Deciphera Pharmaceuticals (NASDAQ:DCPH): Q1 GAAP EPS of -$1.36 misses by $0.05.
Revenue of $0.06M misses by $0.19M.
Cash, Cash Equivalents and Marketable Securities of $691.5M
Tuesday, May 5, 2020
DaVita HealthCare Partners EPS beats by $0.35, revenue in-line
DaVita HealthCare Partners (NYSE:DVA): Q1 Non-GAAP EPS of $1.83 beats by $0.35; GAAP EPS of $1.81 beats by $0.32.
Revenue of $2.84B (+3.6% Y/Y) in-line.
https://seekingalpha.com/news/3569442-davita-healthcare-partners-eps-beats-0_35-revenue-in-lineRemdesivir may be approved in Japan on Thursday – health minister
Gilead Sciences Inc’s antiviral drug remdesivir may be approved in
Japan for domestic COVID-19 patients when the health ministry’s review
board is held on Thursday, Japanese Health Minister Katsunobu Kato said.
Remdesivir was granted emergency use authorization last week by the U.S. Food and Drug Administration for COVID-19, the highly contagious lung disease caused by the new coronavirus, and Gilead filed for fast-track approval in Japan on Monday.
Kato said on a TV news programme on Tuesday if the review board gives its consent, he plans to approve it right away.
“Once imported, we would like to have it used by those who are suffering from serious conditions as soon as possible,” Kato said.
Prime Minister Shinzo Abe on Monday extended a nationwide state of
emergency to May 31, saying the new coronavirus infection rate had yet
to drop enough to justify ending measures aimed at slowing the outbreak.
Even though Japan has not seen a huge outbreak compared with some global hotspots, there are more than 16,000 recorded cases, including 712 from the cruise ship previously quarantined in Yokohama, and 579 deaths, according to public broadcaster NHK.
https://www.reuters.com/article/us-health-coronavirus-japan-remdesivir/remdesivir-may-be-approved-in-japan-on-thursday-health-minister-idUSKBN22H28P
Remdesivir was granted emergency use authorization last week by the U.S. Food and Drug Administration for COVID-19, the highly contagious lung disease caused by the new coronavirus, and Gilead filed for fast-track approval in Japan on Monday.
Kato said on a TV news programme on Tuesday if the review board gives its consent, he plans to approve it right away.
“Once imported, we would like to have it used by those who are suffering from serious conditions as soon as possible,” Kato said.
Even though Japan has not seen a huge outbreak compared with some global hotspots, there are more than 16,000 recorded cases, including 712 from the cruise ship previously quarantined in Yokohama, and 579 deaths, according to public broadcaster NHK.
https://www.reuters.com/article/us-health-coronavirus-japan-remdesivir/remdesivir-may-be-approved-in-japan-on-thursday-health-minister-idUSKBN22H28P
Hepatitis drug could be tested against COVID-19 in India
India’s Zydus Cadila wants to test a form of interferon,
usually used against hepatitis B and C, as a potential treatment for the
virus that causes COVID-19.
According to press reports the company has asked the regulator, the Drugs Controller General of India (DCGI) to test the antiviral pegylated interferon alpha 2-b in adults with COVID-19.
The drug has already been used to treat COVID-19 in China and Cuba and is included in treatment guidelines laid down by the Chinese government.
Press reports cite a senior official from the Indian government, who said that talks are under way and the application is being considered by an expert committee.
Research in the cell cultures in a laboratory in the US found that the SARS-CoV-2 virus is “remarkably sensitive” to recombinant human interferons, reducing viral concentrations by more than 99.99% in certain cells.
The reports noted research in China, Australia and Canada that showed a short-acting form of interferon reduced duration of viral shedding and levels of the inflammatory cytokine Il-6.
IL-6 is a target in other research involving drugs from Roche and Sanofi, as it is thought to overstimulate the body’s immune system in seriously ill COVID-19 patients.
The research suggests that a long-acting version of interferon such as that suggested by Zydus Cadila could be given early in the disease to reduce viral load, reducing the amount of IL-6 produced by the virus and eliminating the harmful immune response.
The drug is not approved in COVID-19 but is marketed under the brand name PegiHep for treatment of hepatitis B and C.
Ahmedabad-based Zydus Cadila is already manufacturing hydrochloroquine, which used in India to treat asymptomatic healthcare workers caring for suspected or confirmed COVID-19 cases, asymptomatic household contacts of laboratory-confirmed cases, and COVID-19 patients with severe disease and requiring ICU management.
