Ipsen’s CEO resigns, to join Ferring unit

French healthcare company Ipsen said on Wednesday its chief executive officer, David Meek, has resigned and will take the helm at FerGene, a unit of Swiss drug company Ferring Pharmaceuticals.

Meek, who had led the Paris-based firm since 2016, will also step down from Ipsen’s board at the end of this year, the company said.

Ipsen has appointed Chief Financial Officer Aymeric Le Chatelier as interim CEO.

Separately, FerGene, a joint venture between Blackstone Life Sciences and Ferring Pharmaceuticals, said Meek will join as CEO effective Jan. 14, 2020. Blackstone said last month it would invest $400 million in the gene therapy venture with Ferring.

https://www.marketscreener.com/IPSEN-5137/news/Ipsen-s-CEO-resigns-to-join-Ferring-unit-29742791/

U.S. finalizing rules to limit sensitive tech exports to China, others

The Commerce Department is putting the finishing touches on five rules covering products like quantum computing and 3-D printing technologies that were mandated by a 2018 law to keep sensitive technologies out of the hands of rival powers.

Before drafting the rules, Commerce sought industry comment last year on a raft of high-tech sectors that it could cover under the law, from artificial intelligence technology to robotics. That fueled concerns among U.S. businesses the department would craft broad, tough regulations that would stymy a host of exports to key customers.

But the internal status update seen by Reuters shows for the first time that Commerce is finishing a first batch of rules that touch on just a few technologies that will be proposed to international bodies before taking effect, a reprieve for U.S. companies.

“Based on their titles, the rules appear to be narrowly tailored to address specific national security issues, which should go a long way to calming the nerves of those in industry concerned that the administration would impose controls over broad categories of widely available technologies,” said Kevin Wolf, former assistant secretary of commerce for export administration.

Commerce declined to confirm any details but said it has a number of proposed rules in the review process.

Despite the apparent reprieve, Commerce could issue more rules in the future regulating sales abroad of cutting-edge items. The document failed to outline when the rule proposals would be made public or what the controls would look like for specific countries, buyers and uses.

In a move that should appeal to U.S. firms, the rules will be submitted to international bodies for approval so that they may be implemented overseas, not just by the United States. That would establish a level playing field for U.S. companies abroad, but would also take much longer to review and go into effect, likely until mid-2021 at the earliest.

Commerce is expected to seek industry comment on the rules before submitting them to the groups, a source said, adding that a sixth rule, covering artificial intelligence, will go into effect in the United States without a comment period.

The revelations come amid growing frustration from Republican and Democratic lawmakers over the slow pace of the rule roll-out, with Senate minority leader Chuck Schumer urging the Commerce Department to speed up the process.

In a statement to Reuters, Republican Senator Tom Cotton said he was “disappointed at the lack of political will” at the Commerce department, accusing it of a “troubling” lack of urgency.

“While bureaucrats and industry shills twiddle their thumbs, the Chinese Communist Party continues to purchase sensitive U.S. technologies with clear military applications,” he said. “I will be digging deep into the Commerce Department’s actions.”

“China firmly opposes the U.S.’ generalization of the concept of national security and abuse of export control measures to interfere with and restrict the normal communications and cooperation between businesses,” Chinese foreign ministry spokesman Geng Shuang said at a regular briefing in Beijing on Wednesday, when asked about the rules.

Limiting tech exports will not disrupt China’s innovation or development, said Geng.

According to the status update, the agency plans to regulate exports of quantum diluted refrigerators, which are used to keep qubits cold in some quantum machines. Qubits are used in quantum computers to perform calculations that would take conventional computers thousands of years.

Major makers of the refrigeration devices include U.K.-based ICE Oxford, Finland-based Bluefors and U.S.-based Janis Research. The rules would apply to exports of goods from the United States as well as shipments of items made abroad that contain a significant amount of U.S. technology or components.

That rule was sent to the Commerce Department’s Office of Policy and Strategic Planning on Nov. 19, along with another rule regulating 3-D printing for explosives, the document shows.

Another regulation on exports of the so called “Gate-All-Around Field Effect transistor technology, which is used to manufacture semiconductors, was awaiting comments from other agencies on Dec. 5.

