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☆ Pot firms surge as US move to ease curbs sparks hopes of legalization
▼ + stars: | 2023-08-31 | by ( ) www.reuters.com time to read: +2 min

Shares of cannabis firms Cronos Group (CRON.TO), OrganiGram Holdings (OGI.TO), Aurora Cannabis (ACB.TO), Canopy Growth (WEED.TO) jumped between 6% and 25%. Verano Holdings (VRNO.CD), Green Thumb Industries (GTII.CD), Cresco Labs (CL.CD) and Curaleaf Holdings (CURA.CD) and Goodness Growth (GDNS.CD) rose between 15% and 37%. "Certainly moving cannabis off of Schedule 1 is the right decision and long overdue. The firm held investments in cannabis retailer and producer Green Thumb, and cannabis data platform Flowhub, according to its website. Reporting by Arunima Kumar in Bengaluru; Editing by Sriraj KalluvilaOur Standards: The Thomson Reuters Trust Principles.

Persons: cagey, Ty Collin, Patrick Rea, Green, Arunima Kumar, Sriraj Organizations: Cronos Group, OrganiGram Holdings, Verano Holdings, Green Thumb Industries, Cresco Labs, Curaleaf Holdings, Cannabis ETF, U.S . Department of Health, Human Services, Drug Enforcement Agency, Banking, Poseidon Garden Ventures, Thomson Locations: U.S, Aurora, Bengaluru

☆ Stocks making the biggest premarket moves: Dollar General, Salesforce, Palantir and more
▼ + stars: | 2023-08-31 | by ( Michelle Fox | ) www.cnbc.com time to read: +4 min

Check out the companies making the biggest moves before the bell:Dollar General — The discount retailer tumbled 15.3% after reporting second-quarter earnings per share of $2.13, missing the StreetAccount consensus estimate of $2.47. Revenue also missed, coming in at $9.80 billion versus the $9.93 billion expected. Campbell Soup — Shares added about 1% after the company reported revenue of $2.07 billion, beating the $2.06 billion expected from analysts polled by Refinitiv. Second-quarter adjusted earnings per share came in at 31 cents, versus the 22 cents expected from analysts polled by Refinitiv. However, its revenue guidance for the third quarter of $2.74 billion to $2.76 billion fell short of the $2.79 billion expected from analysts, per StreetAccount.

Persons: Campbell, Shopify, Morgan Stanley, Salesforce, Goldman Sachs, Cronos, Tilray, Okta, SkyWest, Raymond James, Refinitiv, —, Jesse Pound, Alex Harring Organizations: Revenue, Refinitiv, UBS — U.S, UBS, Cronos, Tilray, U.S . Department of Health, Human Services, Arista Networks, Citi, Arista, postmarket Locations: Austin , Texas, Swiss

☆ Stocks making the biggest moves midday: Tilray, Salesforce, CrowdStrike, Dollar General and more
▼ + stars: | 2023-08-31 | by ( Samantha Subin | ) www.cnbc.com time to read: +5 min

Salesforce — The cloud software company saw its stock jump 3% after it announced quarterly results and guidance that surpassed Wall Street's expectations. Dollar General — The discount retail chain plunged 12.2% Thursday after reporting second-quarter earnings per share of $2.13, which was lower than the StreetAccount consensus estimate of $2.47. Ciena — The network equipment stock surged nearly 16% after topping Wall Street's fiscal third-quarter earnings expectations on the top and bottom lines. Okta — Okta shares surged 13.5% after the access management company topped analysts' second-quarter earnings expectation and issued a strong full-year outlook. Victoria's Secret — The intimate apparel stock popped nearly 7% even after missing second-quarter earnings expectations on both the top and bottom lines.

