e-Pharmatimes

  Introduction The pharmaceutical industry depends heavily on intellectual property (IP) rights to stay innovative and competitive. Without these protections, companies risk losing the chance to profit from their discoveries. Managing a strong IP portfolio helps maximize research and development (R&D) investments, open doors to licensing deals, and keep drugs on the market longer. Still, this field faces many hurdles, including tough patent laws worldwide and changing regulations. At the same time, emerging opportunities can give companies a competitive edge if they master IP management. Understanding Intellectual Property Rights in Pharmaceuticals What Are Intellectual Property Rights? IP rights are legal tools that protect creations and ideas. In pharma, they help companies control and profit from their inventions for a certain time. Types of IP relevant to drugs include patents, trademarks, trade secrets, and data exclusivity. Each has a role in defending the company’s i...

  Mounjaro and Wegovy: Patent Strengths and Business Implications in the Biopharma Industry Introduction In recent years, GLP-1 receptor agonists have taken center stage in fighting obesity and type 2 diabetes. Medications like Mounjaro (Tirzepatide) and Wegovy (Semaglutide) have shown impressive results. Their success relies not just on science but also on clever patent strategies and how companies protect their market share. These drugs are changing lives and are becoming big business. As they grow in popularity, understanding their patent strengths and market moves becomes essential for investors, competitors, and healthcare providers. Understanding Mounjaro and Wegovy: A Comparative Overview What are Mounjaro and Wegovy? Mounjaro contains Tirzepatide, a dual-action drug that targets two hormones linked to appetite and blood sugar levels. Wegovy, on the other hand, uses Semaglutide, a hormone that mimics a hormone called GLP-1. Both medicines are mainly used to help with w...

On May 15, 2025, the U.S. Food and Drug Administration (FDA) approved Zynyz® (retifanlimab-dlwr), developed by Incyte, as the first and only approved first-line treatment for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). This approval encompasses both combination therapy with chemotherapy and monotherapy .( Business Wire , AJMC ) About Zynyz (Retifanlimab-dlwr) Zynyz is a humanized monoclonal antibody that targets programmed death receptor-1 (PD-1), a protein that plays a role in downregulating the immune system. By inhibiting PD-1, Zynyz enhances the body's immune response against cancer cells .( Business Wire ) Clinical Trial Evidence The FDA's approval was based on data from two pivotal clinical trials:( Business Wire ) POD1UM-303/InterAACT2 (Phase 3): This randomized, double-blind trial evaluated the efficacy of retifanlimab-dlwr in combination with carboplatin and paclitaxel in 308 chemotherapy-naïv...

On May 8, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Verastem Oncology's Avmapki™ Fakzynja™ Co-Pack, marking the first-ever FDA-approved treatment specifically for adults with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy .  U.S. Food and Drug Administration About the Treatment The Avmapki Fakzynja Co-Pack combines two oral drugs: avutometinib, a MEK inhibitor, and defactinib, a FAK inhibitor. This dual approach targets the MAPK signaling pathway, which is often dysregulated in LGSOC due to KRAS mutations . The FDA's decision was based on data from the RAMP-201 Phase 2 trial involving 57 patients with KRAS-mutated recurrent LGSOC. Participants received avutometinib 3.2 mg orally twice weekly and defactinib 200 mg orally twice daily for the first three weeks of each four-week cycle. The trial reported an overall response rate of 44%, with responses lasting between 3.3 to 31.1 months ...

Snapshot of Competition in Generic Pharmaceuticals How Companies Compete in Generic Medicines Launching a generic medicine means knowing the players and understanding how they compete. Success depends on clear insights into strengths, weaknesses, and how each brand positions itself. 1. Market Summary Gauge the size and current worth of the generic drugs market. Track market growth and expected trends over time. Note government policies and entry barriers. 2. Main Competitors List leading companies making this generic medicine. Include large international brands and strong local firms. 3. Market Share State what share of the market each key company holds. Show how those shares have shifted or stayed steady. 4. Product Range Describe the types of generic medicines each company offers. Note strengths, dosage forms, and how products are delivered to patients. 5. What Sets Them Apart Highlight what makes each company's product stand out. Show cost benefits, pr...

  The Effect of Patent Term Extensions on Drug Launch Timing Patent term extensions (PTEs) shape how and when new drugs reach the market. These extensions give extra time on a drug's patent, changing the timeline for competition and access. This matters for patients, pharmaceutical companies, and payers. Too early an entry, and research investments may not pay off. Too late, and patients miss out on lower-priced generics. Understanding how patent term extensions work—and how they influence drug launch timing—can shed light on why some treatments remain expensive long after their arrival. The debate sits at the intersection of innovation, patient access, and drug pricing. Understanding Patent Term Extensions and Their Regulatory Framework Photo by RDNE Stock project Patent term extensions were created to address a specific problem. Drug companies lose valuable patent years while waiting for regulatory approval from agencies like the FDA. The clock keeps ticking, but they can’...