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CryoPort Grabs Contracts for Gilead, Novartis CAR-T Products

In the world of developing and manufacturing cell-based therapeutics an approved medication for any indication is only part of the business plan. The other aspect is delivering the product to patients. That’s where logistics companies like CryoPort Inc. come into play.

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U.S. committee recommends GSK shingles vaccine over Merck rival

The committee responsible for U.S. vaccination schedules gave a preferential recommendation to GlaxoSmithKline’s newly approved shingles vaccine Shingrix over Merck’s established product Zostavax.

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2017 Annual Report: Top 50 Companies – The Corner Turned

For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.

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Roche bladder cancer drug struggles

Tecentriq has lost market share to Merck & Co.’s rival Keytruda since a study showed Roche’s immunotherapy drug failed to improve overall survival in bladder cancer.

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House Democrats launch MS drug pricing probe

House Committee on Oversight and Government Reform Democrats are launching an investigation into why prices for MS treatments have nearly quadrupled since 2004.

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ALS IV therapy Radicava launched in U.S.

Radicava (edaravone), an intravenous therapy indicated for all adult patients diagnosed with Lou Gehrig’s disease, has been launched in the U.S. by Mitsubishi Tanabe.

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2017 Annual Report – Top 200 Medicines: Humira Remains Atop The Throne

AbbVie’s biologic therapy Humira for autoimmune disorders continues to dominate the sales landscape; Gilead’s once-daily hepatitis C treatment Harvoni in 2016 repeated its performance as the world’s second-best-selling prescription medicine.

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Special Feature – First Year After Launch: The specialties win again

Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.

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QuintilesIMS white paper: Large benefit for small numbers

The good news … is that innovation is addressing diseases with high-unmet need such as oncology, autoimmune diseases, and central nervous system (CNS) disorders. But, there is a complicating factor in the economic story: the patient population benefiting from launch brands is becoming smaller.

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First Year After Launch: New molecular entities launched in the U.S. during 2015 that generated 2016 sales of at least $200 million

A listing of the the new molecular entities launched in the United States during 2015 that generated 2016 sales of at least $200 million

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Samsung Bioepis launches Remicade biosmiliar

South Korea’s Samsung Bioepis started U.S sales of its copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade.

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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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