EU in advanced talks with Johnson & Johnson on COVID-19 vaccine deal

The European Commission is in advanced talks with pharmaceutical giant Johnson & Johnson to reserve or buy up-front doses of its COVID-19 vaccine under development, two officials familiar with the talks told Reuters.

The move would be the first arranged by the European Union executive since it was mandated last week by the 27 EU national governments to use an emergency fund with more than 2 billion euros ($2.3 billion) available to reach advance purchase or call-option deals with up to six vaccine makers.
The Commission’s deal with the U.S. firm Johnson & Johnson is “in the pipeline”, a top health official from an EU member state said, asking to remain anonymous as was mentioning confidential discussions about vaccines between the EU executive and EU governments.
A second EU source said the Commission had a call with Johnson & Johnson on Tuesday over the possible agreement on its potential vaccine.
A Commission spokesman had no comment. Johnson & Johnson was not immediately available for comment outside U.S. business hours.
It was unclear whether any deal would involve an advance purchase of the vaccine in testing, or an option to buy it.
Johnson & Johnson plans next month to start human clinical trials for its experimental vaccine against the highly contagious coronavirus, which has infected more than 8.36 million people worldwide, with 447,985 deaths.

Germany, France, Italy and the Netherlands said last week they had acquired 400 million potential vaccine doses, in principle available to all member states, from British drugmaker AstraZeneca, which is developing a COVID-19 shot in conjunction with Oxford University.
AstraZeneca signed a similar deal in May with the United States.

DEAL AS SOON AS NEXT WEEK?

The health official from an EU state said the EU deal with Johnson & Johnson could be announced as early as next week, but cautioned that it might take a little longer to finalise, and there were still chances it might not be struck at all.
EU decision-making procedures pose a sticking point for the potential deal, with member states still in talks over the establishment of a steering board for vaccine negotiations with drugmakers, officials told Reuters.
They said that under a draft plan devised by the EU Commission, which is still to be approved by EU governments, a green light from just four member states would be enough to start formal EU talks with a drugmaker.
But, underlining the urgency of securing a vaccine for the EU’s 450 million population, the Commission had already begun talks with Johnson & Johnson even before the steering board has been agreed.

By buying vaccines under development, the EU risks acquiring shots that may eventually prove unsuccessful against COVID-19.
But the risk is justified by the need to secure enough doses for the EU population in the global race for an effective vaccine, EU officials say.
https://www.reuters.com/article/us-health-coronavirus-eu-vaccine/exclusive-eu-in-advanced-talks-with-johnson-johnson-on-covid-19-vaccine-deal-sources-idUSKBN23P1PU

Beijing’s coronavirus outbreak under control, Chinese medical expert says

Beijing has brought its latest coronavirus outbreak under control, a Chinese medical expert said on Thursday, although the capital can still expect sporadic new cases.

The city has recorded 158 infections since confirming the first on June 11 in its worst outbreak since early February, which has been traced to the sprawling wholesale food centre of Xinfadi in its southwest.
Despite just a few cases compared to numbers outside China, authorities have acted quickly to curb contagion risks in the capital, which had recently won praise for its tough countermeasures.
A mere few days after the first case, the city returned to a level two alert, the second-highest in a four-tier virus emergency response system, leading to new curbs on residents’ movements.
“The epidemic in Beijing has been brought under control,” said Wu Zunyou, the chief epidemiologist of China’s Center for Diseases Prevention and Control.
Going by recent case numbers, June 13 was the peak of the current outbreak, Wu told a regular news conference a day after new confirmed cases fell to 21, from 31 the previous day.
“When I say that it’s under control, that doesn’t mean the number of cases will turn zero tomorrow or the day after,” he warned, however.
“The trend will persist for a period of time, but the number of cases will decrease, just like the trend that we saw (in Beijing) in January and February.”

