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Time of India
a day ago
- Business
- Time of India
Zydus moves Delhi HC against order restraining sale of its cancer drug
Zydus Lifesciences on Thursday moved the division bench of the Delhi High Court against its single judge's earlier order that temporarily restrained the Ahmedabad-based drug maker from manufacturing, selling biosimilar of US pharma giant E.R. Squibb's patent Nivolumab , a therapeutic antibody used in the treatment of cancer. The Division Bench while refusing to stay the single judge's interim order sought response from the US pharma company, which had alleged patent infringement of its blockbuster anticancer drug Opdyta (nivolumab) branded as Opdivo in other countries. In India, Nivolumab is being imported and marketed as Opdyta. Explore courses from Top Institutes in Please select course: Select a Course Category PGDM Technology Digital Marketing Data Science Others Management Cybersecurity Healthcare Data Science Product Management Public Policy MBA others Design Thinking Finance Leadership Project Management CXO MCA Data Analytics Artificial Intelligence Operations Management healthcare Degree Skills you'll gain: Financial Analysis & Decision Making Quantitative & Analytical Skills Organizational Management & Leadership Innovation & Entrepreneurship Duration: 24 Months IMI Delhi Post Graduate Diploma in Management (Online) Starts on Sep 1, 2024 Get Details While Squibb alleged that Zydus was conducting clinical trials for nivolumab and had plans to launch it during is valid patent period, the Indian company denied the allegations, saying its product ZRC-3276 does not infringe upon the existing patents, was following the regulatory provisions and had applied for a marketing approval with the central drug regulatory agency. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Simoes Filho: Unsold Furniture Liquidation 2024 (Prices May Surprise You) Unsold Furniture | Search Ads Learn More Undo Zydus argued that its product, ZRC-3276, is bio-similar to Squibb Nivolumab, but bio-similarity by itself does not substantiate infringement as it is based upon product-to-product comparison, whereas, infringement required claim to product mapping. The generic drug maker claimed that process steps were already known from the prior art and even several techniques for the preparation of human anti-PD1 antibodies were well-known on the priority date of the suit patent. Live Events The post-grant opposition that was filed by its subsidiary Zydus Healthcare led to the recommendation for revocation of the suit patent by the Opposition Board, and the said recommendation clearly showed that such a method was commonly employed to produce antibodies, the Ahmedabad-based drug manufacturer claimed. On July 18, Justice Mini Pushkarna had noted that E.R. Squibb shall suffer irreparable loss in case an interim relief was not granted. Therefore, the single judge had restrained Zydus from selling a biosimilar of Nivolumab till the main suit was decided.
Medscape
2 days ago
- Business
- Medscape
FDA Declines to Approve New Melanoma Therapy
The FDA has declined to approve a new oncolytic immunotherapy, vusolimogene oderparepvec (RP1), to treat advanced melanoma. The agency recently issued a complete response letter to the company, Replimune Group, rejecting its biologics license application that sought approval for the new agent in combination with nivolumab (Opdivo) to treat adults with advanced melanoma. In the complete response letter, the FDA indicated that it can't approve the biologics license application for vusolimogene oderparepvec because the company's IGNYTE trial 'is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness,' Replimune explained in a press release. According to Replimune, the complete response letter also noted that the trial data 'cannot be adequately interpreted due to the heterogeneity of the patient population,' and that 'there are items related to the confirmatory trial study design which need to be addressed.' 'We are surprised by the FDA decision and disappointed for advanced melanoma patients who have limited treatment options, as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data,' stated Sushil Patel, PhD, Replimune's chief executive officer. Vusolimogene oderparepvec is the lead product candidate for the biotech company. Patel further noted that the issues raised in the complete response letter were not 'raised by the agency in mid- and late-cycle reviews.' Additionally, he said, 'we had also aligned on the design of the confirmatory study.' The FDA's response to the biologics license application for the new agent, along with its recently announced policy requiring randomized, controlled trials for approval of COVID vaccines in healthy Americans younger than 65 years, may signal that the agency is taking a tougher stance on new drug approvals. Replimune plans to 'urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1,' according to its statement. Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@ or on X @SW_MedReporter.
