UnitedHealthcare Community Plan of Kentucky on Monday said it was
chosen as one of five organizations that will administer the state of
Kentucky’s Medicaid program, beginning on January 1.
The UnitedHealth Group Inc. company said it will “offer health
benefit plans for a portion of approximately 1.2 million eligible adults
and children who meet qualifications for the state’s Medicaid program.”
Currently, UnitedHealthcare employs nearly 800 people in Kentucky and
works with a number of local organizations and nonprofits, the company
said.
Amy Johnston, the chief executive of UnitedHealthcare Community Plan
of Kentucky, said “Our mission is to help people live healthier lives
and to help make the health system work better for everyone, and we are
committed to improving the overall health of Kentucky Medicaid plan
participants.”
https://www.marketscreener.com/UNITEDHEALTH-GROUP-14750/news/UnitedHealth-UnitedHealthcare-Chosen-to-Serve-Kentucky-Medicaid-Beneficiaries-30740897/
Monday, June 8, 2020
BioCryst’s berotralstat long term study suggests reductions in attack rate
New data from APeX-2 and APeX-S trials of BioCryst Pharmaceuticals’s (BCRX +6.2%) once-daily oral berotralstat demonstrated
sustained decrease in attack frequency and improvements in quality of
life scores over 48 weeks, in hereditary angioedema (“HAE”) patients.
Berotralstat was also safe and generally
well-tolerated over 48 weeks in total of 342 patients with 232
patient-years of daily oral dosing.
Gastrointestinal events led to discontinuation of berotralstat in 3.2% of patients.
Drug-related serious adverse events occurred in three of 342 subjects and resolved after stopping or interrupting dosing.
In APeX-2, 31 patients were randomized to 150 mg
of berotralstat and at 48 weeks had a mean baseline attack rate of 2.9
attacks per month, which declined to 1.5 attacks per month after one
month and to 1.0 attack per month at 12 months.
In APeX-S, patients completing 48 weeks on 150 mg
(n=73) had a median attack rate of zero attacks per month in six of the
12 months, including month 12 (week 48).
https://seekingalpha.com/news/3581231-biocrysts-berotralstat-long-term-study-suggests-reductions-in-attack-rateSatellite images hint coronavirus started in China earlier than first reported
Researchers at Harvard Medical School say that satellite data and
internet search traffic indicate that the coronavirus pandemic began in
Wuhan, China, months before authorities alerted the World Health
Organization (WHO) about the virus.
Study authors told ABC News that analysis of data from as far back as October of last year indicated a surge in vehicle traffic around hospitals in the city, a spike that coincided with a rise in internet search traffic for “certain symptoms that would later be determined as closely associated with the novel coronavirus” from residents of the city.
“Something was happening in October,” Dr. John Brownstein, the study’s leader, told ABC. “Clearly, there was some level of social disruption taking place well before what was previously identified as the start of the novel coronavirus pandemic.”
“What we’re trying to do is look at the activity, how busy a hospital
is,” Brownstein said. “And the way we do that is by counting the cars
that are at that hospital. Parking lots will get full as a hospital gets
busy. So more cars in a hospital, the hospital’s busier, likely because
something’s happening in the community, an infection is growing and
people have to see a doctor.”
Chinese authorities, who have been criticized by the Trump administration for their response to the coronavirus outbreak, alerted the WHO in late December that an unknown virus was spreading throughout Wuhan and other cities. U.S. officials have contended that China was slow to provide information about the virus, and have accused the WHO of shielding China from criticism.
“We can confirm that the Chinese Communist Party did all that it could to make sure that the world didn’t learn in a timely fashion about what was taking place,” Secretary of State Mike Pompeo said in May.
“President Trump
has been very clear. We’re going to hold those responsible accountable,
and we’ll do so on a timeline that is our own,” he added.
Brownstein cautioned to ABC that his team’s research was not the final verdict on China’s response to the virus and that more studies were needed to determine the exact date and origin of the coronavirus.
“This is all about a growing body of information pointing to something taking place in Wuhan at the time,” he said. “Many studies are still needed to fully uncover what took place and for people to really learn about how these disease outbreaks unfold and emerge in populations. So this is just another point of evidence.”
https://thehill.com/policy/healthcare/public-global-health/501621-researchers-satellite-images-hint-coronavirus-started
Study authors told ABC News that analysis of data from as far back as October of last year indicated a surge in vehicle traffic around hospitals in the city, a spike that coincided with a rise in internet search traffic for “certain symptoms that would later be determined as closely associated with the novel coronavirus” from residents of the city.