Persons: Salesforce, Marc Benioff, CrowdStrike, Ciena, Morgan Stanley, Shopify, StreetAccount, Chewy, UGI, Raymond James, —, Macheel, Sarah Min, Yun Li, Alex Harring, Michelle Fox, Pia Singh, Jesse Pound Organizations: Aphria Inc, U.S . Department of Health, Human Services, Tilray Brands, Cronos, Revenue, Technologies, Arista Networks, Citi, Refinitiv, StreetAccount, Signet, UBS — U.S, Suisse Locations: Leamington , Ontario, Switzerland

☆ Fact Check-Ivermectin still not FDA-approved to treat COVID
▼ + stars: | 2023-08-30 | by ( Reuters Fact Check | ) www.reuters.com time to read: +5 min

Ivermectin is not FDA-approved for COVID treatment, but misleading posts cast the attorney’s statement as though it represented a change in the drug’s status. Referring to ivermectin, a post on messaging platform X, formerly known as Twitter, said: “The FDA now says the Nobel Prize winning drug is approved to treat COVID” (here). Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said that “FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID” (see 22:26 timestamp) and “FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID” (see 31:30 timestamp). “In general, off-label uses have evidence for efficacy and safety that is less than that required to have an indication FDA-approved. Ivermectin is not FDA-approved to treat COVID but the agency does not prohibit physicians from prescribing the drug off-label.

Persons: ivermectin, Ivermectin, COVID, Ashley Cheung Honold, Randall Stafford, ”, ” Stafford, “, Stafford, Ryan Abbot, ” Abbot, Read Organizations: U.S . Food, Drug Administration, FDA, Twitter, Facebook, U.S ., Appeals, Fifth Circuit, Department of Health & Human, COVID, YouTube, Justice, Stanford School of Medicine, University of Surrey, University of California, al, “, Reuters Locations: Los Angeles, Apter

Beneath the trimmed flower is a tray collecting shake, cannabis flower that has naturally broken down through handling. Marijuana is currently a Schedule I drug under the Controlled Substances Act, meaning it's deemed to have no currently accepted medical use and a high potential for abuse. The news sent shares of several cannabis companies, including Canopy Growth , Tilray Brands and Cronos Group , jumping Wednesday. "Certainly, moving cannabis off of Schedule 1 is the right decision and long overdue," Rea said in a statement. "Though a full descheduling would be preferred and likely most appropriate for cannabis, we welcome smart decisions and progress towards full legalization and regulation in the legal cannabis industry."

Persons: James Romano, Patrick Rea, Rea Organizations: U.S . Department of Health, Human Services, Drug, Administration, CNBC, Wednesday, Marijuana, Tilray Brands, Cronos, Bloomberg, HHS, DEA, Poseidon Garden Ventures Locations: Medway, U.S

☆ US health officials look to move marijuana to lower-risk drug category
▼ + stars: | 2023-08-30 | by ( ) www.reuters.com time to read: +3 min

REUTERS/Tom Brenner/Pool/File Photo Acquire Licensing RightsAug 30 (Reuters) - The U.S. Department of Health and Human Services (HHS) has recommended easing restrictions on marijuana, a department spokesperson said on Wednesday, following a review request from the Biden Administration last year. Nearly 40 U.S. states have legalized marijuana use in some form, but it remains completely illegal in some states and at the federal level. The scheduling recommendation for marijuana was provided to the Drug Enforcement Agency (DEA) on Tuesday as part of President Biden's directive to HHS, the spokesperson said. "As part of this process, HHS conducted a scientific and medical evaluation for consideration by DEA. DEA will now initiate its review," a DEA spokesperson said.

Persons: Rachel Levine, Tom Brenner, Biden, Biden's, Karine Jean, Pierre said, Cannabis, George Archos, Sourasis Bose, Mrinalika Roy, Shilpi Majumdar, Shounak Dasgupta, Shailesh Organizations: Department of Health, Human Services, Health, Education, Labor, Capitol, REUTERS, U.S . Department of Health, Drug Enforcement Agency, HHS, DEA, Marijuana, Department of Justice, House Press, Tilray Brands, Cronos, Verano Holdings, Thomson Locations: Washington , U.S, U.S, United States, Canada, North America, Bengaluru

He said that once implemented, the prices on negotiated drugs will decrease for up to 9 million seniors who currently pay as much as $6,497 in out-of-pocket costs per year for these prescriptions. This kicks off the negotiation process for the 10 drugs whose new prices will go into effect in 2026. U.S. laws had prohibited Medicare from negotiating pharmaceutical prices as part of its prescription drug program that began about 20 years ago. CMS Director Dr. Meena Seshamani said Medicare plans to use a review process to make sure insurance companies keep clinically appropriate access to negotiated drugs. Two analysts said they expect the negotiated prices to move beyond Medicare and affect commercial markets for these drugs by 2026, when they come into effect.

