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Wednesday, April 8, 2020

FDA OKs Pfizer’s Braftovi combo for certain type of colorectal cancer

The FDA approves the combination of Pfizer’s (NYSE:PFE) Braftovi (encorafenib) and Eli Lilly’s (NYSE:LLY) Erbitux (cetuximab) for the treatment of adults with BRAF V600E mutation-positive metastatic colorectal cancer who have received prior therapy, a Priority Review and Breakthrough Therapy indication.
A pivotal late-stage showed that the combo extended overall survival compared to cetuximab + chemo.
https://seekingalpha.com/news/3559539-fda-oks-pfizers-braftovi-combo-for-certain-type-of-colorectal-cancer

The top 2 meds prescribed for COVID-19 patients

Azithromycin and hydroxychloroquine are the top two prescription medications physicians around the world have used to treat COVID-19 patients, according to a new global survey.
Sermo, a healthcare data collection company and social platform for physicians, is conducting a weekly survey among physicians globally. The current results are for the second wave of the survey, conducted March 30-April 2. Physicians could select more than one option.
Of the 1,662 physicians who reported treating COVID-19 patients, half said they used azithromycin or similar antibiotics; 44 percent said they used hydroxychloroquine or chloroquine; and 36 percent said they used bronchodilators.
The physicians who reported treating COVID-19 patients also said that certain over-the-counter medications have been effective, including acetaminophen (42 percent) and cold medications, such antihistamines, decongestants and cough medications (29 percent).
https://www.beckershospitalreview.com/patient-safety-outcomes/the-top-2-meds-prescribed-for-covid-19-patients.html

Medtronic sees 5x ramp in ventilator production to meet COVID-19 demand

Medtronic (NYSE:MDT) announces that its Puritan Bennett 560 ventilator will be available next month in the U.S. under emergency use authorization from the FDA (it is currently sold in 35 countries around the world at an average price of just under $10K).
By month-end, it expects to be producing 400 ventilators per week (four models), increasing to 700/week by the end of May and 1,000/week by the end of June, a five-fold increase compared to pre-COVID-19 levels. It projects that it will produce 25K ventilators across all platforms over the next six months.
A remote access feature for another ventilator model, the PB980, enabling clinicians to adjust the settings outside of the ICU, is in limited market release in the U.S. in two hospitals. If the feature is well-received, the release will be expanded later this month.
Shares up 1% after hours.
https://seekingalpha.com/news/3559507-medtronic-sees-5x-ramp-in-ventilator-production-to-meet-covidminus-19-demand

Facebook building coronavirus ‘heat map’ by asking users about symptoms

Facebook announced it would start to ask some of its U.S.-based users about their health in an effort to give researchers more information about self-reported COVID-19 patients.
In a blog post, the Mark Zuckerberg-led company said it will put a link at the top of some users’ News Feeds to point them to the survey that could help pinpoint where health care resources are best needed.
“The survey — run by Carnegie Mellon University Delphi Research Center — will be used to generate new insights on how to respond to the crisis, including heat maps of self-reported symptoms,” Facebook wrote in the blog post. “This information can help health systems plan where resources are needed and potentially when, where and how to reopen parts of society. If the results are helpful, we’ll make similar surveys available in other parts of the world.”
There will be three new tools as part of the project: a co-location map that could help predict where COVID-19 cases may appear next; movement range tools that show where people are staying near home or traveling around town; and a “social connectedness index,” which aims to show friendships across states and countries, to help epidemiologists better predict where the disease will spread and what areas might need support.
The data, which is part of Facebook’s Data for Good project, would be aggregated.
“Individual survey responses with Facebook, and Facebook won’t share information about who you are with the researchers,” Facebook added in the post.
To protect privacy, a random ID number will be sent to Carnegie Mellon that will get sent back to Facebook once a user completes the survey. A single data point, known as a “weight value,” will help to correct for sample bias.
“COVID-19 has inherent delays that challenge the pace at which we seek to evaluate policy impact towards a measured response,” Dr. Daniel Klein of the Institute for Disease Modeling said in the post. “Mobility data from Facebook’s Data for Good program provides a near real-time view of important correlates of disease transmission. This data, in combination with other sources, allows us to make better models to inform public health decisions.”
Facebook added that if the results are helpful to researchers, similar surveys would come for other parts of the globe.
The move is the latest from the tech giant in the fight against the coronavirus pandemic. In March, Facebook provided information for its more than 2 billion users on how to spot fake news in an effort to stop the spread of misinformation.
Separately in March, Facebook said it would provide $100 million in grants to aid small businesses during the pandemic.
As of Tuesday morning, more than 1.36 million coronavirus cases have been diagnosed worldwide, more than 368,000 of which are in the U.S., the most impacted country.
https://nypost.com/2020/04/08/facebook-building-coronavirus-heat-map-by-asking-users-about-symptoms/

Mylan to donate 10M doses of malaria drug as production ramps up

Mylan N.V. (MYL +5.7%) announces that its production of malaria med hydroxychloroquine sulfate at its Morgantown, WV site has advanced ahead of schedule and has enabled the supply of additional product earlier than expected for COVID-19 patients.
It is donating 10M doses to the U.S. Department of Health and Human Services for possible use in clinical studies or under emergency use authorization. It is also donating product to the World Health Organization (WHO).
Shipments to wholesalers are underway.
https://seekingalpha.com/news/3559464-mylan-to-donate-10m-doses-of-malaria-drug-production-ramps-up

Anika Therapeutics beefs up liquidity amid COVID-19 disruptions

Aimed at strengthening its financial position during the uncertainties associated with the current pandemic, Anika Therapeutics (NASDAQ:ANIK) is drawing $50M from its existing credit facility, beefing up its total liquidity to ~$140M.
It potentially has another $50M per an accordion feature and it is exploring additional funding sources since it wants to maintain its business and staff during COVID-19. It has implemented a number of short-term expense controls as well.
Shares down 3% after hours.
https://seekingalpha.com/news/3559480-anika-therapeutics-beefs-up-liquidity-amid-covidminus-19-disruptions

Organogenesis has prelim 1Q20 revenue, withdraws FY20 revenue guidance

Organogenesis (ORGO +3.9%) announces it has withdrawn the previously announced revenue guidance for FY20, due to the impact of COVID-19.
Company reported preliminary 1Q20 results, expects Net revenue between $61M and $61.6M, up 7% to 8% from last year, vs. consensus of $60.64M; and net revenue from PuraPly products between $32.1M and $32.5M, up by 26% to28% from last year.
Company to report 1Q20 financial results after the market closes on May 11, 2020.
https://seekingalpha.com/news/3559494-organogenesis-reports-preliminary-1q20-revenue-and-withdraws-fy20-revenue-guidance