Tagged as: AstraZeneca

FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU

On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. ENHERTU, which is now FDA-approved for five indications, is a…

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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. AstraZeneca raised three challenges to the IRA’s Drug Price Negotiation Program: Counts I and…

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PTAB Issues Final Written Decision Finding Seagen Antibody-Drug Conjugate Patent Claims to be Unpatentable

On January 16, 2024, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office issued a Final Written Decision in a post-grant review (PGR) (PGR2021-00030) of claims in US Patent No. 10,808,039 (“the ’039 patent”) owned by Seagen. The PGR, filed by Daiichi Sankyo, Inc….

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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. They are: Eliquis (apixaban, Bristol Myers Squibb) Jardiance (empagliflozin, Boehringer Ingelheim) Xarelto (rivaroxaban, Janssen Pharms) Januvia (sitagliptin phosphate, Merck Sharp Dohme) Farxiga (dapagliflozin, AstraZeneca AB) Entresto (sacubitril;…

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Bristol-Myers Squibb and AstraZeneca Settle Anti-PD-L1 Antibody Product Litigation

We previously reported on Bristol-Myers Squibb’s (“BMS”) complaint alleging AstraZeneca’s PD-L1 antibody product, IMFINZI (durvalumab), infringed U.S. Patent No. 9,402,899 (“the ’899 patent”). BMS alleged that the ’899 patent covers “Nobel Prize winning methods of treating cancer” by using “an antibody to inhibit the interaction between PD-1 and PD-L1 to…

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Bristol-Myers Squibb Files Patent Infringement Complaint Against AstraZeneca Regarding Anti-PD-L1 Antibody Product

On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of U.S. Patent No. 9,402,899 (“the ’899 patent”).  BMS alleges that the ’899 patent covers “Nobel Prize winning methods of treating cancer”…

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Trial Scheduled for April 2024 in BMS Patent Case Against AstraZeneca Regarding Anti-PDL1 Antibodies

The District of Delaware has issued a scheduling order, setting a trial for April 2024, in Bristol Myers Squibb’s (BMS) patent case against AstraZeneca.  BMS filed its complaint against AstraZeneca on March 17, 2022, alleging infringement of eight patents related to anti-PD-L1 antibodies.  According to BMS, the case “relates to…

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Biosimilar Buyouts: AbbVie Buyout of Allergan Receives Approval of Irish High Court; Gedeon Richter Buys Tocilizumab Biosimilar

On May 8, 2020, AbbVie announced that it completed its acquisition of Allergan plc, having received approval by the Irish High Court.  AbbVie and Allergan had previously announced, on May 5, 2020, that the U.S. Federal Trade Commission accepted the proposed consent order in connection with the acquisition.  As part of…

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