“Something was happening in October,” Dr. John Brownstein, the study’s leader, told ABC. “Clearly, there was some level of social disruption taking place well before what was previously identified as the start of the novel coronavirus pandemic.”
Chinese authorities, who have been criticized by the Trump administration for their response to the coronavirus outbreak, alerted the WHO in late December that an unknown virus was spreading throughout Wuhan and other cities. U.S. officials have contended that China was slow to provide information about the virus, and have accused the WHO of shielding China from criticism.
“We can confirm that the Chinese Communist Party did all that it could to make sure that the world didn’t learn in a timely fashion about what was taking place,” Secretary of State Mike Pompeo said in May.
Brownstein cautioned to ABC that his team’s research was not the final verdict on China’s response to the virus and that more studies were needed to determine the exact date and origin of the coronavirus.
“This is all about a growing body of information pointing to something taking place in Wuhan at the time,” he said. “Many studies are still needed to fully uncover what took place and for people to really learn about how these disease outbreaks unfold and emerge in populations. So this is just another point of evidence.”
https://thehill.com/policy/healthcare/public-global-health/501621-researchers-satellite-images-hint-coronavirus-started
3 months after its B round, Akouos files an IPO to the tune of $100M
Boston-based hearing loss gene therapy biotech Akouos is gunning for a
$100 million IPO amid a near invulnerable market for public-seeking
biotechs.
This comes just three months after it grabbed a $105 million series B funding round from a host of big names including the likes of 5AM Ventures, New Enterprise Associates, Novartis Venture Fund and Partners Innovation Fund as well as new participants Cowen Healthcare Investments, Polaris and Pivotal bioVenture Partners, which led the round.
Back in March, and in conjunction with its raise, the biotech also appointed Vertex and Biogen research veteran Vicki Sato, Ph.D., and Pivotal bioVenture Partners Managing Partner Heather Preston, M.D., to its board.
Now, in the middle of a pandemic, it wants to follow many other biotechs and gun for an IPO worth $100 million to help push its lead program AK-OTOF into the clinic.
The biotech is targeting monogenic forms of sensorineural hearing loss. These forms arise when changes to single genes cause sensory cells or nerve fibers in the inner ear to malfunction.
In its SEC-1 filing, the biotech said that, after speaking with the FDA: “We are designing our phase 1/2 trial to include auditory brainstem response (ABR) as an efficacy endpoint. We believe that this will enable us to quickly determine a clinical response and potentially result in rapid advancement towards a pivotal trial.
“We plan to submit an investigational new drug application for AK-OTOF for OTOF-mediated hearing loss to the FDA in 2021, and we expect to report preliminary clinical data in 2022.”
As it sees it, there is a great hope for gene therapy for hearing loss, but the issue is delivery: “We believe genetic medicine development for hearing disorders has been hindered by the unique anatomical delivery challenges of the inner ear,” it said in its filing.
To get around this, the biotech has combined a proprietary vector library of synthetic adeno-associated viruses (AAVs) that recreates the evolutionary lineage of current naturally occurring viruses, known as ancestral AAV, or AAVAnc, and a new, what it says is a “minimally invasive delivery approach,” that allows it to use AAV-enabled multimodal capabilities, including viral delivery, “to the target cell population where the full-length transgene is split into two vectors, known as a dual vector method.”
It plans to file on the Nasdaq under the ticker “AKUS.”
https://www.fiercebiotech.com/biotech/three-months-after-its-b-round-akouos-files-ipo-to-tune-100m
This comes just three months after it grabbed a $105 million series B funding round from a host of big names including the likes of 5AM Ventures, New Enterprise Associates, Novartis Venture Fund and Partners Innovation Fund as well as new participants Cowen Healthcare Investments, Polaris and Pivotal bioVenture Partners, which led the round.
Back in March, and in conjunction with its raise, the biotech also appointed Vertex and Biogen research veteran Vicki Sato, Ph.D., and Pivotal bioVenture Partners Managing Partner Heather Preston, M.D., to its board.
Now, in the middle of a pandemic, it wants to follow many other biotechs and gun for an IPO worth $100 million to help push its lead program AK-OTOF into the clinic.