According to a COVID-19 therapy tracker from the Milken Institute think tank, there are 199 treatments in consideration for the disease, and 123 vaccines.
According to the World Health Organization, there are eight potential vaccines for COVID-19 that have made it through to clinical trials.
According to press reports the company has asked the regulator, the Drugs Controller General of India (DCGI) to test the antiviral pegylated interferon alpha 2-b in adults with COVID-19.
The drug has already been used to treat COVID-19 in China and Cuba and is included in treatment guidelines laid down by the Chinese government.
Press reports cite a senior official from the Indian government, who said that talks are under way and the application is being considered by an expert committee.
Research in the cell cultures in a laboratory in the US found that the SARS-CoV-2 virus is “remarkably sensitive” to recombinant human interferons, reducing viral concentrations by more than 99.99% in certain cells.
The reports noted research in China, Australia and Canada that showed a short-acting form of interferon reduced duration of viral shedding and levels of the inflammatory cytokine Il-6.
IL-6 is a target in other research involving drugs from Roche and Sanofi, as it is thought to overstimulate the body’s immune system in seriously ill COVID-19 patients.
The research suggests that a long-acting version of interferon such as that suggested by Zydus Cadila could be given early in the disease to reduce viral load, reducing the amount of IL-6 produced by the virus and eliminating the harmful immune response.
The drug is not approved in COVID-19 but is marketed under the brand name PegiHep for treatment of hepatitis B and C.
Ahmedabad-based Zydus Cadila is already manufacturing hydrochloroquine, which used in India to treat asymptomatic healthcare workers caring for suspected or confirmed COVID-19 cases, asymptomatic household contacts of laboratory-confirmed cases, and COVID-19 patients with severe disease and requiring ICU management.
According to a COVID-19 therapy tracker from the Milken Institute think tank, there are 199 treatments in consideration for the disease, and 123 vaccines.
According to the World Health Organization, there are eight potential vaccines for COVID-19 that have made it through to clinical trials.
Hepatitis drug could be tested against COVID-19 in India
Army offers $25M for development of wearable coronavirus detector
The US Army has put out a $25 million bid to speed up the development
of wearable coronavirus detectors that can identify early signs of the
illness, according to a new report.
The military put out a request for project proposals through its Medical Technology Enterprise Consortium on Monday — and hopes to award up to 10 contracts within weeks, Stars and Stripes reported. The contagion has already infected nearly 5,000 service members.
“There is a dire and urgent need for development of rapid, accurate wearable diagnostics to identify and isolate pre-symptomatic COVID-19 cases and track/prevent the spread of the virus,” said the Army’s proposal, according to the outlet.
The “minimally invasive” kits should not affect the user’s daily activity — and must be capable of monitoring for symptoms including elevated temperature, respiratory difficulty, antibodies against COVID-19 and molecular biomarkers that indicate exposure, the bid says.
The Army is seeking existing, proven technology rather than a new system — and companies involved in development should be ready and able to produce on a large scale, according to the bid.
The Army is hoping the detectors could help identify those without symptoms who unknowingly spread the virus, which has been a problem in the past, the outlet reported.
“Physiologic surveillance for COVID-19 positive individuals that do not yet show clear medical symptoms is an ultimate goal,” the proposal said.
The winning bidders must work to obtain any necessary FDA approvals — including an Emergency Use Authorization within the first 45 days of the contract, Nextgov.com reported.
https://nypost.com/2020/05/05/us-army-wants-to-develop-wearable-coronavirus-detectors/
The military put out a request for project proposals through its Medical Technology Enterprise Consortium on Monday — and hopes to award up to 10 contracts within weeks, Stars and Stripes reported. The contagion has already infected nearly 5,000 service members.
“There is a dire and urgent need for development of rapid, accurate wearable diagnostics to identify and isolate pre-symptomatic COVID-19 cases and track/prevent the spread of the virus,” said the Army’s proposal, according to the outlet.
The “minimally invasive” kits should not affect the user’s daily activity — and must be capable of monitoring for symptoms including elevated temperature, respiratory difficulty, antibodies against COVID-19 and molecular biomarkers that indicate exposure, the bid says.
The Army is seeking existing, proven technology rather than a new system — and companies involved in development should be ready and able to produce on a large scale, according to the bid.
