion—68% of the company’s total revenues—so it’s no wonder investors have been expressing some concerns about potential rivals movin...

Merck's Remicade discounting put squeeze on biosims—and broke U.K. law, officials say Under biosimilar assault in Europe, Merck rolled out cut-rate deals on Remicade to defend its brand from cheaper options, then-brand-new to the market. Now, the U.K.’s competition authority claims the pharma giant “broke competitio...

AstraZeneca's new benralizumab helps severe asthma patients cut back on steroids AstraZeneca's respiratory candidate benralizumab can help some severe asthma patients cut down on—or even stop—the unsavory steroid pills they use daily to stave off attacks, a new study showed. Dubbed Zonda, the phase 3 trial found tha...

AstraZeneca slapped with second Complete Response Letter Having a potential blockbuster sidelined because of manufacturing issues is bad enough, but AstraZeneca has now had that experience twice—both times receiving a complete response letter from the FDA. For a second time, AstraZeneca has received a complete respo...

US FDA grants approval for Novartis' Ilaris to treat Periodic Fever Syndromes Novartis received approval to market its Periodic Fever Syndrome drug Ilaris (cancakinumab). The drug targets the syndrome, and will be used to treat a group of diseases that cause serious recurrent fever and pathogenic inflammation throug...

Introduction: Cardiovascular disease is the leading cause of mortality worldwide due to increased level of Low Density Lipoprotein, cholesterol, which is a major modifiable risk factor. One of the risk factors is atherosclerosis caused when high levels of LDL-C in the blood build up in the inner walls of arteries, t...