Pharma News
14 Sep 2025 to 20 Sep 2025
Sep 20, 2025
Major Cancer Treatment Now Available for Easier Administration | MedPage Today
The FDA has approved a subcutaneous formulation of pembrolizumab (Keytruda Qlex) for various solid tumors, combining it with berahyaluronidase alfa for easier administration. This new option allows for quicker injections every 3 to 6 weeks, while maintaining efficacy comparable to the intravenous version. The approval is supported by a trial showing similar response rates between the two formulations.
Sep 20, 2025
Clinical studies indicate potential for GLP-1 weight loss medication - NewsBreak
Eli Lilly's experimental GLP-1 pill, orforglipron, has shown promising results in clinical trials, promoting significant weight loss without injections, outperforming oral semaglutide. The drug could expand obesity treatment access and is set for FDA review later this year. In type 2 diabetes trials, orforglipron also demonstrated superior blood sugar control compared to semaglutide.
Sep 20, 2025
Abbvie's Popular Medications and Surge in Institutional Interest Propel Shares to 48th Position in the S&P 500
Abbvie's stock has seen increased institutional interest due to its strong portfolio, including blockbuster drugs Humira and Imbruvica, despite patent expirations. Analysts are optimistic about Abbvie's focus on high-margin biologics and R&D in oncology and immunology. However, short-term traders are cautious ahead of earnings, with bearish options positioning noted.
Sep 20, 2025
The Significance of Pharmaceutical Patents and Their Effect on the Industry - A Focus on India
Patents are essential in the pharmaceutical industry, protecting innovations and driving drug discovery. Companies like Pfizer and Novo Nordisk benefit significantly from patents, which secure profits and encourage investment in research. However, high prices limit access to medicines, particularly in developing nations. The rise of generics, led by firms like Cipla, offers a solution post-patent expiration, balancing profit with public health needs.
Sep 19, 2025
Sobi's Tryngolza (Olezarsen) Receives EU Approval: A Potential Game-Changer for a Rare Genetic Condition
Sobi and Ionis Pharmaceuticals secured EU approval for Tryngolza (olezarsen) to treat familial chylomicronemia syndrome (FCS), a rare genetic disorder. The drug demonstrated a 77% reduction in triglyceride levels and a 100% reduction in pancreatitis events in clinical trials. With a projected annual revenue of $75–80 million, Tryngolza positions Sobi for significant growth in the rare disease market.
Sep 19, 2025
NMPA Unveils Proposed Guidelines for Data Protection (Data Exclusivity) - Mondaq
In March 2025, China's NMPA proposed new draft measures for data protection, offering up to six years of exclusivity for innovative drugs, vaccines, and biologics, and three years for modified drugs and first generics. These measures aim to enhance the domestic pharmaceutical industry and attract foreign drugs, reflecting China's evolving regulatory landscape in drug approval and data protection.
Sep 19, 2025
Impact of GLP-1 medications being included in the WHO Essential Medicines List - Labiotech.eu
The World Health Organization has added GLP-1 agonists, including semaglutide (found in Ozempic and Wegovy), to its Essential Medicines List, aiming to improve global access to these treatments for type 2 diabetes and obesity. This move is expected to drive policy changes, lower prices, and expand availability, marking a significant shift in addressing metabolic diseases.
Sep 19, 2025
Important Factors to Consider for siRNA Patent Applications in Europe - Lexology
The article discusses the advancements in RNA interference (RNAi) and the development of short interfering RNA (siRNA) therapeutics, including FDA-approved drugs like Patisiran (ONPATTRO™) and Lumasiran (OXLUMO™). It highlights the patent landscape for siRNA inventions, emphasizing the need for robust data to demonstrate technical advantages and the importance of a strong intellectual property strategy in the evolving field of RNAi therapeutics.
Sep 19, 2025
Merck Receives US Authorization for More User-Friendly Formulation of Cancer Treatment Keytruda - Bloomberg
Merck & Co. has received US approval for Keytruda Qlex, a new formulation of its cancer drug Keytruda. This version can be administered as a quick subcutaneous injection in about two minutes, compared to the original's half-hour intravenous infusion. Clinical trials show Keytruda Qlex is equally effective, significantly reducing time for patients and caregivers.
Sep 19, 2025
Clinical studies indicate potential for GLP-1 weight loss medication - UPI.com
Eli Lilly's experimental GLP-1 pill, orforglipron, has shown promising results in clinical trials, promoting significant weight loss without injections. It outperformed the oral semaglutide, Rybelsus, in both weight loss and blood sugar control for type 2 diabetes patients. Lilly plans to submit orforglipron for FDA review later this year, potentially expanding obesity treatment options.
Sep 19, 2025
GLP-1 Giants Face Off: Eli Lilly Takes on Novo Nordisk's Market Leadership in an Intensifying Competition
Eli Lilly (NYSE: LLY) is rapidly gaining ground on Novo Nordisk (NYSE: NVO) in the GLP-1 market, driven by its dual-action drugs Mounjaro and Zepbound, which have shown superior weight loss results. As Eli Lilly captures U.S. market share, Novo Nordisk faces challenges despite its established semaglutide portfolio. The competition is accelerating innovation and could reshape metabolic disease treatment and public health.
Sep 19, 2025
Will MRK's Latest Medications Propel Sustained Growth as Keytruda Faces Expiration?
