PharmaFocus Today – Page 10 – media

Mirum and Incyte’s Atebrioz Wins FDA Approval for Rare Bone Disorder FOP

On September 25, Mirum Pharmaceuticals and Incyte announced that the U.S. FDA approved Atebrioz™ (zilurgisertib) to reduce new heterotopic ossification (HO) volume in patients aged 12 and older with fibrodysplasia ossificans progressiva (FOP). Zilurgisertib is a once-daily oral small-molecule inhibitor of activin receptor-like kinase 2 (ALK2), directly blocking the key signaling pathway driving abnormal bone formation in soft tissue. FOP is an ultra-rare progressive genetic disorder in which soft tissue gradually ossifies, causing severe mobility impairment. The approval was based on the pivotal Phase 2 PROGRESS study. Mirum licensed worldwide rights from Incyte. Source: https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-and-Incyte-Announce-U-S–FDA-Approval-of-Atebrioz-zilurgisertib-for-Adult-and-Pediatric-Patients-with-Fibrodysplasia-Ossificans-Progressiva/default.aspx
- Source: drugdu
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- September 29, 2026
J&J in Talks to Sell DePuy Synthes to Apollo

Johnson & Johnson is in talks to sell its orthopedics business DePuy Synthes to private equity firm Apollo Global Management for approximately $20 billion. DePuy Synthes was formed from J&J’s 1998 ($3.5B) and 2012 ($21.3B) acquisitions of DePuy and Synthes, covering joint reconstruction, sports medicine, trauma, and the Velys orthopedic surgical robot.DePuy Synthes generated $9.258B in 2025, growing only 1.1% vs. 6.1% for J&J’s broader MedTech segment. Stryker overtook it as global #1 in orthopedics with ~$11.4B. Chinese centralized procurement also pressures the business. H1 2026 sales were $4.801B (+5.6%), showing recovery. J&J has not officially announced the deal; a spin-off remains an option. Source: https://news.yaozh.com/archive/49060.html
- Source: drugdu
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- September 29, 2026
APAC Leadership Transition and Cyberattack Hits Full-Year Guidance

Boston Scientific announced that Arthur Butcher, EVP and Head of International MedSurg, will retire. Butcher joined in 1996, served as EVP & President of Asia Pacific from 2020-2022, and has led MedSurg & APAC Group since 2022 after over 30 years with the company. He will step down on January 1, 2027. Boston Scientific has also been recovering from a major cyberattack identified on August 25, 2026 that disrupted global operations. On September 8, the company stated the incident could materially impact Q3 and full-year results, and it expects to miss prior net sales growth and adjusted EPS guidance. This follows a July 29 guidance cut to 5%-6% organic growth due to slowing electrophysiology and Watchman momentum. Source: https://news.yaozh.com/archive/49062.html
- Source: drugdu
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- September 29, 2026
Huadong Medicine Discloses Positive Top-line Results for Weight-loss Drug, Pipeline May Be Revalued

Huadong Medicine announced that its wholly-owned subsidiary Sino-American East China has achieved positive top-line results in the China Phase III trial (HDM1002-301) of its Class 1 innovative oral small-molecule GLP-1 receptor agonist HDM1002 tablets for weight management in overweight or obese individuals. All dosage groups met all primary and key secondary endpoints at week 44; continued treatment resulted in sustained weight loss further decreasing at week 52 without a plateau; significant improvements in cardiometabolic markers, substantial reduction in liver fat content, and optimized body composition were observed; safety and tolerability were consistent with the GLP-1 class with no new signals. The company has completed Pre-NDA communication and will soon submit a marketing application in China. Research institutions indicate the biopharmaceutical industry will benefit from upcoming policies, with related companies expected to see improved performance. Source: https://finance.eastmoney.com/a/202609283885024341.html
- Source: drugdu
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- September 29, 2026
Core Product Velyso Granted Orphan Drug Designation in Japan

On September 28, Leads Biolabs-B (09887) announced that its core product Velyso® (opatidijumimab, a PD-L1/4-1BB bispecific antibody) has been granted orphan drug designation by the Japanese Ministry of Health, Labour and Welfare for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This is the third orphan drug designation that Velyso® has received, following those from the U.S. Food and Drug Administration and the European Commission, marking a further expansion of its global regulatory recognition into major Asian markets. Source: https://finance.eastmoney.com/a/202609283885132814.html
- Source: drugdu
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- September 29, 2026
What Are Buyers Looking For, and What Are Suppliers Focused On?

