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Covis Pharma’s statement to The Times about Makena

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The next combines a number of statements from Covis Pharma despatched by way of e mail. It has been organized for readability.

Covis Pharma’s response:

Makena is the one FDA-approved remedy to cut back the chance of preterm beginning in ladies with a historical past of spontaneous preterm beginning and its security profile for the mom and child are properly established. As such, Covis is concentrated on extra analysis to additional show the efficacy of Makena and to protect continued, inexpensive entry for indicated sufferers.

The present regulatory standing pertains particularly to conflicting efficacy information, because the product’s security was confirmed in each the unique scientific trial [known as the Meis trial] that resulted within the accelerated approval and within the subsequent confirmatory trial.

17P is the one FDA-approved class of branded and generic remedies to assist forestall the chance of preterm beginning in ladies with a historical past of spontaneous preterm beginning, and the totality of information on 17P and the branded model Makena helps its continued constructive benefit-risk profile and the necessity for continued affected person entry.

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On condition that Makena quickly grew to become the usual of care within the U.S. following its approval primarily based on the outcomes of the Meis trial, it grew to become infeasible to enroll high-risk sufferers within the U.S. in a placebo-controlled confirmatory scientific trial. It was due to this fact essential to enroll sufferers outdoors of the U.S. within the confirmatory trial, referred to as PROLONG. Consequently, the demographics of enrolled sufferers in PROLONG had been considerably completely different from these enrolled within the U.S.-based Meis trial, together with an total decrease danger of preterm beginning (in each the placebo and remedy arms).

Extra particularly, Meis enrolled 59% U.S. black ladies whereas PROLONG solely enrolled 6.6% U.S. black ladies. PROLONG affected person inhabitants was overwhelmingly made up of white European ladies. The relevance of the distinction in demographics is the social determinants of well being and due to this fact the completely different degree of preterm beginning danger every group could also be topic to.

Whereas each trials demonstrated a constructive security profile for 17P, Meis — which had a various, U.S.-based participant inhabitants — and PROLONG — which had an overwhelmingly white, lower-risk European participant inhabitants — confirmed completely different efficacy outcomes.

In 2020, preterm beginning and its issues had been the second-largest contributor to toddler dying throughout the nation, disproportionately affecting folks of shade who’re regularly underrepresented in scientific research.

We’re dedicated to serving to suppliers and indicated sufferers entry Makena and the Makena Care Connection helps sufferers by connecting eligible sufferers to prescription assist and monetary help. Since 2018, ~115,000 sufferers have been directed to Makena Care Connection by their physicians. As well as, beneath Covis’ possession, Covis has diminished the web worth of Makena for its payer and state purchasers, which is reflective of Covis’ dedication to creating Makena accessible to at-risk sufferers.

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We observe that the $700 worth per dose isn’t correct and the precise worth per dose for many payers and states is considerably much less.

Covis has urged the FDA to permit for additional research throughout the U.S. well being care system to grasp which, if any, populations could profit most from 17P. We’re happy that the FDA has granted our request for a listening to to deal with these crucial points.

Covis is unable to touch upon actions carried out by AMAG Prescribed drugs previous to Covis’ possession, together with any feedback made on the FDA Advisory Committee assembly in 2019.

Concerning the research by the Public Well being Institute in Oakland that discovered a most cancers danger: Excluding the formulation, this research affords no comparability to Makena, the one FDA-approved remedy to cut back the chance of preterm beginning in ladies with a historical past of singleton spontaneous preterm beginning, nor does it distinguish between an earlier model of the drug launched within the Nineteen Fifties to deal with a distinct affected person inhabitants for a distinct goal. Present scientific steering stays unchanged, as famous by the American School of Obstetricians and Gynecologists, which has acknowledged that “as a consequence of limitations within the design, the research’s findings usually are not conclusive and shouldn’t affect observe.”

We are able to additionally refer you to the next supplies for extra background on 17P:

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• “Position of progestogens in ladies in danger for spontaneous preterm beginning: the ultimate phrase?” Ibrahim SA, Haas DM. Lancet; 397:1158-1159. (2021)

• “Security evaluate of hydroxyprogesterone caproate in ladies with a historical past of spontaneous preterm beginning” Sibai B, Saade GR, AF Das AF, Gudeman J. J Perinatol. (2020)

• “Re-examining the Meis Trial for Proof of False-Constructive Outcomes” Sibai B, Saade GR, Das AF. Obstet Gynecol; 136(3):622-627. (2020)

• ACOG Assertion on 17p Hydroxyprogesterone Caproate (2019)

• “17-OHPC to Forestall Recurrent Preterm Start in Singleton Gestations (PROLONG Examine): A Multicenter, Worldwide, Randomized Double-Blind Trial” Blackwell SC et al. J Perinatol; 37(2):127-136. (2019)

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• “4-12 months follow-up of youngsters uncovered to 17alpha hydroxyprogesterone caproate (17P) in utero” Northern A. Am J Obstet Gynecol; 195(6,56). (2006)

• “Prevention of Recurrent Preterm Supply by 17 Alpha-Hydroxyprogesterone Caproate” Meis PJ et al., N Engl J Med; 348:2379-2385. (2003)

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TikTok cyberattack targets CNN, Paris Hilton and other high-profile accounts

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TikTok cyberattack targets CNN, Paris Hilton and other high-profile accounts

TikTok is investigating a cyberattack targeting “a number of high-profile” accounts, including media outlet CNN and celebrity Paris Hilton.