TOUGH CURBS

While Beijing has not been placed under a strict lockdown for all but a trickle of authorised personnel, as imposed in the central city of Wuhan where the virus first emerged late last year, the Chinese capital has imposed tough travel curbs.
Residents of 32 neighbourhoods designated medium-risk and one area deemed high-risk have been barred from leaving the city, while residents of low-risk areas must show proof of negative disease tests in order to leave the city.
Hundreds of thousands of residents have been tested in just a few days as authorities stepped up efforts to identify those infected by the Xinfadi cases or who caught the virus there.
Since May 30, as many as 200,000 people from all over Beijing have been to Xinfadi, officials said.
People trying to enter Beijing must also be tested and isolated at centralised locations for quarantine.
Air and land transport services have been curbed. Other provinces and cities, including the financial hub of Shanghai, are subjecting arrivals from Beijing to days of quarantine, effectively deterring travellers.
In the past week, the provinces of Hebei, Liaoning, Sichuan and Zhejiang have reported a handful of cases linked to the Xinfadi cluster.

A small city in Hebei with new infections due to Beijing went into a partial lockdown on Thursday, denying vehicles entry and stopping residents with fever and coughs from leaving.
https://www.reuters.com/article/us-health-cornavirus-china/beijings-coronavirus-outbreak-under-control-chinese-expert-says-idUSKBN23P029?il=0

NYC businesses clamoring to enter Phase Two, but confused by de Blasio

Confusion is rampant as Big Apple businesses seeking to open under Phase Two as soon as next week grapple with unclear guidance from Mayor Bill de Blasio — and whether or not they’ll be able survive in a coronavirus-ravaged world.
“New York State came out with some guidelines, but is the city following those or does the city have its own guidelines?” wondered James O’Brien, the co-owner of Brooklyn restaurant Popina Wednesday.
“It’s not like I’m just sitting back hitting refresh on [city] websites every day looking for guidance, I’m out here working trying to save this business,” the Cobble Hill restaurateur told The Post.
Gov. Andrew Cuomo said Wednesday that New York City is on track to enter Phase Two of the state’s four-phase reopening plan this coming Monday, but de Blasio has still not committed to that date and continues to say only that a city outdoor dining plan will come “soon.”
Rita Ragone, a celebrity beauty expert who operates a Midtown hair salon that can finally reopen for business in Phase Two, griped, “When the governor and mayor don’t see eye to eye on a reopening date for service industries such as salons … it really becomes a frustrating issue for our businesses and livelihoods.
“So many are hanging in the balance of deciding to open or leave New York City for good. But for those of us that are willing and more than prepared to open, we can’t book, can’t hire back employees, and our business plans are in limbo,” Ragone said. “It’s just ridiculous.”
Restaurants and bars can open for outdoor dining under Phase Two, as well as office spaces, real estate services, in-store retail, barbershops and hair salons, car dealerships and houses of worship — all at limited capacity.
“It’s frustrating because we can’t really prepare,” said Victor Ortega, the co-owner of Black Iron Burger, which has two outposts  — one in Midtown and the other in Brooklyn’s Park Slope, where the mayor owns two houses.
Andrew Rigie, the head of the NYC Hospitality Alliance, told The Post, “There is incredible uncertainty and even desperation among many restaurant owners who can no longer manage the financial burden of being shut down by the government.”
“Getting the outdoor dining requirements rolled out as soon as possible so they can plan is critically important, but these small business owners also need to know when they will be permitted to open so they can plan and start bringing some money into their businesses,” Rigie added.
De Blasio has previously said Big Apple restaurants will be able to temporarily create seating on sidewalks, in parking spaces and in open streets during Phase Two — and has said that the city will identify new open streets on commercial strips with a high number of eateries and bars — but has still not unveiled the locations of those streets.
Abi Yavuz, 41, the owner and manager of Verde, an eatery on Smith Street in Carroll Gardens, Brooklyn said that Smith Street, known as Brooklyn’s Restaurant Row, is a natural contender to turn into an open street.
“From Union Street to Atlantic Avenue, there’s 80 percent restaurants,” said Yavuz, who explained that the four tables he will only be allowed to have spaced six-feet-apart in his eatery’s backyard won’t be enough.
“Nobody will be able to make money,” he said.
With more space to put out tables, Yavuz said he can serve up to 40 people instead of just a maximum of 16 people in the restaurant’s backyard.
“At least if we have outdoor seating in front of the restaurant I could put 10 tables for four, which means 40 people, so I won’t lose 60, 70 percent of business,” he said.
The de Blasio administration said that any of the Big Apple’s 26,000 restaurants can utilize curbside seating as long as they comply with city guidelines and register online through a self-certification process.

