Opinion: What does ‘bona fide competition’ actually mean in the biologics market?
STAT
SEPTEMBER 6, 2023
29, Medicare released its highly anticipated list of 10 therapies for which it plans to establish a price by 2026.
2026 Related Topics 
Pandemic vaccination regulations extended to 2026
The Pharmacist
NOVEMBER 1, 2023
Vaccination regulations adopted due to the Covid pandemic will be extended until 2026 following a Government consultation. Ministers will extend the regulations until 1 April 2026 to support the supply, distribution and administration of Covid and flu vaccines as the country transitions out of the pandemic.
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Concerns prescribing service will not be ready by 2026
The Pharmacist
SEPTEMBER 11, 2024
Slow progress on the community pharmacy prescribing pathfinder project has sparked concerns that a viable commissioned community pharmacy prescribing service will not be ready by 2026, The Pharmacist has learned.
Draft legislation sets out steps for cutting business rates for pharmacies from 2026
The Pharmacist
NOVEMBER 21, 2024
The government has published draft legislation outlining a ‘permanent’ cut in business rates for retail, hospitality and leisure (RHL) properties from 2026, including pharmacies. The tax cut will be funded by a tax rise for the very largest business properties, such as online sales warehouses.
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Multi-sector pharmacist training no longer mandatory for 2026/27
The Pharmacist
DECEMBER 17, 2024
Pharmacy employers will not have to offer multi-sector training placements in 2026/27, NHS England (NHSE) has announced.
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Lundbeck planning for four novel drugs in phase 3 in 2026
pharmaphorum
OCTOBER 24, 2024
Denmark's Lundbeck has said that efforts to build its R&D portfolio are on track to deliver four new molecular entities (NMEs) in phase 3 trials in 2026, including an epilepsy drug from its recently announced $2.6 billion takeover of Longboard Pharma.
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STAT+: Biden administration makes opening offers in Medicare drug price negotiations
STAT
FEBRUARY 1, 2024
The negotiated prices won’t take effect until 2026. The Biden administration will publish the final prices by Sept. 1 of this year after the negotiation process ends. Continue to STAT+ to read the full story…
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Dengue is spreading and Sanofi is pulling the market’s only vaccine. What’s next?
PharmaVoice
OCTOBER 23, 2024
As Sanofi prepares to halt production on its dengue vaccine in 2026, locally acquired infections in the U.S. are raising the alarm.
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STAT+: Grail announces layoffs as it looks to push forward blood-based cancer detection test
STAT
AUGUST 13, 2024
In a press release, the company said that the cuts would help it extend its cash reserves from the second half of 2026 into 2028. The Bay Area biotech brought in $32 million during the quarter but also reported a net loss of $1.6 Continue to STAT+ to read the full story…
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STAT+: Grocers are pushing legislation they claim would enhance food safety. Advocates say it would gut FDA rules
STAT
APRIL 16, 2024
It would carve grocers, restaurants, and food warehouses out of a major portion of the FDA’s rules, which are meant to help regulators quickly track down the cause of a foodborne outbreak, and it would delay enforcement of the entire food safety program, slated to begin in 2026, by several years.
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AI to revolutionise drug development by 2026
European Pharmaceutical Review
SEPTEMBER 12, 2023
Over 50 percent of respondents answered that machine learning for optimisation of manufacturing processes will be the technology that will be used routinely in the pharmaceutical industry by 2026. The post AI to revolutionise drug development by 2026 appeared first on European Pharmaceutical Review.
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STAT+: Medicare already covers GLP-1s for half of seniors with obesity, new report finds
STAT
OCTOBER 9, 2024
The Congressional Budget Office estimates that 29 million beneficiaries would qualify for weight loss drugs in 2026. Drugs for those conditions already exist, and they’re often generic. But a lot of people are switching to GLP-1s. Continue to STAT+ to read the full story…
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GS Krishnan re-elected ABLE President for 2024 -2026
Express Pharma
APRIL 2, 2024
GS Krishnan, President of Association of Biotechnology Led Enterprises (ABLE) has been re-elected for another two-year term from April 2024 – 2026. The post GS Krishnan re-elected ABLE President for 2024 -2026 appeared first on Express Pharma.
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Dr R. N. gupta elected National President of Indian Pharmaceutical Association for 2024-2026 term
Express Pharma
SEPTEMBER 23, 2024
Gupta has been elected as the National President of the Indian Pharmaceutical Association (IPA) for the term 2024-2026. Dr Gupta’s term will run from October 1, 2024 to 30th September 2026. gupta elected National President of Indian Pharmaceutical Association for 2024-2026 term appeared first on Express Pharma. The post Dr R.
STAT+: Research misconduct claims are growing. Will new rules help universities investigate them?
STAT
SEPTEMBER 20, 2024
The new guidance will affect nearly 6,000 universities and other institutions with projects funded by HHS, which have until 2026 to comply.
