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Sunday, January 26, 2020

Bayer gets Japanese approval for prostate cancer drug Nubeqa

Bayer and Orion’s prostate cancer drug Nubeqa (darolutamide) is gaining steam in its battle against rivals from J&J and Pfizer/Astellas as Japan becomes the latest country to approve the drug.
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorisation to Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC).
In Japan, over 89,000 men are estimated to be diagnosed with prostate cancer annually, making it the second most-common cancer diagnosis in Japanese men (after stomach cancer).
The drug was approved by the FDA in July last year. With darolutamide, Bayer is hoping to take market share from J&J’s Erleada (apalutamide) and Pfizer/Astellas’ Xtandi (enzalutamide), which have become standard therapies at several different stages of the disease.
Bayer and Orion think that their drug may have a safety advantage over competitors and is tipped to break through the billion-euro annual sales barrier.
Analysts agree that the side effect profile is favourable based on trial data so far, but efficacy is comparable and this may not be enough to win over prescribers looking for an improvement on the rivals, which have only recently been approved in this use.
The Japanese approval, like the US greenlight, is based on data from the phase 3 ARAMIS trial in men with non-metastatic castration-resistant disease, which showed a statistically significant improvement in metastasis-free survival for darolutamide plus androgen deprivation therapy (ADT).
In ARAMIS, 1,509 patients were randomised in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.
The trial showed that Nubeqa plus androgen deprivation therapy (ADT) demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT group.
J&J’s Erleada was first to market in this indication, approved in February last year after data in the SPARTAN trial showing MFS of 40.5 months, compared with 16.2 months in patients taking placebo.
Pfizer/Astellas’ rival Xtandi was approved in the same indication shortly after – in the PROSPER trial MFS was 36.6 months for those treated with Xtandi plus ADT, compared with 14.7 months in those treated with placebo and ADT.
Bayer is also developing darolutamide in metastatic hormone-sensitive prostate cancer, where the phase 3 prostate cancer trial ARASENS is testing its safety and efficacy.
Bayer gets Japanese approval for prostate cancer drug Nubeqa

Third US case of coronavirus confirmed in California

California is now home to the third US case of the deadly coronavirus, officials there revealed early Sunday, joining Chicago and the Seattle, Wash. area, where the first cases were announced last week.
The news was announced as health officials in China said that the virus’ ability to spread was stronger than earlier thought.
That’s because unlike with SARS, the coronavirus is infectious during its one-to-14-day incubation period, China’s National Health Commissioner, Ma Xiaowei, said at a Sunday press conference, Reuters reported.
News of the California case was announced by officials with the Orange County Health Care Agency.
“The OC Health Care Agency’s (HCA) Communicable Disease Control Division received confirmation from the Centers for Disease Control and Prevention (CDC) this evening that an Orange County, California case has tested positive for the novel coronavirus,” the agency said in a tweeted release.
The patient, whose identity was kept private, was described as a traveler from Wuhan, China — the outbreak’s epicenter.
The patient had reached out to the agency prior to being diagnosed, and “was provided guidance in order to reduce exposure to the public while awaiting laboratory confirmation from the CDC,” the release said.
“The individual has now been transported to a local hospital and is in isolation in good condition.” Persons the patient had close contact with are being monitored.
No additional details were released.
Worldwide, an estimated 2,000 people, almost all of them in China, have been sickened by the virus, Reuters reported.
China’s National Health Commission said Sunday that 56 people, all in China, have been killed by the disease.
Isolated cases have been reported throughout Asia, and in France and Australia.
The first case in Canada was reported Saturday night, Reuters reported.
The CDC advises that while there is as yet no vaccine, all viruses can be prevented by washing one’s hands, especially before eating, and by avoiding touching one’s eyes, nose and mouth with unwashed hands, or close contact with people who are sick.
https://nypost.com/2020/01/26/california-now-home-to-third-us-case-of-coronavirus/

