Search Results for “Amgen” – Page 2 – media

FDA panel says Amgen’s Phase III lung cancer KRAS drug data is unreliable

AUS Food and Drug Administration (FDA’s) Oncology Advisory Committee (AdCom) has raised questions about the upcoming decision to grant traditional approval of Amgen’s high-profile KRAS G12C inhibitor Lumakras (sotorasib). Lumakras was granted accelerated approval in May 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations, who had received at least one prior systemic therapy. This approval was based on the CodeBreaK 200 trial (NCT04303780) of sotorasib versus docetaxel. Lumakras generated $285m in sales last year worldwide, according to Amgen’s 2022 annual report to shareholders. The latest AdCom questioned the reliability of the data In the briefing document released by the FDA from the meeting, several features of the Codebreak trial were listed that were inconsistent with a sufficient well-controlled trial. The main issue noted was that too many patients were allowed to swap between the treatment and control arms ...
- Source: drugdu
- 172
- October 10, 2023
Amgen Fails to Secure FDA Adcomm Support for Full Lumakras Approval

By Tristan Manalac Pictured: Amgen’s office in Massachusetts/iStock, hapabapa The FDA’s Oncologic Drugs Advisory Committee on Thursday voted against Amgen, which is seeking to convert the accelerated approval of its oral G12C KRAS inhibitor Lumakras (sotorasib) to full approval in non-small cell lung cancer. In a 10-2 vote, the panel of external experts found that Amgen’s progression-free survival (PFS) data from the Phase III confirmatory CodeBreaK 200 study could not be reliably interpreted. In particular, the adcomm noted the high number of study dropouts, the small sample size and potentially biased behavior of the trial’s investigators. “No one expects a perfect [randomized controlled trial] but what we hope for is a small number of issues in trial conduct and an effect large enough to withstand the uncertainties caused by those issues,” committee member Mark Conaway, professor at the Division of Translational Research and Applied Statistics at the University of Virginia ...
- Source: drugdu
- 124
- October 9, 2023
Amgen Completes Purchase of Horizon Therapeutics

Acquisition includes company’s inflammatory disease medicines. Image Credit: Adobe Stock Images/SciePro Amgen revealed in a company press release that it has officially finished its purchase of Horizon Therapeutics for an approximate value of $27.8 billion. According to the company, the acquisition includes: • Alignment with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases. • Strengthening of Amgen’s leading inflammation portfolio by adding first-in-class, early-in-lifecycle medicines such as Tepezza (teprotumumab-trbw), Krystexxa (pegloticase) and Uplizna (inebilizumab-cdon), which treat rare inflammatory diseases. • Leveraging of Amgen’s world-class capabilities in biologics research and development, process development and manufacturing, as well as Amgen’s presence in more than 100 countries around the world. • Generating robust cash flow to support capital allocation priorities, including ongoing investment in innovation while sustaining a commitment to an investment grade credit rating. • Acceleration of revenue growth; expected to be ...
- Source: drugdu
- 192
- October 8, 2023
Amgen and Horizon Therapeutics settle FTC lawsuit

Amgen and Horizon Therapeutics have reached a consent order agreement with the Federal Trade Commission (FTC) to resolve an ongoing administrative lawsuit. This sets the stage for Amgen to proceed with the last steps in finalising the acquisition of Horizon. In December last year, Amgen reached an agreement to acquire the complete issued and to-be-issued ordinary share capital of Horizon Therapeutics for $116.50 (€107.82) per share in cash or nearly $27.8bn on a fully diluted basis. As a result of the agreement, Amgen and Horizon anticipate submitting joint proposals to dismiss the preliminary injunction motion and lift the temporary restraining order (TRO) in the US District Court for the Northern District of Illinois. In May this year, the FTC took legal action in federal court to prevent the transaction, arguing that it would allow Amgen to leverage rebates from its successful drugs to exert influence over insurance companies and pharmacy ...
- Source: drugdu
- 171
- September 6, 2023
Amgen’s $28B Horizon buyout cleared for takeoff after FTC, states settle

After months of legal wrangling, Amgen is free to go forward with its $27.8 billion buyout of Horizon Therapeutics. Friday, the U.S. Federal Trade Commission (FTC) said it reached a proposed consent order with Amgen to address the “potential competitive harm” that could result from the merger deal. Alongside the FTC, attorneys general from six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are moving to dismiss their injunction requests. The FTC first filed its antitrust lawsuit against Amgen in May in an attempt to block the sale. In its suit, FTC argued that Amgen could leverage its lucrative product portfolio to “entrench the monopoly positions” of Horizon’s thyroid eye disease drug Tepezza and the company’s gout treatment Krystexxa. For its part, Amgen has promised not to use that tactic with Horizon’s drugs. In a press release Friday, the company said it “has consistently stated to the FTC, the courts and ...
- Source: drugdu
- 108
- September 5, 2023
FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