 

Stephen Elkins, the owner of Forest Hills Station House, a bar in Forest Hills, Queens said that the “uncertainty” surrounding the reopening process “has been incredible.”
“It’s been terrible just trying to figure out how to go about doing business. I don’t see why the mayor wouldn’t put a stamp on [the Phase Two date],” said Elkins, adding that business at the watering hole has been down 75 percent.
“I’m only excited for Phase Two because it gets us closer to Phase Three when we can have a 50 percent capacity indoor crowd.”
Those in the real estate industry were just as eager.
“We’ve been prepared for this from having already opened in our markets in California, Texas and Florida. We’re ready for it, we’re queued up for everything we need to do,” said Douglas Elliman president Scott Durkin.
“It would be wonderful if the state and local governments in New York would decide that we’d be reopening on Monday,” said Durkin, noting that the city real estate world is ready to boom.
“Between our agents being ready and chomping at the bit to get back to work, they’re being pushed by their buyers and sellers to get back to work because everyone has a need,” he said. “We’ve never seen such pent up demand like this.”
Retail shops can’t wait to welcome customers back inside, either.
Arthur Lee, a manager at The Gold Standard, a jewelry and pawn shop in Forest Hills, Queens, said, “A big part of our business is helping people who need cash, and I’m excited to deal with them in a more personal and respectful way, where there are less barriers.”
He has been hoping for the city to move into Phase Two on Monday so he can actually let customers into the store to try on jewelry as well.
Lee claimed that the mayor “doesn’t commit to a lot of things, and when he does it’s usually the wrong choice.”
“I don’t think in the end he’ll agree to Monday. I think he’ll push it to the first week of July. But we’ll see. We’re watching,” said Lee.
Linda Pagan, the owner of The Hat Shop in Soho, echoed those remarks about de Blasio, saying, “He doesn’t seem to take decisive action. It can be frustrating.”
“I just want to do it the right way, in an organized way, so that we can put it behind us and then get back to business,” said Pagan.
https://nypost.com/2020/06/17/nyc-businesses-want-to-enter-phase-two-but-confused-by-de-blasio/

NYC, state failed to fund nursing home watchdogs – report

The city and state severely shortchanged a federally mandated program designed to protect nursing home residents, leading to the disproportionate death toll of elderly New Yorkers from the coronavirus, a new report by City Comptroller Scott Stringer charges.
The investigation found that New York City has just one full-time ombudsman for every 8,650 long-term-care residents when national guidelines dictate one watchdog for every 2,000 people.
There are only six watchdogs assigned to visit the city’s 50,000 residents across 244 facilities. In Queens, a single ombudsman assisted by nine volunteers is responsible for watching over 17,000 residents in 84 facilities.
Over 20,000 residents in 80 long-term care facilities across the five boroughs have no assigned ombudsman.
The state ranked 40th nationally in full-time ombudsmen per bed in 2018.
Mayor de Blasio contributed zero dollars to five years of funding for the program in 2017, and Gov. Cuomo contributed just $600,000 for the city. The lowball amount works out to $7.34 per resident bed while the rest of the nation spends more than twice that on the program, according to the report.
“This investigation is heartbreaking, especially as New York City continues to battle the global COVID-19 pandemic that has devastated our parents and grandparents in long-term-care facilities,” Stringer said.