Big pharma joins hunt for coronavirus vaccine as outbreak escalates

Big pharma has joined the hunt for a vaccine for the deadly coronavirus outbreak that is beginning to spread around the world from its origins in China.
As the number of confirmed cases globally increased to 800, and the death toll reached 26 people, Paul Stoffels, chief scientific officer at Johnson & Johnson, said the company’s scientists had already begun working on a potential vaccine.
In the UK, 14 people have been tested and none have been positive, although the experts predict it will reach the country.
Stoffels told the BBC Radio 4’s Today news and current affairs radio programme that J&J’s scientists have already done “basic work” on a vaccine.
Any vaccine is at least a year away said Stoffels, although this is a vast improvement on development time seen for the Ebola virus, which took several years to produce.
Stoffels told the BBC: “The sequence of the virus, the genetic material, has been available for a few weeks. Most of the laboratories in the pharmaceutical industry are able to work from that information to construct vaccines.
“As an industry we are just people and we feel about the world and use our capabilities to make a difference. The lab technicians and scientists without me asking told me today they advanced the first version of a vaccine in the laboratory.
“There is so much technology now that you can do this very fast. That will take several months before the product will be able to be tested in the clinic.”
Meanwhile, the Coalition for Epidemic Preparedness Innovations (CEPI), said it had begun three programmes to develop vaccines against the new virus strain, dubbed nCoV-2019.
The vaccine development efforts will build on existing partnerships with US biotech Inovio and The University of Brisbane in Australia.
A public-private partnership launched at Davos in 2017, CEPI is already working with Inovio on a DNA vaccine candidate against Middle East Respiratory Syndrome (MERS), and is looking at “molecular clamp” vaccines with the university that could work against several different viruses.
Moderna has agreed to manufacture an mRNA vaccine against 2019-nCoV, which will be funded by CEPI.
The Vaccine Research Center, part of the US National Institute of Allergy and Infectious Diseases (NIAID), worked with Moderna to design the vaccine.
NIAID, part of the US-government funded National Institutes of Health, will conduct pre-clinical studies and a US-based phase 1 clinical study.
Big pharma joins hunt for coronavirus vaccine as outbreak escalates

Scientist who simulated virus global impact: ‘Cat’s already out of the bag’

‘Probably, the cat’s already out of the bag.’
Eric Toner, M.D.
Scientist and scholar Eric Toner, quoted above in an excerpt from a Friday interview with the business-news channel CNBC, explained that China’s efforts to contain the current outbreak of a fast-moving upper-respiratory illness are “unlikely to be effective.”
The comments come as the Centers for Disease Control and Prevention confirmed a second case of coronavirus in the U.S.
Cases of the illness, which is related to SARS, or severe acute respiratory syndrome, have now turned up in a number of countries beyond China, where the illness originated in Wuhan City.
The number of infections has risen to 1,300, according to the Wall Street Journal. On top of that, the official death toll has risen to at least 42, including a doctor treating flu-stricken patients in Wuhan, from 26 yesterday. The Journal also reported that the outbreak was overwhelming China’s local-area resources and hospitals.
Beijing has shut down parts of the Great Wall, as well as more than a dozen cities, restricting movement of some 46 million people, and canceling events related to the Lunar New Year, one of the busiest periods of travel and consumerism in the country.
The Journal on Saturday, citing people described as familiar with the situation, reported that a charter flight was being arranged by the U.S. government to evacuate U.S. citizens and diplomats from Wuhan.
CNBC reported that Hong Kong leader Carrie Lam has declared a virus emergency in the city of 7.3 million, extending school cancellations until Feb. 17 and barring visits to China.
Toner, an M.D. and researcher at the Johns Hopkins Center for Health Security, took part in a simulation, undertaken in partnership with the World Economic Forum and the Bill & Melinda Gates Foundation, that posited such a disease could kill 65 million people within 18 months under the right circumstances.
Coronaviruses, with SARS among that group, are infections of the respiratory tract that can lead to illnesses like pneumonia or the common cold.
Toner told Business insider during an interview that he hasn’t completed research on the current strain of the Wuhan coronavirus, known as 2019-nCoV, but said that the death toll could run in the millions if the influenza were resistant to modern vaccines and was as easy to catch as the common flu.