Merck (MRK) faces a patent cliff as its key cancer drug, Keytruda, approaches loss of exclusivity in 2028, generating over 50% of its pharmaceutical sales. The company is developing new strategies, including a subcutaneous formulation and new products like Capvaxive and Winrevair, to drive growth. However, competition from other firms poses challenges. Merck's stock has declined 18% year-to-date.
Sep 19, 2025
FDA Approves New Keytruda Injection for Cancer Treatment - The New York Times
Merck's Keytruda shot significantly reduces administration time to about two minutes, compared to 30 minutes for the original infusion, enhancing patient convenience. Despite potential side effects, oncologists believe patients will prefer the quicker option. Merck has filed nearly 300 patents to protect Keytruda, potentially delaying competition until after 2028.
Sep 19, 2025
Eli Lilly Set to Achieve Record-Breaking Q3 2025 with Soaring Earnings Per Share and Revenue Estimates
Eli Lilly and Company (NYSE: LLY) is projected to achieve significant earnings growth in Q3 2025, driven by its successful incretin-based drugs, Mounjaro and Zepbound. Analysts anticipate an EPS of $6.17 to $6.42 and revenue around $15.42 billion. The company’s robust pipeline and strategic manufacturing expansions further solidify its market leadership in diabetes and obesity treatments.
Sep 19, 2025
Merck Receives Favorable Response from EU Agency for Major Cancer Treatment
The European Medicines Agency's Committee for Medicinal Products for Human Use has issued two positive opinions for Merck & Co. Inc.'s Keytruda (pembrolizumab). One opinion supports a new subcutaneous administration route, while the other recommends Keytruda for neoadjuvant and adjuvant treatment of locally advanced head and neck squamous cell carcinoma. Final decisions are expected by Q4 2025.
Sep 19, 2025
The US FDA has granted approval for Merck's injectable formulation of its highly successful cancer treatment, Keytruda.
The FDA has approved Merck's new subcutaneous formulation of Keytruda, branded as Keytruda Qlex, enhancing convenience for cancer patients. This injectable version can be administered in 1-2 minutes, compared to 30 minutes for IV infusion. Merck anticipates availability in the U.S. by late September, aiming for 30-40% adoption within two years, as it faces biosimilar competition.
Sep 19, 2025
Merck's Popular Cancer Medication Keytruda Receives Approval for More Convenient Dosage Form
Merck & Co. has received US approval for Keytruda Qlex, a new formulation of its cancer drug Keytruda. This version can be administered as a quick subcutaneous injection in about two minutes, compared to the original's half-hour intravenous infusion. Clinical trials show Keytruda Qlex is equally effective, significantly reducing time for patients and caregivers.
Sep 19, 2025
Merck Receives US Authorization for More User-Friendly Formulation of Cancer Treatment Keytruda
Merck & Co. has received US approval for Keytruda Qlex, a new formulation of its cancer drug Keytruda. This version can be administered as a quick subcutaneous injection in about two minutes, compared to the original's half-hour intravenous infusion. Clinical trials show Keytruda Qlex is equally effective, significantly reducing time for patients and caregivers.
Sep 19, 2025
AI, Gene Treatments, and Obesity Medications Transform a Billion-Dollar Industry | FinancialContent
The pharmaceutical industry is undergoing a significant transformation driven by advancements in biologics, gene therapies, and AI integration. Companies like Amgen Inc. and CRISPR Therapeutics are leading in these areas, while obesity treatments from Novo Nordisk and Eli Lilly are booming. Regulatory changes are reshaping market dynamics, emphasizing the need for strategic agility and collaboration to navigate this evolving landscape.
Sep 19, 2025
Merck Obtains FDA Authorization for Updated Formulation of Cancer Treatment Keytruda - AInvest
Merck has received US approval for Keytruda Qlex, a new subcutaneous formulation of its cancer drug Keytruda, allowing administration in just two minutes instead of 30. This change is expected to attract 40% of current patients over two years, as Merck faces patent expiration in 2028. The success of Keytruda Qlex will depend on its pricing and overall value.
Sep 19, 2025
Groundbreaking Ruling by UPC Court of Appeal Transforms the European Generics Market
The UPC Court of Appeal has granted a provisional injunction against Zentiva Portugal, affirming Boehringer Ingelheim's claim of imminent patent infringement regarding its drug Ofev, which contains nintedanib. The ruling clarifies that completing national procedures for generics can trigger injunctive relief, even before commercialization, marking a significant precedent in pharmaceutical patent law. Zentiva must pay EUR199,000 in interim awards.
Sep 19, 2025
Huayuan Biotech Develops Solutions for lncRNA Drug Research and Introduces Innovative Delivery System
Huayuan Biotech has made significant advancements in lncRNA drug R&D, developing a new liver-targeting delivery system in collaboration with the Shenzhen Institutes of Advanced Technology. Their innovative siRNA drugs show promise in treating type 2 diabetes and metabolic syndrome, demonstrating improved efficacy and safety. The company has partnered with WuXi AppTec to expedite clinical translation of these multi-effect drugs.
Sep 19, 2025
FDA Awards Orphan Drug Status to NS-051/NCNP-04 for Duchenne Muscular Dystrophy
The FDA has granted Orphan Drug Designation to NS-051/NCNP-04, developed by NS Pharma, Inc., for treating Duchenne muscular dystrophy. This designation offers benefits like tax credits and potential market exclusivity, aimed at addressing the rare genetic disorder affecting fewer than 200,000 individuals in the U.S. Duchenne primarily impacts boys, leading to muscle degeneration.