Under fire, Gov. Cuomo announces probe of nursing home coronavirus allegations

“Tragically our failure to support long-term care can be measured in human suffering amid the pandemic. The disproportionately high number of COVID-19 deaths among our long-term-care-facility residents must be a wake-up call,” he added.
The ombudsmen identify abuse and neglect in nursing homes and other long-term-care facilities but have been barred along with other visitors from checking in on residents during the coronavirus pandemic.
State Assemblyman Richard Gottfried (D-Manhattan) has asked the governor to connect residents to ombudsmen through the telephone and e-mail during the crisis.

 

“Scott Stringer is right on target about the underfunding of the Long Term Care Ombudsman Program,” Gottfried told The Post.
“It’s a vital program for nursing-home residents and their families, and it relies heavily on volunteers. Our nursing homes are chronically understaffed, and the state’s quality enforcement is understaffed and lax,” he said.
Of the state’s nearly 25,000 coronavirus deaths, 6,208 were nursing-home residents, about half of those fatalities were in New York City facilities.
Stringer recommends increasing city and state funding to at least $2.5 million annually to provide for a full-time ombudsman for every 2,000 nursing-home residents.
A spokeswoman for de Blasio claimed funding for the program was the state’s sole responsibility.
A rep for Cuomo said visitors were barred from the facilities during the pandemic to stop the spread of COVID-19.
“The thesis of this report is just plain wrong,” said Cuomo spokesman Richard Azzopardi.
He added that the state’s Department of Health has inspected 1,000 nursing homes since March 1, and last year ombudsmen investigated 4,880 complaints.
“We’re currently working on ways to reinvent the program to expand volunteer base and give increased options for communication between residents and ombudsmen that are less reliant on in-person visits,” Azzopardi said.
https://nypost.com/2020/06/17/nyc-albany-failed-to-fund-nursing-home-watchdogs-report/

Chi-Med’s fruquintinib Fast Track’d for colorectal cancer

The FDA has granted Fast Track Designation for the development of Hutchison China MediTech’s (NASDAQ:HCM) fruquintinib, for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor therapy.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Chi-Med is initiating a Phase III registration study, known as the FRESCO-2 study, in refractory mCRC in U.S., Europe and Japan.  patient enrollment is expected to begin in mid-2020.

HCM retains all rights to fruquintinib outside of China and is partnered with Eli Lilly in China.

https://seekingalpha.com/news/3584023-chi-meds-fruquintinib-fast-trackd-for-colorectal-cancer

‘Warp Speed’ plan for coronavirus vaccines comes into focus

• Drugmakers selected for “Operation Warp Speed,” the White House’s ambitious plan to develop a coronavirus vaccine in record time, will enjoy priority access to manufacturing capacity secured by the U.S. government, as well as to needed supplies like glass vials.
• Announced by President Donald Trump on May 15, Operation Warp Speed is a Manhattan Project-like attempt to test, manufacture and distribute a safe and effective vaccine to Americans by early next year. On Tuesday, administration officials shared more specifics, revealing they aim to have 300 million doses ready by January 2021.
• Whether any vaccine is proven by then to prevent coronavirus infection is far from guaranteed, however. A handful of experimental vaccines, such as Moderna’s and AstraZeneca’s, have advanced quickly into mid-stage testing, with large Phase 3 trials planned for this summer. U.S officials said they aim to support about seven candidates through Operation Warp Speed.

