Indivior withdraws 2020 forecast on coronavirus-led uncertainty

British drugmaker Indivior PLC withdrew its annual financial forecast on Wednesday, citing uncertainties due to the coronavirus pandemic.

The company said it does not expect to be in a position to provide revised forecast numbers until the duration and extent of the market disruptions caused by the outbreak are known.
The blow from the pandemic, which has severely dented global financial markets, comes at a time when Indivior has already been losing market share for its best-selling opioid addiction treatment Suboxone to cheaper alternatives.
The British drugmaker said on Wednesday it had seen a decline in demand for Sublocade and Perseris injections in recent weeks, largely due to patients being unable to visit their healthcare providers’ offices and a resulting shift to remote prescribing.
Indivior had gross cash of about $911 million and net cash of approximately $673 million as of March 31, the company said, adding that it will provide an update on its financial performance and business developments at its first-quarter results announcement on April 30.
(This story corrects paragraph 4 to “decline in demand for Sublocade and Perseris injections” from “decline in demand for Suboxone and other products”).

https://www.marketscreener.com/INDIVIOR-19344116/news/Indivior-withdraws-2020-forecast-on-coronavirus-led-uncertainty-30382578/

Foxconn Teams Up With Medtronic to Produce Ventilators

Foxconn Technology Group–best known for assembling Apple Inc.’s iPhones in China–is working with medical-device maker Medtronic PLC to develop and produce ventilators, the Taiwanese contract-assembly giant said Wednesday.
The move comes as the U.S. and other countries scramble to secure enough ventilators, which help patients severely ill with the coronavirus who have trouble breathing on their own. Besides traditional ventilator makers including Medtronic, new players such as General Motors Co. and Ford Motor Co. have joined the production crew to produce the device.
Foxconn’s announcement comes after Medtronic Chief Executive Omar Ishrak said on CNBC earlier this week that the two companies plan to produce the ventilators together at Foxconn’s Wisconsin plant over the next four to six weeks. “Currently, medical and technical personnel of both companies are working together closely. We hope to speed up the mass-production schedule,” Foxconn said.
In China, where the number of Covid-19 patients surged earlier, Foxconn has been producing millions of masks since February to help address medical-supply shortages. Meanwhile, Medtronic recently shared the design specifications for a ventilator product to allow other companies to produce it.

https://www.marketscreener.com/MEDTRONIC-PLC-20661655/news/Medtronic-Foxconn-Teams-Up-With-Medtronic-to-Produce-Ventilators-30383171/

CDC considers changing guidelines for those exposed to coronavirus

The Centers for Disease Control and Prevention (CDC) is considering new guidelines for those exposed to the coronavirus who do not show symptoms. 
The newly proposed guidelines would allow asymptomatic people who were exposed to the virus to resume work under the conditions that they would wear a mask and have their temperature checked regularly.
“I can tell you the CDC will have new guidance tomorrow that the CDC will be publishing for people who were in proximity to an individual that tested positive for coronavirus but have no symptoms,” Vice President Pence said during Tuesday’s coronavirus task force briefing. 

“Some of the best minds here at the White House are beginning to think about what recommendations will look like that we give to businesses, that we give to states, but it will all, I promise you, be informed on putting the health and well-being of the American people first,” Pence said.
The newly proposed guidance would aim to reduce some of the more restrictive CDC guidelines, which require essential workers to isolate for 14 days if exposed to the virus, regardless of whether or not they show symptoms.
Deborah Birx, the coronavirus response coordinator for the White House coronavirus task force, told CBS News on Wednesday that the upcoming advisories by the CDC would be “a very important piece” moving forward with handling the outbreak. 
“It looks at degree of exposure and really making it clear that exposure occurs within 6 feet for more than 15 minutes, so really understanding where you shouldn’t be within 6 feet of people right now,” Birx said. “But if you’re in a work situation where you have to be, there will be a series of recommendations that if you had had a significant exposure of what specifically to do, and if you’ve had a less exposure what to do.”
Pence added Tuesday night that the current focus is on the “point of need” for essential works but is also operating on a separate track for the rest of the public to follow in future recommendations.
https://thehill.com/policy/healthcare/worker-safety/491815-cdc-considers-changing-guidelines-for-those-exposed-to

