Merck Sharp & Dohme Corp.

Federal Circuit Rules Patent Term Extensions for Reissue Patents Based on Original Patent Issue Date

2 months ago

• The U.S. Court of Appeals for the Federal Circuit has affirmed that patent term extensions (PTE) for reissue patents should be calculated from the original patent's issue date, not the reissue date. • Merck's sugammadex patent (for BRIDION®) will retain its full five-year patent term extension through January 2026, rejecting Aurobindo's argument that would have reduced protection by over three years. • The ruling aligns with the Hatch-Waxman Act's purpose of compensating pharmaceutical companies for patent exclusivity lost during FDA regulatory review periods.

Patent Dispute Emerges Between Merck and Halozyme Over Injectable Keytruda Formulation

3 months ago

• Halozyme Therapeutics and Merck are heading into a patent battle over the development of an injectable formulation of the blockbuster cancer drug Keytruda. • The dispute centers around Halozyme's drug delivery technology, which could potentially transform Keytruda's administration from intravenous to subcutaneous injection. • This legal confrontation highlights the growing importance of drug delivery innovations in the pharmaceutical industry, particularly for established cancer therapeutics.

PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial

3 months ago

• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months. • The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk. • Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.

TME Pharma Partners with aimed analytics to Advance AI-Driven Cancer Drug Development

4 months ago

• TME Pharma, a clinical-stage oncology company, has established a strategic collaboration with aimed analytics to enhance drug discovery and optimization through artificial intelligence technologies. • The company's lead candidate NOX-A12 has shown promising results in glioblastoma trials, receiving FDA fast track designation when combined with radiotherapy and bevacizumab. • TME Pharma's pipeline focuses on targeting the tumor microenvironment (TME) and cancer immunity cycle, with ongoing clinical trials including the GLORIA study for brain cancer and OPTIMUS study for pancreatic cancer.

China NMPA Approves Padcev Plus Keytruda for Advanced Urothelial Cancer

4 months ago

• China's NMPA has approved Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer (la/mUC). • The approval is based on the EV-302 trial, which showed the combination significantly improved overall and progression-free survival compared to platinum-based chemotherapy. • The combination represents the first non-platinum treatment option for Chinese patients with advanced urothelial cancer in the first-line setting. • This approval marks a significant advancement in the treatment landscape, offering hope for longer survival to Chinese patients with advanced urothelial carcinoma.

Advancements in HER2-Positive Gastric Cancer Treatment Landscape

6 months ago

• The HER2+ gastric cancer market is expected to grow significantly between 2019 and 2032, driven by increasing prevalence and awareness. • Breakthrough Therapy Designation was granted to KN026, a HER2 bispecific antibody, in combination with chemotherapy for HER2-positive gastric cancer. • Enhertu (trastuzumab deruxtecan) was approved in the EU as a monotherapy for advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma after trastuzumab-based treatment.

Evorpacept Enters Phase 2 Trial for Platinum-Resistant Ovarian Cancer

7 months ago

• ALX Oncology's evorpacept is being evaluated in a Phase 2 trial for recurrent platinum-resistant ovarian cancer. • The trial combines evorpacept with liposomal doxorubicin and pembrolizumab (KEYTRUDA®). • The study is led by UPMC Hillman Cancer Center, with Merck providing pembrolizumab. • Evorpacept is also being evaluated in combination with zanidatamab for HER2-positive and HER2-low metastatic breast cancer, with results to be presented at SABCS 2024.

Supreme Court's Merck v. Albrecht Decision Continues to Reshape Drug Litigation

8 months ago

• The Supreme Court's decision in _Merck Sharp & Dohme Corp. v. Albrecht_ has significantly impacted preemption defenses in pharmaceutical litigation, particularly concerning failure-to-warn claims. • The Fosamax multidistrict litigation (MDL) has been directly affected, with the initial ruling against certain claims reversed, leading to ongoing legal debate and reinterpretation. • Legal interpretations of preemption, including the FDA's role and the evidence required for conflict preemption, are being actively re-evaluated in light of the _Albrecht_ decision.

Immunotherapy Drug Shows Potential to Cure Advanced Lung Cancer

6 years ago

A study involving Yale Cancer Center and Smilow Cancer Hospital researchers has shown that the immunotherapy drug pembrolizumab (Keytruda) significantly increases survival rates for patients with advanced non-small cell lung cancer (NSCLC), marking a significant advancement in lung cancer treatment.