To be sure, an outbreak of SARS about 17 years ago claimed nearly 800 lives and infected more than 8,000 people worldwide. However, the death toll from that 2002-03 disease was nowhere near a million.
To put things into further perspective, the most virulent pandemic, the 1918 influenza, also known as the Spanish flu, killed an estimated 20 million to 50 million people.
Toner said that his coronavirus simulation “was not [focused primarily on] the number of deaths; it was to point out that there could be societal and economic consequences from a severe pandemic, not just health consequences.” The simulation was also geared toward engendering international cooperation, making the case that governments and private companies alone can’t adequately respond to a pandemic.
One report estimates that a pandemic could cause an average annual economic loss of 0.7% of global GDP — or $570 billion.
Meanwhile, the World Health Organization on Thursday wasn’t sounding global alarm bells about the illness either, declaring the coronavirus an emergency in China but falling short of calling the outbreak an international emergency. U.S. health officials also have said that the risk domestically from the illness is low.

However, the coronavirus was exacting a toll on the U.S. stock market. The Dow Jones Industrial Average DJIA, -0.58% on Friday lost 170 points, or 0.58%, closing just beneath 28,990 after having slipped as low as 28,843 in afternoon trading. Meanwhile, the S&P 500 SPX, -0.90% fell 30 points, or 0.9%, to 3,295. The Nasdaq Composite Index COMP, -0.93% declined by 87 points, or 0.93%, to finish the week at 9,315, after touching am intraday record high in early action.
Toner said the WHO may have made a mistake by not declaring 2019-nCoV an international emergency.