Time of India
5 days ago
- Business
- Time of India
Zydus Life's plans for cancer biosimilar hit a legal hurdle
Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Mumbai: The Delhi High Court has issued an interim injunction against Ahmedabad-based drug maker Zydus Lifesciences after a case filed by the US pharma giant Bristol Myers Squibb alleging patent infringement on its blockbuster anticancer drug Opdyta nivolumab ) branded as Opdivo in other restraining order comes as a setback for the Indian drug maker which was running clinical trials in India for the launch of the biosimilar versions of nivolumab. The earliest patent for the drug expires in India on May 2, 2026. The next hearing for the case is August 101-page order issued on July 18 by Justice Mini Pushkarna ruled that the defendants, and all others acting on its behalf, are restrained from manufacturing, using, selling, offering for sale, importing, exporting, advertising, or dealing in any biosimilar/similar biologic of nivolumab, the suit patent, during the pendency of the present suit. The order stated the plaintiffs shall suffer irreparable loss, in case the interim relief as prayed for, was not injections are one of the many latest generation immunotherapy drugs also known as checkpoint inhibitors increasingly used to treat several types of cancers including skin, lungs, kidneys, and Hodgkin lymphoma. It works by activating the body's T-cells or immune cells by targeting a protein called PD-1, thereby unleashing an attack on the cancer vials are sold in India for roughly '2 lakh but for patients who are part of the company's assistance or access programs, the drug is available at a slab-wise discounted the India data is not available, globally Bristol Myers Squibb recorded Opdivo sales of $9.3 billion in 2024. Indian companies have launched biosimilars at half the cost of those charged by their global in Indian patent laws told ET that the court has taken a view that stockpiling of a product during its active patent life amounts to infringement and to release it or flood the market is not legally valid."This opinion may have implications for the other ongoing disputes like the weight-loss drug semaglutide (branded Wegovy) case between Novo Nordisk and Dr. Reddy's Labs or Roche versus Natco for Risdiplam (drug used for a rare disease called spinal muscular atrophy or SMA) case," a senior lawyer petition from BMS noted that Zydus Lifesciences was conducting clinical trials for nivolumab and on its investigation found that the company had plans to launch it during the patent period. The Indian company, it said, had applied for a marketing approval with the central drug regulatory its part, lawyers on behalf of Zydus defended saying its product ZRC-3276 does not infringe upon the existing patents and is following the regulatory was represented by a battery of top lawyers including Harish Salve, Dushyant Dave, and Rajiv Nayar, while Squibb & Sons was represented by Sandeep Sethi, PS Raman, Amit Sibal and Pravin Anand, among others.
The Mainichi
15-07-2025
- Health
- The Mainichi
Japan research team discovers new gut bacterium that boosts cancer immunotherapy
TOKYO -- A Japanese research team led by the National Cancer Center Japan announced in the British journal Nature on June 14 that it has discovered a new type of gut bacterium that enhances the effectiveness of cancer immunotherapy drugs, raising hopes for the development of new treatments that further strengthen the immune response against cancer. Cancer immunotherapy leverages the body's immune system to attack cancer cells. One class of drugs, known as immune checkpoint inhibitors -- including PD-1 inhibitors such as Opdivo -- works by releasing the "brakes" that cancer uses to evade immune cell attacks, thereby restoring the immune system's natural ability to target tumors. However, even when used in combination with other treatments, checkpoint inhibitors are effective in only about 20% of patients over the long term. Previous studies have shown that transplanting stool from patients who responded well to these drugs into non-responders can improve outcomes, suggesting that gut bacteria play a key role. Until now, the mechanism by which gut bacteria influence cancers located far from the intestines, such as in the lungs, was not well understood. The research team found that patients who responded well to immunotherapy had high levels of a type of gut bacterium from the Ruminococcaceae family. These patients experienced longer-lasting treatment effects and had more T cells -- immune cells that attack cancer -- present within their tumors. The team identified this bacterium as a new strain, named YB328. In mouse experiments, administering both checkpoint inhibitors and YB328 led to tumor shrinkage, and even when YB328 was given together with stool transplanted from non-responders, the drug's effectiveness improved. Further investigation revealed that YB328 activates dendritic cells -- immune system "commanders" that orchestrate immune responses -- in the gut. These dendritic cells then travel from the intestines to distant tumor sites, where they activate nearby T cells and enhance the immune attack on cancer. Hiroyoshi Nishikawa, head of the Cancer Immunology division at the National Cancer Center Research Institute, commented, "Not only could administering this bacterium to (drug) non-responders improve outcomes, but adding it to responders' treatment regimens may further boost effectiveness."
