STAT

AUGUST 22, 2023

German drugmaker Boehringer Ingelheim is the latest pharmaceutical company to sue the federal government over a law that would allow Medicare to negotiate certain drug prices, Reuters reports. Continue to STAT+ to read the full story…

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Big Molecule Watch

JULY 18, 2023

On June 30, 2023, the Centers for Medicare & Medicaid Services (CMS) released its updated final program guidance covering the Inflation Reduction Act’s Medicare Drug Price Negotiation Program for the first round of negotiations, which will occur during 2023 and 2024 and result in prices that will be effective beginning in 2026.

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Drug Pricing 52

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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Drug Pricing 308

Big Molecule Watch

MAY 9, 2024

Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program. Briefing on dispositive motions has completed in the remaining district court challenges to the Drug Price Negotiation Program. Lead Case No.

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Drug Pricing 67

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. That leaves three years for pharma companies to prepare.

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Big Molecule Watch

OCTOBER 2, 2023

Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the Drug Price Negotiation Program of the Inflation Reduction Act. New Complaint by Novo Nordisk Also on Friday, Novo filed a new Complaint challenging the Drug Price Negotiation Program and CMS’s actions in implementing it.

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FDA Law Blog: Biosimilars

JUNE 26, 2023

Kirschenbaum — As we and others closely following drug pricing have predicted, multiple additional lawsuits have followed in the wake of Merck’s challenge to the Inflation Reduction Act (IRA) price negotiation provisions in the D.C. By Faraz Siddiqui & Alan M. federal district court on June 6 (see our post here ).

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Drug Pricing 59

STAT

MARCH 7, 2024

— Pharma industry giants including Bristol Myers Squibb, Johnson and Johnson, Novartis, and Novo Nordisk deployed a half-dozen lawyers to a courtroom here Thursday in a bid to dismantle Medicare’s new drug price negotiation program, just hours before President Biden is set to glorify it in his State of the Union.

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Putting Patients First Blog

MARCH 21, 2024

Medicare Drug Price Negotiation Program The rising costs of prescription drugs has consistently been an area of concern for patients and for the financial health of Medicare. The Roundtable identified lessons learned that can be used to inform future listening sessions and CMS’ broader patient engagement strategies.

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Drug Pricing 52

Putting Patients First Blog

MARCH 21, 2024

Medicare Drug Price Negotiation Program The rising costs of prescription drugs has consistently been an area of concern for patients and for the financial health of Medicare. The Roundtable identified lessons learned that can be used to inform future listening sessions and CMS’ broader patient engagement strategies.

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Drug Pricing 52

pharmaphorum

JUNE 2, 2022

Evaluate Pharma’s recent Orphan Drug Report subtitled its overview of the market ‘Niche no longer.’ This is based on the relative success orphan drugs have achieved, in terms of the number of approvals and the sales figures achieved for this area.

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Putting Patients First Blog

APRIL 27, 2023

NHC Medicare Drug Price Negotiation Program Comments April 27, 2023 By: Allen Pinn, Coordinator, Policy April 14, the National Health Council (NHC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Medicare Drug Price Negotiation Program, established under the Inflation Reduction Act.

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Drug Pricing 52

STAT

AUGUST 29, 2023

On Tuesday morning, the Department of Health and Human Services unveiled its long-awaited list of the 10 medicines that will be subject to price negotiation in 2026 under the Inflation Reduction Act.

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Drug Pricing 239

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program. Harm The Court reviewed the parties’ arguments on “irreparable harm to Plaintiffs.”

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STAT

JULY 18, 2023

WASHINGTON — Pharmaceutical giant Johnson & Johnson on Tuesday became the third drugmaker to sue the Biden administration over its new Medicare drug price negotiation program. J&J joins a flurry of litigation challenging the Medicare drug price negotiation program, which is set to start this fall.

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Drug Pricing 243

STAT

JULY 19, 2023

Johnson & Johnson became the third drugmaker to sue the Biden administration over its new Medicare drug price negotiation program, STAT notes. J&J joins a flurry of litigation challenging the Medicare drug price-negotiation program, which is set to start this fall. Chamber of Commerce have also filed suit.

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Drug Pricing 211

STAT

AUGUST 29, 2023

Postcards and telegrams are accepted… Medicare announced the first 10 drugs selected for a new drug-price negotiation program , STAT reports. The drugs include Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, and a product that goes by names including Fiasp and NovoLog.

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Drug Pricing 240

STAT

FEBRUARY 1, 2024

… The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, but declined to disclose any details , STAT tells us. The Biden administration will publish the final prices by Sept. Best of luck and, as always, do stay in touch.

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Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

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BioPharma Dive

AUGUST 25, 2023

The drugmaker's lawsuit comes the week before the Biden administration is set to announce the first 10 drugs subject to negotiated prices in 2026.

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Drug Pricing 98

FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. at least one drug” has been approved and marketed. The court found numerous flaws with this argument.

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pharmaphorum

OCTOBER 27, 2022

Under the legislation, which has been slammed by pharma industry groups, Medicare pricing negotiations for some high-cost drugs would get underway in 2026, with drugmakers forced to pay rebates if prices rise faster than inflation.

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Drug Pricing 52

Safe Biologics

MAY 10, 2024

View ASBM’s educational fact sheet “Interchangeability: US vs EU” here. Biden’s SOTU: 500 Drugs To Be Subject to Medicare Drug Price Controls On March 7th, President Biden gave his State of the Union address to Congress, wherein he laid out upcoming policy priorities for a potential second term.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug.

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Integra X Files

JUNE 19, 2023

They have an incentive to keep prices as low as possible. The looming problem is how Medicare will contend with rising drug prices. Most new entrants are expensive biologics and other specialty drugs. This is attributable to competition between plan sponsors to attract Medicare enrollees.

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Putting Patients First Blog

AUGUST 28, 2023

This bill aims to delink the compensation of PBMs from drug prices. Medicare Price Negotiations After being signed into legislation a year ago, a significant aspect of the Inflation Reduction Act is coming to fruition.

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Packaging Drug Pricing 52

STAT

AUGUST 15, 2023

But a report from three Democratic senators found consumers had trouble getting discounted insulin from pharmacies nationwide and were often charged more than what the drug manufacturers promised. Department of Justice lambasted a request by the U.S. businesses and patients. Continue to STAT+ to read the full story…

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Drug Pricing 209

Safe Biologics

OCTOBER 10, 2023

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.

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Putting Patients First Blog

APRIL 14, 2023

60: Input Process for Future Program Guidance The NHC appreciates the opportunity to comment on initial program guidance for IPAY 2026 and seeks clarification on processes for seeking feedback moving forward. Including this information in the explanation will help patient advocates develop the most useful data for future negotiations.

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Safe Biologics

APRIL 10, 2023

CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022.

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Safe Biologics

SEPTEMBER 11, 2023

September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. 1] 90% of new cancer drugs are available in the U.S.

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Pharmaceutical Technology

JANUARY 16, 2023

The topic of inflation overlaps with drug pricing strategy themes. Policymakers are attempting to respond to inflation crises by introducing new frameworks on the regulation of drug prices. Similar echoes are heard in Europe, where pressure to curb price growth will stay a priority.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars 64

Pharmaceutical Technology

JANUARY 16, 2023

The topic of inflation overlaps with drug pricing strategy themes. Policymakers are attempting to respond to inflation crises by introducing new frameworks on the regulation of drug prices. Similar echoes are heard in Europe, where pressure to curb price growth will stay a priority.

Drug Pricing 52

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars 52