Amazon Care launches in Seattle

Amazon’s (NASDAQ:AMZN) virtual health clinic for employees is now live in Seattle for workers and dependents operating out of the corporate headquarters.

The Amazon Care app provides virtual consultations, allows patients to schedule a follow-up visit, and offers prescription delivery.

The primary care clinic is the latest stage in Amazon’s healthcare push, which included the $753M acquisition of online pharmacy PillPack in 2018.

https://seekingalpha.com/news/3543211-amazon-care-launches-in-seattle

Seattle Genetics PADCEV nabs 1st-line bladder cancer accelerated review

Seattle Genetics (NASDAQ:SGEN) and collaboration partner Astellas Pharma (OTCPK:ALPMF) announce Breakthrough Therapy status in the U.S. for antibody-drug conjugate PADCEV (enfortumab vedotin-ejfv), combined with Merck’s (NYSE:MRK) Keytruda (pembrolizumab), for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in a first-line setting.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

The FDA approved PADCEV in December 2019 for urothelial cancer patients who have previously received a PD-1/L1 inhibitor and platinum-based chemo before or after surgery.

https://seekingalpha.com/news/3543233-seattle-genetics-padcev-nabs-accelerated-review-for-first-line-bladder-cancer

FDA Ad Com in April for Lilly imaging agent

The FDA’s Medical Imaging Drugs Advisory Committee will meet on Thursday, April 23, to review and discuss the marketing application from Eli Lilly (NYSE:LLY) unit Avid Radiopharmaceuticals seeking approval of radiographic diagnostic agent flortaucipir F18 for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of tau protein aggregates associated with Alzheimer’s disease.

https://seekingalpha.com/news/3543254-fda-ad-com-in-april-for-lilly-imaging-agent

Five Prime up 5% on Seattle Genetics license deal

Five Prime Therapeutics (FPRX +5%) is up out of the gate this morning, albeit on below-average volume, in reaction to its global license agreement with Seattle Genetics (SGEN N/A) aimed at developing and commercializing novel antibody-drug conjugates (ADCs) using Five Prime-developed monoclonal antibodies.

Under the terms of the deal, Five Prime will receive $5M upfront, up to $295M in milestones for the first ADC and tiered mid-single-digit royalties on net sales. It will apparently receive up to $230M in milestones for the second product ($525M – 295M).

https://seekingalpha.com/news/3543264-five-prime-up-5-on-seattle-genetics-license-deal

Adamis poised to refile U.S. application for opioid overdose med next quarter

Based on a recent meeting with the FDA, Adamis Pharmaceuticals (ADMP -13%) believes that it can generate the necessary data to support the resubmission of its marketing application next quarter for opioid overdose med Zimhi (high-dose naloxone injection).

The agency has requested additional Chemistry, Manufacturing and Controls (CMC) information, specifically extractables and leachables testing from the syringe and glassware.

Investors appear disappointed with the timeline.

Shares plummeted in November 2019 after the company disclosed the receipt of a CRL in response to its initial filing.

https://seekingalpha.com/news/3543291-adamis-poised-to-refile-u-s-application-for-opioid-overdose-med-next-quarter

Genentech Tecentriq Gets Priority Review in Advanced Non-Small Cell Lung Cancer

Roche Holding AG’s Genentech unit on Wednesday said the U.S. Food and Drug Administration accepted for priority review the company’s supplemental biologics license application as a first-line monotherapy for certain forms of advanced non-small cell lung cancer.

Genentech said the application covers Tecentriq for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.

Genentech said the agency set a target action date of June 19 for the application.

https://www.marketscreener.com/ROCHE-HOLDING-AG-9364975/news/Roche-Genentech-Gets-FDA-Priority-Review-for-Tecentriq-in-Advanced-Non-Small-Cell-Lung-Cancer-30018253/

Integra LifeSciences Holdings EPS beats by $0.01, misses on revenue

Integra LifeSciences Holdings (NASDAQ:IART): Q4 Non-GAAP EPS of $0.68 beats by $0.01; GAAP EPS of $0.18 misses by $0.13.

Revenue of $395.13M (+3.1% Y/Y) misses by $2.38M.

Press Release

https://seekingalpha.com/news/3543102-integra-lifesciences-holdings-eps-beats-0_01-misses-on-revenue