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☆ U.S. spending $5 billion to speed up development of new COVID vaccines
▼ + stars: | 2023-04-10 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Dado Ruvic/IllustrationWASHINGTON, April 10 (Reuters) - The U.S. government is spending over $5 billion on an effort to speed up the development of new COVID-19 vaccines and treatments, a Department of Health and Human Services (HHS) spokesperson and a Biden administration official said on Monday. "While our vaccines are still very effective at preventing serious illness and death, they are less capable of reducing infections and transmission over time," the HHS spokesperson said. "Project NextGen will accelerate and streamline the rapid development of the next generation of vaccines and treatments through public-private collaborations," said the administration official. The project, set to be based at HHS, will coordinate across the government and with the private sector on advancing a pipeline of new vaccines and treatments, the HHS spokesperson said. The project also seeks to speed up the development of vaccines that produce mucosal immunity and can be administered through the nose, in hopes they can dramatically reduce infection and transmission rates.

Any impact on the FDA will depend on details of the judge's ruling in the case known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas, a conservative former Christian activist. The court could order mifepristone pulled from the market while it considers a final ruling. It would call into question the entire drug approval process, said Laurie Sobel, associate director for Women's Health Policy at the Kaiser Family Foundation. 'SO MUCH UNCERTAINTY'The possibility of its approvals being overruled would likely see the FDA become more cautious, Lee said.

☆ Exclusive: US to build $300 mln database to fuel Alzheimer's research
▼ + stars: | 2023-04-03 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and various government agencies, they said. The database could help identify healthy people at risk for Alzheimer's, which affects about 6 million Americans, for future drug trials. The U.S. Medicare health plan for older adults will likely require such tracking in a registry as a condition of reimbursement for Leqembi. Silverberg said the data platform could also help researchers working in other disease areas understand which patients are most at risk and the impact of medications. The system would be built in a secure computing environment with a number of restrictions to ensure the privacy of people's health data, Silverberg said.

WASHINGTON, March 31 (Reuters) - The U.S. government announced on Friday a lower than expected 1.1% average cut of 2024 reimbursement rates for health insurers that offer coverage through the Medicare Advantage program, boosting shares of the market's largest players. Health insurers who operate Medicare Advantage plans have come under pressure after the government last month proposed new rules for an audit program to avoid overpaying them. The companies are among the largest players in the Medicare Advantage market in which private insurers are paid a set rate by the government to manage member healthcare. Medicare Advantage covers nearly half of the 65 million people enrolled in the government's Medicare program for people aged 65 and older or disabled. The agency pegged the spending increase in the traditional Medicare program, which in previous years was the main factor determining how much the agency pays Medicare Advantage insurers, at 2.3%, up from 2.1% in its initial proposal.

Of the various potential rulings possible in the case involving the abortion pill mifepristone, either of those outcomes would be unprecedented judicial intervention in the agency's regulatory process. Some of the FDA's options could be politically and legally risky both for the agency and mifepristone suppliers, they said. The FDA said the pill was deemed safe after extensive studies and use, and that the challenge comes much too late. Under FDA statutes and regulations, drug approval withdrawal generally begins with an informal hearing, which can entail extensive document preparation and the convening of an advisory committee. Overseas provider Aid Access, an Austria-based service that ships abortion medication to U.S. patients, said it would continue providing the pill no matter how the FDA responds.

☆ US declines to force lower price on cancer drug Xtandi
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

WASHINGTON, March 21 (Reuters) - The U.S. government will not force Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T) to lower the price of their prostate cancer drug Xtandi using its emergency "march-in" authority, the National Institutes of Health (NIH) said on Tuesday. Patient group the Union for Affordable Cancer Treatment first filed a petition calling on the NIH to use its authority to lower the drug's price in March 2016. The NIH said in a letter made public on Tuesday that its analyses in response to the petition found the prostate cancer treatment was widely available. "NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug," the letter said. Progressive lawmakers in the Democratic Party have been calling on President Joe Biden's administration to use its march-in authority to lower drug prices.

The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.