HHS: Calif.’s Abortion Coverage Mandate Violates Federal Law

The Department of Health and Human Services (HHS) sent California a letter saying that the state’s mandatory abortion coverage rule for insurers violates federal law and could result in federal funding for the state being withdrawn, the department announced Friday.
Roger Severino, director of HHS’s Office for Civil Rights, said Friday morning on a phone call with reporters that his office was also looking at other states for possible violation of the Weldon Amendment, which bars federal agencies from making grants to entities that discriminate against healthcare providers who don’t provide abortions. “We are aware of complaints with respect to other states and can’t comment on any potential or active investigations but we’re sending the message that if any state does what California has done would be likewise found to be in violation.”
Although Severino did not name specific states, three states require all private health plans to cover abortion with no copays, according to the Guttmacher Institute, a pro-choice organization that tracks abortion laws: Oregon, New York, and Illinois. Washington and Maine require private plans that cover prenatal care to also cover abortion. State laws covering insurance-related issues apply only to fully-insured health plans, not the “self-insured” plans offered by most large employers.
Issue Surfaced 6 Years Ago
In August 2014, California’s Department of Managed Health Care sent letters to seven health plans — Aetna, United Healthcare, Blue Shield of California, GEMCare, Anthem Blue Cross, Health Net, and Kaiser Permanente — informing them that “the Knox-Keene Health Care Service Plan Act of 1975 requires the provision of basic healthcare services and the California Constitution prohibits health plans from discriminating against women who choose to terminate a pregnancy. Thus, all health plans must treat maternity services and legal abortion neutrally” and must provide coverage for abortions. “As a result of this action, 28,000 people lost their plans that don’t cover abortion,” Severino said.
HHS received complaints about the coverage mandate from two California religious organizations, Severino said: the Missionary Guadalupanas of the Holy Spirit, a Catholic order of religious sisters; and Skyline Wesleyan Church, a non-profit Christian church. “This is a redux of the promises made under Obamacare: ‘If you like your plan, you can keep it,'” Severino said. “That’s not the case here,” since people who had previously “enjoyed abortion-free plans” had to either get another plan or drop out of insurance coverage altogether, he added. “That’s not only wrong, but it’s against the law.”
California has 30 days to come into compliance with the law, he added. “This is the second time California violated [the] Weldon amendment; now they’re repeat offenders.” Severino was referring to a 2018 Supreme Court case known as National Institute of Family and Life Advocates v. Becerra. The case involved a state requirement that crisis pregnancy centers, which offer pregnant women support services as an alternative to abortion, have to post a notice advertising that the state provides free and low-cost access to reproductive healthcare, including abortion. The Supreme Court sided with the crisis pregnancy centers, ruling that they didn’t have to post such a notice.
“Conscience laws have been left dormant and ignored by previous administrations for far too long, and violators will be held accountable,” said Severino. “If California wants to provide abortion services, they can do so. What the state is not free to do is force people to pay for other peoples’ abortions and force private employers to pay for coverage of other peoples’ abortions, and to force parents to pay for coverage for abortion for their children. That a state cannot do while receiving federal funds.”
Governor Weighs In
California Gov. Gavin Newsom (D) criticized the administration’s move. “Despite a federal opinion four years ago confirming California’s compliance with the Weldon Amendment, the Trump administration would rather rile up its base to score cheap political points and risk access to care for millions than do what’s right,” Newsom said in a statement. “California will continue to protect a woman’s right to choose, and we won’t back down from defending reproductive freedom for everybody — full stop.”
Groups on both sides of the issue also weighed in. “Today’s announcement is just the latest move in the administration’s unending effort to take away access to reproductive healthcare, including abortion, and ultimately to control women’s bodily autonomy,” Jamille Fields Allsbrook, director of women’s health and rights at the Center for American Progress, a left-leaning think tank here, said in a statement. “This rollback comes days after the Trump administration took the unprecedented step toward allowing Texas to use federal funds to discriminate against trusted family planning providers — including but not limited to Planned Parenthood — undermining patients’ access to sexual and reproductive healthcare.”
Allsbrook also criticized the Trump administration’s recently finalized rule requiring insurers on the Affordable Care Act’s health insurance exchanges who provide abortion coverage to issue separate bills for that coverage to their enrollees. “These three actions are among many this administration has taken over the course of the past 3 years to target reproductive healthcare,” she said.
Conservative Group Responds
In contrast, the Alliance Defending Freedom — a conservative legal organization — praised the move. “We commend the Trump administration and HHS’s Office for Civil Rights for investigating and taking corrective action against the state of California for its flawed policies, persistent violation of federal law, and its willful disregard for the civil rights and conscience rights of its citizens,” Alliance legal counsel Denise Harle said in a statement. “No one should force a church or any other employer to participate in funding abortion.”
The HHS action came on the same day as the annual March for Life here, organized each year by anti-abortion groups on or near the anniversary of Roe v. Wade, the 1973 Supreme Court decision legalizing abortion. President Trump appeared at the march, saying, “It is my profound honor to be the first president in history to attend the March for Life!” Previous presidents sent remarks on video to the march.
“Unborn children have never had a stronger defender in the White House,” Trump said. “Young people are the heart of the March for Life – and it is your generation that is making America a pro-family, pro-life nation!”
https://www.medpagetoday.com/obgyn/pregnancy/84528

China scrambles to contain ‘strengthening’ virus

The ability of the new coronavirus to spread is strengthening and infections could continue to rise, China’s National Health Commission said on Sunday, with nearly 2,000 people in China infected and 56 killed by the disease.
A handful of cases have been reported outside China, including in Thailand, Australia, the United States and France, with health authorities around the world racing to prevent a pandemic.
The newly-identified coronavirus has created alarm because there are still many unknowns surrounding it, such as how dangerous it is and how easily it spreads between people. It can cause pneumonia, which has been deadly in some cases.
China’s National Health Commission Minister Ma Xiaowei said the incubation period for the virus can range from one to 14 days, and the virus is infectious during incubation, which was not the case with Severe Acute Respiratory Syndrome (SARS).
SARS was a coronavirus that originated in China and killed nearly 800 people globally in 2002 and 2003.
“According to recent clinical information, the virus’s ability to spread seems to be getting somewhat stronger,” Ma told a packed media briefing on the second day of the Lunar New Year holiday, adding that knowledge of the virus was limited.
Containment efforts, which have thus far included transportation and travel curbs and the cancellation of big events, will be intensified, Ma said.
The virus, believed to have originated late last year in a seafood market in the central Chinese city of Wuhan that was illegally selling wildlife, has spread to cities including Beijing and Shanghai. Hong Kong has six confirmed cases.