The Army is hoping the detectors could help identify those without symptoms who unknowingly spread the virus, which has been a problem in the past, the outlet reported.
“Physiologic surveillance for COVID-19 positive individuals that do not yet show clear medical symptoms is an ultimate goal,” the proposal said.
The winning bidders must work to obtain any necessary FDA approvals — including an Emergency Use Authorization within the first 45 days of the contract, Nextgov.com reported.
https://nypost.com/2020/05/05/us-army-wants-to-develop-wearable-coronavirus-detectors/
Experimental gene-based COVID-19 vaccine advancing
Massachusetts Eye and Ear and Massachusetts General Hospital (MGH),
members of Mass General Brigham, today announced progress towards the
testing and development of an experimental vaccine called AAVCOVID, a
novel gene-based vaccine candidate against SARS-CoV2, the virus that
causes COVID-19.
The AAVCOVID vaccine program was developed in the laboratory of Luk H. Vandenberghe, Ph.D., director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear and Associate Professor of Ophthalmology at Harvard Medical School. It is currently in preclinical development with a plan to begin clinical testing in humans later this year. Mason Freeman, MD, director and founder of the MGH Translational Research Center is leading the efforts to develop the clinical studies intended to establish safety and efficacy of the experimental vaccine.
The AAVCOVID Vaccine Program is a unique, gene-based vaccine strategy that uses adeno-associated viral (AAV) vector, a clinically established gene transfer technology leveraging the properties of a harmless viral carrier. AAV is used to deliver genetic sequences of the SARS-CoV-2 Spike antigen so the body can develop an immune response to the coronavirus. AAV technology has been used extensively in the field of gene therapy, and substantial experience and capacity exists for manufacturing and clinical use of AAV-based medicines. Two AAV-based drugs have been approved by U.S. Food and Drug Administration in recent years.
The AAVCOVID vaccine candidate will be administered by an intramuscular injection. Currently, tests are underway in animal models, and initial manufacturing activities have begun. Based on the preclinical findings, one or more candidates will advance into the clinical phase of testing in humans.
While several types of COVID-19 vaccines are in development worldwide, AAV technology offers several distinct advantages, including its adaptability and potential to elicit a beneficial immune response in people. In addition, other versions of AAV technology have been tested in the clinic for more than two decades with a favorable safety record.
“AAV is a superior technology for safe and efficient gene delivery, and the unique technologies we are applying in AAVCOVID support the potential for a potent immunity to be induced to SARS-CoV-2 from a single injection,” said Dr. Vandenberghe. “In a crisis, we can harness the power of molecular biology and develop a draft of a vaccine in weeks, and that’s what was done here. Now, clinical studies are needed to establish safety and efficacy of our novel approach,” he said.
“While many organizations are engaged in generating vaccine candidates to prevent COVID-19 disease, it is very far from certain what the best approach will be,” said Dr. Freeman. “Dr. Vandenberghe’s unique vaccine method brings an elegant, novel and extremely creative approach to meeting our goal: to protect our most vulnerable patients as well as the healthcare workers who care for them during this and future viral outbreaks.”
The team is advised by experts at Massachusetts General Hospital and the Mass General Brigham Innovation Fund and includes deep involvement of experts from industry with experience in vaccine development, regulatory affairs, and manufacturing. The research is funded by philanthropic support led by Wyc Grousbeck, Boston Celtics lead owner and CEO and Mass. Eye and Ear Chairman, his wife Emilia Fazzalari, CEO of Cinco Spirits Group LLC, the Grousbeck family, and others.
“This is what innovation looks like. It is a combination of both the scientific insight of Dr. Vandenberghe and his team as well as the nimble and collaborative spirit of the institutions and donors who have come together to move this program from idea to promising vaccine candidate at lightning speed,” said Joan W. Miller, MD, Chief of Ophthalmology at Mass. Eye and Ear, Massachusetts General Hospital, and Brigham and Women’s Hospital, and Chair of Ophthalmology and David Glendenning Cogan Professor of Ophthalmology at Harvard Medical School.
“We are deeply grateful to all involved in this collaboration, and especially to the donors who generously stepped up to spearhead the initial funding of this program,” said John Fernandez, President of Mass. Eye and Ear.
