US keeps missile system in Philippines as China tensions rise

 The United States has no immediate plans to withdraw a mid-range missile system deployed in the Philippines, despite Chinese demands, and is testing the feasibility of its use in a regional conflict, sources with knowledge of the matter said.

The Typhon system, which can be equipped with cruise missiles capable of striking Chinese targets, was brought in for joint exercises earlier this year, both countries said at the time, but has remained there.

The Southeast Asian archipelago, Taiwan's neighbour to the South, is an important part of U.S. strategy in Asia and would be an indispensable staging point for the military to aid Taipei in the event of a Chinese attack.

China and Russia have condemned the first deployment of the system to the Indo-Pacific, accusing Washington of fuelling an arms race.

China's foreign ministry said on Thursday it was very concerned about the plan to keep the system in place.

"It seriously threatens the security of regional countries and intensifies geopolitical confrontation," ministry spokesperson Lin Jian told a press briefing.

The deployment, some details of which have not been previously reported, comes as China and U.S. defence treaty ally the Philippines clash over parts of the hotly contested South China Sea. Recent months have brought a series of sea and air confrontations in the strategic waterway.

Philippine officials said Filipino and U.S. forces continued to train with the missile system, which is on the northern island of Luzon, facing the South China Sea and is close to the Taiwan Strait. They said they were not aware of immediate plans to return it, even though the joint exercises end this month.

A Philippine army spokesman, Colonel Louie Dema-ala, told Reuters on Wednesday that training was ongoing and it was up to the United States Army Pacific (USARPAC) to decide how long the missile system would stay.

A public affairs officer for USARPAC said the Philippine army had said the Typhon could stay beyond September and soldiers trained with it as recently as last week, engaging "in discussions over employing the system, with a focus on integrating host nation support."

A senior Philippine government official and another person familiar with the matter said the U.S. and the Philippines were testing the feasibility of using the system there in the event of a conflict and how well it works in that environment. Both spoke on condition of anonymity.

The government official said the Typhon - which is intended to be mobile and moved as needed - was in the Philippines for a "test on the feasibility of deploying it in country so that when the need arises, it could easily be deployed here."

The office of Philippine President Ferdinand Marcos Jr did not respond to a request for comment.

'SLEEPLESS NIGHTS'

The U.S army flew the Typhon, which can launch missiles including SM-6 missiles and Tomahawks with a range exceeding 1,600 km (994 miles), to the Philippines in April in what it called a "historic first" and a "significant step in our partnership with the Philippines".

A satellite image taken on Wednesday by Planet Labs, a commercial satellite firm, and reviewed by Reuters showed the Typhon at the Laoag International Airport, in Ilocos Norte province.

The senior government official who spoke to Reuters said there were no immediate plans to withdraw it.

"If ever it will be pulled out, it is because the objective has been achieved and it may be brought (back) in after all the repairs or the construction would have been done," the official said, adding that there was strategic value for the Philippines in keeping the system to deter China.

"We want to give them sleepless nights."

ANTI-SHIP WEAPONS

The U.S. has been amassing a variety of anti-ship weapons in Asia, as Washington attempts to catch up quickly in an Indo-Pacific missile race in which China has a big lead, Reuters has reported.

Although the U.S. military has declined to say how many will be deployed in the Indo-Pacific region, more than 800 SM-6 missiles are due to be bought in the next five years, according to government documents outlining military purchases. Several thousand Tomahawks are already in U.S. inventories, the documents showed.

China has denounced the deployment of the Typhon several times, including in May when Wu Qian, spokesperson for China's defense ministry, said Manila and Washington had brought “huge risks of war into the region”.

Russian President Vladimir Putin in June cited the deployment when announcing his country would resume production of intermediate- and shorter-range nuclear-capable missiles.

Philippine Foreign Affairs Secretary Enrique Manalo in July assured his Chinese counterpart the presence of the missile system in his country posed no threat to China and would not destabilise the region.

China has fully militarised at least three of several islands it built in the South China Sea, which it mostly claims in full despite a 2016 arbitral ruling that backed the Philippines, arming them with anti-ship and anti-aircraft missiles, the U.S. has said.