Persons: Joe Biden, Jonathan Ernst, Biden, Joe Biden’s, Januvia, Xarelto, Johnson, Boehringer Ingelheim, Eli Lilly's, Jardiance, Mohit Bansal, Entresto, Eli Lilly, Merck, Bristol Myers, Giovanni Caforio, Caforio, enrollees, Meena Seshamani, Stelara, Amgen, Evan Seigerman, Patrick Wingrove, Mike Erman, Manas Mishra, Nandita Bose, Caroline Humer, Bill Berkrot Organizations: Social Security, University of Tampa, REUTERS, U.S, Bristol Myers Squibb, Pfizer, Merck, Co's, Johnson, Novo Nordisk, NYSE Arca Pharmaceutical, U.S . Centers, Medicare, Medicaid Services, Reuters Graphics Wells, Novartis, AstraZeneca, Bristol, J, U.S . Department of Health, Human Services, BMO Capital, Thomson Locations: Tampa , Florida, U.S, Amgen's, Jardiance, Germany, Bengaluru, Washington

REUTERS/Brendan McDermid/File Photo/File Photo Acquire Licensing RightsAug 25 (Reuters) - AstraZeneca (AZN.L) said on Friday it has sued the U.S. government to block parts of a program that gives the Medicare health insurance plan the power to negotiate lower drug prices. The program faces at least seven other court challenges, including from leading industry group PhRMA and drugmakers Johnson & Johnson (JNJ.N), Merck & Co (MRK.N), Bristol Myers Squibb (BMY.N) and privately-held Boehringer Ingelheim. The drug price negotiation program is part of President Joe Biden's signature Inflation Reduction Act (IRA). ‍AstraZeneca said the program would deter continued development of treatments such as its cancer drug Lynparza and rare blood disorder drug Soliris, which carry orphan drug status for multiple conditions. An HHS spokesperson said in a statement that the agency "will vigorously defend the President's drug price negotiation law, which is already helping to lower healthcare costs for seniors and people with disabilities."

Persons: Brendan McDermid, drugmakers Johnson, Johnson, Joe Biden's, AstraZeneca, Bhanvi, Dhanya Ann Thoppil, Shilpi Majumdar Organizations: AstraZeneca, New York Stock Exchange, REUTERS, U.S, Merck & Co, Bristol Myers Squibb, U.S . Department of Health, Human Services, Thomson Locations: British, Delaware, United States, U.S, Bengaluru

☆ US govt awards $1.4 bln for development of new COVID therapies, vaccines
▼ + stars: | 2023-08-22 | by ( ) www.reuters.com time to read: +1 min

The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid/File Photo Acquire Licensing RightsCompanies Regeneron Pharmaceuticals Inc FollowAug 22 (Reuters) - The U.S. government said on Tuesday it had awarded $1.4 billion for the development of new therapies and vaccines against COVID-19, including a $326 million contract with Regeneron Pharmaceuticals (REGN.O) for a next-generation antibody therapy for prevention of infections. The funding to Regeneron is a part of a $5 billion initiative dubbed "Project NextGen" by the U.S. Department of Health and Human Services (HHS). The funding also includes $1 billion for four mid-stage clinical trials of new COVID vaccines, and $100 million to Global Health Investment Corp - a non-profit organization that invests in new technologies that will accelerate responses to diseases. Reporting by Pratik Jain in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

Persons: Brendan McDermid, Regeneron, Pratik Jain, Maju Samuel Organizations: Regeneron Pharmaceuticals, REUTERS, U.S, COVID, U.S . Department of Health, Human Services, U.S . Food, Drug Administration, Omicron, Global Health Investment Corp, Thomson Locations: Westchester, Tarrytown , New York, U.S, Bengaluru

☆ The doctors, dentists and anthropologists striving to identify Maui's victims
▼ + stars: | 2023-08-20 | by ( Joseph Ax | ) www.reuters.com time to read: +7 min

While the work can be emotionally taxing, DMORT members already confront death in their day jobs as funeral directors, medical examiners and coroners. DNA samples have become a crucial tool; Sebastian said the Maui team has partnered with a company that can process DNA in just hours. But the Sept. 11, 2001, attacks represented a pivot point, when DMORT teams helped city authorities sift through thousands of remains. Wildfires represent a relatively new response area for DMORTs; teams responded to the 2018 Camp fire that killed 85 in California and the 2020 Oregon wildfires. "As we're starting to see this era of 'polycrisis,' making sure we have enough DMORT team members that we can deploy is going to be really important," O'Connell, the senior HHS official, said.