The transistors are expected to play a major role in newer, faster semiconductors that are under development by Taiwan Semiconductor Manufacturing Co, Samsung Electronics Co Ltd and Intel Corp.

Two other rules would regulate chemicals used to make Russian nerve agent Novichok and single-use chambers for chemical reactions.

https://www.marketscreener.com/news/U-S-finalizing-rules-to-limit-sensitive-tech-exports-to-China-others–29738521/?countview=0

FDA Approves Sale of Low-Nicotine Cigarettes

The U.S. Food and Drug Administration on Tuesday approved the sale of two reduced-nicotine cigarettes.

Moonlight and Moonlight Menthol cigarettes were given the green light because they contain much less nicotine than traditional cigarettes and they could help adult smokers kick the habit, the FDA said. But the agency noted that its review of the reduced-nicotine cigarettes concluded that nonsmokers, including youth, are unlikely to start using these cigarettes. People who experiment with them are also less likely to become addicted than people who experiment with conventional cigarettes.

On average, conventional cigarettes made in the United States have a nicotine content of 10 to 14 mg per cigarette compared with 0.2 to 0.7 mg per cigarette in the two newly approved cigarettes. Both are marketed by 22nd Century Group.

In its announcement Tuesday, the FDA emphasized that despite this approval, there are no safe tobacco products and people who do not use tobacco products should not start. “Conventional cigarettes are designed to create and sustain addiction to nicotine,” Mitch Zeller, J.D., director of the FDA Center for Tobacco Products, said in a statement. “In announcing the FDA’s comprehensive plan to regulate tobacco and nicotine in July 2017, we noted our commitment to taking actions that will allow more addicted smokers to reduce their dependence and decrease the likelihood that future generations will become addicted to cigarettes.”

More Information

https://www.physiciansbriefing.com/internal-medicine-21/cigarette-smoking-tobacco-health-news-665/fda-approves-sale-of-low-nicotine-cigarettes-753148.html

Out-of-Pocket Costs for Medicare Recipients Will Rise in New Year

Seniors on Medicare are going to take a hit to the pocketbook in 2020, with premiums and deductibles set to increase on coverage for medical services and prescription drugs.

The standard monthly premium for Medicare Part B will rise $9.10, to $144 a month, the U.S. Centers for Medicare and Medicaid Services (CMS) announced.

The annual deductible for Part B also will increase $13 to $198 per year, CMS said.

Both increases are relatively large compared to 2019, when the Part B premium rose $1.50 a month and the deductible $2 for the year.

“This year there’s an unusual tick up in the Part B premium that could be a real concern for people living on a fixed income,” said Tricia Neuman, director of the Henry J. Kaiser Family Foundation’s Program on Medicare Policy.

The Part B premium increase will affect people enrolled in original Medicare as well as those who are covered under Medicare Advantage, said David Lipschutz, associate director of the Center for Medicare Advocacy.

“One thing I definitely wanted to make clear is that the increase in the Part B premium itself also applies to everyone on Medicare Advantage,” he said. “People on Medicare Advantage have to continue to pay the part B premium.”

Some, but not all, Medicare Advantage plans cover the Part B premium as part of their package, Lipschutz added.

The annual inpatient hospital deductible for Medicare Part A is also increasing to $1,408 a year, up $44. In 2019, the increase was $24.

These cost increases will wipe out much of the 1.6% cost-of-living (COLA) increase for Social Security benefits in 2020, CBS News reported. The COLA amounts to about $24 extra a month for the average retiree.

Medicare Part A covers inpatient hospital stays, nursing facility care and some home health care services. Part B covers doctor visits, outpatient hospital treatment, durable medical equipment, and certain home health care and medical services not covered by Part A.

Unless Congress acts, the prescription benefit in Medicare Part D also will start drawing a lot more money out of the pockets of seniors taking pricey drugs, the experts added.

The Affordable Care Act (ACA) included a provision that limited how much a senior with Part D would pay out-of-pocket after reaching a “catastrophic coverage” threshold, Neuman and Lipschutz said.