Sep 19, 2025
Novo Secures EU Approval for Weekly Diabetes Medication Kyinsu - Bloomberg.com
The European Medicines Agency's review panel has recommended approval for Novo Nordisk A/S's diabetes drug Kyinsu, a once-weekly injection combining insulin and semaglutide, the active ingredient in Ozempic. This approval would provide patients with type 2 diabetes another option for managing their condition.
Sep 18, 2025
New weight loss injection promotes shedding pounds without altering dietary habits - Daily Mail
A new weight loss drug, RES-010, developed by Resalis Therapeutics, aims to tackle obesity by boosting metabolism without suppressing appetite. Currently in phase 1 clinical trials, RES-010 targets the miR-22 molecule to enhance fat metabolism and mitochondrial activity. Promising results in mice suggest it may lead to long-lasting weight loss with minimal lean mass loss. Initial human trial findings are expected in early 2025.
Sep 18, 2025
Weekly GLP-1 Medications Lead to Notable Decrease in Cardiovascular Risk - Drug Topics
A recent study published in Diabetes Research and Clinical Practice found that once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including Ozempic and Trulicity, significantly reduce cardiovascular risks and healthcare costs compared to other glucose-lowering therapies in Medicare beneficiaries with type 2 diabetes and atherosclerotic cardiovascular disease. The findings support the guideline-recommended use of GLP-1 RAs for this population.
Sep 18, 2025
ICRA projects the Indian pharmaceutical industry will experience a growth of 7-9% in FY26, despite challenges in the US market.
India's pharmaceutical industry is projected to achieve a revenue growth of 7-9% in FY26, according to ICRA's latest sector outlook, despite ongoing challenges in the U.S. market impacting performance.
Sep 18, 2025
Pharmacy Busted for Distributing Counterfeit Alburel Injections Valued at ₹4.5 Lakh
The FDA and Pune City Police have dismantled a counterfeit drug operation, seizing fake Alburel (Human Normal Albumin IP) injections valued at over ₹4.5 lakh across Pune, Mumbai, and Raigad. Multiple raids resulted in several arrests as authorities continue to combat the distribution of fake pharmaceuticals.
Sep 18, 2025
In-Depth Analysis: Oral Medications for Obesity Approaching Approval - BioSpace
Eli Lilly's oral GLP-1 therapy, orforglipron, showed disappointing results in the Phase III ATTAIN-1 study, presenting a challenge in the competitive obesity market. Analysts noted that while orforglipron may gain approval, it faces stiff competition from Novo Nordisk's Wegovy (semaglutide) and other companies like Roche and Viking Therapeutics, as the oral weight loss market expands.
Sep 18, 2025
Patients with psoriasis undergoing GLP-1RA treatment experience a 78% reduction in mortality risk and a 44%...
Patients with psoriasis on glucagon-like peptide-1 receptor agonists (GLP-1RA) show a 78% lower mortality risk and 44% fewer cardiovascular events, according to research presented at the EADV Congress 2025. This study suggests GLP-1RA may offer significant health benefits beyond diabetes and obesity management, particularly for psoriasis patients at higher cardiovascular risk.
Sep 18, 2025
Grace Therapeutics Obtains Sixth Patent for GTx-104 Intravenous Treatment | GRCE Stock Update
Grace Therapeutics has been granted a sixth U.S. patent for its I.V. dosing regimen of GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH). This patent extends protection until 2043, enhancing the company's intellectual property portfolio. GTx-104 has shown promising results in the Phase 3 STRIVE-ON safety trial, demonstrating reduced hypotension compared to oral nimodipine.
Sep 18, 2025
AIPPI: Customized medicine challenges the boundaries of patent legislation in Asia
At AIPPI’s World Congress 2025, experts discussed the impact of AI on the pharmaceutical industry, focusing on drug discovery and post-market surveillance. The debate highlighted challenges in the patent system regarding AI disclosure, inventive steps, and inventorship, as AI continues to reshape the landscape of pharma.
Sep 18, 2025
Novo Nordisk collaborates with Pocketpills to offer Ozempic and Wegovy through online sales.
Novo Nordisk Canada has partnered with Pocketpills for home delivery of its diabetes and obesity drugs, Ozempic and Wegovy. This collaboration aims to streamline the prescription process and offer discounts through Novo Nordisk's savings card. As demand for Ozempic surges, with over $1.6 billion in sales this year, the market is set to change as generics may enter next year.
Sep 18, 2025
Novartis' Patent for Heart Failure Medication Vymada in India Declared Invalid - Medical Dialogues
The Indian Deputy Controller of Patents revoked Novartis' patent on the sacubitril-valsartan complex, key to its top-selling heart failure drug Vymada, citing lack of demonstrated therapeutic advantage. This ruling, following challenges from the Indian Pharmaceutical Alliance, may lead to lower-cost generics entering the market, reducing treatment costs for patients.