Persons: Mike Blake, it's, Frank Sebastian, Kathryn Pinneri, Sebastian, Paul Sledzik, Sledzik, Dawn O'Connell, I've, DMORTs, Hurricane Maria, David Hunt, I'm, Hunt, O'Connell, Joseph Ax, Paul Thomasch, Diane Craft Organizations: REUTERS, U.S . Department of Health, Human Services, Maui, federal, HHS, World Trade Center, Thomson Locations: Lahaina, Maui, Hawaii, U.S, Seattle, United States, hijackings, Montgomery County , Texas, MAUI, Long, Shanksville , Pennsylvania, Puerto Rico, New York, Indiana, DMORTs, California, Oregon

☆ U.S. Watchdog Halts Studies at N.Y. Psychiatric Center After a Subject’s Suicide
▼ + stars: | 2023-08-10 | by ( Ellen Barry | More About Ellen Barry | ) www.nytimes.com time to read: +1 min

Federal regulators have suspended research on human subjects at the Columbia-affiliated New York State Psychiatric Institute, one of the country’s oldest research centers, as they investigate safety protocols across the institute after the suicide of a research participant. The decision affected 417 studies, of which 198 have continuing participation. Of those, 124 receive federal funding. It is unusual for the U.S. regulatory office to suspend research, and this suggests that investigators are concerned that potential violations of safety protocols occurred more broadly within the institute. Almost 500 studies, with combined budgets totaling $86 million, are underway at the institute, according to its website.

Persons: Kate Migliaccio, “, Carla Cantor Organizations: Columbia, New, Psychiatric Institute, U.S . Department of Health, Human Services, Human

☆ What Happens When You Stop at One Glass of Wine a Day?
▼ + stars: | 2023-07-27 | by ( Lettie Teague | ) www.wsj.com time to read: 1 min

SMALL DOSES One glass of wine per day means exactly that. According to government guidelines, you can’t save up your allotment and splurge on the third day. Illustration: Mitch BluntREADING THE MOST recent Dietary Guidelines for Americans from the U.S. Department of Agriculture and U.S. Department of Health and Human Services, I found that women are advised to drink one glass of wine or less and men two glasses or less daily. Do many follow this advice?

Persons: Mitch Blunt Organizations: U.S . Department of Agriculture, U.S . Department of Health, Human Services Locations: U.S

☆ U.S. orders antiviral drugs worth $138 million from SIGA Tech
▼ + stars: | 2023-07-27 | by ( ) www.reuters.com time to read: +1 min

Companies SIGA Technologies Inc FollowJuly 27 (Reuters) - SIGA Technologies Inc (SIGA.O) on Thursday said it has won a new contract for its antiviral drug, Tpoxx, from the U.S. Department of Health and Human Services, sending the company's shares up about 20% after the bell. The order is for delivery of about $113 million worth of oral Tpoxx treatment courses and about $25 million worth of the intravenous formulation of the treatment, SIGA said. SIGA expects to fully deliver the order of oral Tpoxx drugs in 2023 and expects to start delivering IV TPOXX in 2024. Prior to the delivery of the IV drugs, it will focus on fulfilling a prior IV order, the company said. The U.S. Centers for Disease Control and Prevention expanded its use to help tackle the spread of mpox in 2022.

