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Tuesday, August 18, 2020

Change Healthcare fills out next-gen med imaging platform in Nucleus.io buy

August 18, 2020

Change Healthcare (CHNG -0.3%) has acquired Nucleus.io, a developer of advanced, fully enabled, cloud-native imaging and workflow technology.
The acquisition accelerates Change’s timeline to implement a complete cloud-based, end-to-end enterprise imaging solution.
The deal expands Change’s addressable market with the inclusion of Nucleus.io’s 7,500 customers.

Albireo under pressure on elobixibat strikeout in NASH

Thinly traded micro cap Albireo Pharma (NASDAQ:ALBO) is down 12% after hours on light volume in reaction to topline results from a Phase 2 clinical trial evaluating constipation med elobixibat for the treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

The 47-subject study met the primary endpoint demonstrating a statistically significant change from baseline in LDL-cholesterol (“bad” cholesterol) at week 16 compared to placebo but failed to achieve any of the secondary NASH endpoints thereby failing to show proof-of-concept.

The company will cease development in NASH as a result.

The oral ileal bile acid transporter inhibitor is marketed in Japan under the brand name GOOFICE.


Supernus Pharmaceuticals EPS beats by $0.16, misses on revenue

Supernus Pharmaceuticals (NASDAQ:SUPN): Q2 GAAP EPS of $0.65 beats by $0.16.

Revenue of $126.73M (+21.0% Y/Y) misses by $5.27M.



Fauci: Don’t see US mandating COVID-19 vax for general public

Anthony Fauci, the nation’s top infectious diseases expert, said Tuesday he doesn’t see the U.S. mandating a COVID-19 vaccine.

“I don’t think you’ll ever see a mandating of vaccine particularly for the general public,” Fauci said during a livestreamed interview with Healthline.

Fauci, the director of the National Institute of Allergy and Infectious Diseases, noted that some workplaces, particularly those in health care fields, might prevent employees from coming to work or interacting with patients if they haven’t been vaccinated for the flu. 

Schools generally require students be vaccinated for measles and other infectious diseases before they are allowed to attend classes. 

But Fauci said he’d “be pretty surprised if you mandated it for any element of the general public.”

There are several vaccine candidates in clinical trials, and some look promising at providing a level of protection against COVID-19. 

While no vaccine has been approved yet by the Food and Drug Administration (FDA), experts are already grappling with how to convince the American public to get vaccinated.

Vaccine hesitancy has been a public health issue for several years now, especially among parents of young children.  



A Gallup poll released earlier this month found 1 in 3 Americans would not get a COVID-19 vaccine available today if it were free and approved by the FDA. 

Sixty-seven percent of white Americans said they would get the vaccine, compared to 59 percent of nonwhite Americans. People who lived in rural areas were less likely to say they would get vaccinated than people who lived in small towns, suburbs or large cities. 

Asked what the U.S. could do about people who refuse to get vaccinated, Fauci replied: “They have the right to refuse a vaccine. I don’t think you need a contingency plan. If someone refuses the vaccine in the general public, then there’s nothing you can do about that. You cannot force someone to take a vaccine.” 


Accelerate Diagnostics up 13% on FDA emergency use nod for COVID-19 test

Accelerate Diagnostics (NASDAQ:AXDX) announces FDA emergency use authorization of privately held BioCheck’s SARS-CoV-2 IgM and IgG Combo Test and its fully automated MS-Fast instrument.

Accelerate will commercialize the chemiluminescence test and analyzer in the U.S. per the companies’ agreement inked in April.


MorphoSys tafasitamab added to U.S. guidelines to treat type of blood cancer

MorphoSys AG (NASDAQ:MOR) and collaborator/licensee Incyte (NASDAQ:INCY) announce that Monjuvi (tafasitamab-cxix) has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-cell lymphomas.

Specifically, the NCCN guidelines in the U.S. now include Monjuvi in combination with lenalidomide with a Category 2A designation as an option for the treatment of previously-treated adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma who are ineligible for autologous stem cell transplant (ASCT).

The FDA approved Monjuvi earlier this month for DLBCL.


FDA OKs Mylan’s generic version of Biogen MS med Tecfidera

The FDA has approved Mylan’s (MYL -0.6%) generic version of Biogen’s (BIIB -0.3%) top seller Tecfidera (dimethyl fumarate).

The agency signed off on the application after a federal judge in West Virginia invalidated a patent on the multiple sclerosis drug. Biogen intends to appeal the decision.

Tecfidera accounted for 32% of Biogen’s Q2 revenue ($1,182M/3,682M).