NMC Health says it can’t oppose administration request made by creditor

NMC Health NMC, , the Middle Eastern hospital operator that was a FTSE 100 component, on Wednesday said it will be unable to oppose a filing by one of its creditors, Abu Dhabi Commercial Bank, to have it put into administration. NMC Health shares have been halted since late February on concern over unauthorized debts. “The Board has written to the Court indicating that, notwithstanding strenuous efforts to address Creditors’ concerns, it has not been able to secure their alignment and support and has been advised by its counsel that it is not in a position to oppose the application successfully. Accordingly, it expects the Company to be placed into administration in due course,” said NMC in a statement. NMC Health shares suffered after the short seller Muddy Waters drew attention to the firm.
https://www.marketwatch.com/story/nmc-health-says-it-cant-oppose-administration-request-made-by-creditor-2020-04-08

FDA OKs generic version of Merck bronchospasm med

The FDA approves Mumbai-based Cipla Limited’s generic version of Merck’s (MRK +2.6%) Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation for the treatment or prevention of bronchospasm in patients at least four years old who have reversible obstructive airway disease and the prevention of exercise-induced bronchospasm.

This is the first generic Proventil HFA approved in the U.S.

https://seekingalpha.com/news/3559435-fda-oks-generic-version-of-merck-bronchospasm-med

Warning: Autoimmunity on the Rise in the U.S.

The prevalence of autoimmunity, as suggested by the presence of antinuclear antibodies (ANA), has been rising in the United States, a large cross-sectional study found.
Data from the National Health and Nutrition Examination Survey (NHANES) showed an overall ANA prevalence of 11% (95% CI 9.7-12.6) for 1988-1991; 11.5% (95% CI 10.3-12.8) for 1999-2004; and 15.9% (95% CI 14.3-17.6) for 2011-2012 (P<0.0001 for trend), according to Frederick W. Miller, MD, PhD, of the National Institute of Environmental Health Sciences in Research Triangle Park, North Carolina, and colleagues.

As they reported online in Arthritis & Rheumatology, those numbers corresponded with totals of 22 million, 27 million, and 41 million affected individuals across the 25-year time frame.
The presence of ANA is the most common biomarker for autoimmunity, occurring in patients with many conditions such as systemic lupus erythematosus and rheumatoid arthritis. The antibodies also are sometimes seen in the general population, particularly among women and the elderly and after exposures to chemicals and infections, Miller and co-authors noted.
“Growing evidence suggests that autoantibodies precede the onset of symptomatic autoimmune disease by many years; thus, ANA may be an intermediate marker on the pathway to disease or may signal increased susceptibility to autoimmune diseases through related causal pathways,” the researchers explained.
Earlier studies had suggested that the rates of autoimmune disease were increasing, but it’s been unclear whether this represented better detection or a true increase, so Miller and colleagues analyzed the prevalence of ANA positivity in the nationally representative NHANES database for 1988-2012.