New York Post
08-07-2025
- Health
- New York Post
Doctors have figured out a way to use herpes to fight untreatable advanced cancer
Herpes has been called 'the gift that keeps on giving' — finally, its presence has come in handy. Roughly two-thirds of the global population has been infected with herpes simplex virus type 1 (HSV-1), which typically causes painful and unsightly blisters around the mouth. University of Southern California researchers have found a way to rebrand this oft-embarrassing sore subject by genetically modifying HSV-1 and administering it to patients with treatment-resistant, advanced skin cancer along with an anti-cancer medication. 4 About 3.8 billion people worldwide have been infected with herpes simplex virus type 1 (HSV-1), which typically causes painful and unsightly blisters around the mouth. – In a recent clinical trial, this one-two punch shrank tumors by at least 30% in around one-third of the 140 participants. Nearly one in six saw their tumors completely disappear. 'These findings are very encouraging because melanoma is the fifth most common cancer for adults, and about half of all advanced melanoma cases cannot be managed with currently available immunotherapy treatments,' said Dr. Gino Kim In, a medical oncologist with Keck Medicine of USC. Advanced melanoma means the skin cancer has spread from its initial location to other parts of the body, such as lymph nodes, the liver or the brain. Immunotherapy to help the immune system attack cancer cells, targeted therapy and radiation therapy are common treatment options. 4 This is a close-up of the herpes virus, which may hold the key in the battle against advanced melanoma. BSIP/Universal Images Group via Getty Images 'The survival rate of untreatable advanced melanoma is only a few years, so this new therapy offers hope to patients who may have run out of options to fight the cancer,' In said. In January, the Food and Drug Administration granted priority review to RP1 (the genetically modified HSV-1) with the anti-cancer medication nivolumab (marketed as Opdivo) for advanced melanoma patients whose cancer had not responded to immunotherapy. Nivolumab blocks a key protein that cancer cells use to evade the immune system, paving the way for the immune system to recognize and attack these cells. The idea is that nivolumab would enhance the effects of RP1, which targets, infects and replicates in tumor cells to destroy them — while sparing healthy tissue. In told The Post that RP1 was developed by knocking out specific genes in HSV-1 so that it no longer causes cold sores. 'Additional genetic modifications were made to the virus to stimulate the immune system to better fight the cancer and to help the virus more efficiently interact with and kill tumor cells,' In said. 4 Nivolumab blocks a key protein that cancer cells use to evade the immune system, paving the way for the immune system to recognize and attack these cells. luchschenF – In the USC trial, researchers injected RP1 into superficial tumors on or near the skin's surface and into tumors deeper in the body, like in the liver or lungs. We're Tracking Prime Day Live! Unlock exclusive NYP codes and real-time deals on everyday must-haves. See Your Deals The combination therapy was administered every two weeks for up to eight cycles. Afterwards, the patients who started to see results took just nivolumab every four weeks for up to two years. Researchers were stunned to notice a difference in the size of the treated and untreated tumors. The untouched tumors shrank or disappeared as often as the injected ones. 'This result suggests that RPI is effective in targeting cancer throughout the entire body and not just the injected tumor,' said In, 'which expands the potential effectiveness of the drug because some tumors may be more difficult or impossible to reach.' 4 Dr. Gino Kim In, a medical oncologist with Keck Medicine of USC, is one of the lead investigators on the trial. Keck Medicine of USC RP1 was reported to be well-tolerated among the participants. Results from the trial were published Tuesday in the Journal of Clinical Oncology and recently presented at the American Society of Clinical Oncology annual meeting. In and his team launched a phase 3 trial to study the effects of this treatment in over 400 cancer patients. People interested in participating in the trial, sponsored by RP1 manufacturer Replimune, should contact Sandy Tran at
