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AbbVie Receives CHMP Positive Opinion for Humira

The EMA’s CHMP granted a positive opinion for Humira (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age.

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CSL Behring Receives Orphan-Drug Exclusivity for Haegarda

FDA granted orphan-drug exclusivity for Haegarda for the prevention of hereditary angioedema attacks.

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Pfizer, Merck KGaA skin cancer drug gets EMA nod for approval

(Reuters) – European regulators on Friday recommended approving Pfizer Inc and Merck KGaA’s immuno-oncology drug Bavencio to treat a rare type of skin cancer called Merkel cell carcinoma. In May, Bavencio was approved by the U.S. Food and Drug Administration to treat bladder cancer and in March to treat Merkel cell carcinoma. (bit.ly/2vIbPPG) Bavencio, known […]

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EU medicines agency recommends approval of Novartis leukemia drug Rydapt

ZURICH (Reuters) – A European Medicines Agency (EMA) panel recommended on Friday approval of a new Novartis drug to be used against a tough-to-cure form of blood cancer as the Swiss drugmaker makes headway on refreshing its oncology portfolio. The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Rydapt against acute myeloid leukemia […]

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UK will pay for Roche breast cancer drug

A breast cancer drug at the center of a prolonged pricing row in Britain will now be paid for routinely following a discount deal between Roche and the NHS.

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Hundreds of Patient Deaths Linked to Roche’s RA Drug Actemra

Roche’s seven-year-old rheumatoid arthritis drug Actemra is being linked to hundreds of deaths due to undisclosed side effects.

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The Best Defense is a Good Quality Offense

While data help manufacturers fix plant-floor problems and trace quality issues to their source, it also can prevent recalls. Why not proactively use data to attain an end-to-end view of operations so that product quality can be ensured while reducing recalls?

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New MS Drug Linked to Deadly Brain Infection

Roche is investigating a case of a German patient diagnosed with a deadly brain infection called PML after taking one dose of the company’s new MS drug Ocrevus.

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WHO wants transparency, market revamp for fairer drug pricing therape

The world needs greater transparency on the pricing of medicines – and an overhaul of some approaches – in order to increase access to life-saving drugs, global health experts said.

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In Europe, U.S., modern AIDS drugs add extra 10 years of life expectancy

Life expectancy for young HIV-positive adults has risen by 10 years in the United States and Europe.

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