The analysis included 14,211 individuals ages 12 and older from the three time periods who completed questionnaires on demographics and health factors and also provided blood samples. Indirect immunofluorescence was used to detect ANA.
Of the included individuals, 13.9% were positive for ANA. At all three time intervals, the likelihood of ANA positivity was two to three times higher for women than men, with odds ratios of 2.53 (95% CI 1.90-3.36) for 1988-1991, 2.97 (95% CI 2.30-3.84) for 1999-2004, and 1.94 (95% CI 1.57-2.40) for 2011-2012.
Antibody positivity also was more common among individuals age 50 and older compared with adolescents, with odds ratios of 3.63 (95% CI 2.02-6.55), 1.80 (95% CI 1.23-2.63), and 1.71 (95% CI 1.21-2.42) for the three time periods, respectively.
The odds of ANA positivity also were higher for blacks and Mexican-Americans in the earliest time period, but ethnic/racial differences declined in the two later time periods.
In a time-trend analysis, the researchers reported “strong evidence” for an increasing prevalence of ANA positivity in the two later time periods compared with the first (reference) period, with overall prevalence odds ratios of 1.02 (95% CI 0.85-1.24) for 1999-2004 and 1.47 (95% CI 1.22-1.78, P<0.0001 vs reference) by 2011-2012.

The greatest rise in prevalence was between the second and third time periods, and by 2011-2012 the prevalence odds ratios were significantly increased in these subgroups (vs the baseline period):

• Men, OR 1.73 (95% CI 1.31-2.30, P<0.0001)

• Women, OR 1.35 (95% CI 1.08-1.69, P=0.008)

• Adolescents, OR 2.88 (95% CI 1.64-5.04, P<0.0001)

• Older adults, OR 1.51 (95% CI 1.17-1.95, P=0.001)

• Non-Hispanic whites, OR 1.66 (95% CI 1.30-2.12, P<0.0001)

• Overweight individuals, OR 1.88 (95% CI 1.33-2.65, P=0.0001)

• Second-hand smoke exposure, OR 1.65 (95% CI 1.29-2.12, P=0.0002)

• Moderate/heavy alcohol consumption, OR 2.41 (95% CI 1.55-3.75, P<0.0001)

“Our novel and robust findings suggest that ANA prevalence increased substantially in the U.S. over the 25-year time frame examined,” the investigators wrote.
They described the “dramatic” increase in ANA positivity in adolescence as “particularly concerning if ANA are harbingers of increased susceptibility to future autoimmune diseases.”
A study limitation, the team said, was the cross-sectional design.
The researchers added: “Additional studies to complement our exploratory investigation, particularly of the aforementioned sociodemographic groups, should be the focus of future research to determine the driving forces underlying these ANA increases and to inform the development of possible preventative measures.”

Last Updated April 08, 2020

Disclosures

The authors reported no financial conflicts of interest.

Primary Source

Arthritis & Rheumatology

Source Reference: Dinse G, et al “Increasing prevalence of antinuclear antibodies in the United States” Arthritis Rheum 2020; DOI: 10.1002/art.41214.

https://www.medpagetoday.com/rheumatology/generalrheumatology/85842

Generic drugmakers win EU okay to cooperate in coronavirus fight

Generic drugmakers will be allowed to cooperate to supply hospital medicines for COVID-19 patients without fear of breaching the bloc’s competition rules, EU antitrust regulators said on Wednesday.
The step is the latest loosening of the bloc’s strict antitrust rules to help tackle the novel coronavirus pandemic.
The European Commission, the EU executive, has allowed EU governments to hand out subsidised loans, grants and defer tax payments to thousands of companies.
Regulators said waiving antitrust rules for generic drugmakers, which produce the largest part of critical hospital medicines, will help to avoid shortages.
“In the current circumstances, this temporary cooperation appears indeed justifiable under EU antitrust law, in view of its objective and the safeguards put in place to avoid anticompetitive concerns,” the EU executive said in a statement.
It will provide a business document, known as a comfort letter, to industry body Medicines for Europe, giving guidance on what will be allowed.

Specifically, it will address a voluntary cooperation project among pharmaceutical producers, both members and non-members of the generic drugmakers’ association.
Enforcers will monitor the market to ensure that companies do not fix prices or abuse their market power, the Commission said.
https://www.reuters.com/article/us-health-coronavirus-antitrust/generic-drugmakers-win-eu-okay-to-cooperate-in-coronavirus-fight-idUSKBN21Q1FR