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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Vaccines 246

STAT

NOVEMBER 12, 2024

  The South San Francisco biotech expects to begin testing its lead drug candidate in clinical trials by early 2026. Continue to STAT+ to read the full story…

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STAT

NOVEMBER 18, 2024

The positive results from muscle-performance tests come from a small number of patients, but after consulting with the Food and Drug Administration, Regenxbio has expanded its current clinical trial so that it can support the submission of an accelerated approval application in 2026.

Drug Development 226

Drug Development 226

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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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.

Drug Pricing 57

Drug Pricing 57

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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Diabetes 302

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

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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Drug Pricing 262

PharmaVoice

AUGUST 16, 2024

The final negotiations slash drug prices between 38% and 79% for Medicare’s 2026 calendar year.

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Drug Pricing 148

STAT

SEPTEMBER 6, 2023

29, Medicare released its highly anticipated list of 10 therapies for which it plans to establish a price by 2026.

Biosimilars 308

Biosimilars Drug Pricing 308

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

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.

Drug Development 268

Drug Development 268

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.

Drug Pricing 276

Drug Pricing 276

BioPharma Dive

OCTOBER 18, 2024

Detailed data from a Phase 2b/3 study of Merck’s treatment clesrovimab should support the company’s efforts to win approval by the 2025-2026 season.

Hospitals 107

Hospitals 107

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…

Drug Pricing 303

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 303

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

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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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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Outsourcing Pharma

SEPTEMBER 17, 2024

One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.

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Outsourcing Pharma

OCTOBER 3, 2024

The proceeds of the financing will support the development of LoQus23âs lead candidate, a small molecule inhibitor that is expected to enter the clinic in 2026.

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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

Drug Pricing 300

Drug Pricing 300

Pharmaceutical Commerce

AUGUST 16, 2024

By 2026, the first 10 drugs for individuals with Part D coverage—whose medications are mainly used to treat cancer, diabetes, and heart disease—will see discounts off of list prices ranging from 38-79%.

Drug Pricing 98

Drug Pricing Diabetes 98

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.

Diabetes 294

Diabetes 294

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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Express Pharma

OCTOBER 22, 2024

These include meeting 40 per cent of power demand from renewable energy by FY 2026-27 and 100 per cent by FY 2032-33. The company aims to become carbon neutral in direct operations by FY 2032-33, achieve Zero Waste to Landfill by FY 2032-33, and achieve water positivity by the same year.

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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.

Drug Pricing 301

Drug Pricing 301

BioPharma Dive

NOVEMBER 5, 2024

Rallybio is headed into a mid-stage trial with enough cash to last it through 2026, but biotech's down market has made the company's journey difficult.

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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.

Vaccines 267

Vaccines 267

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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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.

Biosimilars 240

Biosimilars Drug Pricing 240

BioPharma Dive

OCTOBER 24, 2024

As Sanofi prepares to halt production on its dengue vaccine in 2026, locally acquired infections in the U.S. are raising the alarm.

Vaccines 56

Vaccines 56

Express Pharma

OCTOBER 22, 2024

These include meeting 40 per cent of power demand from renewable energy by FY 2026-27 and 100 per cent by FY 2032-33. The company aims to become carbon neutral in direct operations by FY 2032-33, achieve Zero Waste to Landfill by FY 2032-33, and achieve water positivity by the same year.

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BioPharma Dive

OCTOBER 7, 2024

The company is committing to make at least 2 million doses of its long-acting PrEP therapy available in low- and middle-income countries next year and in 2026.

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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.

Vaccines 124

Vaccines 124

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

Drug Pricing 265

Drug Pricing Diabetes 265

FDA Law Blog: Biosimilars

MARCH 19, 2024

Hyman, Phelps & McNamara, P.C. (HP&M), HP&M), the largest dedicated food and drug law firm in the U.S., is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). This prestigious appointment recognizes Ms.

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BioPharma Dive

OCTOBER 9, 2023

The purchase agreement with Chongqing Zhifei Biological Products is part of GSK’s plan to double sales of the shingles vaccine by 2026.

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Vaccines 110