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Tuesday, June 1, 2021

Corbus Licenses 2 Integrin Targeting mAbs for Cancer and Fibrotic Diseases

 

  • Corbus diversifies pipeline with two new mAbs that target integrins that inhibit activation of TGFβ

  • High potency anti- α vβ8 mAb licensed from University of California San Francisco and
    anti-αvβ6/αvβ8 mAb licensed from Panorama Research Inc.

  • Both mAbs expected to start Phase 1 testing in 2022

  • Capital and resources in place to advance multiple programs into clinical development

  • Company to host conference call and webcast today, Tuesday, June 1, 2021 at 8:30 a.m. ET

Conference Call and Webcast Information:

Corbus management will host a conference call and webcast presentation for investors, analysts, and other interested parties today, Tuesday, June 1, 2021, at 8:30 a.m. ET.

To participate on the call, please dial (877) 407-3978 (domestic) or (412) 902-0039 (international). The live webcast will be accessible on the Events page of the Investors section of the Corbus website, www.corbuspharma.com, and will be archived for 90 days.

https://finance.yahoo.com/news/corbus-pharmaceuticals-licenses-two-integrin-110500226.html

Abiomed Acquires preCARDIA, Breakthrough Med Device Compan, to Improve Outcomes for Heart Failure

Abiomed (NASDAQ: ABMD) has acquired preCARDIA, developer of a proprietary catheter and controller that will complement Abiomed’s product portfolio to expand options for patients with acute decompensated heart failure (ADHF). The preCARDIA system is uniquely designed to rapidly treat ADHF-related volume overload by effectively reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function.

Annually, more than one million patients are admitted to hospitals in the United States with ADHF. Despite available pharmaceutical treatments, heart failure is the leading cause of hospitalization in patients older than 65 years of age. preCARDIA provides heart failure specialists a minimally invasive solution with the potential to improve patient outcomes and lower the cost of care by providing early intervention with this new technology.

preCARDIA’s catheter-based system includes a proprietary superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC. Potential benefits for patients include improved response to medical management of ADHF, reduced duration of hospital stay, reduced re-hospitalizations and improved quality of life. The system is based on an invention by Navin Kapur, MD, and Richard Karas, MD, PhD, at the Molecular Cardiology Research Institute at Tufts Medical Center in Boston.

The design of the preCARDIA system allows for straightforward placement by physicians and hemodynamic monitoring by medical staff. The system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

https://finance.yahoo.com/news/abiomed-acquires-precardia-breakthrough-medical-120300985.html

Scripps' EHR back online nearly 4 weeks after ransomware attack

 Scripps Health's Epic EHR system and online patient portal were restored May 27, nearly four weeks after a ransomware attack knocked the San Diego-based health system's network offline, The San Diego-Union Tribune reported. 

Scripps President and CEO Chris Van Gorder penned a letter to patients May 24 updating them on the situation, but wrote that Scripps is limited in the amount of information it can share with patients since it could put the system "at an increased risk of coming under further attack, and of not being able to restore [its] systems safely and as quickly as possible." 

In the update, Mr. Van Gorder confirmed that the May 1 cyberattack involved ransomware, and he told patients that Scripps would have its EHR back online this week. The health system restored its website May 20. 

A Scripps nurse told the Tribune that the EHR returned to service at 4 a.m. on May 27. Scripps regained read-only access to Epic last week, which let staff look up past test results, clinician notes and other records created before the May 1 attack. 

Scripps said it is unsure whether any patient data was affected by the incident and that it will notify any affected individuals if their data was exposed once the investigation ends.

https://www.beckershospitalreview.com/cybersecurity/scripps-ehr-back-online-nearly-4-weeks-after-ransomware-attack.html

Yale children's hospital launches long COVID-19 program

 Yale New Haven (Conn.) Children's Hospital has launched a post-COVID-19 program for teens and children still experiencing effects weeks or months after the infection, according to a news release shared with Becker's May 28. 

The program will connect pediatric patients to a network of specialists, including infectious disease experts, pulmonologists and cardiologists, based on the persistent symptoms patients are experiencing.

"This program was developed in direct response to the needs we are seeing in our patients as well as hearing from their parents and pediatricians in our community," Rebecca Ciaburri, RN, performance manager of quality and safety at Yale New Haven Children's, said in a news release. "From the teenager who had COVID-19 several months ago and still has chest tightness to the younger child who had minimal COVID-19 symptoms after a positive test, but now has headaches, we need to support our children and families who are no longer positive for the virus yet still have symptoms." 