Once they reach that threshold, seniors pay 5% of their prescription costs. Until then, they pay 25% of the costs for brand-name drugs and 37% of generic drug costs.

But that ACA provision expires this year. When that happens, the catastrophic coverage threshold will jump $1,250, the Kaiser Family Foundation estimates. People will have to pay $6,350 out-of-pocket before reaching the threshold.

“There will be a jump up in the threshold, which means that people with high drug spending will have to pay more before they can get this extra help,” Neuman said.

Both the Senate and the House of Representatives have bills in the works that could address this Part D increase, but it’s hard to predict whether Congress will be able to cooperate on a solution, Neuman and Lipschutz said.

“No matter what your allegiances are, everyone agrees something should be done about the high cost of prescription drugs,” Lipschutz said.

It’s not all bad news, however.

Folks with Medicare Advantage are expected to pay lower premiums, even with the increase in Part B, according to the CMS.

On average, Medicare Advantage premiums are expected be at their lowest in the past 13 years, and 23% lower than in 2018, the CMS said.

Medicare Advantage enrollees also will have more plans to choose from. The Kaiser Family Foundation estimates that the average beneficiary will have access to 28 plans, compared with a low of 18 in 2014.

Original Medicare is the traditional fee-for-service program offered by the federal government, while Medicare Advantage plans are an alternative provided through private insurance companies.

Medicare beneficiaries spent an estimated $5,460 out-of-pocket for health care in 2016, according to the Kaiser Family Foundation. About 58% went to medical and long-term care services, with the remainder spent on premiums for Medicare and supplemental insurance.

More information

The Kaiser Family Foundation has more about Medicare out-of-pocket spending.

SOURCES: Tricia Neuman, Sc.D., director, Henry J. Kaiser Family Foundation Program on Medicare Policy, Washington, D.C.; David Lipschutz, J.D., associate director, Center for Medicare Advocacy, Washington, D.C.

https://consumer.healthday.com/senior-citizen-information-31/medicare-news-422/out-of-pocket-costs-for-medicare-recipients-will-rise-in-new-year-753047.html

Zogenix announces positive Fintepla results

Zogenix (NASDAQ:ZGNX) announces that The Lancet has published the results of its Phase 3 trial for Fintepla in children and young adults with Dravet syndrome, a rare, catastrophic form of epilepsy.

The primary endpoint was the change in mean monthly frequency of convulsive seizures. Patients receiving a dose of 0.7 mg/kg/day achieved a 62.3% greater reduction compared to placebo.

The group treated at 0.2 mg/kg/day compared to placebo, the secondary endpoint, showed a 32.4% grater reduction in frequency.

https://seekingalpha.com/news/3526977-zogenix-announces-positive-fintepla-results

FTC to block DNA sequencer Illumina’s acquisition of PacBio, calls it ‘monopolist’

The Federal Trade Commission is challenging DNA sequencing giant Illumina’s proposed $1.2 billion purchase of rival Pacific Biosciences, alleging the acquisition would eliminate “a nascent competitive threat” to Illumina’s monopoly in deciphering genetic material.

“When a monopolist buys a potential rival, it can harm competition,” the deputy director of the FTC’s Bureau of Competition, Gail Levine, said Tuesday in a statement. “These deals help monopolists maintain power. That’s why we’re challenging this acquisition.”

Illumina has become dominant in the field of next-generation DNA sequencing by building machines that sequenced DNA more cheaply and rapidly than several competitors, many of which have gone out of business. Since Illumina entered the sequencing market in 2007 with the acquisition of a company called Solexa, the cost of sequencing a human genome has dropped from more than $200,000 to as little as $1,000, a rate of improvement that has outpaced Moore’s law, the increase in speed that guides the improvement of microprocessors. Since that acquisition, Illumina’s share price has increased 1,500%.

Pacific Biosciences, or PacBio, was one of several companies that emerged a decade ago and attempted to challenge Illumina and failed. But PacBio has survived because its technology, which did not live up to its early projections of speed and efficiency, can do something Illumina can’t. Illumina’s DNA sequencers work by reading out tiny fragments of DNA code and re-assembling them. PacBio’s technology, though less accurate, can read out much bigger pieces, called “long reads” by scientists. Using the two technologies together can produce more accurate genetic information.