Sep 18, 2025
Biogen plans to acquire the startup Alcyone to facilitate the delivery of RNA medications - BioPharma Dive
Biogen is acquiring Alcyone Therapeutics for $85 million to enhance delivery systems for neurological medicines, specifically targeting antisense oligonucleotides. The deal includes rights to ThecaFlex DRx, an implantable device for administering Spinraza, Biogen's drug for spinal muscular atrophy. This acquisition aims to improve patient experience and expand treatment options amid rising competition from Roche and Novartis.
Sep 18, 2025
Dilip Shanghvi of Sun Pharma emphasizes that flexibility is crucial for thriving in unpredictable circumstances.
Dilip Shanghvi of Sun Pharma and Vivek Chaand Sehgal of Motherson Group emphasized the necessity of quick adaptation for business success at the IFQM Symposium. They discussed the challenges of the 'BANI' world, asserting that adaptability is crucial for overcoming obstacles and achieving growth.
Sep 18, 2025
ETNB Shares Surge Following Roche's Major Acquisition News – A Game-Changing Moment for Biotech!
Roche has announced a surprise acquisition of 89bio, Inc. (ETNB) for up to $3.5 billion, offering $14.50 per share, a 79% premium. Shareholders may also receive contingent value rights tied to the success of 89bio's drug, pegozafermin. This deal highlights the dynamic nature of biotech investments, with potential benefits and risks for investors as the transaction awaits regulatory approval.
Sep 18, 2025
Roivant and Pfizer's treatment demonstrates a 'Patient-Focused Advantage' for a rare inflammatory disorder.
Roivant's dual inhibitor brepocitinib successfully met its primary and all nine key secondary endpoints in the Phase III VALOR trial for dermatomyositis. With FDA filing expected in 2026, analysts project brepocitinib could generate $2 billion in sales by 2032. The drug showed significant clinical response and a favorable safety profile, outperforming competitors like Argenx's efgartigimod and AstraZeneca's anifrolumab.
Sep 17, 2025
Indian API Manufacturers Prepare for Expiration of Ozempic Patent - KNN India
Indian pharmaceutical companies, including Dr. Reddy’s Laboratories and Macleods Pharmaceuticals, are gearing up for the 2026 patent expiry of Novo Nordisk’s weight-loss drugs Wegovy and Ozempic, which contain Semaglutide. They aim to produce generic versions, despite competition from Chinese firms and challenges in scaling production. Early investments in API production could position them for a lucrative market opportunity.
Sep 17, 2025
Could legal issues in the US impact the growth of India's obesity medication market? - Mint
Indian drugmakers, including Sun Pharmaceutical and Dr Reddy’s Laboratories, are preparing to launch generic versions of semaglutide, the active ingredient in weight-loss drugs Ozempic and Wegovy, as patents expire. Despite over 1,800 lawsuits in the US regarding severe side effects, experts believe these will not impact sales in India, where the market for GLP-1 drugs is expected to grow significantly.
Sep 17, 2025
AstraZeneca's asthma medication does not succeed in study related to 'smoker's lung' - The Economic Times
AstraZeneca's Fasenra failed to reduce flare-ups in COPD patients during a late-stage trial, marking a setback for the company. However, AstraZeneca plans to analyze the data further. In contrast, its rare disease drug Saphnelo achieved success in a lupus trial.
Sep 17, 2025
Areteia announces successful phase 3 results for oral competitor to biologic asthma treatments - Fierce Biotech
Areteia Therapeutics has achieved a phase 3 success with its oral drug dexpramipexole for eosinophilic asthma, showing significant lung function improvements compared to placebo in the Exhale-4 trial. This milestone supports its aim to compete with injectable biologics like AstraZeneca’s Fasenra and GSK’s Nucala in the multibillion-dollar asthma market.
Sep 17, 2025
Reasons Behind the Surge in Roivant Sciences Stock Today - The Globe and Mail
Roivant Sciences and Priovant Therapeutics reported positive phase 3 results for brepocitinib, a potential blockbuster treatment for dermatomyositis, an autoimmune disease. Patients showed significant improvement with the drug, leading to plans for FDA approval in 2026. Roivant's shares surged 11.4% following the announcement, as it owns 75% of Priovant.
Sep 17, 2025
Daiichi Sankyo (TSE:4568): Analysis of Valuation Following FDA Approval of R-DXd for Ovarian Cancer
Daiichi Sankyo Company, in partnership with Merck, has received Breakthrough Therapy Designation from the U.S. FDA for its investigational drug raludotatug deruxtecan (R-DXd) for certain ovarian cancers. Despite a challenging year for its stock, analysts view Daiichi Sankyo as significantly undervalued, with potential for future growth driven by its antibody-drug conjugate pipeline.
Sep 17, 2025
New study investigates the potential of a weight-loss component in combating Alzheimer's disease - The Independent
Novo Nordisk is exploring the potential of its obesity drug, semaglutide, to treat Alzheimer’s disease, with trial results expected by late 2025. Despite a low success probability, a positive outcome could significantly boost revenue. The company is also restructuring, cutting 9,000 jobs to save costs amid competition from Eli Lilly and declining sales.
Sep 17, 2025
Intense showdown over Stelara persists as Janssen secures victory against Samsung Bioepis.
The District Court of The Hague has upheld Janssen's patent EP 3 883 606 for its drug Stelara, which treats ulcerative colitis. Samsung Bioepis, challenging the patent's validity, has announced an appeal following the ruling. The ongoing dispute highlights the competitive landscape for biosimilars in Europe, particularly regarding Stelara's second medical use patent.