China says its military facilities in the Spratly Islands are purely defensive, and that it can do what it likes on its territory.

https://www.yahoo.com/news/exclusive-us-keeps-missile-system-033649167.html

UnitedHealth tech unit's rivals say new, post-hack customers are staying

 Smaller rivals to UnitedHealth's tech unit Change Healthcare say they are signing longer-term contracts with hospitals and other customers who had temporarily switched from the company after February's cyberattack shut down the unit's services.

The new contracts landed by Waystar and privately held Availity and Inovalon show a shift to healthcare practices signing deals with multiple service providers instead of relying on a single vendor, in what may be the first sign of needed change in an industry. Health tech experts said the move to more than one vendor is long overdue, but was hastened by the hack.

Change makes up only 1% of revenue at healthcare giant UnitedHealth but processes about 50% of medical claims in the U.S. for around 900,000 physicians, 33,000 pharmacies, 5,500 hospitals and 600 laboratories. About 1 in 3 U.S. patient records are processed in some way at Change, according to the company.

"The industry is realizing that the single point of failure is just too risky in the current environment," Eron Kelly, president of Change's smaller rival Inovalon, said.

FEBRUARY HACK

In the days and weeks after the Feb. 21 ransomware attack, many doctors and hospitals struggled to file claims, resorting to paper to verify insurance coverage as the electronic systems were taken offline. For months, many struggled to be paid.

The hack hurt people doing business directly with UnitedHealth, but many providers also realized they had indirect exposure through other software vendors. UnitedHealth estimates the hack's cost at up to $2.45 billion this year.

Wall Street analysts and tech experts said it was difficult to quantify any changes in market share or if the market had increased, citing a lack of data.

Roger Connor, CEO of Optum Insight, the division that includes Change, said in an emailed statement that the company has brought back a "very secure" technology system that is resonating with customers.

"We're not only trying to bring volume back into our current customers. We're also working to bring new clients in," said Connor.

KEEPING CUSTOMERS

Inovalon's Kelly said after the hack, the company contracted with organizations whose ranks included about 344,000 separate providers, such as doctors, pharmacists, and nurse practitioners. That compares with more than 8 million providers nationally, which are counted using their unique national provider identification numbers, according to government data.

About 98% of those providers are now on long-term contracts, Kelly said.

Some "payers" - typically health insurers and other groups handling reimbursements to providers - who previously had exclusive contracts with Change, had also shifted, Kelly added.

Availity, a firm backed by health insurer Elevance, launched Lifeline, a free, scaled down version of its services for claims processing, after the hack. The service helped process claims for over 300,000 providers such as doctors, hospitals and other medical practices across 120 health organizations, said CEO Russ Thomas.

Since the hack through mid-July, Lifeline helped with claims worth an estimated $315 billion, the company said.

Now, it is working to make the clients permanent.

"We are out meeting with the clients, sharing the full scope of what we can do for them, and fortunately, having some good success in converting to long-term clients," said Thomas.

The company declined to disclose how many customers became permanent.

Recently-listed Waystar also sped up how quickly hospitals and doctors' practices could switch to its software platform for managing their finances, allowing them to get up and running within 72 hours of signing a contract.

It also rapidly scaled up back-end operations to deal with more than 30,000 providers joining the company's platform.

The company has said that most of its clients have signed standard contracts for two- and three-year terms.

ADDING VENDORS

Some providers of software for smaller, independent healthcare practices, such as privately-held Tebra's billing program Kareo and TherapyNotes, used by mental health practices, are either leaving Change or adding an additional vendor.

Tebra had used Change for verifying patients' insurance eligibility in its Kareo software, but has shifted about 99.7% of that traffic to other service providers, according to Tebra Chief Technology Officer Kyle Ryan.

About 10% of the company's electronic claims volume had also moved through Change before the hack and that number is now down to 2%, Ryan said in e-mail.

Jeremy Wall, managing director at global strategy consulting firm Stax, said that providers are also likely adding more vendors than switching completely.