Persons: SIGA, Phil Gomez, Sriparna Roy, Devika Organizations: SIGA Technologies, U.S . Department of Health, Human Services, U.S . Food, Drug Administration, U.S . Centers for Disease Control, U.S . Department of Defense, World Health Organization, Thomson Locations: mpox, Bengaluru

☆ Victims of Cyberattack on File-Transfer Tool Pile Up
▼ + stars: | 2023-07-19 | by ( Catherine Stupp | ) www.wsj.com time to read: +6 min

The list of companies hit by a cyberattack on a widely used software tool continues to expand and several victims have filed lawsuits alleging mishandling of data. The continued disclosure of new victims affected by hackers exploiting a vulnerability in MoveIt, a common file-transfer tool from Progress Software, underscores how cyberattacks can ripple through supply chains. Some companies have been drawn into data breaches without having used MoveIt because their business partners use it. The Cl0p ransomware group has taken responsibility for the cyberattacks and posted data from some victims on its underground website. A 2021 cyberattack on a tool similar to MoveIt—Accellion’s File Transfer Appliance—had similar ripple effects.

Persons: ”, Brett Callow, cyberattacks, Callow, Genworth, PBI, “, Shell, Rob Carr, Suzie Squier, Johns, Johns Hopkins, Emsisoft’s Callow, Catherine Stupp Organizations: Progress Software, . Progress, Progress, Shell, BBC, Energy Department, Genworth Financial, Social, PBI Research Services, U.S . Department of Health, Human Services, Colorado State University, BG Group, Johns Hopkins University, Getty Locations: British, MoveIt, Kaseya, Johns Hopkins

☆ Insurers Deny Medical Care for the Poor at High Rates, Report Says
▼ + stars: | 2023-07-19 | by ( Reed Abelson | More About Reed Abelson | ) www.nytimes.com time to read: +1 min

Private health insurance companies paid by Medicaid denied millions of requests for care for low-income Americans with little oversight from federal and state authorities, according to a new report by U.S. investigators published Wednesday. Medicaid, the federal-state health insurance program for the poor that covers nearly 87 million people, contracts with companies to reimburse hospitals and doctors for treatment and to manage an individual’s medical care. About three-quarters of people enrolled in Medicaid receive health services through private companies, which are typically paid a fixed amount per patient rather than for each procedure or visit. The report by the inspector general’s office of the U.S. Department of Health and Human Services details how often private insurance plans refused to approve treatment and how states handled the denials. Doctors and hospitals have increasingly complained about what they consider to be endless paperwork and unjustified refusals of care by the insurers when they fail to authorize costly procedures or medicines.

Organizations: Medicaid, U.S, U.S . Department of Health, Services

July 18 (Reuters) - Johnson & Johnson (JNJ.N) sued the U.S. government on Tuesday, becoming the latest drugmaker seeking to block a program that gives the Medicare government health insurance plan the power to negotiate lower drug prices. The pharmaceutical industry says the drug price negotiation program under President Joe Biden's signature Inflation Reduction Act law will curtail profits and compel drugmakers to curb development of groundbreaking new treatments. The U.S. Centers for Medicare and Medicaid Services (CMS) in September is expected to select the first 10 drugs to target for negotiations with settled prices set to take effect in 2026. The law is on our side," a spokesperson for the U.S. Department of Health and Human Services said in a statement. It broadly follows the other related lawsuits, arguing that the program is unconstitutional and amounts to "confiscation of constitutionally protected property."

Persons: Johnson, Joe Biden's, drugmakers, Biden, Janssen, Bhanvi, Michael Erman, Krishna Chandra Eluri, Susan Heavey Organizations: Johnson, U.S, drugmakers Bristol Myers Squibb, Merck & Co, U.S . Chamber of Commerce, Pharmaceutical Research, Manufacturers of America, Commerce, U.S . Centers, Medicare, Medicaid Services, U.S . Department of Health, Human Services, District of, Thomson Locations: U.S, District of New Jersey, Bengaluru, New Jersey

WASHINGTON, June 28 (Reuters) - The U.S. Department of Health and Human Services (HHS) was among those affected by a wide-ranging hack centered on a piece of software called MOVEit Transfer, Bloomberg News reported on Wednesday. The report comes as the hackers behind the massive breach claimed credit for stealing data from two major law firms, Kirkland & Ellis LLP and K&L Gates LLP. Kirkland and K&L did not immediately return messages left after hours. The group has previously insisted it doesn't deliberately steal data from government organizations, but that doesn't mean that data hasn't been compromised. Bloomberg cited a person familiar with the incident at HHS as saying that tens of thousands of records could have been exposed.

