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Thursday, July 9, 2020

UnitedHealthcare reverses policy that limited coverage of insulin pumps

UnitedHealthcare will expand what insulin pumps it considers in-network after a policy change limited which devices were covered.
JDRF, which funds Type 1 diabetes research and led a campaign calling on health insurers to expand choices for in-network Type 1 diabetes therapies, said the policy change was a “direct result of the T1D community’s advocacy.”
In February 2019, UnitedHealthcare expanded an existing agreement with Medtronic that denoted the devicemaker’s insulin pumps preferred products for children with Type 1 diabetes. The move, which UnitedHealthcare said considered the quality and cost of the devices, effectively limited in-network options for the insulin pump from three to two.
UnitedHealthcare will now cover Tandem Diabetes insulin pumps as in-network.

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Fred Hutch to serve as coordinating center for COVID-19 vaccine clinical trials

Seattle-based Fred Hutchinson Cancer Research Center was named the coordinating center for vaccine clinical trials within the COVID-19 Prevention Network.
The network, funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, was established to enroll volunteers in large-scale clinical trials testing investigational vaccines and monoclonal antibodies that could protect people from COVID-19.
A team headquartered at Fred Hutch will lead operations across at least five large-scale efficacy trials, with more than 100 clinical trial sites in the U.S. and abroad.
“I’m optimistic that the extraordinary cooperation of industry, government and the scientific community, working in concert with the citizenry of our country, as well as our international partners, will allow us to conduct these trials with the highest standards of safety and scientific accuracy,” said Larry Corey, MD, past president and director of the cancer research center and principal investigator of the COVID-19 Prevention Network operations center located at Fred Hutch.

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Merck Gets FDA Priority Review of Keytruda in Classical Hodgkin Lymphoma

Merck & Co. on Thursday said the U.S. Food and Drug Administration granted priority review for the expanded use of its cancer drug Keytruda as second-line treatment for adults with relapsed or refractory classical Hodgkin lymphoma.
The Kenilworth, N.J., drug maker said its application is based on data from a Phase 3 study in which Keytruda showed a significant improvement in progression-free survival compared to brentuximab vedotin, a current standard of care in this patient population.
Merck said classical Hodgkin lymphoma accounts for more than 90% of cases of Hodgkin lymphoma, which affects about 7,400 patients a year in the U.S.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months. Merck said the agency set a target action date of Oct. 30 for the application.

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FDA grants fast review of AstraZeneca Brilinta to prevent recurring strokes

July 9, 2020

The FDA has granted a fast review of AstraZeneca’s cardiovascular diseases drug Brilinta (ticagrelor) in the new indication that aims to reduce the chances of patients having recurring strokes. 
The faster six-month Priority Review is for an indication covering reduction of subsequent stroke in patients who experienced an acute ischemic stroke, or transient ischemic attack (TIA). 
This sets up a potential decision date in the final quarter of the year, AZ said in a statement.
The filing was based on results from the phase 3 THALES trial, which showed aspirin plus Brilinta 90 mg used twice daily for 30 days resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone. 
There were no surprises in terms of safety, with results in line with those seen in previous trials. 
The data from the THALES trial will be published in a peer reviewed journal and presented at a forthcoming medical congress. 
An anti-platelet drug, Brilinta was first approved in 2011 to reduce cardiovascular death and heart attack in patients with acute coronary syndromes. 
Since then it has been approved by the FDA in a new crushed form for those unable to take tablets, and for long-term use in patients with a history of heart attack in 2015. 
At the beginning of last month AZ added another indication to reduce risk of a first heart attack or stroke in high-risk patients with coronary artery disease. 
A blockbuster with sales of more than $400 million in Q2, Brilinta is in a highly competitive market where many doctors may choose the cheaper option of prescribing generic clopidogrel, originally marketed by Sanofi under the brand name Plavix. 
It has a direct competitor from Eli Lilly, Effient (prasugrel), which also works by inhibiting production of platelets by targeting a receptor known as P2Y12-ADP. 
Stroke is the second leading cause of death worldwide, with 6.2 million stroke-related deaths in 2017, of which 2.7 million were due to ischaemic stroke. 
Patients who experience an acute ischaemic stroke or TIA are at high risk of developing subsequent ischaemic events, with particularly high risk within 30 days after the initial event and the highest risk period being the first 24 hours after the initial event. 