"Starting on April 1, Medicare beneficiaries will pay lower coinsurance for Part B drugs that raise prices faster than inflation," White House Domestic Policy Adviser Susan Rice told reporters on a press call. Companies that raise prices higher than the inflation rate will be required to pay Medicare the difference in the form of a rebate. The government will start invoicing the companies for the rebates in 2025 but Medicare will start reducing out-pocket-costs for members in April. Medicare began examining the price increases in October 2022 for Medicare Part B drugs, often used in the hospital, that are complicated biologic drugs or drugs with only one manufacturer. Price increases for half of all drugs covered by Medicare outpaced inflation from 2019 to 2020, which averaged 1% that year.

☆ US VA to cover Eisai, Biogen Alzheimer's treatment Leqembi
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

March 13 (Reuters) - Eisai Co Ltd and Biogen Inc (BIIB.O) said on Monday that the U.S. Department of Veteran Affairs (VA) will provide coverage of their Alzheimer's treatment Leqembi to veterans at an early stage of the memory-robbing disease. Leqembi has so far been approved in the U.S. under the Food and Drug Administration's accelerated review program. The treatment is currently undergoing the FDA's standard review process, which will weigh its impact on cognitive function. Eisai and Biogen have said they expect full U.S. approval for Leqembi by summer or late this year, which would likely open up coverage by Medicare and other health insurers. Reporting by Ahmed Aboulenein in Washington and Pratik Jain in Bengaluru; Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

[1/3] A pharmacist holds a bottle of the drug Eliquis, made by Bristol Myers Squibb and Pfizer, at a pharmacy in Provo, Utah, U.S. January 9, 2020. The government will launch the negotiation process in September by naming the first drugs it plans to target. "We couldn't have the other parts of the IRA without this Medicare negotiation," said Sean Dickson, director of the West Health Policy Center, a non-partisan healthcare think tank. Eliquis, which Bristol Myers (BMY.N) shares with Pfizer (PFE.N), Ibrance, and Imbruvica, sold by AbbVie and Johnson & Johnson (JNJ.N), appear on every list. Pfizer, Novo Nordisk and J&J declined to comment on the likelihood their drugs would be included in the first round of negotiations.

Eli Lilly, along with Sanofi (SASY.PA) and Novo Nordisk (NOVOb.CO) make up 90% of the U.S. market for insulin. Biden, a Democrat, on Tuesday called on Congress and other manufacturers to lower the price of insulin as Lilly had done. The list price for Lispro, a cheaper version of its Humalog insulin, is currently $82.41 for 100 units/mL vials. List prices for drugs often differ from what patients actually pay, including after insurance and other assistance programs. Ricks said the company's insulin price cuts had been planned for some time and were accounted for in Eli Lilly's December financial forecast, which projected 2023 revenue of at least $30.3 billion.

The Centers for Medicare and Medicaid (CMS) said it would test the models in the Medicare health program for people age 65 or over and the disabled and the Medicaid program for the poor. The agency also said it would work on developing a mandatory model for payment methods for drugs approved by the U.S. Food and Drug Administration (FDA) under its Accelerated Approval Program (APP). CMS will announce the first model's start date "as soon as operationally feasible", it said. Development on the Medicaid gene and cell therapy model will start in 2023 and launch for testing in 2026. The agency will start working with the FDA on the accelerated approval model in 2023 but has no planned launched date yet.

☆ U.S. government to start imposing inflation penalties on drugmakers in 2025
▼ + stars: | 2023-02-09 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Russell Boyce/IllustrationWASHINGTON, Feb 9 (Reuters) - The U.S. government will begin imposing penalties in 2025 on drug companies that charge its Medicare program prices that rise faster than inflation, the Centers for Medicare & Medicaid Services said on Thursday. The agency issued initial guidance on how it will implement a provision in President Joe Biden's signature Inflation Reduction Act that penalizes drugmakers for raising prices faster than inflation. "The Medicare Prescription Drug Inflation Rebate Program will require drug companies with excessive increases in drug prices to pay rebates to Medicare," CMS Administrator Chiquita Brooks-LaSure said in a statement. Companies that raise prices higher than the inflation rate will be required to pay Medicare the difference in the form of a rebate. Price increases for half of all drugs covered by Medicare outpaced inflation from 2019 to 2020, which averaged 1% that year.