"What we have seen and heard from people in the market is that a pretty large portion of the people who moved over to another vendor have stayed over with that vendor," Wall said.

https://finance.yahoo.com/news/unitedhealth-tech-units-rivals-post-100240679.html

'Muslim Americans moving to Jill Stein in potential blow to Kamala Harris'

 Arab-American and Muslim voters angry at U.S. support for Israel's offensive in Gaza are shunning Democrat Kamala Harris in the presidential race to back third-party candidate Jill Stein in numbers that could deny Harris victories in battleground states that will decide the Nov. 5 election.

A Council on American-Islamic Relations data released this month based on a late August poll showed that in Michigan, home to a large Arab American community, 40% of Muslim voters backed the Green Party's Stein. Republican candidate Donald Trump got 18% with Harris, who is President Joe Biden's vice president, trailing at 12%.

Stein also leads Harris among Muslims in Arizona and Wisconsin, battleground states with sizable Muslim populations where Biden defeated Trump in 2020 by slim margins.

Harris was the leading pick of Muslim voters in Georgia and Pennsylvania, while Trump prevailed in Nevada with 27%, just ahead of Harris' 26%, according to the CAIR poll of 1,155 Muslim voters nationwide. All are battleground states that have swung on narrow margins in recent elections.

Biden won the 2020 Muslim vote, credited in some exit polls with more than 80% of their support, but Muslim backing of Democrats has fallen sharply since Israel's nearly year-long action in Gaza.

About 3.5 million Americans reported being of Middle Eastern descent in the 2020 U.S. Census, the first year such data was recorded. Although they make up about 1% of the total U.S. population of 335 million, their voters may prove crucial in a race that opinion polls show to be close.

On Tuesday, Harris called for an end to the Israel-Gaza war and the return of hostages held by Hamas in Gaza. She also said Israel must not reoccupy the Palestinian enclave and backed a two-state solution.

But at closed-door meetings in Michigan and elsewhere, Harris campaign officials have rebuffed appeals to halt or limit U.S. arms shipments to Israel, community leaders say.

"Decades of community organizing and civic engagement and mobilizing have not manifested into any benefit," said Faye Nemer, founder of the Michigan-based MENA American Chamber of Commerce to promote U.S. trade with the Middle East.

"We're part of the fabric of this country, but our concerns are not taken into consideration," she said.

Stein is aggressively campaigning on Gaza, while Trump representatives are meeting with Muslim groups and promising a swifter peace than Harris can deliver.

The Harris campaign declined to comment on the shifting dynamics; officials tasked with Muslim outreach were not available for interviews.

Stein's 2016 run ended with just over 1% of the popular vote, but some Democrats blamed her and the Green Party for taking votes away from Democrat Hillary Clinton. Pollsters give Stein no chance of winning in 2024.

But her support for a permanent ceasefire in Gaza, for an immediate U.S. arms embargo on Israel and for student movements to force universities to divest from weapons investments have made her a star in pro-Palestinian circles. Her running mate Butch Ware, a professor at the University of California, Santa Barbara, is Muslim.

This month Stein spoke at ArabCon in Dearborn, Michigan, an annual gathering of Arab Americans and was featured on the cover of The Arab American News under the headline "The Choice 2024." Last week in an interview with The Breakfast Club, a New York radio program, she said, "Every vote cast for our campaign is a vote against genocide," a charge that Israel denies.

TRUMP TEAM CAMPAIGNS FOR ARAB AMERICAN VOTES

At the same time, the Trump team has hosted dozens of in-person and virtual events with Arab Americans and Muslims in Michigan and Arizona, said Richard Grenell, Trump's former acting Director of National Intelligence.

"Arab American leaders in Detroit know this is their moment to send a powerful message to the Democrat party that they shouldn’t be taken for granted," Grenell said. Trump has said he would secure more Arab-Israeli peace deals.

The Trump outreach and Stein's appeal could translate into numbers that might threaten Harris. The Green Party is on most state ballots, including all battleground states that could decide the election, except for Georgia and Nevada, where the party is suing to be included.

