FDA OKs Merck combo antibiotic for bacterial pneumonia

Under Fast Track, Priority Review and Qualified Infectious Disease Program status, the FDA approves Merck’s (NYSE:MRK) Recarbrio (imipenem, cilastatin, relebactam) for adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

The combo antibiotic was first approved in the U.S. in July 2019 for complicated urinary tract and complicated intra-abdominal bacterial infections.

https://seekingalpha.com/news/3580626-fda-oks-merck-combo-antibiotic-for-bacterial-pneumonia

FDA accepts Adamas application for expanded use of Gocovri

The FDA accepts for review Adamas Pharmaceuticals’ (NASDAQ:ADMS) supplemental marketing application seeking approval to use Gocovri (amantadine) to treat OFF episodes in Parkinson’s disease (PD) patients receiving levodopa-based therapy. The agency’s action date is February 1, 2021.

The dopamine promoter was first approved in the U.S. in August 2017 for the treatment of dyskinesia (uncontrolled movements) in PD patients receiving levodopa-based therapy with or without concomitant dopaminergic medications.

https://seekingalpha.com/news/3580632-fda-accepts-adamas-application-for-expanded-use-of-gocovri

Self-driving cars could only prevent a third of U.S. crashes: study

Self-driving cars, long touted by developers as a way to eliminate road deaths, could likely only prevent a third of all U.S. road crashes, according to a study released on Thursday.
The Insurance Institute for Highway Safety (IIHS), a research group financed by U.S. insurers, found the remaining crashes were caused by mistakes that self-driving systems are not equipped to handle any better than human drivers.
Partners for Automated Vehicle Education, a consortium of self-driving companies and researchers, said in a statement on Thursday the study wrongly assumed that automated cars could only prevent crashes caused by perception errors and incapacitation.
Some 72% of crashes were avoidable, based on the study’s calculations, if accidents caused by speeding and violation of traffic laws were included, the consortium said.
Traffic experts say roughly nine in 10 crashes result from human error and more than 36,000 people are estimated to have died in U.S. car crashes last year.

Self-driving vehicle developers, including traditional automakers and technology companies, have repeatedly positioned fully automated driving as a tool to drastically reduce road deaths.
But not all human mistakes can be eliminated by camera, radar and other sensor-based technology, according to the IIHS analysis of more than 5,000 representative police-reported crashes nationwide.

One-third of all crashes were the exclusive result of sensing and perception errors, or driver incapacitation, the study found.
Most crashes were due to more complex errors, such as making wrong assumptions about other road users’ actions, driving too fast or too slow for road conditions, or making incorrect evasive maneuvers. Many crashes resulted from multiple mistakes.
“Our goal was to show that if you don’t deal with those issues, self-driving cars won’t deliver massive safety benefits,” said Jessica Cicchino, IIHS vice president for research and a coauthor of the study.
https://www.reuters.com/article/us-autos-self-driving/self-driving-cars-could-only-prevent-a-third-of-u-s-crashes-study-idUSKBN23B294

Protesters should ‘highly consider’ coronavirus tests, U.S. health official says

A top U.S. health official cautioned on Thursday that protests sweeping across the country could increase the spread of the novel coronavirus, particularly in cities that have struggled to control the outbreak, and that participants should “highly consider” getting tested.

Huge crowds have taken to the streets of dozens of cities since the death of George Floyd in Minneapolis police custody set off unrest that has roiled America in the midst of the coronavirus pandemic.
Protests have occurred in Minneapolis and Washington, D.C., where there has been significant transmission of the virus, Robert Redfield, director for the Centers for Disease Control and Prevention (CDC), testified before a Congressional committee.
“Those individuals that have partaken in these peaceful protests or have been out protesting, and particularly if they’re in metropolitan areas that really haven’t controlled the outbreak…we really want those individuals to highly consider being evaluated and get tested,” Redfield told a U.S. House of Representatives subcommittee.

“I do think there is a potential unfortunately for this to be a seeding event,” he said, referring to spreading the virus.
Other public health experts and government officials have also warned the large street protests could cause a spike in new coronavirus cases.
Concerns that a second wave of the virus could also spill over into flu season in the fall have heightened fears of the potential pressure on the nation’s healthcare system.
The CDC is seeking emergency use authorization for a test to detect and differentiate flu from COVID-19, Redfield said in prepared testimony for the House subcommittee on Labor, Health and Human Services, Education, and Related Agencies.