WASHINGTON, Feb 9 (Reuters) - The Federal Emergency Management Agency (FEMA) said on Thursday it will close all COVID-19 disaster declaration incident periods on May 11 when the U.S. government ends two major pandemic-related emergency declarations. All 50 states, five territories and three tribal nations are seeing a major disaster declaration for COVID-19, said FEMA Associate Administrator for Response and Recovery Anne Bink. "With the administration's announcement to end the public health emergency and the national emergency declaration on May 11, 2023, today we announced the incident period for all FEMA COVID-19 disaster declarations will also close on May 11 2023," Bink told reporters on a press call. All eligible costs under the FEMA disaster declarations will continue to be eligible until May 11, and there will be a follow-up period afterwards for applicants to submit reimbursement requests, said Bink. Reporting by Ahmed Aboulenein; Additional reporting by Rami Ayyub; editing by Jonathan OatisOur Standards: The Thomson Reuters Trust Principles.

Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association (ADA). They tried, and failed, to extend the benefit to everyone with health insurance when they were voting on the IRA. Without Congressional approval, the Biden administration cannot impose the cap on private insurance plans and is unlikely able to create a subsidy for the uninsured, experts said. Some Medicaid plans for low-income individuals and private insurance plans also cap the monthly cost of insulin at $35. It is unclear if his proposal would include those without health insurance, who often have to pay the full price for the life-sustaining drug.

☆ U.S. seeks to expand birth control coverage under Obamacare
▼ + stars: | 2023-01-30 | by ( Ahmed Aboulenein | ) www.reuters.com time to read: +1 min

A sign on an insurance store advertises Obamacare in San Ysidro, San Diego, California, U.S., October 26, 2017. REUTERS/Mike BlakeWASHINGTON (Reuters) -Women whose employers have opted out of covering contraceptives under their health insurance plans on religious grounds would gain no-cost access to birth control under a rule proposed by the Biden administration on Monday. The Affordable Care Act (ACA), also known as Obamacare, requires private insurance plans to cover recommended preventive services including contraception without any patient cost-sharing, but current regulations grant exemptions for religious or moral objections. If the new rule is implemented, women enrolled in plans governed by the ACA would gain birth control coverage regardless of employer exemption, the U.S. Department of Health and Human Services (HHS) said in a statement. The rule would also remove employer moral objections as grounds for exemption from coverage but keep religious ones in place.

Crump said he and the Nichols family had spoken with President Joe Biden on Friday and urged him to use Nichols' death to galvanize support for the act's passage. Nichols' mother was coping with her son's death by believing he was destined to change the world, Crump said on ABC's "This Week" on Sunday. Nichols' death is the latest high-profile example of police using excessive force against Black people and other minorities. Crump said Nichols' death should finally prompt lawmakers to act. The officers were charged on Thursday with second-degree murder, assault, kidnapping, official misconduct and oppression in Nichols' death and dismissed from the department.

☆ Anti-abortion protesters break into Walgreens AGM meeting room
▼ + stars: | 2023-01-26 | by ( ) www.reuters.com time to read: +2 min

Jan 26 (Reuters) - Anti-abortion protesters broke into the room where Walgreens Boots Alliance Inc (WBA.O) held its annual shareholders meeting in Newport Coast, California on Thursday for its decision to start selling abortion pills, the pharmacy chain said. "Today, directly after the close of official business of our annual shareholders meeting, a small group of protesters entered the meeting room without authorization," Walgreens Senior Director for External Relations Fraser Engerman told Reuters. "It was a wild annual shareholders meeting," said Walgreens shareholder and AGM attendee John Chevedden. "The protesters knew what they were doing because they found a way to enter the room from behind the podium. "Upon leaving the meeting there were about 50 noisy protesters with signs just outside of the resort grounds," he said via email.

[1/2] People wear masks as a protection against the coronavirus disease (COVID-19) pandemic in New York City, New York, U.S., December 12, 2022. REUTERS/Eduardo MunozJan 11 (Reuters) - The U.S. health department on Wednesday extended the COVID-19 pandemic's status as a public health emergency, allowing millions of Americans to continue receiving free tests, vaccines and treatments. The emergency was first declared in January 2020, when the coronavirus pandemic began, and has been renewed each quarter since then. When it expires, private insurance and government health plans will take on COVID healthcare costs for most Americans. Reporting by Leroy Leo in Bengaluru and Ahmed Aboulenein; Editing by Shinjini Ganguli, Bill Berkrot and Devika SyamnathOur Standards: The Thomson Reuters Trust Principles.