The biotech is targeting monogenic forms of sensorineural hearing loss. These forms arise when changes to single genes cause sensory cells or nerve fibers in the inner ear to malfunction.
In its SEC-1 filing, the biotech said that, after speaking with the FDA: “We are designing our phase 1/2 trial to include auditory brainstem response (ABR) as an efficacy endpoint. We believe that this will enable us to quickly determine a clinical response and potentially result in rapid advancement towards a pivotal trial.
“We plan to submit an investigational new drug application for AK-OTOF for OTOF-mediated hearing loss to the FDA in 2021, and we expect to report preliminary clinical data in 2022.”
As it sees it, there is a great hope for gene therapy for hearing loss, but the issue is delivery: “We believe genetic medicine development for hearing disorders has been hindered by the unique anatomical delivery challenges of the inner ear,” it said in its filing.
To get around this, the biotech has combined a proprietary vector library of synthetic adeno-associated viruses (AAVs) that recreates the evolutionary lineage of current naturally occurring viruses, known as ancestral AAV, or AAVAnc, and a new, what it says is a “minimally invasive delivery approach,” that allows it to use AAV-enabled multimodal capabilities, including viral delivery, “to the target cell population where the full-length transgene is split into two vectors, known as a dual vector method.”
It plans to file on the Nasdaq under the ticker “AKUS.”
https://www.fiercebiotech.com/biotech/three-months-after-its-b-round-akouos-files-ipo-to-tune-100m
After 11 years, Sanofi returns rights to eye gene therapies to Oxford Biomedica
Oxford Biomedica is currently most well known for its work on
COVID-19 vaccines and its tie-up with AstraZeneca, but a much older deal
sits with French Big Pharma Sanofi.
All the way back in 2009, the year of a major viral pandemic , Oxford Biomedica penned a deal to license out its ophthalmology gene therapies, SAR422459 for Stargardt disease, a disease that causes progressive damage of the macula) and SAR421869, for Usher’s Syndrome type 1b where patients are born with severe to profound hearing loss, to Sanofi.
Last year, and a full decade later, Sanofi said it didn’t want to develop the meds anymore and was seeking a partner. Now, a year after this update, Sanofi has simply tossed them back to their creator.
“Following completion of a company-wide portfolio review, Sanofi intends to return to OXB [Oxford Biomedica] the rights to [its] ophthalmology gene therapy programs.”
In a brief update, the U.K.-based biotech added: “The timing of return of these programs and operational details are yet to be determined. However, when the rights to the two programs are returned, the group will undertake its own internal evaluation to determine the potential future for these programs and decide whether to commit further resources to them. “
SAR422459 had been in a phase 1/2 proof-of-concept study, but was axed last week ahead of this announced, according to clinicaltrials.gov. SAR421869, meanwhile, is in a clinical trial to evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome type 1B. It’s still classed as active but not recruiting in the small, open-label trial that’s been ongoing for six years.
Oxford Biomedica’s collaboration and license agreement with Bioverativ (a Sanofi spinoff), for the development and manufacturing of lentiviral vectors to treat hemophilia, “remains unaffected by this announcement,” the company added.
https://www.fiercebiotech.com/biotech/after-11-years-sanofi-kicks-backs-rights-to-unwanted-gene-therapies-to-oxford-biomedica
All the way back in 2009, the year of a major viral pandemic , Oxford Biomedica penned a deal to license out its ophthalmology gene therapies, SAR422459 for Stargardt disease, a disease that causes progressive damage of the macula) and SAR421869, for Usher’s Syndrome type 1b where patients are born with severe to profound hearing loss, to Sanofi.
Last year, and a full decade later, Sanofi said it didn’t want to develop the meds anymore and was seeking a partner. Now, a year after this update, Sanofi has simply tossed them back to their creator.
“Following completion of a company-wide portfolio review, Sanofi intends to return to OXB [Oxford Biomedica] the rights to [its] ophthalmology gene therapy programs.”
In a brief update, the U.K.-based biotech added: “The timing of return of these programs and operational details are yet to be determined. However, when the rights to the two programs are returned, the group will undertake its own internal evaluation to determine the potential future for these programs and decide whether to commit further resources to them. “
SAR422459 had been in a phase 1/2 proof-of-concept study, but was axed last week ahead of this announced, according to clinicaltrials.gov. SAR421869, meanwhile, is in a clinical trial to evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome type 1B. It’s still classed as active but not recruiting in the small, open-label trial that’s been ongoing for six years.