President Xi Jinping said during a politburo meeting on Saturday that China was facing a “grave situation”.
On Sunday, China announced a temporary nationwide ban on the sale of wildlife in markets, restaurants, and e-commerce platforms. Wild and often poached animals packed together in Chinese markets are blamed as incubators for viruses to evolve and jump the species barrier to humans.
Snakes, peacocks, crocodiles and other species can also be found for sale via Taobao, an e-commerce website run by Alibaba.
The New York-based Wildlife Conservation Society called on China to make the ban permanent.
The U.S. State Department said it will relocate personnel at its Wuhan consulate to the United States and will offer a limited number of seats to private U.S. citizens on a Jan. 28 flight to San Francisco.
Japanese Prime Minister Shinzo Abe said on Sunday the government was working with Chinese authorities to arrange a charter flight for any Japanese nationals who wish to return from Wuhan.
The World Health Organization this week stopped short of calling the outbreak a global health emergency, but some health experts question whether China can continue to contain the epidemic.
On Sunday, China confirmed 1,975 cases of patients infected with the new coronavirus as of Jan. 25, while the death toll from the virus has risen to 56, state broadcaster CCTV reported.
No fatalities have been reported outside China.
The outbreak has prompted widening curbs on movements within China, with Wuhan, a city of 11 million, on virtual lockdown, with transports links all-but severed except for emergency vehicles.

CANCELLATIONS AND MISTRUST

Health authorities in Beijing urged people not to shake hands but instead salute using a traditional cupped-hand gesture. The advice was sent in a text message that went out to mobile phone users in the city on Sunday morning.
Beijing also postponed the reopening of the city’s schools and universities after the Lunar New Year holiday, state radio reported. Hong Kong had already delayed the reopening of schools to Feb. 17.
Health officials in Orange County, California, reported that a third case of the virus had been registered in the United States, in a traveler from Wuhan, who was in isolation and in good condition.
On Saturday, Canada declared a first “presumptive” confirmed case in a resident who had returned from Wuhan. Australia confirmed its first four cases.
China has called for transparency in managing the crisis, after a cover-up of the spread of the deadly SARS virus eroded public trust, but officials in Wuhan have been criticized for their handling of the current outbreak.
“People in my hometown all suspect the real infected patients number given by authorities,” said Violet Li, who lives in the Wuhan district where the seafood market is located.
“I go out with a mask twice a day to walk the dog – that’s the only outdoor activity,” she told Reuters by text message.
The outbreak has overshadowed the start of the Lunar New Year, when hundreds of millions of Chinese travel at home and abroad to be with families, with public events canceled and many tourist sites shut.
Overall passenger travel declined by nearly 29 percent on Saturday, the first day of the Lunar New Year, from a year earlier, with air passengers down nearly 42 percent, a transportation ministry official said.
Many cinemas across China are also closed with major film premieres postponed.
Cruise operators including Royal Caribbean Cruises, Costa Cruises, MSC Cruises and Astro Ocean Cruises said that they canceled a combined 12 cruises that had been scheduled to embark from Chinese ports before Feb. 2.
Hong Kong Disneyland and the city’s Ocean Park were closed on Sunday. Shanghai Disneyland, which expected 100,000 visitors daily through the Lunar New Year holidays, has already closed.
Airports around the world have stepped up screening of passengers from China, although some health officials and experts have questioned the effectiveness of these efforts.
https://www.reuters.com/article/us-china-health/china-scrambles-to-contain-strengthening-virus-idUSKBN1ZP02B