Redfield said in the prepared testimony the CDC is working with drugmakers to maximize the availability of influenza vaccines, and with healthcare providers “to develop contingency plans so that people can be vaccinated in a safe environment.”
Major flu vaccine makers include British-based GlaxoSmithKline, France’s Sanofi and Australia’s CSL.
U.S. pharmacy chains have been preparing a big push for flu vaccinations in October, hoping to prevent tens of thousands of serious cases that could flood hospitals along with new COVID-19 cases.
Redfield also said the World Health Organization (WHO) continues to be a “close colleague” in public health efforts.
President Donald Trump said on Friday the United States will end its relationship with the WHO over the body’s handling of the coronavirus pandemic.

During Redfield’s appearance, Democrats criticized the Trump administration’s response to the outbreak, which has led to more than 107,000 U.S. deaths.
“I have such admiration for the work that you and the CDC do, but if you and the CDC are driving this bus, you’re taking us in a dangerous direction,” said Rosa DeLauro, a Democratic congresswoman from Connecticut.
Asked about the delay in widely available coronavirus testing long into the U.S. outbreak, Redfield pointed to corporate America.
“It took unfortunately weeks and weeks and weeks before the private sector stepped up and developed what we now have,” he told the panel, noting that more than 17 million coronavirus tests have now been done in the United States.
https://www.reuters.com/article/us-health-coronavirus-congress-cdc/protesters-should-highly-consider-coronavirus-tests-u-s-health-official-says-idUSKBN23B2HE

Inovio to begin Phase 1/2 trial of COVID-19 DNA vaccine in South Korea

Inovio Pharmaceuticals (NASDAQ:INO), the International Vaccine Institute, and Seoul National University Hospital announce a partnership to start a Phase 1/2 clinical trial of Inovio’s COVID-19 vaccine INO-4800 in South Korea.

The 2nd-stage trial of INO-4800 will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand to enroll an additional 120 people aged 19-64 years.

The trial is expected to start later in June.

https://seekingalpha.com/news/3580328-inovio-to-begin-phase-1-2-trial-of-covidminus-19-dna-vaccine-in-south-korea

Gilead, Galapagos filgotinib shows sustained benefit in RA studies

Gilead Sciences (NASDAQ:GILD) and collaboration partner Galapagos NV (NASDAQ:GLPG) announce week 52 results from two Phase 3 clinical trials, FINCH 1 and FINCH 3, evaluating JAK1 inhibitor filgotinib in adults with moderately to severely active rheumatoid arthritis (RA). The data are being virtually presented at EULAR.

80.7% (n=1,417/1,755) of participants in FINCH 1 completed 52 weeks of treatment. Both doses of filgotinib showed sustained efficacy in primary and secondary outcome measures. A greater proportion of patients in the 200 mg filgotinib arm achieved low disease activity and clinical remission compared to patients receiving adalimumab [AbbVie’s (NYSE:ABBV) Humira].

78.1% (n=975/1,249) of patients in FINCH 3 completed 52 weeks of treatment. All showed sustained efficacy through week 52 based on clinical response, physical function and radiographic progression. Higher proportions of patients in the filgotinib 200 mg + methotrexate, 100 mg + methotrexate and filgotinib 200 mg monotherapy arms achieved ACR20 (20% improvement in RA symptoms), ACR50, ACR70 and disease remission compared to methotrexate alone. Patients receiving filgotinib showed less progression of structural damage compared to methotrexate monotherapy.

No new safety signals were observed in either study.

Marketing applications have been filed in the U.S., Europe and Japan for the indication.

https://seekingalpha.com/news/3580332-gilead-and-galapagos-filgotinib-shows-sustained-benefit-in-ra-studies

Late-stage gastric cancer study of Chi-Med’s fruquintinib to continue

Hutchison China MediTech Limited (Chi-Med) (NASDAQ:HCM) announces that its Phase 3 clinical trial, FRUTIGA, evaluating fruquintinib, combined with Taxol (paclitaxel), in patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have progressed after first-line chemo, will continue without modification. The action was based on a planned interim data review by the independent Data Monitoring Committee.

Fruquintinib starves tumors of their blood supply via inhibiting vascular endothelial growth factor receptors (VEGFR) 1, 2 & 3, which play key roles in tumor-related angiogenesis (formation of new blood vessels).

The drug was approved in China in September 2018 and was commercially launched there by Eli Lilly (NYSE:LLY) under the brand name Elunate for the treatment of patients with metastatic colorectal cancer that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type).

Chi-Med retains all rights to fruquintinib ex-China.

https://seekingalpha.com/news/3580344-late-stage-gastric-cancer-study-of-chi-meds-fruquintinib-to-continue