“The unprecedented coronavirus pandemic has challenged us all, and overcoming it demands the best thinking and the most creative ideas from our scientific and clinical teams supported and strengthened by our philanthropic communities,” said Peter L. Slavin, MD, President of MGH. “This collective spirit of innovation, resolve and generosity is the most powerful weapon we have to fight this formidable virus.”
About the AAVCOVID Technology
The AAVCOVID Vaccine Program is a gene-based vaccine strategy that seeks to deliver genetic sequences of the SARS-CoV-2 using an adeno-associated virus (AAV) vector, a harmless virus that serves as a delivery vehicle into the body.
Vaccination with AAVCOVID delivers the gene code for antigens from the SARS-CoV-2 Spike protein following a low dose intramuscular injection, which is designed to elicit an immune response to prevent infection. This approach is supported by extensive experience with the safety of the AAV technology platform in other diseases, including the use of AAVs in two FDA-approved medicines, and preclinical studies on immunogenicity.
Dr. Vandenberghe and his laboratory began work on the vaccine in mid-January following the Wuhan outbreak and the first publication of genetic sequences of the new coronavirus. Using a specific AAV with desirable vaccine properties, the program seeks to induce immunity to prevent infection and or disease in healthy populations.
AAV is also a rapidly adaptable technology. If a new strain of the SARS-CoV-2 virus emerges, the genetic code inside the AAVCOVID vaccine can be exchanged for an updated genetic code and processed into an updated vaccine in weeks, according to the researchers.
The AAVCOVID vaccine program was developed in the laboratory of Luk H. Vandenberghe, Ph.D., director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear and Associate Professor of Ophthalmology at Harvard Medical School. It is currently in preclinical development with a plan to begin clinical testing in humans later this year. Mason Freeman, MD, director and founder of the MGH Translational Research Center is leading the efforts to develop the clinical studies intended to establish safety and efficacy of the experimental vaccine.
The AAVCOVID Vaccine Program is a unique, gene-based vaccine strategy that uses adeno-associated viral (AAV) vector, a clinically established gene transfer technology leveraging the properties of a harmless viral carrier. AAV is used to deliver genetic sequences of the SARS-CoV-2 Spike antigen so the body can develop an immune response to the coronavirus. AAV technology has been used extensively in the field of gene therapy, and substantial experience and capacity exists for manufacturing and clinical use of AAV-based medicines. Two AAV-based drugs have been approved by U.S. Food and Drug Administration in recent years.
The AAVCOVID vaccine candidate will be administered by an intramuscular injection. Currently, tests are underway in animal models, and initial manufacturing activities have begun. Based on the preclinical findings, one or more candidates will advance into the clinical phase of testing in humans.
While several types of COVID-19 vaccines are in development worldwide, AAV technology offers several distinct advantages, including its adaptability and potential to elicit a beneficial immune response in people. In addition, other versions of AAV technology have been tested in the clinic for more than two decades with a favorable safety record.
“AAV is a superior technology for safe and efficient gene delivery, and the unique technologies we are applying in AAVCOVID support the potential for a potent immunity to be induced to SARS-CoV-2 from a single injection,” said Dr. Vandenberghe. “In a crisis, we can harness the power of molecular biology and develop a draft of a vaccine in weeks, and that’s what was done here. Now, clinical studies are needed to establish safety and efficacy of our novel approach,” he said.
“While many organizations are engaged in generating vaccine candidates to prevent COVID-19 disease, it is very far from certain what the best approach will be,” said Dr. Freeman. “Dr. Vandenberghe’s unique vaccine method brings an elegant, novel and extremely creative approach to meeting our goal: to protect our most vulnerable patients as well as the healthcare workers who care for them during this and future viral outbreaks.”
The team is advised by experts at Massachusetts General Hospital and the Mass General Brigham Innovation Fund and includes deep involvement of experts from industry with experience in vaccine development, regulatory affairs, and manufacturing. The research is funded by philanthropic support led by Wyc Grousbeck, Boston Celtics lead owner and CEO and Mass. Eye and Ear Chairman, his wife Emilia Fazzalari, CEO of Cinco Spirits Group LLC, the Grousbeck family, and others.
“This is what innovation looks like. It is a combination of both the scientific insight of Dr. Vandenberghe and his team as well as the nimble and collaborative spirit of the institutions and donors who have come together to move this program from idea to promising vaccine candidate at lightning speed,” said Joan W. Miller, MD, Chief of Ophthalmology at Mass. Eye and Ear, Massachusetts General Hospital, and Brigham and Women’s Hospital, and Chair of Ophthalmology and David Glendenning Cogan Professor of Ophthalmology at Harvard Medical School.