The social media giant said this week in a statement that it is in direct contact with “affected account owners to restore access, if needed,” and has taken measures to prevent future incidents.

In particular, a TikTok spokesperson said, the company has been “collaborating closely with CNN to restore account access and implement enhanced security measures” after the news organization was targeted on the app by “malicious actors.”

“We are dedicated to maintaining the integrity of the platform and will continue to monitor for any further inauthentic activity,” the TikTok rep added.

The spokesperson did not provide any information about the identities and possible motive of the hackers. According to the Associated Press, the attack occurred through the app’s direct-messaging feature and one of the other marks was Hilton. The attack on Hilton’s account was unsuccessful, said a person familiar with the matter who was not authorized to comment.

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The Times has reached out to reps for CNN and Hilton for comment.

The cyberattack is the latest hurdle for TikTok, which sued the United States government last month for creating a new law that would effectively ban the short-form video platform in the country unless its current Chinese parent company, ByteDance, sells the app’s American operations.

Several TikTok content creators have also taken legal action against the government for allegedly violating their free speech rights with the legislation.

Additionally, TikTok is facing a round of layoffs expected to affect employees in its global content, marketing and user departments, according to technology-focused news outlet the Information, which first reported on the job cuts.

Times staff writer Wendy Lee and the Associated Press contributed to this report.

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After repeated delays, Starliner finally blasts into space

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After repeated delays, Starliner finally blasts into space

Beoing’s Starliner capsule with two astronauts aboard was finally launched into space Wednesday after a series of delays that have vexed the troubled aerospace giant.

The test flight of the crew ship, developed to service the International Space Station, took off as scheduled at 7:52 a.m. Pacific from the Cape Canaveral Space Force Station in Florida.

The capsule reached orbit after 32 minutes of flight and is expected to dock with the station around 9:15 a.m. Pacific tomorrow. It’s the first time the capsule has carried astronauts after two prior uncrewed test flights.

The last scheduled launch of the CST-100 Starliner, which is years behind SpaceX in servicing the space station, was halted Saturday less than four minutes before liftoff by the ground computer that controls the final steps of the process. The problem was traced to a faulty computer power supply unit that was replaced.

The capsule was originally set to blast off May 6, but that flight was scuttled hours before liftoff because of a malfunctioning valve on the Atlas V rocket that launches it into space. The Atlas V, considered a reliable workhorse, is manufactured by United Launch Alliance, a joint venture of Boeing and Lockheed Martin.

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Additional launch dates were missed last month after a helium leak was found in the Starliner’s propulsion system, which maneuvers the capsule. NASA and Boeing officials decided the leak was not serious enough to replace a defective seal, which would have taken months, and instead developed software fixes to work around it.

“For all practical purposes, SpaceX has become the player in the launch market. It’s never good to have a monopoly,” said aerospace analyst Marco Caceres of Teal Group, who applauded the flight’s initial success. “The best Boeing can hope for now is that they remain a player in this segment of the market.”

The 15-foot diameter capsule is only the sixth spacecraft that NASA astronauts have ridden since the dawn of the space age, the first being the Project Mercury capsule and the most recent being SpaceX’s Crew Dragon.

Veteran astronauts Butch Wilmore and Suni Williams, who have previously flown to the space station, are expected to spend about a week testing the capsule before returning to Earth mid-month.

The capsule will touch down in the Arizona or New Mexico desert in a parachute ground landing pioneered by the Soviets decades ago, rather than the ocean landings typical of U.S. space flights. Ground landings make it easier to refit the reusable capsule for future missions, though Starliner also can land in water in an emergency.

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The flight, also carrying 760 pounds of cargo to the space station, is critical for the Arlington, Va., aerospace company, which is far behind SpaceX in launching a crewed capsule to service the space station.

Both companies were given multibillion-dollar contracts in 2014 to develop their crafts, and since 2020 Elon Musk’s Hawthorne company has ferried more than a half dozen crews aboard its Crew Dragon to the station — while Boeing has managed only two remote flights, including one in May 2022 that docked with the orbiting lab.

The companies were chosen by NASA after the agency has had to rely on the Russian program to send U.S. astronauts to the station when the space shuttle program ended in 2011. Assuming the Starliner mission goes well, it would then be certified to send four-person operational crews to the station for six-month missions. NASA would then have two U.S. spacecraft to service the station, but it also plans to continue to send some American astronauts via the Russian Soyuz craft.

Russia and the U.S. were the primary builders of the space station, and play critical roles in keeping it aloft.