Biden defeated Trump in 2020 by just thousands of votes in some states, thanks in part to the support of Arab and Muslim voters in states where they are concentrated, including Georgia, Michigan, Pennsylvania and Wisconsin.

Biden won Michigan by 154,000 votes in 2020, but Trump defeated Democrat Hillary Clinton there by fewer than 11,000 votes in 2016. The state is home to overlapping groups of more than 200,000 registered voters who are Muslim and 300,000 who report ancestry from the Middle East and North Africa.

In Philadelphia, which has a large Black Muslim population, activists have joined a national "Abandon Harris" campaign. They helped organize protests during her debate with Trump last week.

Philadelphia CAIR co-chair Rabiul Chowdhury said, "We have options. If Trump pledges to end the war and bring home all hostages, it's game over for Harris." Trump has said the war would never have erupted if he were president. It's unclear how he would end it. Trump is a firm supporter of Israel.

In Georgia, where Biden won in 2020 by 11,779 votes, activists are rallying 12,000 voters to commit to withhold votes from Harris unless the Biden administration acts by Oct. 10 to halt all arms shipments to Israel, demands a permanent ceasefire in Gaza and the West Bank, and pledges to uphold a U.S. law that imposes an arms embargo on nations engaged in war crimes.

Thousands have already signed similar pledges in New Jersey, Pennsylvania and Wisconsin.

U.S. Representative Dan Kildee, a Michigan Democrat, said he worries about the impact the Gaza war will have in November. He said not only Arab Americans and Muslims, but a much broader group of younger voters and others are also upset.

"You can't unring a bell," he said, adding Harris still had "the space and grace" to shift gears, but time was running out.

https://www.yahoo.com/news/muslim-americans-moving-jill-stein-101001989.html

'Trump, allies sue over claims that non-citizens might vote'

 Donald Trump and his Republican allies claim that the Nov. 5 U.S. presidential election could be skewed by widespread voting by non-citizens in a series of lawsuits that democracy advocates say are 'meant to sow distrust.'

At least eight lawsuits have been filed challenging voter registration procedures in four of the seven swing states expected to decide the election contest between Trump and his Democratic rival, Vice President Kamala Harris.

Trump and his allies say the legal campaign, which includes a wide-ranging challenge to the citizenship status of voters in Arizona, is a defense of election integrity.

The Trump campaign referred a request for comment to a spokesperson for the Republican National Committee, who said, "We believe our lawsuits will stop non-citizen voting, which threatens American votes."

It is a felony offense for a non-citizen to vote in a federal election and independent studies have shown it rarely happens.

Backers of Trump's strategy say that even one illegally cast ballot is too many.

Ohio Secretary of State Frank LaRose, a Republican, told a congressional panel last week that non-citizen voting is a rarity but that enforcement is necessary to keep it that way. He said his office recently identified nearly 600 non-citizens from state voter rolls that contain about 8 million registrants in total.

"We found 135 this year that had voted. We found another 400 that were registered but hadn't yet voted. And this idea that it's already illegal? It's illegal to hijack airplanes, but we don't get rid of the TSA," LaRose said.

90-DAY RULE

Federal law prohibits large-scale changes to voter rolls within 90 days of an election as well as purges that target particular class of voters, such as recently naturalized citizens, which the U.S. Justice Department reminded states of in an advisory last week.

That, democracy advocates say, shows that Trump and his allies' strategy in pursuing these suits is not to secure major changes in the electorate, but to lay the groundwork for contesting individual state results if he loses, both in the courts and by trying to persuade elected officials to take action.

"Lawsuits over non-citizens on voter registration rolls are meritless. But they're part of a weaponized public relations campaign to erode confidence in elections," said Dax Goldstein, senior counsel for the nonpartisan States United Democracy Center, which promotes election security and fairness.

The race is close in the seven most competitive states: Arizona, Georgia, Michigan, Nevada, North Carolina, Pennsylvania and Wisconsin.

If a Harris win were to hang on just one or two states, a successful Trump challenge to a defeat in those states could be enough to reverse the election's outcome.

