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Market Access

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Novartis Targets Quick Launches For Zolgensma in Europe

The Swiss major is offering a ‘Day One’ access program to governments and reimbursement agencies for Zolgensma, which is already available in France and will be shortly in Germany.

Approvals Gene Therapy

FDA Approval Makes Deciphera’s Qinlock First Fourth-Line GIST Drug

Qinlock (ripretinib), approved as the US FDA rejected Blueprint Medicines’ Ayvakit (avapritinib) in the same indication, is priced on par with the rival drug cleared in January for a narrower GIST use.

Launches Approvals

AZ To Adopt Indication-Based Pricing For Farxiga In Heart Failure

AstraZeneca's biopharmaceuticals president Ruud Dobber tells Scrip that the price for Farxiga in the heart failure indication should reflect its potential to improve survival and reduce the need for hospitalization.

Pricing Strategies Cardiovascular

Alexion Buys Out Portola, But Analysts Don’t See Value

The acquisition brings Alexion the bleeding reversal agent Andexxa, which execs called a synergistic addition to its portfolio – but analysts are struggling to see the match with Alexion’s chronic rare disease therapies.

Deals M & A

GSK Cancer R&D Chief Sees Three Key Approvals In Q2

GlaxoSmithKline expects regulatory approval for three key cancer products by the middle of this year, anchoring it as a leading oncology company, Axel Hoos tells Scrip.

Approvals Commercial

GSK’s Zejula Wins First-Line Ovarian Cancer Use

Winning an expanded US FDA indication for Zejula as a first-line ovarian cancer treatment further vindicates GSK’s hefty purchase price for Tesaro and sets the scene for more therapeutic extensions for the PARP inhibitor, oncology R&D chief Axel Hoos told Scrip.

Clinical Trials Companies

Could Gilead Make A Profit From Remdesivir?

All being well, Gilead could gain emergency approval for remdesivir by early May - but arriving at a 'reasonable' price and devising rapid access programs will be a major challenge.

Coronavirus COVID-19 Market Access

NICE Gives Landmark Nod To Bayer's Vitrakvi

Vitrakvi is the first in a new generation of tumor-agnostic drugs to be made available on the NHS after Bayer and NICE finally reached agreement over pricing and access while more data is collected on its clinical effectiveness.

Cancer Health Technology Assessment

Daiichi Sankyo Enters Europe's Cholesterol Market

The Japan-headquartered drugmaker says there is a need for affordable oral treatment options on top of currently available lipid-lowering therapies and the two drugs it licensed from Esperion can meet that need.

Cardiovascular Approvals
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