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