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- A U.S. jury found Takeda Pharmaceutical liable for $885 million in damages for delaying generic competition of constipation drug Amitiza through an anticompetitive scheme. - The verdict marks the first time a pharmaceutical company has been found liable by a jury in class action litigation over pay-for-delay agreements since the 2013 Supreme Court ruling. - Under federal antitrust law, the $885 million award could be automatically tripled to several billion dollars, representing a significant financial penalty for the Japanese drugmaker. - The case centered on a 2014 settlement where Takeda allegedly paid Par Pharmaceutical $210 million to delay launching generic lubiprostone until January 2021, postponing competition by six years.
- The FDA has granted Breakthrough Therapy Designation to adrabetadex for infantile-onset Niemann-Pick disease type C, based on survival analyses showing improved outcomes compared to external controls. - Adrabetadex directly addresses the underlying pathology of NPC by re-establishing intracellular cholesterol trafficking, marking a potential therapeutic breakthrough for this devastating neurodegenerative disorder. - Beren Therapeutics plans to submit a New Drug Application in the near future, with the drug expected to be eligible for Priority Review given its orphan drug status. - The designation represents a significant regulatory milestone for a disease with extremely poor prognosis, where early-infantile-onset cases have a mean survival of approximately 5.6 years.
- Mallinckrodt will present two poster studies on TERLIVAZ (terlipressin) at Kidney Week 2025, examining the effects of paracentesis and chronic kidney disease in HRS-AKI patients. - The presentations include a post hoc analysis of the Phase III CONFIRM trial and real-world outcomes data from the Premier U.S. hospital database. - TERLIVAZ remains the first and only FDA-approved treatment for hepatorenal syndrome with rapid kidney function decline, affecting over 60,000 Americans annually.
- A jury awarded Mallinckrodt $9.5 million in damages following a patent infringement lawsuit related to nitric oxide therapy technology. - The legal victory involves intellectual property rights for nitric oxide treatments, which are critical therapeutic interventions in certain medical conditions. - This patent dispute resolution demonstrates the ongoing importance of protecting pharmaceutical innovation in specialized therapeutic areas like nitric oxide delivery systems.
- A Delaware federal judge ruled that the hypothetical negotiation date for patent damages in the Mallinckrodt v. Airgas case should be November 2023, when Airgas launched its competing product, rather than November 2022 when the ANDA was filed. - The dispute centers on patents covering INOmax and DSIR Plus delivery systems, which provide nitric oxide therapy for treating hypoxic respiratory failure in neonates and children. - The court's timing decision impacts potential damages calculations and establishes that licensing negotiations should be tied to actual product launch rather than ANDA filing dates. - Multiple summary judgment motions were decided, with the court granting some patent validity claims while denying others based on disputes over claim scope and prior art analysis.
- Mallinckrodt will present five clinical analyses of TERLIVAZ (terlipressin) for hepatorenal syndrome with rapid reduction in kidney function (HRS-AKI) at Digestive Disease Week 2025 in San Diego. - TERLIVAZ is the first and only FDA-approved treatment for improving kidney function in adults with HRS-AKI, a rare and life-threatening condition affecting approximately 42,000 Americans annually. - The presentations will include real-world evidence on treatment outcomes in various patient populations, including those on transplant waitlists and with alcohol-associated liver disease.
- Mallinckrodt plc and Endo Inc. have agreed to merge in a $6.7 billion transaction, with Endo shareholders receiving $80 million in cash and owning 49.9% of the combined entity. - The merger is expected to create a pharmaceutical giant generating $3.6 billion in revenue and $1.2 billion in adjusted EBITDA by 2025, with at least $150 million in annual synergies by the third year. - The combined Dublin-based company will maintain global operations across the U.S., Europe, India, Australia, and Japan, with Mallinckrodt's CEO Siggi Olafsson leading the newly formed organization.
- The DEA has approved Takeda Pharmaceuticals to increase production of Vyvanse by 24% to address ongoing shortages of ADHD medications. - This decision follows a request from the FDA in July to ensure an adequate supply of lisdexamfetamine for both domestic and global needs. - The increased production limit includes 6236 kg for domestic demand and 4678 kg for foreign demand of finished dosage medications. - Generic versions of Vyvanse have been approved from 11 drugmakers after Takeda lost exclusivity last year.
• The FDA issued a Complete Response Letter for SpecGx LLC's abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets. • The agency provided guidance on areas needing further evaluation before the NDA can be resubmitted for potential approval. • Mallinckrodt plans to meet with the FDA to discuss the letter and explore pathways for approval, emphasizing the drug's potential to mitigate opioid abuse.
