相关临床试验
4
4 进行中
药物批准
217
批准总数
监管机构
3
监管机构数
成立时间
N/A
尚未招募
4
100.0%
- Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a Stelara biosimilar for Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. - Henlius and Organon received Canadian approval on 24 March 2026 for Bildyos and Tuzemty, denosumab biosimilars referencing Prolia and Xgeva respectively. - Apotex's Denoza and Biocon's Bosaya and Vevzuo added further Canadian denosumab approvals in early April 2026, deepening the competitive field. - As of September 2026, Europe had approved 14 ustekinumab and 15 denosumab biosimilars, while the US had approved 8 and 19 respectively.
- The EMA's CHMP has issued a positive opinion recommending approval of Cavoley, a biosimilar referencing Amgen's Neulasta (pegfilgrastim). - Cavoley is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adults receiving cytotoxic chemotherapy for malignancy. - Data submitted to the EMA demonstrate Cavoley has comparable quality, safety and efficacy to the reference product Neulasta. - The opinion marks the 12th pegfilgrastim biosimilar to receive a positive CHMP opinion in Europe, underscoring sustained therapeutic value in oncology care.
- The FDA classified a nationwide recall of levothyroxine sodium tablets as Class II on July 17 after routine stability testing found the tablets were subpotent, meaning they contain less active drug than labeled. - The recall, initiated by manufacturer Lupin Pharmaceuticals and distributed by Major Pharmaceuticals and Cardinal Health, covers seven strengths (25–150 mcg) across 12 products with expiration dates extending to January 2027. - Patients are advised to continue taking their medication, as stopping a recalled drug can cause more harm than continuing, and pharmacies are not required to notify patients directly. - Experts note the recall demonstrates the system working as intended, with routine monitoring and blood tests allowing clinicians to detect low thyroid function before significant adverse effects occur.
- The Unified Patent Court revoked Sanofi's patent EP 2 493 466 protecting the anti-tumor use of cabazitaxel in combination with prednisone or prednisolone for treating hormone-refractory metastatic prostate cancer. - Multiple generic companies including Accord Healthcare, Zentiva, Stada, and Dr. Reddy's successfully challenged the patent through counterclaims for revocation at the Munich local division. - The court's decision follows similar rulings in France and earlier favorable decisions for generics in the UK and Germany, allowing generic versions of the chemotherapy drug Jevtana to enter European markets.
- The CPHI Pharma Awards 2025 finalists have been announced across 14 categories, showcasing advances in synthetic biology, AI-enabled formulation, sustainable packaging, and patient access initiatives. - Notable innovations include Lonza's Design2Optimize platform, Evonik's world-first functional ready-to-fill capsule for ileo-colonic drug delivery, and Celtic Renewables' green chemical transformation technology. - Winners will be announced on October 28, 2025, at the opening ceremony of CPHI Frankfurt, highlighting technologies that may influence manufacturing scalability and clinical development strategies.
- The FDA quietly permitted more than 150 exempted products from officially banned foreign factories to continue shipping to the United States for over a dozen years to prevent drug shortages. - ProPublica's investigation revealed that most exempted drugs came from factories in India, with additional facilities in China and Hungary, despite dangerous manufacturing failures that led to import bans. - The agency did not regularly test these exempted drugs or proactively monitor safety reports describing products with foul odors, abnormal taste, or consumers experiencing unexplained health problems. - Several factories remain banned but continue receiving exemptions, while the FDA kept this practice largely hidden from the public without releasing a comprehensive list until now.
- The FDA upgraded a recall of over 160,000 bottles of levothyroxine sodium tablets to Class II status on July 23, indicating moderate public health risk. - The recall was initiated because the medication content falls below approved specifications, making the thyroid medication subpotent. - Levothyroxine sodium is used to treat hypothyroidism and is one of the most widely prescribed medications in the United States. - The recalled products were manufactured by India-based Intas Pharmaceuticals for North Carolina-based Accord Healthcare across multiple lot numbers and expiration dates.
- The District Court The Hague dismissed nullity suits from Accord Healthcare and Sandoz against Xtandi's basic patent EP 1 893 196 and its Dutch SPC, maintaining protection until June 2028. - Generic companies challenged the patent's priority claims, arguing the lead compound RD 162 was previously published, but the court rejected their arguments. - The ruling continues Astellas and University of California's successful European defense of Xtandi patents, following similar victories in the UK and Germany. - Appeals remain pending in the UK regarding the same patent, while Dutch appeals are expected as generic companies previously appealed a related formulation patent decision.
- Esperion Therapeutics has reached a settlement agreement with Micro Labs that prevents the generic manufacturer from marketing a version of NEXLETOL (bempedoic acid) before April 19, 2040. - The agreement resolves patent litigation initiated by Esperion in response to Micro Labs' Abbreviated New Drug Application seeking approval for a generic version of the cholesterol-lowering medication. - Litigation against eight other ANDA filers continues, with no guarantee that these ongoing cases will prevent other generic versions from entering the market before the 2040 patent expiration.
- Sakar Healthcare received its second Marketing Authorization from the European Union for an oncology injection product targeting colorectal cancer treatment. - The approval follows the company's first EU marketing authorization received in April 2025 for treating breast cancer, non-small cell lung cancer, and prostate cancer. - The company has several additional oncology products under EU registration and expects to receive marketing authorizations within the coming months. - Sakar's strategic partnership with Accord Healthcare provides access to commercial infrastructure across 45 countries in the EU and UK markets.