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IDEAYA launches early-stage study of IDE196 in eye cancer

IDEAYA Biosciences (IDYA -2.4%) has dosed the first patient in a Phase 1 clinical trial evaluating the combination of IDE196, a protein kinase C inhibitor and Pfizer’s Mektovi (binimetinib), a MEK inhibitor, in metastatic uveal melanoma.
Primary objectives are safety, tolerability, pharmacokinetics and identifying the recommended dose for the Phase 2 portion.
The Phase 1/2 trial will assess IDE196 as monotherapy for solid tumors with GNAQ/11 mutations or PRKC fusions.
Pfizer will supply binimetinib for the trial.
Interim data should be available in late 2021 to early 2022.

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New $1 billion fund aims to steer antibiotic companies in tough market

Several large drugmakers including Merck & Co Inc (MRK.N) and Pfizer Inc (PFE.N) on Thursday unveiled a $1 billion fund to bolster struggling antibiotic companies and sustain a pipeline for new treatments.
Antibiotic makers have struggled with anemic investment and bankruptcies, even after the approval of new drugs, as fears of drug-resistant microbes force hospitals to adopt a more conservative approach toward such treatments.
Public health authorities have raised alarms about a looming health crisis, saying deaths from antibiotic-resistant bacteria could dwarf that from the COVID-19 pandemic.
The fund, led by the International Federation of Pharmaceutical Manufacturers & Associations, seeks to serve as a temporary solution until new legislation can offer a more permanent fix in the market.
It aims to help shore up investment in smaller biotech companies after several large drugmakers, such as Sanofi SA (SASY.PA) bowed out of the antibiotics space.
“The fund is being developed to buy time for the future,” said Eli Lilly and Co (LLY.N) CEO David Ricks. “We are probably buying 4-5 years of time with this initiative.”
Other companies participating in the fund include Johnson & Johnson (JNJ.N), Novartis (NOVN.S) and GlaxoSmithKline (GSK.L).
The initiative “gives these biotechs access to the kinds of capabilities that large pharmaceutical companies have, such as manufacturing and regulatory,” said Silas Holland, head of external affairs for the fund and director of global public policy at Merck.
An independent scientific panel will review and recommend funding for companies developing promising novel antibiotics, Holland said. The group’s goal is to bring two to four new antibiotics to patients within a decade.

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A Study on Infectivity of Asymptomatic SARS-CoV-2 Carriers

Abstract

Background: An ongoing outbreak of coronavirus disease 2019 (COVID-19) has spread around the world. It is debatable whether asymptomatic COVID-19 virus carriers are contagious. We report here a case of the asymptomatic patient and present clinical characteristics of 455 contacts, which aims to study the infectivity of asymptomatic carriers.
Material and methods: 455 contacts who were exposed to the asymptomatic COVID-19 virus carrier became the subjects of our research. They were divided into three groups: 35 patients, 196 family members and 224 hospital staffs. We extracted their epidemiological information, clinical records, auxiliary examination results and therapeutic schedules.
Results: The median contact time for patients was four days and that for family members was five days. Cardiovascular disease accounted for 25% among original diseases of patients. Apart from hospital staffs, both patients and family members were isolated medically. During the quarantine, seven patients plus one family member appeared new respiratory symptoms, where fever was the most common one. The blood counts in most contacts were within a normal range. All CT images showed no sign of COVID-19 infection. No severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections was detected in 455 contacts by nucleic acid test.
Conclusion: In summary, all the 455 contacts were excluded from SARS-CoV-2 infection and we conclude that the infectivity of some asymptomatic SARS-CoV-2 carriers might be weak.
Keywords: Asymptomatic carrier; Contacts; Infectivity; SARS-CoV-2.

Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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