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STAT+: Freespira bets on slow and steady, amid spectacular digital health collapses
STAT
JUNE 18, 2024
Freespira CEO Joe Perekupka told STAT the company believes it will break even by the end of 2025 and will become cash flow positive in 2026. Perekupka said Freespira hopes to enroll 2,500 people in its treatment this year — twice last year’s sales — and to double its patients again in 2025 and 2026.
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STAT+: Novartis to spend $200 million in further bid to boost radiopharma manufacturing, market dominance
STAT
SEPTEMBER 4, 2024
The sites are expected to employ another 90 people and open by 2026. The pharmaceutical giant will spend more than $200 million to construct the new facility in Carlsbad, Calif., and expand its site in Indianapolis, representatives told STAT exclusively.
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STAT+: Grail, aiming to launch a blood test for cancer, faces host of challenges as it debuts on Nasdaq
STAT
JUNE 24, 2024
But that deal, though eventually closed, was scuttled by regulatory issues in both the U.S. and Europe, and European regulators forced Illumina to spin Grail back out. Grail now says it expects to file for full approval in the U.S. In the meantime, the company is running an annual loss of about $500 million a year.
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Opinion: How the drug price negotiation program could affect Medicare Part D beneficiaries
STAT
SEPTEMBER 8, 2023
The negotiation, informed by confidential data from manufacturers and analysis by the Centers for Medicare and Medicaid Services, will result in a maximum fair price for each drug, which will be announced Sept. 1, 2024, and will take effect Jan. The Congressional Budget Office has estimated that the negotiations could save Medicare about $3.7
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STAT+: Nick Leschly departs Bluebird Bio spinout amid restructuring, layoffs
STAT
SEPTEMBER 12, 2023
The cuts extend the company’s cash runway into 2026. It also plans to allocate less money to a couple of drug candidates, including one that is currently on hold with the Food and Drug Administration. The company was formed in 2021 when the team behind Bluebird Bio decided to split its drug pipeline down the middle.
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Opinion: I’m the director of the Center for Medicare. Here’s how we executed the first round of drug price negotiation
STAT
OCTOBER 29, 2024
billion in estimated out-of-pocket savings for people with Medicare prescription drug coverage when the negotiated prices are set to go into effect in 2026.
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STAT+: Google’s Verily to offer GLP-1 drugs through Lightpath, its retooled chronic care app
STAT
JUNE 11, 2024
Lightpath Metabolic, expected to be available in 2026, will not only include programs for people with type 1 and type 2 diabetes and hypertension — as the current iteration of Onduo does — but will also offer GLP-1 drug prescriptions.
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STAT+: Medicare is urged to consider Amgen patent maneuvers when negotiating the price for a drug
STAT
OCTOBER 31, 2023
As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues the agency should factor in controversial patent maneuvers for one drug that will have cost the program nearly $2 billion in additional spending by 2026.
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STAT+: ViiV takes steps to widen access to HIV prevention drug, but continues to encounter criticism
STAT
OCTOBER 8, 2024
The latest effort involves tripling the annual supply of the drug, a long-acting medication known as cabotegravir, in hopes of making more than 2 million doses available during 2025 and 2026.
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White House’s open-access research directive scrambles long-entrenched models, raising key questions
STAT
OCTOBER 3, 2022
1, 2026, opening up JAMA’s or Nature’s website, and being able to read any article for free. Most people who heard the news likely envisioned making a cup of coffee on Jan. Read the rest…
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STAT+: CRO claims there was no misconduct in Lyme vaccine trial it ran for Pfizer
STAT
OCTOBER 11, 2023
The decision meant that data from roughly half of the trial were scrapped, which delayed their plans to seek regulatory approval for the shot until 2026, instead of 2025. Pfizer and Valneva maintained there were no safety issues or adverse events prompting the decision, and instead blamed unspecified problems with the conduct of the study.
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STAT+: Pharmalittle: Winners and losers from Medicare drug-negotiation list; Novo strikes deal to keep lead in weight-loss drugs
STAT
AUGUST 30, 2023
Department of Health and Human Services named 10 medicines that will be subject to price negotiations for the Medicare program in 2026, a milestone and a point to start appraising the impact of the law , STAT explains. Have a wonderful day, and please do stay in touch. … On Tuesday, the U.S. The landscape here is complicated.
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Opinion: HHS’s proposed rule pays lip service to addressing the climate crisis, the greatest threat to human health
STAT
MAY 20, 2024
Even assuming that all of these hospitals voluntarily report their greenhouse gas emissions, they constitute a trivial amount of one of the world’s largest sources of such emissions, making up nearly 9% of total annual U.S. greenhouse gas emissions and 4.5% of the total worldwide , along with an equal amount of toxic air pollutants.
