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 292

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 292

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 293

Drug Pricing 293

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 282

Drug Pricing 282

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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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 254

Vaccines 254

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 216

Biosimilars Drug Pricing 216

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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BioPharma Dive

MARCH 18, 2024

The funding could extend the cash-strapped gene therapy maker’s financial runway to 2026, but only if the company successfully hits certain milestones.

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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.

Vaccines 108

Vaccines 108

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 122

Vaccines 122

PharmaTech

SEPTEMBER 15, 2023

According to a press release, the implications go to the extent that within the next 10 years, more than 50% of approved drugs will involve AI in their development and/or manufacturing.

Drug Development 52

Drug Development 52

Express Pharma

APRIL 4, 2024

First phase with a builtup area of 29,000 square meters to be completed within a year, second phase by 2026 Gujarat-based SAVA Healthcare conducted the ground-breaking ceremony of its second manufacturing plant, in the Smart Industrial Park (SIP) of Madhya Pradesh Industry Development Corporation (MPIDC) in March.

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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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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…

Diabetes 211

Diabetes Biosimilars 211

STAT

JANUARY 30, 2024

Five Wall Street analysts and two investors told Reuters they expect the negotiations over prices that will go into effect in 2026 to result in cuts ranging from the statutory minimum of 25% to as much as 60% when the final numbers are set in September. … Pharmaceutical companies are due to receive by Thursday the U.S.

Diabetes 218

Diabetes Pharmaceutical Companies Pharmaceutical Companies 218

The Pharmacist

MARCH 7, 2024

A new tax on vaping products will be introduced from October 2026, chancellor Jeremy Hunt announced in yesterday’s Spring Budget.

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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…

Vaccines 191

Vaccines Drug Pricing Diabetes Pharmaceutical Companies 191

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.

Drug Pricing 196

Drug Pricing 196

Pharmaceutical Technology

NOVEMBER 8, 2023

The company’s cash reduction measures are expected to extend its cash runway into 2026.

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PharmExec

AUGUST 29, 2023

Lawsuit comes amid announcement of the first 10 drugs eligible for negotiated prices in 2026.

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Express Pharma

OCTOBER 31, 2023

Zydus will pay an upfront consideration of GBP 68 million and yearly earn-outs until 2026 depending on achievement of certain agreed milestones towards acquisition of the LiqMeds Group of companies. The transaction will be EPS accretive for Zydus from the first year of acquisition.

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Pharmaceutical Technology

JULY 20, 2023

The centre is planned for completion in 2026, along with plans to build a $400m biologics manufacturing plant.

Biosimilars 74

Biosimilars 74

Express Pharma

AUGUST 30, 2023

As per the settlement with the innovator, Ajanta can launch Topiramate on February 1, 2026 or earlier under certain circumstances. Ajanta Pharma has received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg and 200 mg.

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The Pharmacist

NOVEMBER 13, 2023

Widespread prescribing by pharmacists from 2026 is likely to add a ‘judicious’ approach to medicines prescribing, chief pharmaceutical officer (CPhO) for England David Webb suggested at the Royal Pharmaceutical Society’s (RPS) Annual Conference last week.

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The Guardian - Pharmaceutical Industry

JANUARY 25, 2024

In a statement on Wednesday, Haleon recalled eight batches of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult, with expiration dates from October 2025 to June 2026. Continue reading.

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The Pharmacist

JUNE 23, 2023

The Government will work with pharmaceutical contractors to guard against risks of fraud relating to inappropriate claims and reimbursements and ‘contractual fraud’ to help meet a savings target of £500 million for the NHS between now and 2026.

Community Pharmacies 73

Community Pharmacies 73

Big Molecule Watch

NOVEMBER 6, 2023

The final “maximum fair price” will be published by September 1, 2024, and manufacturers must “provide access” to the drug to Medicare beneficiaries at a price no higher than the “maximum fair price” beginning January 1, 2026. In that case, according to CMS’s guidance, STELARA would cease to be “selected” on January 1, 2027.

Drug Pricing 67

Drug Pricing Biosimilars 67

The Guardian - Pharmaceutical Industry

NOVEMBER 30, 2022

Patients unlikely to receive lecanemab before 2026 and health service does not yet have necessary infrastructure Drug slows cognitive decline in Alzheimer’s patients, study reveals A reorganisation of NHS dementia care is needed to ensure UK patients can receive a groundbreaking drug that slows the progression of Alzheimer’s disease, doctors say.

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STAT

NOVEMBER 1, 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 , STAT writes. At

Biosimilars 223

Biosimilars 223

Express Pharma

JANUARY 11, 2024

Following these, the US market anticipates the 2026 introduction of additional URAT1 inhibitors – ABP-671 and SAP-001 – along with tigulixostat, a xanthine dehydrogenase inhibitor, and a topical sodium bicarbonate therapy.” Dapansutrile is the second anti-inflammatory therapy that is forecasted to launch in 2026.

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Biosimilars Compounding 84

Pharmaceutical Technology

SEPTEMBER 23, 2022

It will expire on 24 November 2026, and the paediatric exclusivity lasts until 24 May 2027. Additionally, Merck has signed patent litigation settlement deals with various generic firms, permitting them to offer generic versions of Januvia and Janumet to the US market in May 2026, or before under specific conditions.

Vaccines 69

Vaccines 69

Pharmacy Times

AUGUST 30, 2023

Any new prices established after negotiations will be effective on January 1, 2026.

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Big Molecule Watch

OCTOBER 18, 2023

NKF”), exclusive rights to commercialize the three biosimilar insulin products upon approval by the FDA, estimated to be on or around 2026. The agreement grants Meitheal and its parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., THDB and NKF will jointly handle product development and supply.

Biosimilars 62

Biosimilars 62

European Pharmaceutical Review

JULY 10, 2023

billion in 2026. Given their short shelf-life, there is a need for methods that generate more rapid results for emerging advanced therapy medicinal products (ATMPs) such as cell and gene therapies. Currently, there are more than 2,000 active clinical trials for cell and gene therapies, 1 with the market expected to grow from $8.6

Compounding 86

Compounding 86

Express Pharma

JANUARY 22, 2024

The WHO estimates that 40-60 million doses will be required each year by 2026, rising to 80-100 million by 2030. GSK in 2015 published results of a large-scale clinical trial showing it reduced the risk of severe malaria by around 30 per cent. More than 30 African countries have expressed interest in introducing the vaccine.

Vaccines 103

Vaccines 103

pharmaphorum

SEPTEMBER 30, 2022

That challenged the ‘708 patent – which expires in November 2026 – as well as one other (No. Viatris could still take its cases further, but for now Merck has retained market exclusivity for Januvia, Janumet, and Janumet XR until at least 2026.

Diabetes 58

Diabetes Vaccines 58