Persons: Ellis, cl0p, Gates, Kirkland, doesn't, Cl0p didn't, Jon Clay, TrendMicro, Raphael Satter, Lincoln Organizations: U.S . Department of Health, Human Services, Bloomberg, Kirkland, Gates, HHS, Progress Software, Thomson Locations: Russian

[1/2] A worker arrives at the Department of Health and Human Services in Washington, October 1, 2013. REUTERS/James Lawler Duggan/File PhotoWASHINGTON, June 28 (Reuters) - The U.S. Department of Health and Human Services (HHS) was among those affected by a wide-ranging hack centered on a piece of software called MOVEit Transfer, a source at HHS said on Wednesday. "While no HHS systems or networks were compromised, attackers gained access to data by exploiting the vulnerability in the MOVEit Transfer software of third-party vendors," a health department official familiar with the matter said. Hackers behind the massive breach also claimed credit for stealing data from two major law firms, Kirkland & Ellis LLP and K&L Gates LLP. Kirkland and K&L did not immediately return messages left after hours.

Persons: James Lawler Duggan, Ellis, cl0p, Gates, Kirkland, doesn't, Cl0p didn't, Jon Clay, TrendMicro, Raphael Satter, Lincoln Organizations: Department of Health, Human Services, REUTERS, WASHINGTON, U.S . Department of Health, HHS, Kirkland, Gates, Bloomberg, Progress Software, Thomson Locations: Washington, Russian

☆ Opinion | Approaches to Mental Illness
▼ + stars: | 2023-06-17 | by ( ) www.nytimes.com time to read: +1 min

To the Editor:Re “There’s a Reason So Many People Quit Antipsychotic Drugs,” by Daniel Bergner (Opinion guest essay, June 4):Thank you to Mr. Bergner and The New York Times for countering hate and prejudice and raising a voice of reason on the subject of forced psychiatric treatment. There are so many of us: those who were harmed by forced treatment, those whose loved ones were harmed, those who lost loved ones to horrible physical side effects of psychotropic medications or to suicide when people chose death over another round of forced treatment. Patients flock to the few places that offer effective, humane treatment modalities (Open Dialogue, Soteria House). Providing housing without preconditions along with access to voluntary mental health services is the best evidence-based practice recommended by the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and used with great results all over the world. But it does not create a lot of profit for pharmaceutical companies and psychiatric hospitals.

Persons: Daniel Bergner, Bergner Organizations: New York Times, Mental Health Services Administration, U.S . Department of Health

June 9 (Reuters) - The U.S. Chamber of Commerce on Friday sued the federal government, challenging a new law that for the first time gives Medicare the power to negotiate drug prices with pharmaceutical companies. In a complaint filed in federal court in Dayton, Ohio, the chamber said the pricing program violated drugmakers' due process rights under the U.S. Constitution by giving the government "unfettered discretion" to dictate maximum prices. Other drugmakers have also objected to the pricing program, which is part of last year's Inflation Reduction Act. The chamber also warned that allowing the pricing program would set a bad precedent. The case is Dayton Area Chamber of Commerce et al v Becerra et al, U.S. District Court, Southern District of Ohio, No.

Persons: Biden, Karine Jean, Pierre, Neil Bradley, Becerra, Jonathan Stempel, Bill Berkrot Organizations: U.S . Chamber, Commerce, U.S, U.S . Department of Health, Human Services, Medicare, Medicaid Services, Merck & Co, CMS, Merck, Dayton Area, Court, Southern District of, Thomson Locations: Dayton , Ohio, Washington ,, Dayton, U.S, Southern District, Southern District of Ohio, New York

The deal would preserve the mandate nationwide while appeals play out, but allow the employer challenging the mandate, Texas-based Braidwood Management, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services without co-pays for its employees for now. The preventive care mandate, part of the Affordable Care Act (ACA) often referred to as Obamacare, covers services recommended by a federal task force. The ruling does not apply to services the task force recommended before the ACA was enacted in 2010, including breast cancer screening. More than 150 million people were eligible for preventive care free of charge as of 2020 under the ACA, according to data from the U.S. Department of Health and Human Services. The Biden administration has said O'Connor's ruling threatens public health.