Additionally, the children's hospital offers a program to clear athletes who've had COVID-19 to return to sports, as well as a program for the management of multisystem inflammatory syndrome — a rare condition potentially linked to COVID-19.

https://www.beckershospitalreview.com/patient-safety-outcomes/yale-children-s-hospital-launches-long-covid-19-program.html

South Korea says J&J's COVID-19 shots fully taken up

 South Korea closed its first phase of reservations for Johnson and Johnson COVID-19 vaccines on Tuesday as military personnel signed up for all 800,000 shots on offer, the government said.

South Korea received one million doses of the vaccine this week after the United States almost doubled a pledge made during President Moon Jae-in's first summit with U.S. President Joe Biden last month.

Authorities designated the vaccine for military-related personnel, including reserve forces and the civil defence corps, as well as people planning overseas business trips or diplomatic missions.

Around 3.7 million people are eligible to receive the single-dose vaccine and a total of 800,000 had signed up in less than 16 hours since reservations began on Tuesday, the Korea Disease Control and Prevention Agency (KDCA) said in a statement.

The KDCA closed the reservations at 800,000 doses, but said others can book their shots when more vaccines are available.

South Korea has inoculated 5.79 million people, or 11% of its population, with a first dose of the two-dose vaccines from AstraZeneca or Pfizer. It aims to vaccinate 14 million by the end of this month.

It said the plan is on track as more vaccine shipments are due to arrive later this month and willingness to get vaccinated appears to be rising, lured by incentives.

A survey in May showed 69.2% of respondents were willing to get vaccinated, up from 61.4% a month earlier, Lee Sang-won, a senior health official, told a briefing.

The government on Tuesday allowed people who have received at least one dose to have family gatherings without restrictions and visit nursing homes.

Those fully vaccinated will no longer be required to wear masks outdoors from July.

The country has reported 459 new confirmed cases on Monday, bringing the total tally to 140,799 infections, with 1,963 deaths.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-South-Korea-says-J-J-s-COVID-19-shots-fully-taken-up-35484520/

EU to decide on Astrazeneca's $39 billion Alexion deal by July 5

 

EU antitrust regulators will decide by July 5 whether to clear Anglo-Swedish drugmaker AstraZeneca's $39 billion bid for U.S.-based Alexion, a European Commission filing showed on Tuesday.

AstraZeneca sought EU approval on Monday for the deal, its largest ever in a bet on rare-disease immunology and to boost its business, which includes a fast-growing cancer medicines unit and a major COVID-19 vaccine.

The Commission can either clear the deal with or without conditions or it can open a four-month long investigation if it has serious concerns.

The UK Competition Authority and Markets Authority is also reviewing the bid which has already received the green light in the United States, Canada, Brazil and Russia.

https://www.marketscreener.com/quote/stock/ALEXION-PHARMACEUTICALS-8334/news/Alexion-Pharmaceuticals-nbsp-EU-to-decide-on-Astrazeneca-s-39-billion-Alexion-deal-by-July-5-35484631/

Sanofi halts venglustat kidney disease clinical program

 French pharma company Sanofi has announced that it has halted the clinical programme of venglustat in autosomal dominant polycystic kidney disease (ADPKD).

Although the safety profile of venglustat remains consistent with previously reported results, a Phase II/III trial of the drug did not meet its futility criteria.

In addition, the study confirmed venglustat effectively inhibits the glycosphingolipid (GSL) pathway by demonstration a reduction in the lip GL-1.

The STAGED-PKD study was stopped for futility after an independent analysis of the annualised rate change in total kidney volume (TKV) in patients receiving venglustat compared to placebo.

In a statement, Sanofi said that trends from this analysis showed venglustat did not provide meaningful reduction in TKV growth rate – the primary endpoint of stage one of the study.

The company added that the analysis suggests the reduction of GSLs may not play a significant role in the prevention of kidney cyst growth, meaning it may not be a primary pathway associated with the progression of ADKPD.

“The venglustat development programme started with our confidence in the promise of a potential breakthrough treatment to address the unmet needs of people living with lysosomal storage disorders,” said John Reed, global head of research and development at Sanofi.

“In parallel, we set out to evaluate venglustat in autosomal dominant polycystic kidney disease, a leading cause of kidney transplant. This outcome is not what we hoped for, especially for these patients. However, our research has furthered the scientific understanding of ADPKD by demonstrating that modulating the GSL pathway is insufficient to restore kidney function in adults affected by this disease,” he added.

Sanofi has completed studies and also has additional active studies currently evaluating venglustat in Gaucher disease type 3, Fabry disease and GM2 Gangliosidosis, which are all lysosomal storage disease caused by inherited genetic abnormalities.

http://www.pharmatimes.com/news/sanofi_halts_venglustat_clinical_programme_in_adpkd_1370973