The U.S. government has already committed sizable funds to advance vaccine candidates from Moderna, Johnson & Johnson and AstraZeneca, as well as a smaller sum for a vaccine being developed by Sanofi and GlaxoSmithKline.
That money, granted through the Biomedical Advanced Research and Development Authority, will support large-scale clinical studies, as well as help fund the manufacture of hundreds of millions of doses in parallel with testing.
No companies have been announced as among the roughly seven finalists envisioned by Operation Warp Speed, although The New York Times and Bloomberg reported in early June that the field had been narrowed to include five to seven drugmakers.
Meanwhile, the U.S. is also investing in contract manufacturers, producers of drug vials and syringe makers — capacity and supplies that would be preferentially available for developers taking part in Operation Warp Speed.
New York-based Corning, for example, recently received $204 million from the U.S. government to ramp up its production of a more durable type of glass vial. Access will be prioritized for “designated BARDA vaccine and drug development partners,” Corning said.
Contract manufacturer Emergent Biosolutions, which was awarded up to $628 million by BARDA, said it will support the “leading COVID-19 vaccine candidates selected by the U.S. government.” The Maryland-based company is already working with AstraZeneca and J&J.
“Vaccine, therapeutic and diagnostic developers involved with OWS will be the primary beneficiaries of the manufacturing and distribution capacity,” a senior administration official said in a statement to BioPharma Dive. “However, OWS will not reject the idea of assisting other developers with promising solutions.”
Developing a safe and effective vaccine in the 12 to 18 month timeline being pushed by U.S. government officials would be a tremendous scientific feat in and of itself. But producing any such vaccine at a global scale, and distributing it to hundreds of millions of people, is also a monumental challenge — making the additional support the U.S. government can bring potentially critical.
Drug vials, for instance, could be a major bottleneck for vaccine developers.
“The challenge is not so much to make the vaccine itself, it’s to fill vials,” said Pascal Soriot, CEO of AstraZeneca, on a May conference call hosted by an industry trade group. “There’s not enough vials in the world.”
Through investments in Corning and a lesser known company called SiO2, the U.S. government hopes to boost vial production by nearly 300 million vials per year.
Stevanato, Gerresheimer and Schott — three of the world’s largest vial manufacturers — said Tuesday they’re committed to supplying enough vials for any successful coronavirus vaccine.
The U.S. government’s support comes with conditions, though. Companies that are backed by Operation Warp Speed will provide the U.S. government an allocation of the vaccines they develop, and a senior administration official said Tuesday a successful vaccine would be available for free to any American who can’t afford to pay.
Americans would be first in line for vaccines procured by the U.S. government but, “to the extent there is a surplus, [the U.S. has] an interest to ensuring folks around the world are vaccinated,” the official said.
https://www.biopharmadive.com/news/warp-speed-coronavirus-vaccine-benefits/579991/

GSK arthritis treatment Voltaren approved for over-the-counter sales

GlaxoSmithKline’s Voltaren Arthritis Pain Gel, which was formerly a prescription drug, can now be purchased over-the-counter, the company announced Tuesday.
The treatment has been available as a doctor-prescribed treatment for more than 10 years. The FDA approved Voltaren for over-the-counter sale in February and it has just now hit stores as an OTC product. It’s the first OTC prescription-strength, non-steroidal anti-inflammatory topical gel for arthritis pain available in the U.S., according to GlaxoSmithKline.

GlaxoSmithKline partnered with pop star Paula Abdul for an ad campaign announcing the treatment’s new over-the-counter status.
Abdul said in a statement that her doctor previously prescribed her Voltaren for her own arthritis.

“I’ve put my joints through a lot over the years,” she said. “Dancing, jumping, flipping – it’s my heart and soul, but I’ve been pushing my joints to the limit for decades as a result.”
More than 32 million people in the U.S. suffer from osteoarthritis, the most common form of arthritis, according to the Centers for Disease Control and Prevention. The condition is caused by damage to joint cartilage between bones. It can leave people in aching pain and with stiffness, decreased flexibility and swelling.

“The OTC availability of Voltaren Arthritis Pain helps to provide greater access to an effective topical treatment option for joint pain patients, so more people with osteoarthritis pain can find relief,” said Jissan Cherian, U.S. director of OTC marketing for GlaxoSmithKline’s consumer healthcare.

The arthritis drug market was worth nearly $25 billion as of 2018 and is forecast to reach more than 36 billion by 2027, according to market research firm Reports and Data.
https://www.foxbusiness.com/markets/gsk-arthritis-treatment-voltaren-approved-for-over-the-counter-sales