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EU approves fifth copy of AbbVie’s Humira

Europe approved a fifth copy of AbbVie’s $18-billion-a-year biologic Humira – the world’s best-selling prescription medicine – ramping up competition among makers of less-expensive biotech drugs.

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Europe ready to cash in on cheap copies of AbbVie biotech drug

AbbVie faces a crunch moment in Europe in mid-October 2018 when less-expensive copies of the U.S. drugmaker’s $18-billion-a-year biologic drug Humira – the world’s best-selling prescription medicine – hit the market.

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Amgen Announces Top-Line Results From Phase 3 Study Of ABP 710, Biosimilar Candidate To Infliximab

Amgen announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with Remicade (infliximab) in patients with moderate-to-severe rheumatoid arthritis.

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Novartis receives EU approval for biosimilar Zessly

Novartis’ Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.

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Gilead, Verily to Tackle Three Inflammatory Diseases

Gilead Sciences and Google/Alphabet’ Verily Life Sciences teamed up to focus on three inflammatory diseases: rheumatoid arthritis, inflammatory bowel disease and lupus-related diseases.

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Celltrion Shares Fall After FDA Issues Warning Letter

Shares of South Korea-based Celltrion were down more than 5 percent after the company announced it received a warning letter from the U.S. Food and Drug Administration after the regulatory agency inspected a company drug manufacturing facility.

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Pfizer’s Xeljanz Gets FDA Nod As Joint Disease Treatment

The U.S. FDA approved two doses of Pfizer Inc.’s medicine Xeljanz for treating active psoriatic arthritis.

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Merck profit beat clouded by NotPetya attack, shares dip

Merck & Co. reported profit ahead of Street estimates on strong sales of its cancer drug Keytruda, but total revenue fell in third-quarter 2017 from disruptions due to the NotPetya cyber attack and loss of market share for many of the company’s older drugs.

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Incyte Discloses Promising New Data in Combo Drug Trial With Merck & Co.’s Keytruda

Incyte Corporation will have an abstract published at the European Society for Medical Oncology (ESMO) meeting in early September with new and updated data from its ongoing Phase I/II trial of epacadostat in combination with Merck & Co.’s Keytruda in advanced melanoma.

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Biosimilar version of Humira approved in Europe

A biosimilar version of AbbVie Inc.’s blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc. and Samsung Biologics, was approved by EU regulators.

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GlaxoSmithKline’s new boss streamlines R&D

GSK’s new chief executive announced plans to narrow the focus of the group’s drug research by ditching 30-plus projects to improve returns in its core pharma business.

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Novartis gets European OK for biosimilar of Amgen’s Enbrel

Novartis’ generics unit Sandoz said the European Commission approved Erelzi – the company’s biosimilar to Amgen’s Enbrel – to treat inflammatory diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis.

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EU backs second biosimilar copy of Humira

European regulators recommended approval of a second copy of AbbVie’s rheumatoid arthritis drug Humira, the world’s top-selling medicine.

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Boehringer Ingelheim presents phase III results demonstrating clinical equivalence of adalimumab biosimilar candidate to Humira

Boehringer Ingelheim announced results from the pivotal Phase III VOLTAIRE-RA1 study, confirming that its adalimumab biosimilar candidate BI 695501 and Humira have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis.

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AbbVie’s RA drug succeeds in late-stage trial

AbbVie’s rheumatoid arthritis drug was superior to a placebo in a late-stage study involving patients that have not responded adequately to standard treatments.

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