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Approvals

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Pipeline Watch: Phase III Readouts For Cabotegravir, Filgotinib

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Latecomer Alunbrig Faces Entrenched Rivals After US 1L Approval

First-line lung cancer approval will expand potential market for Takeda's ALK contender but the latecomer is also facing some well-established class competition in the setting.

United States Approvals

Sunovion Plans September Launch For Parkinson’s 'Off' Episode Drug Kynmobi

Kynmobi is an important approval for parent company Sumitomo Dainippon ahead of the loss of exclusivity for Latuda. Sunovion hopes to launch after COVID-19 social distancing requirements ease.

Approvals Neurology

AZ/Merck & Co' s Lynparza Gets US Approval For Prostate Cancer

Lynparza has received the green light from the FDA for advanced prostate cancer, its fourth tumor type, and while it may not be the first PARP inhibitor to be approved for this indication, analysts are expecting the drug to lead the class.

Cancer Approvals

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

New Approvals In Spotlight As China Gears For National Congress

In a sign that attention in China may be shifting back to more routine regulatory work as the local coronavirus outbreak appears to recede, authorities have granted approvals to multiple new drugs for cancer and rare diseases, as the government gears up to hold its delayed annual congress in Beijing.

Approvals China

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

Roche's Tecentriq Notches Approval For First-Line NSCLC Monotherapy

The company is getting more attention these days for its TIGIT inhibitor tiragolumab in combination with Tecentriq for 1L NSCLC, but a new 1L monotherapy indication for Tecentriq helps it compete against Keytruda. 

Approvals ImmunoOncology

Clovis’s Rubraca Is First PARP For Prostate Cancer, But AZ’s Lynparza Coming Soon

The limitations of launching during the pandemic will make it difficult to capitalize on a short window between the approvals.

Approvals Launches
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