Sep 17, 2025
Ollin launches with $100 million in funding and aims to compete with leading eye medications | BioPharma Dive
Ollin Biosciences has launched with $100 million in funding to develop eye treatments OLN324 and OLN102, aiming to outperform Roche's Vabysmo and Amgen's Tepezza. OLN324 targets VEGF and Ang2 for age-related macular degeneration, while OLN102 inhibits IGF-1R and TSHR for thyroid eye disease. Clinical trials for OLN324 are set for 2026, with OLN102 testing starting next year.
Sep 17, 2025
Senior executive describes Novo Nordisk's Alzheimer's study as a 'gamble' - TradingView
Novo Nordisk's senior executive described the ongoing trial of its obesity drug semaglutide for Alzheimer's treatment as a "lottery ticket" due to its uncertain yet significant potential. Results from the pivotal EVOKE trials are expected by the end of 2025, exploring semaglutide's ability to slow cognitive decline in early-stage Alzheimer's patients. The company remains focused on obesity and diabetes.
Sep 17, 2025
Indian pharmaceutical companies, including Dr. Reddy's and Macleods, are gearing up for the patent expiration of Ozempic, a weight-loss medication.
Indian companies, including Dr Reddy's and Macleods, are preparing to produce ingredients for generic weight-loss drugs as Novo Nordisk's patents near expiration. They aim to capture a significant global market but will face competition from Chinese firms. Key challenges include securing quality materials and scaling up production.
Sep 17, 2025
NPPA sets retail prices for nine new drug combinations, according to DrugsControl Media Services.
The National Pharmaceutical Pricing Authority (NPPA) has set the retail prices for nine new drug combinations, which include three anti-inflammation fixed dose combinations (FDCs) and six antidiabetic combinations, as of September 17, 2025.
Sep 17, 2025
Kalexo Bio Established to Create Dual-Target siRNA Treatment 2MW7141 for Heart Conditions
Kalexo Bio has been established by Mabwell (Shanghai) Bioscience Co., Ltd. and Aditum Bio to develop 2MW7141, a dual-target siRNA therapy for cardiovascular disorders. This initiative follows an exclusive global license agreement, aiming to address unmet medical needs through innovative biotechnology solutions.
Sep 17, 2025
CDSCO states that cocrystals of approved active pharmaceutical ingredients must undergo the new drug approval process.
The Central Drugs Standard Control Organisation (CDSCO) has announced that cocrystals of approved active pharmaceutical ingredients (APIs) must undergo the new drug approval process. Companies are required to submit applications in accordance with the New Drugs and Clinical Trials Rules 2019 for these cocrystals, which are considered new drugs.
Sep 17, 2025
ICMR calls for restrictions on antibiotic sales due to their diminishing effectiveness against dangerous superbugs.
India's ICMR has proposed restrictions on the sale of newly launched antibiotics, suggesting they should only be available through select hospital pharmacies. This move aims to combat the rising misuse and resistance to these drugs, which has led to concerns over the effectiveness of antibiotics against superbugs.
Sep 17, 2025
Delhi High Court provides clarification on the extent of Section 104A in a dispute over biologics and process patents - IAM
The Delhi High Court ruled in F Hoffman-La Roche v Zydus Lifesciences that Roche must prove its product is identical to Zydus's biosimilar Sigrima before Zydus is compelled to disclose its manufacturing process under Section 104A of the Patents Act. The court emphasized that mere similarity is insufficient for invoking this provision, ensuring protection of trade secrets.
Sep 17, 2025
Arch Solidifies Its Status as a Top Player in Kidney Care - GlobeNewswire
Arch Biopartners Inc. has acquired a pre-clinical platform for developing chronic kidney disease (CKD) drugs targeting interleukin-32 (IL-32). Led by Dr. Justin Chun, the program aims to address the unmet medical need affecting over 800 million globally. Arch has filed patents for new drug compositions and methods, enhancing its kidney drug portfolio and potential for partnerships.
Sep 17, 2025
China's Cases on Extending Pharmaceutical Patent Terms Uncover a New Landscape for...
China's revised Patent Law, effective June 2021, introduced Pharmaceutical Patent Term Extension (PTE) to compensate for regulatory delays in drug approvals. Landmark cases include Risdiplam, Penpulimab, and Telitacicept, with compensation periods up to five years. This development enhances protection for innovative drugs, marking a shift towards stronger pharmaceutical intellectual property in China.
Sep 17, 2025
Arch Biopartners Purchases IL-32 CKD Platform for $1.85 per Share | ACHFF Stock Update
Arch Biopartners Inc. has acquired a pre-clinical platform for developing new drugs targeting chronic kidney disease (CKD), focusing on interleukin-32 (IL-32). This acquisition, which includes patents for novel drug compositions, positions Arch to address the significant unmet medical need in CKD, affecting over 800 million globally. Dr. Justin Chun will lead the new CKD program.
Sep 17, 2025
Novartis faces a challenge as India cancels Entresto patent due to evergreening issues | MLex
Sep 17, 2025
Tenax Therapeutics awarded European patent for levosimendan application in PH-HFpEF.
Tenax Therapeutics, Inc. announced that the European Patent Office intends to grant a patent for TNX-103 (oral levosimendan) and its formulations for treating pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). This patent, valid until 2040, supports Tenax's upcoming phase 3 study, LEVEL-2, aimed at advancing TNX-103 toward regulatory approval.