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The drugs hit hardest by Medicare price negotiations
PharmaVoice
AUGUST 16, 2024
The final negotiations slash drug prices between 38% and 79% for Medicare’s 2026 calendar year.
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Opinion: STAT+: What the newly released Medicare prices for 10 drugs do and don’t tell us
STAT
AUGUST 16, 2024
billion ) in 2026. Well, there’s CMS’ estimate for how much would have been saved by the Medicare program had the MFPs been in effect in 2023 ( $6 billion ), and the estimate for how much seniors will save out-of-pocket just from the lower prices ( $1.5
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STAT+: How one pharma insider sees the drug pricing reform law: the impact will ‘vary by product and by company’
STAT
OCTOBER 20, 2022
Moreover, the process does not start until 2026. But those medicines can’t have any competing products on the market, and negotiations can’t begin until a small-molecule drug has been available for at least nine years and a biologic for 13 years.
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Regenxbio eyes 2026 filing for Duchenne muscular dystrophy gene therapy
Pharmaceutical Technology
NOVEMBER 19, 2024
Regenxbio’s plans toward a BLA filing in 2026 after positive data from the Phase I/II AFINITY DUCHENNE trial.
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Two former Alexion leaders fight through layoffs and a tough market to maintain a rare disease biotech
PharmaVoice
NOVEMBER 5, 2024
Rallybio is headed into a mid-stage trial with enough cash through 2026, but the cyclical market has made the journey difficult.
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STAT+: Pharmalittle: We’re reading about Amylyx pulling its ALS drug, GLP-1 drugs for Parkinson’s, and more
STAT
APRIL 4, 2024
Novo’s patents in China on Ozempic and the related drug Wegovy are set to expire in 2026, according to its annual report. Novo’s Ozempic sales in China more than doubled last year to $694 million, accounting for 5% of global Ozempic sales. Continue to STAT+ to read the full story…
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STAT+: Pharmalittle: We’re reading about rejection of an AbbVie Parkinson’s drug, PBM markups on mail order, and more
STAT
JUNE 26, 2024
million in sales for ABBV-951 in 2026, according to LSEG data. It is administered subcutaneously, or under the skin, through an infusion pump in order to improve patients’ motor functions. If approved, analysts estimate $619.67 Jacky Rosen (D-Nev.) wants the U.S.
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STAT+: Pharmalittle: We’re reading about the aftermath of FDA vote on MDMA, rising pharma layoffs, and more
STAT
JUNE 6, 2024
But the patent on semaglutide, the active ingredient in both drugs, expires in China in 2026. Ozempic won approval in China in 2021 and Novo Nordisk saw sales of the drug in that region double to $698 million last year. It expects Wegovy to be approved this year. Continue to STAT+ to read the full story…
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STAT+: Pharmalittle: FDA approves Pfizer’s RSV vaccine for newborns; Boehringer sues over IRA
STAT
AUGUST 22, 2023
Jardiance, a diabetes medicine co-marketed by Boehringer, is expected to be among the first drugs to face negotiation once the law takes effect in 2026. Continue to STAT+ to read the full story…
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STAT+: Pharmalittle: We’re reading about the U.K. nixing coverage for a cancer drug, sharing bird flu vaccine data, and more
STAT
JULY 30, 2024
… Four pharmaceutical companies involved in the negotiations over prices for Medicare do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026 , Reuters writes.
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STAT+: Pharmalittle: We’re reading about plans for generic Wegovy, cough syrup warnings, and more
STAT
APRIL 19, 2024
Semaglutide will lose patent protection in those countries in 2026, and Biocon is talking to local manufacturers regarding partnerships to ensure supply. The company, which derives most of its revenue from foreign markets such as the U.S.,
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Valneva, Pfizer push back timeline for Lyme disease vaccine
BioPharma Dive
MAY 4, 2023
After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.
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Pharmacists must continue promotion of folic acid after fortification of flour
The Pharmacist
NOVEMBER 26, 2024
Pharmacists have been urged to continue to promote the importance of folic acid supplementations following news that it will be added to non-wholemeal flour from the end of 2026.
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CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process
Big Molecule Watch
APRIL 6, 2023
The post CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process appeared first on Big Molecule Watch. Click here for their prior alerts on the Part B and Part D inflation rebates.
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STAT+: Pharmalittle: We’re reading about pharma patent maneuvers, the U.S. warning J&J, and more
STAT
SEPTEMBER 18, 2024
to directly negotiate drug prices with manufacturers for the first time, last month slashed the cost of 10 of the world’s biggest medicines by 38% to 79% for 2026. The Inflation Reduction Act, which allows the U.S.
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Healthcare AI from Cera ‘could save NHS and UK £1bn a year’
pharmaphorum
MAY 3, 2024
AI-powered home healthcare model from Cera could save NHS and UK £1bn in 2026 if adopted nationwide, says new study
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