(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…
Search results for: Novartis
Don’t Bank on U.S. Drug Price Rises, Warns GSK Boss
LONDON (Reuters)—Pharmaceutical companies cannot depend on ever increasing prices in the U.S. and will need to find a new balance between incentives for innovation and access to medicines, according to the chief executive of GlaxoSmithKline. High drug prices have come under fierce political fire recently in America, the industry’s biggest and most profitable market, with…
XenoPort’s Psoriasis Drug Found Effective in Phase 2 Trial
(Reuters)—Drug developer XenoPort Inc. said on Tuesday its experimental drug was effective in treating psoriasis, sending its shares up 19% in premarket trading. The oral drug met the main goal in a phase 2 trial of patients with moderate-to-severe chronic plaque-type psoriasis, the company said. XenoPort said it expected to start late-stage trials next year…
FDA Proposes Adding Suffixes to Distinguish Biosimilar Drug Names
WASHINGTON (Reuters)—The U.S. Food and Drug Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded counterparts. The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…
China Gets Tougher for Western Drugmakers
LONDON (Reuters)—The Chinese market is getting tougher for Western pharmaceutical companies as Beijing bears down on a rising healthcare bill and prices come under pressure. The country, which has overtaken Japan as the world’s second largest market for prescription medicines after the U.S., has drawn major investment from global drugmakers in recent years — but…
Secukinumab Effective for Treating Psoriatic Arthritis
NEW YORK (Reuters Health)—The anti-interleukin-17A monoclonal antibody secukinumab improves signs and symptoms in patients with psoriatic arthritis, according to results from Novartis’ FUTURE 2 trial. In earlier studies, secukinumab has demonstrated superior effectiveness to placebo and etanercept in improving the signs and symptoms of psoriasis. Dr. Iain B. McInnes from the University of Glasgow in…
Greece’s Medicine Supply May Be in Jeopardy
BASEL, Switzerland (Reuters)—Drugmakers said on Monday they would continue to ship medicines to Greece in coming weeks, despite mounting unpaid bills, but warned supplies could be in jeopardy if Europe did not take emergency action. “In the worst-case scenario of ‘Grexit’, we believe the integrity of the medicines supply chain may be in jeopardy, which…
Eosinophilia: A Diagnostic Evaluation Guide for Rheumatologists
Clinical Vignette A 45-year-old woman with long-standing asthma and chronic sinusitis has new-onset peripheral neuropathy, arthralgias, fatigue, progressive dyspnea and a nonproductive cough. She has never smoked and has no environmental exposures. Her medications include an albuterol metered-dose inhaler (which she uses daily); an inhaled corticosteroid, montelukast; and ibuprofen (which she takes occasionally). She is…
Zoledronic Acid May Improve Bone Density in Elderly Women
A single injection daily of zoledronic acid may improve bone mineral density (BMD) in frail elderly women in long-term care facilities, a new randomized controlled trial shows. However, the clinical importance of the improvement, observed over a two-year period, remains unclear, Dr. Neil M. Resnick, of the University of Pittsburgh, told Reuters Health in a…
AstraZeneca Hit after Psoriasis Drug Linked to Suicide Fears
LONDON (Reuters)—AstraZeneca’s hopes of topping $45 billion in revenue by 2023 have been dealt a blow by a problem with an experimental psoriasis drug that the drugmaker had viewed as a potential billion-dollar plus seller. Amgen, its partner on the project, announced late on Friday it was ending a collaboration to develop brodalumab after suicidal…
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