Supermarkets Close Pharmacy Counters

In some towns, it’s getting harder to pick up your blood-pressure pills with that gallon of milk and rotisserie chicken.
Hundreds of regional grocery stores in cities from Minneapolis to Seattle are closing or selling pharmacy counters, which have been struggling as consumers make fewer trips to fill prescriptions and big drugstore chains tighten their grip on the U.S. market.
Grocery pharmacies are getting hit on several fronts, analysts and the companies say. They are too small to wrest competitive reimbursement rates on drugs, they aren’t connected to big medical networks or insurers, and they generally lack walk-in clinics and other health services that draw many customers to CVS and Walgreens locations.
“Our establishment had a community feel, it wasn’t overly busy so we got to really care for our customers,” said Phillip Breker, who managed a now-closed pharmacy at Lunds & Byerlys, a Minneapolis-area grocery chain. “I also saw the numbers in the back end and how that soured in the last 10 years. The company made the right decision.”
Grocery pharmacies are the latest casualty of industry consolidation that has for years been forcing mom-and-pop drugstores to close. Even some big players have rethought the market. Target Corp. sold off its pharmacy business to CVS Health Corp. five years ago.
Supermarkets have viewed pharmacies as a tool to draw shoppers in. Fueled by easy profits and relatively low startup costs, legions of stores added pharmacy counters in the 1980s and 1990s. Grocery drugstores proliferated to account for roughly 14% of retail pharmacy prescriptions, according to the National Association of Drug Stores.
The number of grocery pharmacies declined for the first time in years in 2017, the latest year for which data is available, to 9,026, down from 9,344 in 2016.
Consumers are increasingly getting 90-day supplies of their medicines or getting prescriptions delivered in the mail. Those trends are resulting in a decline in foot traffic to supermarket pharmacies, which were typically located at the back of stores. Meantime, profits are ever harder to come by as the health-care industry consolidates.
CVS and Walgreens Boots Alliance Inc., the nation’s biggest players, contributed more than 40% of U.S. prescription revenues in 2018, according to Drug Channels Institute, which provides research on the drug supply chain.
The chains, which now either own or have partnerships with the biggest insurers and pharmacy-benefit managers, are able to secure better deals on drug costs that largely shut out the industry’s smaller players. Pharmacy-benefit managers serve insurers and other clients by choosing which medicines to cover and pushing for lower prices from drugmakers and sellers.
CVS and Walgreens also are working to transform drugstores into health-care hubs, offering services from blood testing to chronic-disease management.
“The biggest companies in health care now have pharmacists and doctors, they own medical practices, and they own urgent-care clinics,” Baird analyst Eric Coldwell said. Grocery pharmacies “have none of this. They have a store to go into to buy lemons and bread.”
The tougher conditions come as the entire drugstore industry copes with a shift to online shopping and shrinking profits in prescription medicines, which often disproportionately affect smaller players.
Walgreens and CVS have closed or are closing more than 300 underperforming stores, while Rite Aid Corp., the No. 3 U.S. chain, is struggling to turn itself around after regulators blocked a merger with Walgreens in 2017.
Raley’s Supermarkets, a West Sacramento, Calif., chain of about 120 stores, last year shut down a third of its roughly 100 pharmacies and transferred prescriptions to nearby Walgreens, CVS and Rite Aid stores. Those grocery pharmacies had low prescription rates, were losing money and didn’t merit high operating and labor costs, according to Raley’s.
“There is the benefit of having a pharmacy relative to the grocery-sale lift and the convenience factor of having both in the store, but the economics do not work,” said Keith Knopf, chief executive of Raley’s.
Profitability for grocers has become harder to achieve in recent years, and pharmacies play a less important role today in attracting customers, Mr. Knopf said. Raley’s is cutting hours for the remaining pharmacies to improve profits and create efficiency. Pharmacies make up roughly 20% of Raley’s total sales.
Many grocers still view pharmacies as a key part of their business. Kroger Co., the biggest U.S. supermarket chain, said its pharmacy business is expected to improve this year after lower-than-expected profits in 2019. Kroger has said pharmacy shoppers tend to be more loyal, spending three times as much as nonpharmacy customers.
“We’ve been able to connect the relationship with food and are starting to build out new revenue streams,” Kroger finance chief Gary Millerchip said at an investor meeting in November.
Lunds & Byerlys, the Minnesota chain, shut all 14 of its supermarket pharmacies last year. At each location, it posted a sign that has become increasingly common: “The pharmacy is now closed. Your prescription records have been transferred to Walgreens.”
Mr. Breker, the pharmacy manager, now works for Walgreens at a location in a nearby town. “I literally cried at the counter with dozens of people,” he said. “They felt a loss here.”
https://www.marketscreener.com/CVS-HEALTH-CORPORATION-12230/news/The-Pharmacist-Is-Out-Supermarkets-Close-Pharmacy-Counters-29893604/