Jan 6 (Reuters) - Pharmacies across the United States are weighing whether to sell mifepristone, a pill used in medication abortions, following the Food and Drug Administration's announcement earlier this week that they can now do so. The FDA rule will make medication abortion, which accounts for more than half of U.S. abortions, more accessible in states where abortion remains legal, but its impact on pharmacies in the states that have banned abortion remains to be seen. The pharmacy is located near Florida's borders with Georgia and Alabama, where abortion is severely restricted. We're not near an abortion clinic or in a larger city where that happens more," she said. Steve Moore, pharmacist and owner of Condo Pharmacy in Plattsburgh, New York, a state where abortion is legal, plans to dispense the drug.

☆ FDA allows abortion pills to be sold at retail pharmacies, say two drugmakers
▼ + stars: | 2023-01-03 | by ( ) www.reuters.com time to read: +2 min

WASHINGTON, Jan 3 (Reuters) - Retail pharmacies will now be allowed to offer abortion pills in the United States under a regulatory change made by the Food and Drug Administration on Tuesday, the two companies that make the pills said on Tuesday. Pharmacies can apply for certification to distribute mifepristone with the drugmakers and if successful will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber, said Danco Laboratories, one of two companies that make mifepristone. The announcement will not provide equal access to all people, however, GenBioPro, which makes the generic version of mifepristone, said in a statement. Retail pharmacies will have to weigh whether or not to offer the pill and determine where they can do so. Reporting by Eric Beech and Ahmed Aboulenein in Washington, Shivani Tanna and Rahat Sandhu in Bengaluru; Editing by Himani SarkarOur Standards: The Thomson Reuters Trust Principles.

Companies Biogen Inc FollowWASHINGTON, Dec 29 (Reuters) - The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen's (BIIB.O) Alzheimer's drug Aduhelm, which was "rife with irregularities," a congressional report showed on Thursday. The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug. He pointed to the FDA's internal review finding its staff's interactions with Biogen appropriate. "As stated in the congressional report, an (FDA) review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'" Biogen said. Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.

Erie County Executive Mark Poloncarz said the storm's confirmed death toll climbed to 13 on Sunday, up from three reported overnight in the Buffalo region. The latest victims included some found in cars and some in snow banks, Poloncarz said, adding that the death tally would likely rise further. New York Governor Kathy Hochul called it an "epic, once-in-a-lifetime" weather disaster that ranked as the fiercest winter storm to hit the greater Buffalo area since a crippling 1977 blizzard that killed nearly 30 people. RESCUING THE RESCUERSThe latest blizzard came nearly six weeks after a record-setting but shorter-lived lake-effect storm struck western New York. [1/9] A snow plow is left stranded on the road following a winter storm that hit the Buffalo region on Main St. in Amherst, New York, U.S., December 25, 2022.

☆ Deadly blizzard, deemed worst in 45 years, paralyzes greater Buffalo, N.Y.
▼ + stars: | 2022-12-26 | by ( Gabriella Borter | ) www.reuters.com time to read: +4 min

[1/3] Vehicles are left stranded on the road following a winter storm that hit the Buffalo region in Amherst, New York, U.S., December 25, 2022. The greater Buffalo region, lying at the edge of Lake Erie near the Canadian border was one of the hardest-hit places. The governor called it an "epic, once-in-a-lifetime" weather disaster that ranked as the fiercest winter storm to hit Buffalo, New York state's second-largest city, since a crippling 1977 blizzard that killed nearly 30 people. The latest blizzard, which initially overwhelmed emergency crews, came nearly six weeks after a record-setting but shorter-lived lake-effect storm struck western New York. He said one electrical substation knocked offline was sealed off by an 18-foot-tall mound of snow, and utility crews found the entire facility frozen inside.

[1/6] Hoak's restaurant is covered in ice from the spray of Lake Erie waves during a winter storm that hit the Buffalo region in Hamburg, New York, U.S. December 24, 2022. Twenty-eight people have died so far in weather-related incidents across the country, according to an NBC News tally. The Buffalo airport had recorded 43 inches (109 cm) of snow as of 7 a.m ET (1200 GMT) on Sunday, Otto said. "Another one to two feet in general before Monday morning in the Buffalo area is expected," Otto said. "I guess you can say in some ways, the worst of it is over but there's still some pretty significant snowfall that's ongoing around the Buffalo region today."

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