Sep 17, 2025
Indian pharmaceutical manufacturers begin gearing up for the patent expiration of Ozempic, according to a report | Business Upturn
Indian pharmaceutical companies, including Dr. Reddy’s Laboratories Ltd. and Macleods Pharmaceuticals Ltd., are preparing to supply semaglutide, the active ingredient in Novo Nordisk A/S’s weight-loss drugs, Wegovy and Ozempic, as patent protections expire next year. This move underscores India's growing role in the generics market, facilitating the production of alternatives to these popular treatments.
Sep 17, 2025
Generic Oncology Medications Market Projected to Hit US$ 41.1 Billion by 2031 - openPR.com
The generic oncology drugs market is projected to grow from US$ 26.2 billion in 2024 to US$ 41.1 billion by 2031, driven by rising cancer prevalence and patent expirations of major drugs. Chemotherapy generics lead the market, with North America currently dominant, while Asia-Pacific shows the fastest growth potential. Key players include Teva Pharmaceutical Industries, Sandoz, and Dr. Reddy's Laboratories.
Sep 17, 2025
Dr. Reddy's shares attract attention as Indian bulk drug manufacturers allegedly begin gearing up for the patent expiration of Ozempic.
Dr. Reddy’s Laboratories Ltd. is preparing for the upcoming expiry of Novo Nordisk A/S’s patents on its weight-loss drug Ozempic (semaglutide), set to lapse next year. Companies like Macleods Pharmaceuticals Ltd. are scaling up production of semaglutide, emphasizing India's growing role in the global pharmaceutical supply chain for cost-effective drug alternatives.
Sep 17, 2025
Novo Nordisk's Alzheimer's study seen as a 'gamble' - Bilyonaryo
Novo Nordisk's senior executive described the company's trial of semaglutide, its obesity drug, for Alzheimer's treatment as a "lottery ticket" due to uncertain outcomes but significant potential. Results from the pivotal trial are expected by late 2025, marking a significant exploration of GLP-1 drugs beyond obesity and diabetes.
Sep 17, 2025
Novo Nordisk Seeks to Tailor Obesity Treatments and Compete with Lilly - AInvest
Novo Nordisk is set to personalize obesity treatment with new versions of its weight-loss drug Wegovy, including a pill and high-dose shot, aiming for US approval by late 2025 and a launch in early 2026. This strategy seeks to regain market share from Eli Lilly & Co., which offers rival drugs Zepbound and Mounjaro.
Sep 16, 2025
Canada is set to be the testing ground for the upcoming availability of affordable, generic Ozempic.
Sandoz Canada is preparing to launch generic versions of semaglutide-based drugs Ozempic and Wegovy in January 2026, following the expiration of Novo Nordisk's patent. The move is expected to significantly reduce treatment costs, potentially lowering monthly prices from $400 to $135. The Canadian market is poised for competition among multiple generic manufacturers, enhancing access to diabetes and weight-loss medications.
Sep 16, 2025
Should Investors Buy, Hold, or Sell ABBV Stock Following Its Nearly 23% Increase This Year? - The Globe and Mail
AbbVie (ABBV) has seen a 22.5% stock increase this year, outperforming its industry and the S&P 500. The growth is attributed to successful new drugs, Skyrizi and Rinvoq, which are replacing declining Humira sales. AbbVie anticipates combined sales of these drugs to exceed $25 billion by 2025. Despite challenges, the company is well-positioned for continued growth.
Sep 16, 2025
Jazz Unable to Dismiss Avadel's Antitrust Allegations in Sleep Medication Dispute - Bloomberg Law News
Avadel Pharmaceuticals Plc's antitrust claims against Jazz Pharmaceuticals Plc are set for trial, as a judge ruled there is sufficient evidence regarding Jazz's potential misuse of a patent registry to block Avadel's Lumryz, a rival to Jazz's Xyrem narcolepsy drug. The jury trial is scheduled to begin on November 3.
Sep 16, 2025
FDA targets Hims & Hers and weight loss medications in fresh advertising campaign | News | wthitv.com
The FDA has launched a crackdown on Hims & Hers and other online services promoting unofficial versions of popular weight loss drugs, including Wegovy. This initiative marks the Trump administration's first warnings aimed at regulating the advertising of these medications.
Sep 16, 2025
Pharmaceuticals: Costly, Insufficiently Evaluated, and Frequently Ineffective | KPFA
In a discussion on the pharmaceutical industry's practices, Jerry Avorn critiques the launch of blockbuster drugs that often fail to deliver on their promises despite high costs. He highlights the compromised state of drug production and regulation, influenced by profit motives. The conversation references organizations like Alosa Health and the Center for Science in the Public Interest.
Sep 16, 2025
FDA targets Hims & Hers and weight loss medications in fresh advertising campaign - Union-Bulletin
The FDA has launched a crackdown on Hims & Hers and other online services promoting unofficial versions of popular weight loss drugs, including the blockbuster treatment Wegovy. This initiative marks the Trump administration's first warnings aimed at regulating the advertising of these medications.
Sep 16, 2025
The approach to treating with popular medications, including the leading anticancer drug globally, and ...