"Our elections are coming down to just dozens or hundreds of votes," said Republican Representative Anthony D'Esposito, who is seeking re-election this year in a toss-up New York district. "If one person that is not an American citizen has the ability to vote in our election, there is a serious problem."

TARGETING STATES, COUNTIES

The lawsuits, filed by the Trump campaign, the Republican National Committee, the allied America First Legal Foundation and Republican state attorneys general, primarily target state and county election processes, alleging that officials are failing to do enough to prevent non-citizens from registering or remaining on voter lists.

Rick Hasen, a law professor at the University of California, Los Angeles, and an expert on election law, said that the lawyers bringing these cases have reason to use more careful language than Trump and his allies do in discussing them.

"The public messaging is aimed at trying to convince the Republican base that Democrats are trying to steal elections and there's a lot of fraud," Hasen said. "Once you get to court, you are subject to the rules of court, and I think you see lawyers being a lot more circumspect."

Trump tried unsuccessfully to overturn his 2020 loss to Democratic President Joe Biden in a campaign that included more than 60 lawsuits and inspired his supporters' Jan. 6, 2021, attack on the U.S. Capitol.

Nearly all of the 2020 lawsuits filed by Trump and his allies were dismissed for lack of evidence and other issues.

Four of this year's lawsuits, filed in Michigan, Pennsylvania, Kansas and Texas, claim that a 2021 Biden administration initiative involving federal agencies in efforts to promote voter registration is a partisan effort to register voters likely to support Democrats.

Ken Blackwell, a former Ohio secretary of state who chairs the America First Policy Institute's Center for Election Integrity, said on the social platform X last month that the Biden administration was staging an "attempt to weaponize federal agencies into a leftwing election operation that opens the doors to non-citizen voting."

A 41-page complaint filed in Kansas federal court by Republican attorneys general from nine states makes only one reference to voting by undocumented immigrants, alleging that the Biden administration failed to examine the risks that "illegal aliens" may try to register to vote.

The RNC and North Carolina state Republican Party have twice sued that battleground state's election board, making allegations on non-citizen voting. The lawsuits allege the state registered nearly 225,000 voters, about 3% of its total, with insufficient documentation and had not removed from the rolls people who self-identified as non-citizens when reporting for jury duty.

The state is narrowly divided politically with two Republican senators, a Republican-controlled legislature, but a Democratic governor, Roy Cooper, and an evenly split delegation to the U.S. House of Representatives.

A state elections board spokesperson, Patrick Gannon, said it had complied with the jury duty requirement and identified nine registered voters who had claimed not to be citizens.

Those nine will be asked to cancel their registrations if their citizenship status cannot be confirmed, Gannon said, adding that the state cannot force them off the rolls this close to Election Day.

Gannon said the second lawsuit, over an allegedly flawed registration form, "vastly overstates any alleged problems."

In Arizona, a lawsuit filed by Trump-aligned advocacy group America First Legal is seeking to force counties to further investigate about 44,000 voters -- about 1% of the statewide total -- who were allowed to register without providing proof of citizenship.

That dispute revolves around the state's two-tiered voter-registration system, which requires proof of U.S. citizenship to vote in state elections, but does not mandate it in federal elections.

https://www.yahoo.com/news/even-election-trump-allies-sue-100608207.html

4DMT’S Gene Therapy for AMD Clears Phase II, Heads to Late-Stage Studies

 

4D Molecular Therapeutics reported its experimental gene therapy demonstrated a nearly 90% reduction in the need for annualized standard-of-care injections in patients with wet age-related macular degeneration.

4D Molecular Therapeutics announced on Wednesday that its investigational gene therapy 4D-150 demonstrated durable clinical activity in the Phase I/II PRISM study of patients with wet age-related macular degeneration.

In a 30-patient cohort, 4D-150 cut the need for standard-of-care injections by 89% through 52 weeks of follow-up, and 70% of these patients were injection-free, according to 4DMT’s announcement. In another cohort of 27 patients with severe disease, the need for standard-of-care treatment dropped by 83% and 44% were injection-free.