Persons: Biden, District Judge Reed O'Connor, O'Connor, Brendan Pierson, Alexia Garamfalvi, Bill Berkrot Organizations: U.S, Circuit, Appeals, Braidwood Management, Affordable, PrEP, HIV, District, . Constitution, U.S . Senate, U.S . Department of Health, Human Services, Major, Thomson Locations: Texas, Braidwood, U.S, Fort Worth , Texas, ., New York

☆ Merck sues US government to halt Medicare drug price negotiation
▼ + stars: | 2023-06-06 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

NEW YORK, June 6 (Reuters) - Merck & Co (MRK.N) sued the U.S. government on Tuesday, seeking to halt the Medicare drug price negotiation program contained in the Inflation Reduction Act (IRA), which it argues is violates the Fifth and First Amendments to the U.S. Constitution. The Biden administration's drug pricing reform aims to save $25 billion annually by 2031 through price negotiations for Medicare. Merck called the talks with CMS coercive and forces drugmakers to participate in "political Kabuki theater" by pretending negotiations are voluntary. The first ever Medicare drug price reduction process is due to begin in September when CMS identifies its 10 most costly drugs. Merck's top selling drug, cancer immunotherapy Keytruda, could be subject to negotiations as soon as 2028.

Persons: drugmakers, Merck, Ameet, Robin Feldman, Wells, Mohit Bansal, Xavier Becerra, Chiquita Brooks, Michael Erman, Patrick Wingrove, Edwina Gibbs, Nick Zieminski Organizations: YORK, Merck & Co, U.S, U.S . Constitution, Biden, Medicare, District of Columbia, Merck, Reuters, CMS, Harvard Medical School, UC College of the, Supreme, U.S . Department of Health & Human Services, Centers, Medicaid Services, LaSure, HHS, Thomson Locations: U.S ., U.S, San Francisco

☆ Biden taps Bertagnolli to lead National Institutes of Health
▼ + stars: | 2023-05-15 | by ( ) www.reuters.com time to read: +1 min

WASHINGTON, May 15 (Reuters) - U.S. President Joe Biden will appoint Monica Bertagnolli, director of the National Cancer Institute, to lead the National Institutes of Health, the White House said on Monday. Bertagnolli will become the second woman to serve as a permanent director of the NIH after a yearlong search to find a permanent replacement for the agency's long-serving leader, Francis Collins. "Dr. Bertagnolli is a world-class physician-scientist whose vision and leadership will ensure NIH continues to be an engine of innovation to improve the health of the American people," Biden said in a statement. Bertagnolli was appointed in October to head the National Cancer Institute, which is a part of NIH, and also served as head of surgical oncology at the Dana-Farber Brigham Cancer Center, one of the nation's top cancer research facilities. Lawrence Tabak has been performing the director duties since December of that year after previously holding the roles of principal deputy director and deputy ethics counselor since 2010 at NIH.

Homeland Security Secretary Alejandro Mayorkas defended the Biden regulation, saying it aims to encourage migrants to enter using legal pathways. U.S. asylum officers hurried to figure out the logistics of applying the new asylum regulation. COVID EMERGENCY ENDS, ASYLUM BAN BEGINSTrump first implemented Title 42 in March 2020 as COVID swept the globe. The order allowed American authorities to quickly expel migrants to Mexico or other countries without a chance to request asylum. Migrants have been expelled more than 2.7 million times under Title 42, although the total includes repeat crossers.

☆ Pfizer CEO says Medicare will likely face legal action over drug price negotiations
▼ + stars: | 2023-05-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Pfizer CEO Albert Bourla on Thursday said pharmaceutical companies will likely take legal action against Medicare drug price negotiations, which aim to cut costs for older Americans, but will likely reduce company profits. Bourla referred to a provision in the Biden administration's Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. The first negotiations start in September and new prices will go into effect in 2026. Some drugmakers are already preparing to fight Medicare drug negotiations, industry sources told Reuters. Another provision of the Inflation Reduction Act requires Pfizer and other prescription drug companies to refund Medicare through rebates if the prices of their drugs rise faster than the rate of inflation.

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