Boeing has reportedly had to eat $1.5 billion in Starliner cost overruns and can ill afford a failure, especially after two crashes of its 737 Max 8 jets and the blowout of a door plug during a 737 Max 9 flight this year to Ontario International Airport in San Bernardino County.

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Clifton's is reopening (again), this time in a changed downtown

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Clifton's is reopening (again), this time in a changed downtown

Andrew Meieran is about to reopen the doors of one of L.A.’s legendary restaurants in a bid to once again make it an offbeat dining and entertainment destination.

Meieran is the proprietor of Clifton’s Republic, the kitschy, forest-themed restaurant on Broadway in downtown’s Historic Core that for nearly a century served up comfort food such as pot roast, mashed potatoes and Jell-O. The five-story restaurant and bar complex has been closed for the last year after a burst water pipe caused a flood that destroyed the kitchen and collapsed the ceilings on three floors.

Clifton’s is scheduled to reopen next month after extensive repairs and renovations. Among the changes patrons will find is a basement venue several years in the making that Meieran said is “dedicated to innovation and the magic of experiences” with “entertainment, cocktails and culinary offerings.”

Meieran is keeping details under wraps for now, but he has demonstrated a knack for creating provocative entertainment and dining venues through an obsessive attention to offbeat details, as well as a willingness to spend more money than most real estate developers to realize his vision and preserve the historic integrity of his projects.

A Bay Area transplant with a background in real estate development and filmmaking, Meieran emerged on the L.A. scene in 2007 when he opened the Edison, a subterranean nightclub he created in a former power plant deep under a century-old building on 2nd Street.

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In 2010 he took over Clifton’s from the family that had operated it since the 1930s, when founder Clifford Clinton purchased the lease of the former Boos Bros. cafeteria on Broadway and set out to create a space that would evoke the coastal redwoods of the Santa Cruz Mountains, where Clinton spent summers growing up. After taking over, Meieran closed the restaurant for nearly four years for renovations and upgrades and again during the COVID-19 pandemic.

The Times spoke with Meieran to discuss his plans for reviving Clifton’s after the current shutdown, as well as his thoughts about the evolving nature of the bar and restaurant business during a time of change downtown. The interview has been edited for brevity and clarity.

Since the pandemic began, the restaurant business has been battered and put through changes that have made it hard for owners to operate profitably. How do you intend to make a go of it?

People need, and I emphasize “NEED” in capital letters, to be able to disengage from their devices and balance their life with physical and social interaction with people who are there and present around them. We are catering to people who are looking for a much more interactive lifestyle and are craving physical experiences to balance the ubiquitous online presence.

A view of the interior of Clifton’s Republic.

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(Wally Skalij / Los Angeles Times)

Clifton’s exists in L.A.’s collective memory as a vast cafeteria in a whimsical woodland setting, but we don’t see cafeterias much anymore. Why is that? Will we get back Clifton’s as we remember it?

Cafeterias used to be the dominant form of food delivery and food service and now, with very few exceptions, it’s not. There are clear reasons for that that are understandable and reasonable — you need tons of people in a captive audience to make a cafeteria work. You need volume and you need stable, reasonable food prices that you can pass on to your guests. That’s completely absent in this era.

So what will Clifton’s include when it reopens?

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It will be fully operating as a restaurant, lounge and nightlife destination that will include the Brookdale historic dining hall people remember as Forest Glen, Walt Disney’s original inspiration for Disneyland. We’ll also reopen the Monarch Bar on the second floor and the Pacific Seas “adventure bar” on the third floor. The basement will open in midsummer.

Obviously downtown has changed a lot from Clifton’s heyday in the 20th century when Broadway was L.A.’s premier shopping and entertainment district. Occupancy in office buildings, which used to provide a steady source of lunchtime customers, has dwindled substantially since the COVID-19 lockdown. What are the prospects for downtown businesses like Clifton’s?

It’s obviously a very different environment from what it was before the pandemic. People have altered their habits and patterns and businesses have responded accordingly, with some closing and others shifting their focuses. It’s a tectonic level shift, something that hasn’t happened in generations, and it’s happening very rapidly now. It was triggered initially by the pandemic but followed up by technological shifts that have altered the dining experience such as app-based ordering, touchscreens and the potentially revolutionary impact of artificial intelligence.

It’s hard for people to really recognize what’s coming next and where this is all going. Obviously that makes it difficult for a business to respond and for other people to make investments and to determine where we’re going to be in 18 months, three years or five years down the road, which is what you need in business.

Downtown, because of the level of the impact and its density, is slower to respond to change than some other, more nimble communities. It’s like turning a tanker ship that doesn’t turn on a dime. It’s taking a lot more effort and and concerted focus to shift its direction.

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What are the odds that the Historic Core can mount a comeback?

Broadway, in particular, has all of the ingredients that make for extraordinary projects and extraordinary communities sitting here waiting for the right catalyst. It has density, historic infrastructure and buildings that have an intrinsic beauty and an intrinsic connection to guests, residents,and visitors. And it’s got the location in terms of accessibility with plenty of parking and service by transit.

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