By objecting to Amgen’s deal for Horizon, the FTC put to the test new ideas about how drugmaker mergers can harm consumers. Typically, regulators have maintained that overlaps between competing products can give combining companies a more powerful market position, and have sought divestments as a resolution. However, in this case, the FTC argued that Amgen could use rebates and discounts on established drugs like Enbrel to secure favorable insurance coverage for Horizon drugs like Tepezza and Krystexxa. The FTC claimed Amgen has a history of using such “cross-market bundling” practices. The Horizon acquisition was one of the first major opportunities for the FTC to apply the new framework for reviewing pharmaceutical mergers, which agency leadership laid out early in the Biden administration. A pre-trial settlement could reveal the evidence regulators have compiled to support their case, and indicate whether they believe they can prevail in court. In a statement ...
- Source: drugdu
- 115
- August 30, 2023
Amgen and Horizon call FTC’s attempt to block $28B merger unconstitutional in counterclaims

Nicole DeFeudis Editor Amgen and Horizon filed counterclaims against the FTC, alleging the agency’s attempt to block their nearly $28 billion merger “runs roughshod” over provisions of the Constitution. The FTC in May filed a lawsuit in federal court trying to scuttle Amgen’s proposed buyout of Horizon. The agency’s claims center around bundling, a scrutinized industry practice that involves offering multi-product discounts that make it difficult for rivals to compete. Amgen and Horizon previously called the case “as misguided as it is unprecedented,” and they argued the proceeding is unconstitutional on Thursday. Amgen and Horizon argue FTC’s suit to block $28B merger is ‘as misguided as it is unprecedented’ Defendants alleged in new counterclaims that the FTC’s effort violates multiple provisions of the Constitution, including the due process clause of the Fifth Amendment “because the FTC will play the role of investigator, prosecutor and judge.” “The FTC’s case is wholly novel ...
- Source: drugdu
- 112
- July 6, 2023
Amgen’s supplemental Biologics License Application for Blincyto approved by FDA

Amgen has announced the full approval by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). Blincyto is used to treat adults and children with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), who are in their first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approved after additional data was submitted from two phase 3 studies, Blincyto’s accelerated approval is now a full approval. David Reese, executive vice president of research and development at Amgen commented that the treatment was “the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy, and the first to be FDA-approved for MRD in 2018″. He added that the “full approval underscores the clinical benefit of Blincyto for people living with B-ALL”. Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the ...
- Source: drugdu
- 106
- June 27, 2023
States Back FTC in Lawsuit Seeking to Block Amgen-Horizon Deal

Pictured: FTC sign on a wall/iStock Six U.S. states are joining the Federal Trade Commission’s lawsuit seeking to block Amgen’s $27.8 billion buyout of rare disease biotech Horizon Therapeutics, Reuters reported on Thursday. The acquisition “would allow Amgen to monopolize the market for certain crucial medications,” which would make these treatments less affordable and accessible to patients, Illinois Attorney General Kwame Raoul said in a statement. Illinois is one of the states joining the FTC’s lawsuit, along with California, Minnesota, New York, Washington and Wisconsin. In the amended lawsuit, the six states and the FTC are asking the District Court of the Northern District of Illinois to issue a preliminary injunction against the Amgen-Horizon deal while the Commission prepares an administrative complaint, and until decisions have been made about the complaint. The plaintiffs are also seeking a temporary restraining order against the acquisition and any other related transactions. “When drug ...
- Source: drugdu
- 117
- June 25, 2023
Amgen, Horizon blast FTC’s ‘baseless assumptions’ in response to antitrust lawsuit

As Amgen and Horizon pursue their $27.8 billion merger, they’re facing off against the U.S. Federal Trade Commission and its lawsuit to block the deal. Now, in response to the complaint, the companies have called the lawsuit “as misguided as it is unprecedented.”The lawsuit, filed in May, seeks an injunction against the deal on antitrust grounds. Specially, the FTC argued that Amgen could pressure insurers and pharmacy benefit managers to accept higher prices for Horizon’s thyroid eye disease drug Tepezza and gout med Krystexxa based on the company’s “history of leveraging its broad portfolio of blockbuster drugs to gain advantages over potential rivals.” Amgen and Horizon find these allegations “far too speculative” to make the case of probable harm, the two companies said in their response, filed Friday in federal court. The FTC expects Amgen to bundle its rebates in the event of future competition to Horizon’s products, which the ...
- Source: drugdu
- 109
- June 15, 2023

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