Illumina, which has a market capitalization of $48 billion, has said that it sees potential to grow faster by combining the two companies, and argues that the two technologies are complementary, not competing.

“We strongly disagree with the FTC’s decision and will continue to work through the regulatory approval process as we consider next steps,” Illumina spokesman Eric Endicott said in a statement. “We believe that the acquisition will benefit the industry and customers, and the facts of our proposed transaction support this.”

For many investors, it already looked as if the the PacBio deal was in trouble. In October, the United Kingdom’s Competition and Markets Authority concluded that the deal may result in a lessening of competition, and also blocked the merger. At the time, analysts at the investment bank Cowen wrote: “We believe the deal is now highly unlikely to be completed.”

It has been a comparatively tough year for Illumina. Aside from the drama surrounding the PacBio acquisition, the largest in its history, it posted a rare disappointing quarter in July. Its shares are up 9% over the course of 2019.

The FTC moves to block DNA sequencer Illumina’s acquisition of PacBio, calling company a ‘monopolist’

First US study shows strong results for osteoarthritis knee pain treatment

A new study published in Journal of Vascular and Interventional Radiology details the first study of its kind in the U.S. to examine the use of genicular artery embolization (GAE) for extended treatment of knee pain caused by osteoarthritis (OA). Principal investigator of the study, Ari Isaacson, MD, clinical associate professor of vascular and interventional radiology in the UNC School of Medicine, says the results are positive.

“In this study we showed that GAE can be performed safely and that it demonstrates potential efficacy,” Isaacson said.

An estimated 30 million Americans have knee pain as a result of OA. Current treatments for the pain include steroid injections, pain medications and physical therapy. Injections sometimes do not work, and when they do, tend to last only several months, at most. Pain medications are needed daily and can lead to dependence on opioids and toxicity from nonsteroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen). Physical therapy can be taxing and painful. Total knee replacements are an option as well, but because they have a limited lifetime of 15-20 years, they are not performed until a patient reaches an optimal age.

GAE is a minimally invasive procedure that blocks blood flow to certain parts of the knee that can be the source of OA-related pain. More than 80 percent of patients with chronic OA also have chronic inflammation, which leads to synovial angiogenesis – the formation of new arteries in the portion of the knee called the synovium. Blood flow to the new arteries can irritate nerves in the synovium, causing pain. Therefore, blocking blood flow to these arteries relieves that irritation and reduces pain. Past studies from researchers in Japan and Korea have shown the procedure has the potential to provide pain relief for up to a year or more.

During the procedure, interventional radiologists block blood flow by inserting a spaghetti-sized catheter into the arteries through a very small incision. The catheter is then directed through the arteries to the knee using x-ray and iodinated contrast. Once the appropriate knee arteries are identified, spherical particles are injected to create a blockage. Because the catheter is used to select only the tiny abnormal arteries, the majority of the blood flow to the knee is preserved. Patients were under moderate sedation during the short procedure and were discharged the same day. No physical therapy was required and patients felt relief from their knee pain within three days.

The two-site trial, funded by Boston Scientific, included 20 patients – 9 men and 11 women – aged 49 to 84 with moderate to severe knee pain from OA. After the procedure all patients had follow-up visits at one, three, and six months. The decrease in pain reported by participants was significant, so much so that the improvement scores surpassed researchers’ benchmark goal for proving efficacy of the procedure. Nearly all patients still had an improvement in pain after one month. Around 80 percent of patients still had less pain after six months. In addition to less reported knee pain, 65 percent of participants reported a decrease in use of daily pain relief medication.

“We’ve seen that most patients experience a rapid decrease in pain and disability after GAE for OA-related knee pain,” Isaacson said. “This procedure has promise to be a replacement for injections and the daily use of pain medications, but more research is needed.”

Isaacson and fellow researchers are in the process of conducting a randomized control trial, funded by a grant from Medtronic, comparing GAE to a sham procedure in order to determine how much of the improvement observed in these patients may be attributed to placebo. The procedure is currently only available in clinical trials.

https://www.eurekalert.org/pub_releases/2019-12/uonc-fus121719.php