FDA clears Abbott next-gen glucose monitor for young children

The FDA has issued 510(k) clearance for Abbott’s (NYSE:ABT) FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system for patients as young as four years old with diabetes.

The company says the device is the only iCGM system with optional real-time alarms that measure glucose levels every minute over a period of 14 days (wear time).

https://seekingalpha.com/news/3582909-fda-clears-abbott-next-gen-glucose-monitor-for-young-children

Myriad nabs new coverage policies for Prolaris

Myriad Genetics (NASDAQ:MYGN) has received favorable coverage decisions for Prolaris from three new commercial health plans including one of the top five national providers of health insurance.

The first new coverage policy became effective on June 8, 2020, the second becomes effective today and the third one on July 31.

In combination, these health plans cover ~26M commercial lives bringing total commercial coverage for Prolaris up to 55M lives.

Prolaris is a genetic test that directly measures tumor cell growth. The Prolaris test paired with both prostate-specific antigen and Gleason provides the level of aggressiveness of a patient’s individual prostate cancer.

https://seekingalpha.com/news/3582911-myriad-nabs-new-coverage-policies-for-prolaris

Lilly launches late-stage study of baricitinib in COVID-19

Enrollment is underway in a Phase 3 clinical trial, COV-BARRIER, evaluating Eli Lilly’s (NYSE:LLY) Olumiant (baricitinib), an oral JAK1/JAK2 inhibitor licensed from Incyte (NASDAQ:INCY), in hospitalized COVID-19 patients including those with at least one elevated marker of inflammation but not on mechanical ventilation.

The primary endpoint is the proportion of patients receiving 4 mg of baricitinib each day (with background therapy) who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by day 28 compared to placebo (with background therapy).

The trial will enroll ~400 participants across sites in the U.S., Europe and Latin America.

The FDA approved Olumiant in June 2018 for rheumatoid arthritis.

https://seekingalpha.com/news/3582916-lilly-launches-late-stage-study-of-baricitinib-in-covidminus-19

Thermo Fisher nabs accelerated review in U.S. for glioma test

The FDA has granted Breakthrough Device Designation to Thermo Fisher Scientific’s (NYSE:TMO) Oncomine Precision Assay to identify low-grade glioma patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be suitable for Agios Pharmaceuticals’ (NASDAQ:AGIO) vorasidenib.

The designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application.

The companies have been collaborating on companion diagnostics since 2017.

https://seekingalpha.com/news/3582922-thermo-fisher-nabs-accelerated-review-in-u-s-for-glioma-test

Baudax Bio launches Anjeso in U.S.

Baudax Bio (NASDAQ:BXRX) announces the commercial launch of ANJESO (meloxicam) injection, indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

The company has hired, trained, and now deployed 50 acute care sales representatives and that the Centers for Medicare and Medicaid Services has approved transitional pass-through status and established a new reimbursement code for ANJESO.

The code, C9059, is scheduled to become effective July 1.

https://seekingalpha.com/news/3582924-baudax-bio-launches-anjeso-in-u-s

European stocks and U.S. futures slump on fears over rising infections

Shares in Europe slumped on Monday on concern over rising coronavirus infections just as many countries begin opening up after lockdowns.
Down nearly 6% last week, the Stoxx Europe 600 SXXP, -2.48% dropped 2.2%.
The German DAX DAX, -2.70% , French CAC 40 PX1, -2.80% and U.K. FTSE 100 UKX, -2.44% each lost at least 2%.

Rising infections in Arizona, California, Florida and Texas, as well as a new outbreak in Beijing, sent investors scurrying from risky assets.
Futures on the Dow Jones Industrial Average YM00, -3.20% skidded 796 points.
“Overall, it’s possible that globally we are now shielding the vulnerable better and that even if we do see a second wave it might not be as deadly as the first. Anyway, expect the market to be obsessing about these states this week,” said Jim Reid, strategist at Deutsche Bank.
The losses came on the day the U.K. allowed non-essential retailers to resume operations.
Of companies in the spotlight, BP shares BP, -6.35% BP, +2.82% lost nearly 6% after the energy giant said it would take up to $17.5 billion in charges, due to lower assumptions on the oil and natural gas it sells.
https://www.marketwatch.com/story/european-stocks-and-us-futures-slump-on-fears-over-rising-infections-2020-06-15

AstraZeneca to Supply Europe With Covid-19 Vaccines

AstraZeneca PLC said over the weekend that it has reached an agreement with Europe’s Inclusive Vaccines Alliance to supply up to 400 million doses of Oxford University’s Covid-19 vaccine at no profit.
Deliveries will start by the end of 2020, the British pharmaceutical giant said.
The company has recently reached similar agreements with the U.K., the U.S., the Coalition for Epidemic Preparedness Innovations, and Gavi, the Vaccine Alliance for 700 million doses, it said.
AstraZeneca said it is seeking to expand manufacturing capacity further and that it is open to collaborating with other companies in order to meet its commitment to support access to the vaccine during the pandemic.

https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/AstraZeneca-to-Supply-Europe-With-Covid-19-Vaccines-30770091/