Oxford Biomedica’s collaboration and license agreement with Bioverativ (a Sanofi spinoff), for the development and manufacturing of lentiviral vectors to treat hemophilia, “remains unaffected by this announcement,” the company added.
https://www.fiercebiotech.com/biotech/after-11-years-sanofi-kicks-backs-rights-to-unwanted-gene-therapies-to-oxford-biomedica
Movie sex scenes will be replaced with CGI wizardry to cut coronavirus risk
No protection needed for these digital affairs.
As Hollywood prepares to reopen following its coronavirus-induced closure in March, on-set sexual distancing protocols are beginning to be laid out — including animated mating.
The film editors’ trade association has released a 22-page file dictating how “close contact moments” should be “either rewritten, abandoned” or replaced with CGI fixes to minimize spreading COVID-19 while filming, the Sun reports.
As well, all backstage crew will now be expected to wear masks and visors, live audiences remain on pause indefinitely, and actors will be given formal hand washing lessons. Holding auditions behind plexiglass, having “coronavirus compliance officers,” present, keeping unruly children away from sets and limiting the number of people who handle on-set animals are also touted in the document as good tactics for preventing any spread of the disease.
The paper, which was presented to the governors of New York and California this month as evidence that Hollywood is ready to reopen, stops short of vowing to put intimate scenes and fight scenes on hold while acknowledging they have a higher risk of transmission. “Whenever possible, performers shall practice physical distancing,” the report assures.
Hollywood studios quietly began turning to tech back in April, utilizing virtual reality to create digital sets that could be made from home, while staff remained quarantined.
“It can get you into production quickly,” says Kim Libreri, chief technology officer at Epic Games of utilizing certain technology more frequently used by the video game industry.
Tinseltown is also considering implementing tactics long-utilized in the world of the porn, including rigorous testing and a database that lists who is clean and available for work.
“The challenges for sports, for Hollywood and the porn industry are all different but in reality, we each have things we can learn from each other,” says Mike Stabile, rep for the Free Speech Coalition, a trade association for the US adult entertainment industry. “This is obviously a different type of virus, this is a different type of threat, but we understood in general how it would work and what we’d need to do in order to protect ourselves.”
https://nypost.com/2020/06/08/movie-sex-scenes-may-be-replaced-with-cgi-due-to-coronavirus/
As Hollywood prepares to reopen following its coronavirus-induced closure in March, on-set sexual distancing protocols are beginning to be laid out — including animated mating.
The film editors’ trade association has released a 22-page file dictating how “close contact moments” should be “either rewritten, abandoned” or replaced with CGI fixes to minimize spreading COVID-19 while filming, the Sun reports.
As well, all backstage crew will now be expected to wear masks and visors, live audiences remain on pause indefinitely, and actors will be given formal hand washing lessons. Holding auditions behind plexiglass, having “coronavirus compliance officers,” present, keeping unruly children away from sets and limiting the number of people who handle on-set animals are also touted in the document as good tactics for preventing any spread of the disease.
The paper, which was presented to the governors of New York and California this month as evidence that Hollywood is ready to reopen, stops short of vowing to put intimate scenes and fight scenes on hold while acknowledging they have a higher risk of transmission. “Whenever possible, performers shall practice physical distancing,” the report assures.
Hollywood studios quietly began turning to tech back in April, utilizing virtual reality to create digital sets that could be made from home, while staff remained quarantined.
“It can get you into production quickly,” says Kim Libreri, chief technology officer at Epic Games of utilizing certain technology more frequently used by the video game industry.
Tinseltown is also considering implementing tactics long-utilized in the world of the porn, including rigorous testing and a database that lists who is clean and available for work.
“The challenges for sports, for Hollywood and the porn industry are all different but in reality, we each have things we can learn from each other,” says Mike Stabile, rep for the Free Speech Coalition, a trade association for the US adult entertainment industry. “This is obviously a different type of virus, this is a different type of threat, but we understood in general how it would work and what we’d need to do in order to protect ourselves.”
https://nypost.com/2020/06/08/movie-sex-scenes-may-be-replaced-with-cgi-due-to-coronavirus/
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