“We are deeply grateful to all involved in this collaboration, and especially to the donors who generously stepped up to spearhead the initial funding of this program,” said John Fernandez, President of Mass. Eye and Ear.
“The unprecedented coronavirus pandemic has challenged us all, and overcoming it demands the best thinking and the most creative ideas from our scientific and clinical teams supported and strengthened by our philanthropic communities,” said Peter L. Slavin, MD, President of MGH. “This collective spirit of innovation, resolve and generosity is the most powerful weapon we have to fight this formidable virus.”
About the AAVCOVID Technology
The AAVCOVID Vaccine Program is a gene-based vaccine strategy that seeks to deliver genetic sequences of the SARS-CoV-2 using an adeno-associated virus (AAV) vector, a harmless virus that serves as a delivery vehicle into the body.
Vaccination with AAVCOVID delivers the gene code for antigens from the SARS-CoV-2 Spike protein following a low dose intramuscular injection, which is designed to elicit an immune response to prevent infection. This approach is supported by extensive experience with the safety of the AAV technology platform in other diseases, including the use of AAVs in two FDA-approved medicines, and preclinical studies on immunogenicity.
Dr. Vandenberghe and his laboratory began work on the vaccine in mid-January following the Wuhan outbreak and the first publication of genetic sequences of the new coronavirus. Using a specific AAV with desirable vaccine properties, the program seeks to induce immunity to prevent infection and or disease in healthy populations.
AAV is also a rapidly adaptable technology. If a new strain of the SARS-CoV-2 virus emerges, the genetic code inside the AAVCOVID vaccine can be exchanged for an updated genetic code and processed into an updated vaccine in weeks, according to the researchers.
More information: For more information on AAVCOVID vaccine and the researchers’ biographies, see masseyeandear.org/covid-19/vaccine
How Apple, Google will warn you if you’ve been exposed to COVID-19
Apple and Google, which control the world’s most popular smartphone
operating systems, gave a first look Monday at how public health apps
will alert you if you’ve been exposed to the coronavirus.
The two tech giants have been working on new contact tracing tools for public health organizations that can tell you if you’ve crossed paths with someone who later tests positive for the deadly virus.
How it works: The new COVID-19 tools on iPhones and Android devices will use Bluetooth to sense nearby smartphones. When you’ve tested positive, you enter the test result into the app.
With your consent, anyone who was near you over the past 14 days will get a push notification that they have been potentially exposed: “You have recently come into contact with someone who has tested positive for COVID-19. Tap for more information.”
Public health authorities have used contact tracing for years to interview infected people, learn who they’ve been in contact with and advise them on what to do.
The smartphone version could help authorities more quickly lift social distancing constraints or respond to a new outbreak.
Participation is voluntary. Effectiveness of smartphone contact tracing hinges on how many people choose to use it.
Privacy advocates warn the technology being developed is potentially invasive and raises important questions of how to safeguard people’s sensitive health information.
Apple and Google say they’ve taken precautions to make sure tracking data is anonymous and they say apps will not be permitted to track your specific location.
https://techxplore.com/news/2020-05-apple-google-youve-exposed-covid-.html
The two tech giants have been working on new contact tracing tools for public health organizations that can tell you if you’ve crossed paths with someone who later tests positive for the deadly virus.
How it works: The new COVID-19 tools on iPhones and Android devices will use Bluetooth to sense nearby smartphones. When you’ve tested positive, you enter the test result into the app.
With your consent, anyone who was near you over the past 14 days will get a push notification that they have been potentially exposed: “You have recently come into contact with someone who has tested positive for COVID-19. Tap for more information.”
Public health authorities have used contact tracing for years to interview infected people, learn who they’ve been in contact with and advise them on what to do.
The smartphone version could help authorities more quickly lift social distancing constraints or respond to a new outbreak.
Participation is voluntary. Effectiveness of smartphone contact tracing hinges on how many people choose to use it.
Privacy advocates warn the technology being developed is potentially invasive and raises important questions of how to safeguard people’s sensitive health information.
Apple and Google say they’ve taken precautions to make sure tracking data is anonymous and they say apps will not be permitted to track your specific location.
https://techxplore.com/news/2020-05-apple-google-youve-exposed-covid-.html
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