The FDA has approved subcutaneous (SC) formulations for several drugs, including Merck's Keytruda and Ezai's Reckembi, allowing patients to self-administer treatments at home. This shift from intravenous (IV) to SC injections significantly reduces administration time and enhances patient convenience. Other companies, like Daiichi Sankyo, are also exploring SC options for their anticancer drugs, potentially transforming treatment experiences.
Sep 16, 2025
Reasons Behind Eli Lilly's Stock Surge Today - The Globe and Mail
Eli Lilly's investigational obesity drug, orforglipron, may receive expedited FDA approval under a new fast-track program, potentially by year-end. Analysts suggest it is a strong candidate due to its treatment of a significant chronic condition. Additionally, Eli Lilly plans to invest $5 billion in a new manufacturing facility in Virginia, focusing on antibody-drug conjugates.
Sep 16, 2025
Novo Nordisk plans to expand testing of weight-loss medications to include a wider variety of obesity-related conditions.
Novo Nordisk plans to explore the potential of its weight-loss drugs, including Wegovy, to treat various obesity-related health conditions. The company is also awaiting results from a trial testing semaglutide for Alzheimer's disease, which could significantly impact its growth. Meanwhile, Novo Nordisk announced a job cut of 9,000 to save $1.25 billion annually amid competition from Eli Lilly.
Sep 16, 2025
India cancels Novartis' patent for the heart medication Vymada, according to a report - Moneycontrol
Novartis faced a setback as the Indian Patent Office revoked the patent for its cardiac drug Vymada, citing lack of novelty. This decision allows generics from companies like Natco, Torrent Pharma, and MSN Labs to enter the market, potentially lowering prices. Vymada, which combines valsartan and sacubitril, generated $7.8 billion in global sales last year.
Sep 16, 2025
India cancels Novartis' patent for its popular heart medication - Moneycontrol
The Indian Patent Office has revoked Novartis AG's patent for its heart-failure drug Entresto, marketed as Vymada in India, citing a lack of novelty. The ruling, influenced by opposition from the Indian Pharmaceutical Alliance, could lead to affordable generics. Novartis's claims regarding the drug's unique formulation were deemed insufficient, allowing for potential competition in the market.
Sep 16, 2025
Indian Patent Office rejects Novartis' patent application for Vymada, paving the way for generic alternatives.
The Indian Patent Office has annulled Novartis' patent for Vymada (Entresto), a cardiac drug, citing lack of novelty and insufficient evidence of therapeutic advantage. This ruling allows domestic companies like Natco Pharma to produce generics, potentially reducing treatment costs by 30-50%. The decision highlights India's strict patent laws against "evergreening" practices. Novartis may appeal the ruling.
Sep 16, 2025
Tenax Receives European Patent Notification for PH-HFpEF Medication Valid Until 2040 | TENX Stock Update
Tenax Therapeutics announced that the European Patent Office intends to grant a patent for TNX-103 (oral levosimendan) for treating pulmonary hypertension with heart failure and preserved ejection fraction (PH-HFpEF). This patent will provide protection in Europe until at least December 2040, covering various formulations and combinations of levosimendan. The company is preparing to initiate its Phase 3 study, LEVEL-2.
Sep 16, 2025
Tenax Therapeutics Reveals European Patent Office's Plan to Approve ... - The Globe and Mail
Tenax Therapeutics, Inc. announced that the European Patent Office intends to grant a patent for TNX-103 (oral levosimendan) and its formulations for treating pulmonary hypertension with heart failure and preserved ejection fraction (PH-HFpEF). This patent will provide protection until December 2040, enhancing Tenax's global IP portfolio as it prepares for its Phase 3 study, LEVEL-2.
Sep 16, 2025
Tenax Therapeutics Obtains European Patent for TNX-103 and Levosimendan
Tenax Therapeutics, Inc. announced that the European Patent Office intends to grant a patent for TNX-103 (oral levosimendan) and its formulations for treating pulmonary hypertension with heart failure and preserved ejection fraction (PH-HFpEF). This patent will provide protection in Europe until at least December 2040, supporting Tenax's Phase 3 study, LEVEL-2, aimed at regulatory approval.
Sep 16, 2025
India Revokes Novartis Patent for Cardiac Medication Vymada - Pharmacy Business
The Indian Patent Office has annulled Novartis' patent for Vymada (Entresto), a heart failure drug, citing lack of novelty and insufficient inventive step. The decision followed a challenge by the Indian Pharmaceutical Alliance and other companies. With the patent expired, generic versions from firms like Torrent Pharma and Cipla are expected to enter the market.
Sep 16, 2025
Beijing-based startup introduces an AI-driven platform aimed at transforming the drug delivery process - China Daily
Beijing-based METiS TechBio has launched NanoForge, the world's first AI-powered nano delivery platform, aimed at revolutionizing drug design and delivery. Co-founder Chris Lai likened it to "the SpaceX of drug delivery." The platform has generated over 10 million lipid structures and supports targeted delivery across eight human organs. METiS has over 100 patents and a pipeline of advanced therapies, including an oncology candidate nearing regulatory approval.
Sep 16, 2025
China's Cases on Extending Pharmaceutical Patent Terms Uncover a New Landscape for ... - Lexology
China's revised Patent Law, effective June 2021, introduced Pharmaceutical Patent Term Extension (PTE) provisions to compensate for regulatory delays in drug approvals. In 2024, several drugs, including Risdiplam and Penpulimab, received PTE, extending patent protections by up to five years. This marks a significant advancement in China's pharmaceutical intellectual property framework, promoting innovation while balancing public access to medications.