The gene therapy also resulted in sustained benefits in terms of central subfield thickness and mean best-corrected visual acuity.

In terms of safety, PRISM found 4D-150 to be well-tolerated. The frequency for of intraocular inflammation (IOI) was consistent with approved anti-VEGF therapies, which are currently widely used to treat age-related macular degeneration (AMD). Overall, 4DMT documented two IOI episodes in all 71 wet AMD patients enrolled, yielding an incidence rate of 2.8%.

There were no cases of retinal artery occlusions, hypotony, vasculitis, choroidal effusions and endophthalmitis related to the gene therapy.

4DMT CEO David Kirn in a statement called 4D-150 a “potentially paradigm shifting product candidate,” noting that PRISM’s findings highlight “clear reduction in overall treatment burden and potential multiyear clinical benefit in previously treated patients.” The California-based biotech will continue to invest in 4D-150’s development, Kirn said, and push it into late-stage studies.

Alongside the PRISM readout on Wednesday, 4DMT detailed the design of its Phase III 4FRONT development program for 4D-150, which is set to include two double-masked, randomized non-inferiority trials, compared with on-label treatment with Bayer and Regeneron’s Eylea (aflibercept). The gene therapy will be given at a single 3E10 vg/eye dose.

The first study under this program, dubbed 4FRONT-1, has a target enrollment of 500 patients and is set to start in the first quarter of 2025, Kirn said.

The Phase III program design is in alignment with feedback from the FDA under its Regenerative Medicine Advanced Therapy Designation, according to 4DMT.

4D-150 is an investigational gene therapy that uses an intravitreal vector to deliver a transgene that encodes for aflibercept—the active ingredient of Eylea—and an RNAi molecule that blocks the VEGF-C protein. This mechanism of action allows 4D-150 to suppress four different VEGF proteins in the eye, disrupting the key disease pathway in wet AMD.

With 4D-150, 4DMT is seeking to offer a one-time alternative to Eylea, which is injected into the eye every eight weeks, following an initiation regimen. Eylea has become a top-selling treatment in the ophthalmology space. In 2023, the product brought in $5.9 billion in sales worldwide.

https://www.biospace.com/drug-development/4dmts-gene-therapy-for-amd-clears-phase-ii-heads-to-late-stage-studies

GSK Builds Combo Case for RSV, Shingles Shots With Phase III Data

 

If approved, the co-administration of Arexvy and Shingrix could provide a more convenient vaccination regimen for patients and potentially bolster GSK’s faltering sales for both vaccines.

GSK on Wednesday unveiled promising topline Phase III data for a combo regimen of its RSV vaccine Arexvy and shingles shot Shingrix, touting a comparable immunogenicity profile to the individual vaccines.

The company did not provide specific data in its announcement, only noting that co-administering Arexvy with Shingrix resulted in a “non-inferior immune response” compared with inoculation with the vaccines at separate visits. The vaccine combo was also well-tolerated with an “acceptable” safety profile, according to GSK, though it’s not clear if there were more side effects after co-administration of the shots.

“With our co-administration studies, GSK is using its science and technology to help remove barriers to adult immunization, by potentially reducing the number of visits to the healthcare offices and pharmacies and ultimately help to get ahead of RSV and shingles,” Led Friedland, GSK’s vice president of scientific affairs and public health, said in a statement.

GSK will use these Phase III data to build a regulatory case for the co-administration of Arexvy with Shingrix, which, if approved, could help the company shore up sales for these products. The company plans to file submissions with the FDA and the European Medicines Agency, according to the announcement.

Arexvy is the clear leader in the RSV vaccine space, becoming the first approved shot in May 2023, a month ahead of its closest competitor, Pfizer’s Abrysvo. In its third-quarter 2023 earnings report, GSK announced that Arexvy accounted for two-thirds of all retail vaccinations in the U.S., bringing in $859 million in its first full commercial quarter.

In a December 2023 interview with Reuters, GSK CEO Emma Walmsley said that she expects Arexvy to hit blockbuster status. The company took a big step toward this goal in June 2024, when the FDA signed off on the use of Arexvy in younger seniors aged 50 to 59 years.

