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Tuesday, July 7, 2020

Hepion Pharma’s lead candidate shows encouraging action in COVID-19 models

Nano cap Hepion Pharmaceuticals (NASDAQ:HEPA) announces positive results on lead drug CRV431 in two preclinical research models related to COVID-19.
CRV431, a cyclophilin inhibitor, showed anti-inflammatory effects in a non-viral acute lung injury model, outperforming dexamethasone in some measures. It also showed antiviral activity against SARS-CoV-2 in cell culture experiments.
Additional preclinical testing is next up.

FDA panel to review Mallinckrodt application for kidney failure med

As expected, the FDA’s Cardiovascular and Renal Drugs Advisory Committee will conduct a virtual meeting to review and discuss Mallinckrodt’s (MNK +0.8%) marketing application seeking approval to use terlipressin to treat hepatorenal syndrome type 1 (HRS-1), a type of progressive kidney failure in patients with severe liver damage, typically from cirrhosis.
The committee will meet on Wednesday, July 15.

ROCHE HOLDINGS AG: Goldman Sachs gives a Buy rating

Goldman Sachs is positive on the stock with a Buy rating.

GSK, Philip Morris venture tie-up for potential COVID-19 shot

GSK, the world’s largest vaccine maker, on Tuesday announced the latest partnership for its vaccine booster technology to develop and test a potential COVID-19 shot with Canadian biopharmaceutical firm Medicago.
The British drugmaker has shied away from developing its own coronavirus vaccine and instead focused on contributing its adjuvant expertise to at least seven other global institutions or firms such as Sanofi and China’s Clover.
Quebec, Canada-headquartered Medicago is a privately owned company, in which tobacco firm Philip Morris has a 33% stake, and Mitsubishi Tanabe Pharma holds the remaining stake.
London-listed GSK said the companies aim to make their vaccine available in the first half of next year and produce about 100 million doses by the end of 2021. Early-stage testing in humans is expected to begin in mid-July.

Judge questions part of proposed Bayer Roundup settlement

Bayer shares fell more 6% on Tuesday after a U.S. judge questioned part of the German company’s proposed settlement to deal with future claims relating to allegations that its widely used weedkiller Roundup caused cancer.
Last month Bayer agreed to pay as much as $10.9 billion to settle close to 100,000 U.S. lawsuits related to Roundup.
That included $1.25 billion to support a separate class agreement to address potential future litigation. That part of the settlement requires court approval.
“The Court is skeptical of the propriety and fairness of the proposed settlement, and is tentatively inclined to deny the motion,” Judge Vince Chhabria said in a filing with the United States District Court, Northern District of California.
Bayer had planned on creating an independent panel of scientific experts to help assess whether glyphosate caused cancer.
Regulators including the U.S. Environmental Protection Agency and the European Chemicals Agency, have determined glyphosate to be non-carcinogenic, supporting Bayer’s claim that the active ingredient in its Roundup product is safe for agricultural use.
But in a filing published on July 6, Chhabria said: “Even with the consent of both sides, it’s questionable whether it would be constitutional (or otherwise lawful) to delegate the function of deciding the general causation question (that is, whether and at what dose Roundup is capable of causing cancer) from judges and juries to a panel of scientists.”
Chhabria also questioned whether potential claimants want to remain bound by a ruling reached by the proposed scientific panel if research is still ongoing.
“In an area where the science may be evolving, how could it be appropriate to lock in a decision from a panel of scientists for all future cases?,” Chhabria wrote.
In 2015, the World Health Organization’s cancer research arm determined the herbicide to be a “probable carcinogen”, and since 2018, three consecutive U.S. juries, who listened to scientific evidence from both sides during trials, found that Roundup causes cancer.
Responding to Chhabria’s ruling, Bayer said: “We appreciate the judge’s order raising his preliminary concerns with the proposed class settlement, which we take seriously and will address at the preliminary approval hearing on July 24.”

Glaxo: long-acting HIV prevention drug 65% more effective than Truvada

Britain’s GSK said on Tuesday that an injection of its cabotegravir drug given every two months was found to be 65% more effective in preventing HIV infections than Gilead’s Truvada daily oral pills.
HIV incidence rate – or the number of people who contract the infection in a period – was 0.41% with the injection, compared with 1.22% with Gilead’s Truvada, final data from a study presented at the virtual AIDS conference showed.
Truvada is currently the standard of care for preventing HIV, but GSK hopes to challenge its dominance by making shorter, long-lasting regimens and less toxic alternatives through its ViiV Healthcare unit.
“This advancement has the potential to be a game-changer for HIV prevention, offering … the convenience of reduced dosing from daily to just six times per year,” said Kimberly Smith, head of research and development at ViiV Healthcare.
Truvada raked in $2.8 billion in sales last year, both from treating and preventing HIV infections – which cause AIDS, a deadly condition that severely weakens the immune system if not quelled.
Some 75 million people worldwide have been infected with HIV and about 32 million people have died since it began in the 1980s.(bit.ly/3eb4myd)
Cabotegravir and the daily oral pill were both well tolerated in the study, which was conducted on men who engage in sexual activity with other men and transgender women who have sex with men, putting them at risk of contracting HIV, ViiV said.
Among the participants, 80% reported pain or tenderness at the injection site, compared with 31% for those in another branch of the study that were given placebo injections.
ViiV, in which Pfizer and Shionogi hold small stakes, also said two-thirds of adults in the study were under the age of 30, while 12% were transgender women.
ViiV will use the data for regulatory submissions.

Medtronic launches new MiniMed infusion set in U.S.

Medtronic (NYSE:MDT) announces the commercial availability of the MiniMed Mio Advance infusion set to all Medtronic insulin pump users in the U.S.
The company says the new set can be inserted in only four steps with one hand while enabling more insertion sites on the body such as the lower back or back of the arm.