Sep 16, 2025
Beijing-based startup introduces an AI-driven platform aimed at transforming the drug delivery process.
Beijing-based METiS TechBio has launched NanoForge, the world's first AI-powered nano delivery platform, aimed at revolutionizing drug design and delivery. Co-founder Chris Lai likened it to aerospace engineering, addressing challenges in targeted treatment. The platform has generated over 10 million lipid structures and supports multiple drug programs, including an advanced oncology therapy nearing regulatory approval.
Sep 16, 2025
Novo Nordisk highlights potential in drug trials while searching for the next major weight-loss medication - CNBC
Novo Nordisk announced promising late-stage trial results for its new obesity treatment, Cagrilintide, which showed an average weight loss of 11.8% after 68 weeks. The drug, distinct from existing GLP-1s like Wegovy, is noted for its favorable tolerability profile. The company aims to explore Cagrilintide further in the upcoming phase 3 RENEW trial, set to begin in late 2025.
Sep 16, 2025
FDA Targets Hims and Similar Telehealth Platforms in Drug Marketing Campaign
The FDA has issued over 100 warning letters to telehealth companies, including Hims & Hers, for promoting unofficial versions of prescription drugs like Wegovy and Ozempic. The agency criticized misleading claims about these compounded medications, which are not FDA-approved. This marks a significant step in regulating online pharmaceutical advertising, as part of a broader crackdown initiated by the Trump administration.
Sep 15, 2025
Biocon plans to introduce generic alternatives to Ozempic in the coming year - NewsBytes
Biocon plans to launch generic versions of the GLP-1 drug Semaglutide, marketed as Ozempic and Wegovy, after its patents expire in 2031. The company currently sells Liraglutide in the UK and Europe, with a US launch expected by early 2026. The global market for these drugs is projected to exceed $160 billion by 2034.
Sep 15, 2025
Gyala Therapeutics Releases Preclinical Findings on CAR-T Therapy Targeting CD84 for Acute Myeloid Leukemia
Gyala Therapeutics has announced promising preclinical data for its CAR-T therapy, GYA01, targeting CD84 in acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia (T-ALL). The findings, published in *Leukemia*, demonstrate significant anti-leukemic activity. The company secured €3 million in funding to advance GYA01's development, aiming to improve treatment outcomes for these challenging blood cancers.
Sep 15, 2025
FDA Alert: Updates on Merck, Sanofi, Biogen, and Others - BioSpace
The FDA is set to make key decisions this month on several drugs, including Incyte's Opzelura for pediatric eczema, Biogen's higher-dose Spinraza for spinal muscular atrophy, and Merck's subcutaneous Keytruda for cancer. Additionally, Scholar Rock's apitegromab for SMA, Crinetics' paltusotine for acromegaly, and Sanofi's tolebrutinib for multiple sclerosis are under review, along with Fortress Biotech's CUTX-101 for Menkes disease.
Sep 15, 2025
Novo Nordisk Encounters Challenges: Competitive Forces and Compounded Medications Impact...
Novo Nordisk (NASDAQ: NVO) has revised its 2025 sales and profit forecasts downward due to increased competition from Eli Lilly's (NYSE: LLY) Zepbound and the rise of compounded GLP-1 drugs affecting Wegovy sales. Despite a strong first half, the company faces challenges in maintaining market dominance amid regulatory scrutiny and evolving market dynamics in the anti-obesity drug sector.
Sep 15, 2025
India cancels Novartis' patent for heart medication - The Times of India - Indiatimes
The Indian Patent Office has revoked Novartis' patent on Vymada, also known as Entresto, due to lack of novelty, allowing for affordable generics from companies like Natco and Torrent Pharma. This decision may significantly reduce the drug's price, as the Indian Pharmaceutical Alliance and others opposed the patent, citing violations of the Indian Patent Act.
Sep 15, 2025
Bangavax by Globe Biotech secures the inaugural US pharmaceutical patent for Bangladesh.
Globe Biotech Limited has secured a US patent for its Covid-19 vaccine, Bangavax, marking a significant milestone for Bangladesh's pharmaceutical industry. This patent grants Globe exclusive rights for 20 years, enabling the use of its mRNA technology for other vaccines and medicines. Experts believe this achievement will enhance Globe's brand value and pave the way for future innovations in the sector.
Sep 15, 2025
Biocon's CEO announces intentions to introduce a generic version of Ozempic in major markets - CNBC TV18
Biocon CEO announced plans to launch a generic version of Ozempic, targeting key markets as patents expire. The Indian pharmaceutical company aims to capitalize on the growing demand for GLP-1 drugs, with an investment of $5.7 billion to enhance production capacity in the coming years.
Sep 14, 2025
Section 2: Regulatory Factors for Orphan Medications - Intellectual Property - Australia - Mondaq
Australia's orphan drug regulations offer key incentives for drug developers, including patent term extensions and fee waivers for registration. Notably, Zolgensma (onasemnogene abeparvovec), the first gene therapy on the Pharmaceutical Benefits Scheme, exemplifies these benefits, providing critical access to treatment for spinal muscular atrophy. The article emphasizes the importance of aligning patent strategies with regulatory frameworks.
