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Articles by Alexandra Lu
Third Circuit Affirms Rejection Of AstraZeneca's Challenges To IRA Drug Price Negotiation Program
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court's dismissal of AstraZeneca's challenges to the Inflation Reduction Act's Drug Price Negotiation Program and CMS's Guidance implementing the Program. AstraZeneca manufactures Farxiga, one of the drugs selected in the first round of drug price negotiations under the Program. Farxiga (dapagliflozin) is used to treat diabetes, heart disease, and kidney disease.
Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program | JD Supra
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing the Program. AstraZeneca manufactures Farxiga, one of the drugs selected in the first round of drug price negotiations under the Program. Farxiga (dapagliflozin) is used to treat diabetes, heart disease, and kidney disease.
Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing the Program. AstraZeneca manufactures Farxiga, one of the drugs selected in the first round of drug price negotiations under the Program. Farxiga (dapagliflozin) is used to treat diabetes, heart disease, and kidney disease.
Year In Review: Top Legal Developments Of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year's recap of 2023, Regeneron's litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Year in Review: Top Legal Developments of 2024 | JD Supra
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Year in Review: Top Legal Developments of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Year in Review: Top Legal Developments of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year.
IRA Litigation Updates: D.N.J. Rejects Challenges From BMS And Janssen; Four Cases Now On Appeal
On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA's Drug Price Negotiation Program.
IRA Litigation Updates: D.N.J. Rejects Challenges from BMS and Janssen; Four Cases Now on Appeal | JD Supra
On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program.
IRA Litigation Updates: D.N.J. Rejects Challenges from BMS and Janssen; Four Cases Now on Appeal
On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program.
Court Grants Summary Judgment Ending AstraZeneca's Lawsuit Challenging The IRA
Today, the district court for the District of Delaware (Judge Connolly) granted the government's motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA.
Court Grants Summary Judgment Ending AstraZeneca’s Lawsuit Challenging the IRA | JD Supra
Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA.
Court Grants Summary Judgment Ending AstraZeneca’s Lawsuit Challenging the IRA
Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA.
Court Dismisses PhRMA Lawsuit Challenging IRA
Today, the district court for the Western District of Texas granted the government's motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation Reduction Act. The lawsuit was brought by three Plaintiffs: PhRMA, the Global Colon Cancer Association, and the National Infusion Center Association ("NICA").
Court Dismisses PhRMA Lawsuit Challenging IRA | JD Supra
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation Reduction Act. The lawsuit was brought by three Plaintiffs: PhRMA, the Global Colon Cancer Association, and the National Infusion Center Association (“NICA”).
Court Dismisses PhRMA Lawsuit Challenging IRA
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation Reduction Act. The lawsuit was brought by three Plaintiffs: PhRMA, the Global Colon Cancer Association, and the National Infusion Center Association (“NICA”).
FDA Approves Amgen's WEZLANA As Biosimilar To And Interchangeable With Janssen's STELARA (Ustekinumab) – Stelara Is One Of The 10 Drugs Selected By CMS For Drug Price Negotiations Under The Inflation Reduction Act - Food and Drugs Law - United States
Amgen's WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen's STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA. As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen's ustekinumab biosimilar product in May 2023. The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act's Drug Price Negotiation Program.
FDA Approves Amgen’s WEZLANA As Biosimilar to and Interchangeable With Janssen’s STELARA (ustekinumab) | JD Supra
On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA. As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023.
Recent FDA Initiatives To Support Development Of Individualized Cell And Gene Therapies And Rare Disease Therapies
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding "critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs)." Individualized CGTs are therapies "developed for a single patient (or a very small number of patients) based on designing or engineering a product that specifically targets the mechanism underlying a patient's (or...
Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies | JD Supra
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs).” Individualized CGTs are therapies “developed for a single patient (or a very small number of patients) based on designing or engineering a product that specifically targets the mechanism underlying a patient’s (or...
Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs).” Individualized CGTs are therapies “developed for a single patient (or a very small number of patients) based on designing or engineering a product that specifically targets the mechanism underlying a patient’s (or...
IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and New Complaint Filed by Novo Nordisk | Goodwin - JDSupra
Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the Drug Price Negotiation Program of the Inflation Reduction Act.
IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and New Complaint Filed by Novo Nordisk - LexBlog
Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the Drug Price Negotiation Program of the Inflation Reduction Act.
IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce case and New Complaint Filed by Novo Nordisk - Big Molecule Watch
Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the Drug Price Negotiation Program of the Inflation Reduction Act.
BREAKING NEWS - HHS Announces The First 10 Drugs Selected For IRA Drug Price Negotiation Program - Food and Drugs Law - United States
HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act's new Drug Price Negotiation Program.
HHS Announces the First 10 Drugs Selected for IRA Drug Price Negotiation Program | JD Supra
August 29, 2023 To embed, copy and paste the code into your website or blog: HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program.
BREAKING NEWS - HHS Announces the First 10 Drugs Selected for IRA Drug Price Negotiation Program
HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program.
First Drugs Selected for Price Negotiations Under The Inflation Reduction Act To Be Announced Next Week: A Recap of What That Means - The Drug Price Negotiation Program and Pending Legal Challenges | Goodwin - JDSupra
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10 drugs that will be subject to “negotiations” with the government to determine the “maximum fair price” for the drug under Medicare. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29th.
First Drugs Selected for Price Negotiations Under The Inflation Reduction Act To Be Announced Next Week: A Recap of What That Means - The Drug Price Negotiation Program and Pending Legal Challenges - LexBlog
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10 drugs that will be subject to “negotiations” with the government to determine the “maximum fair price” for the drug under Medicare. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29th.
First Drugs Selected for Price Negotiations Under The Inflation Reduction Act To Be Announced Next Week: A Recap of What That Means - The Drug Price Negotiation Program and Pending Legal Challenges - Big Molecule Watch
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10 drugs that will be subject to “negotiations” with the government to determine the “maximum fair price” for the drug under Medicare. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29th.
Parties in Amgen v. Hospira Filgrastim Litigation Stipulate to Dismissal of All Claims | JD Supra
On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in the litigation, with prejudice. The Court (Judge Connolly) has not yet entered the order of dismissal on the docket. The case has been pending since July 2018.
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