However, that same month, the CDC’s Advisory Committee on Immunization Practices narrowed its RSV guidelines, raising its recommended vaccination age from 60 to 75 years. In the age group of 60 to 74 years, only those who are at risk of developing severe disease are advised to get the shot. These changes could stymie the growth of Arexvy.

Meanwhile, GSK’s shingles vaccine Shingrix has more than exceeded the blockbuster mark, bringing in over $4.3 billion in 2023 and contributing heavily to the 25% growth in the company’s vaccine business. However, sales have been slowing. In the second quarter of this year, GSK reported that Shingrix sales dropped 4% year-over-year, due in large part to a new Medicare rule that changed how pharmacies process reimbursements.

https://www.biospace.com/drug-development/gsk-builds-combo-case-for-rsv-shingles-shots-with-phase-iii-data

Vanda Contests FDA Rejection of Gastroparesis Drug, Slams ‘Delayed’ Decision

 

Vanda Pharmaceuticals on Thursday announced that the regulator declined to approve its application, a decision the company says was delayed by more than 185 days and failed to satisfy the requirements of the Federal Drug and Cosmetic Act.

The FDA on Thursday denied to approve Vanda Pharmaceuticals’ drug application for tradipitant, an investigational NK-1R antagonist that the biopharma was proposing for the treatment of gastroparesis.

The company did not reveal the regulator’s reasoning for the rejection, though claimed that the agency’s Complete Response Letter “was conclusory in nature” and that it “generally disregarded the evidence provided.” According to Vanda, the FDA asked that it to run additional studies “with a design and duration inconsistent with the advice of key experts in the field.”

Jefferies analyst Andrew Tsai in a note to investors said that the rejection was “unsurprising,” especially given a failed Phase III study and an outstanding and unaddressed request from the FDA for additional animal and long-term safety analyses. Vanda also expected a negative outcome, noting in its second-quarter business report that the regulator issued a “preliminary notice” flagging “deficiencies” in its application.

Still, the company stands by its application for tradipitant, arguing that the data package includes “substantial evidence” of the drug candidate’s efficacy and shows a favorable benefit-risk profile for gastroparesis. Vanda said it will continue to seek approval for tradipitant in this indication and will sustain its expanded access program for gastroparesis patients.

Vanda is also working on a separate drug application for tradipitant to prevent vomiting in motion sickness, scheduled for filing “later this year,” according to the announcement.

In response to the FDA’s rejection, Vanda delivered a scathing assessment of the agency. According to the company, the regulator’s verdict was delayed by more than 185 days, which is in violation of the Federal Drug and Cosmetic Act’s (FDCA) 180-day leeway for the FDA to review an application and issue an approval or provide an opportunity for a hearing.

“In this case the FDA has failed to do either,” Vanda said.

The biopharma also slammed the FDA’s inaction in seeking external guidance regarding tradipitant’s application—despite the company “repeatedly requesting” that the regulator convene an advisory committee.

Tradipitant is a small molecule antagonist of neurokinin (NK)-1 receptors, which are largely localized in the gastrointestinal tract and in brain regions involved in the vomit reflex. Through this mechanism of action, tradipitant helps counter the nausea and vomiting symptoms that typically occur with gastroparesis.

Vanda supported tradipitant’s regulatory bid with data from various clinical efficacy studies, supplemented by a 12-week open-label study, findings from its expanded-access program and non-animal preclinical studies.

According to the company, “a number of patients” currently on tradipitant treatment have field a citizen petition requesting that the FDA approve tradipitant for gastroparesis.

Tradipitant’s rejection comes days after the biotech sued the FDA, alleging in its complaint earlier this month that the regulator’s process for approving drugs is unconstitutional, according to Bloomberg. The biopharma also took aim at the FDA’s alleged violations of the FDCA in February 2024, when the agency rejected the expansion of Vanda’s Hetlioz (tasimelteon) into insomnia.

https://www.biospace.com/fda/vanda-contests-fda-rejection-of-gastroparesis-drug-slams-delayed-decision