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Monday, August 17, 2020

Bausch + Lomb launches silicone hydrogel disposable contact lens

August 17, 2020

Bausch Health Companies (NYSE:BHC) unit, Bausch + Lomb announces the launch of Bausch + Lomb INFUSE silicone hydrogel (SiHy) daily disposable contact lens with a next generation material infused with ProBalance Technology to help ocular surface homeostasis and help reduce symptoms of contact lens dryness.
The ProBalance Technologyformula is infused into the lens material during the manufacturing process. These proprietary ingredients are released during lens wear.

GenMark up on emergency use application for SARS-CoV-2 test

GenMark Diagnostics (NASDAQ:GNMK) has filed an application with the FDA seeking emergency use authorization for its eSensor SARS-CoV-2 Test, a molecular assay that detects the presence of the coronavirus.

The test is performed on the company’s multiplex molecular diagnostic system called the XT-8 that can generate results from 96 samples in five hours.


Clovis up on rucaparib data in prostate cancer

Clovis Oncology (CLVS +19.5%) jumps on more than double normal volume on the heels of additional data from the Phase 2 TRITON2 study evaluating Rubraca (rucaparib) in metastatic castration-resistant prostate cancer (mCRPC) patients harboring BRCA1/2 mutations. The results, supporting accelerated approval in the U.S. three months ago for this indication, were just published online in the Journal of Clinical Oncology.

Confirmed objective response rate (ORR) per independent radiology review was 43.5% – 56.7%. ORR via investigator assessment was 50.8% – 63.4%.

Confirmed PSA response rate was 54.8%.

On the safety front, the most frequent serious or higher treatment-emergent adverse event was anemia (25.2%).

Related tickers: AstraZeneca (AZN +2.3%), Merck (MRK +1.9%)


Nano-X Imaging sets IPO terms

Nano-X Imaging Ltd. (NNOX) has filed an amended preliminary prospectus for an IPO of ~5.9M ordinary shares at $16 – 18, expected to yield $100M at the midpoint.

The Neve Ilan, Israel-based company makes, what it says, are affordable medical imaging systems that incorporate a novel X-ray source based on a digital microelectromechanical system semiconductor cathode. The company believes its source can achieve the same performance as a legacy X-ray analog cathode.

Its first product, Nanox ARC, will be a 3D tomosynthesis imaging system. Concurrently, it has developed companion cloud-based software called Nanox CLOUD that is designed to provide end-to-end medical imaging service.

2020 Financials (H1): Operating Expenses: $13.8M (+711.8%); Net Loss: ($13.8M) (-711.8%); Cash Burn: ($4.7M) (-327.3%).


Novartis up on Gilenya patent win

Novartis (NVS +1.7%) is up, albeit on below-average volume, on the heels of a favorable ruling by a Delaware court agreeing with the company that generic drugmaker HEC Pharm Co., Ltd.’s marketing application for a generic version of MS med Gilenya (fingolimod) infringes on a Novartis patent that expires in 2027. The judge also upheld the validity of the patent.

The company sued almost two dozen generic drug firms in 2018 for patent infringement but has reached confidential settlements with most.

Gilenya accounted for 8% of its Q2 Innovative Medicine sales ($738M/9,188M).


Bristol Myers Squibb Licenses Dragonfly Therapeutics Program

Bristol Myers Squibb Co. on Monday said it has signed an exclusive agreement to license Dragonfly Therapeutics Inc.’s interleukin-12 investigational immunotherapy program.

The New York biopharmaceutical company said Dragonfly will receive $475 million in near-term upfront payments and is eligible to receive performance-based development, regulatory and commercial milestone payments.

Bristol Myers said the license includes Dragonfly’s extended half-life cytokine DF6002, an investigational immunotherapy being evaluated in adults for the treatment of advanced solid tumors.

Dragonfly, a privately held clinical-stage biopharmaceutical company, in May received U.S. Food and Drug Administration clearance for its investigational new drug application to develop DF6002.

Bristol Myers said it will become responsible for the development and any subsequent commercialization of DF6002 and its related products world-wide, including strategic decisions, regulatory responsibilities, funding and manufacturing, while Dragonfly will receive up to 24% royalties on world-wide net sales.


Anthem, Quest Diagnostics in Strategic Relationship

Anthem Inc. and Quest Diagnostics said Monday they entered into a strategic relationship by collaborating on a variety of outcomes-based programs designed to create an improved health-care experience for consumers and providers beginning Aug. 1.

The companies said they will work together to improve efficiency in care delivery and reduce overall costs by using a broad range of tools and programs to drive operational improvements, create pricing transparency, and enhance health care consumer engagement and outcomes.

The strategic relationship will focus on consumers in California, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, New Hampshire, New York, Ohio, Virginia, and Wisconsin.