From September 16–18, CPHI & PMEC Shenzhen 2026 brought together pharmaceutical companies and industry professionals across APIs, excipients, finished formulations, pharmaceutical machinery, and other segments of the pharma value chain. The Drugdu.com team was on-site throughout the three-day event. We met familiar faces, connected with new companies across different sectors, talked with buyers looking for products and suppliers, and sat down with companies exploring new ways to expand their international business. After three days of conversations, one thing stood out: What matters is not simply how many people you meet at an exhibition, but what buyers and suppliers are actually looking for. Buyers Are Looking for More Than Products “Do you have suppliers for this product?” “Are there other Chinese manufacturers we can compare?” “Can we contact the manufacturer directly?” Many of our conversations with buyers started with a specific product. But finding the product is only the first step. ...
- Source: drugdu
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- September 23, 2026
Novartis acquires Sironax’s blood-brain barrier delivery platform for $125 million

On September 16, Novartis announced the acquisition of biotechnology company Sironax for $125 million, gaining access to its proprietary blood-brain barrier (BBB) delivery platform technology. Sironax’s platform utilizes receptor-mediated transcytosis to efficiently deliver large molecule drugs (such as antibodies and gene therapies) into the central nervous system, addressing the longstanding challenge of large molecules being unable to cross the BBB. The technology platform is expected to significantly enhance Novartis’ drug development capabilities in central nervous system diseases, including Alzheimer’s disease, Parkinson’s disease, and neuro-oncology. This acquisition continues Novartis’ recent strategic investments in neuroscience and rare diseases. Blood-brain barrier delivery technology is considered a key enabling technology for next-generation CNS drug development. Source: https://tldrbio.tech/
- Source: drugdu
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- September 17, 2026
IASO Bio’s in vivo CAR-T IASO208 receives FDA clinical trial clearance

On September 16, IASO Biotherapeutics announced that its investigational new drug application for IASO208, a CD20-targeting in vivo CAR-T product developed on its proprietary InTelliCAR platform, has received FDA clearance in the U.S. As the first lentiviral vector-based in vivo CAR-T product from China to receive FDA IND clearance, IASO208 will directly proceed to a Phase Ib study based on Chinese investigator-initiated trial data, targeting relapsed/refractory B-cell non-Hodgkin lymphoma. In vivo CAR-T is a next-generation cell therapy technology that eliminates the need for ex vivo T cell engineering, instead delivering vectors directly in patients to generate CAR-T cells in vivo. This approach has the potential to dramatically reduce treatment costs and timelines, moving cell therapy toward “off-the-shelf.” The FDA clearance for IASO208 signifies that China is competing on par with the international community in the in vivo CAR-T space, further deepening IASO Biotherapeutics’ internationalization in cell therapy. Source: http://m.toutiao.com/group/7686078944797311529/
- Source: drugdu
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- September 17, 2026
NMPA accepts marketing registration application for Velsipity domestic manufacturing transfer

On September 17, Everest Medicines announced that CDE of the NMPA has accepted the marketing registration application for Velsipity (etrasimod arginine tablets) for the transfer of manufacturing from overseas to domestic production, and has granted Priority Review. Local production is expected to commence in 2027. Velsipity was approved by NMPA in February 2026 for adult patients with moderate to severe active ulcerative colitis (UC) who have an inadequate response, loss of response, or intolerance to conventional therapies or biologics. Source: https://finance.eastmoney.com/a/202609173876680142.html
- Source: drugdu
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- September 17, 2026
Ziprasidone mesylate from SSY Group has been approved for registration as an active pharmaceutical ingredient.

On September 16, SSY Group announced that its ziprasidone mesylate has been approved by the NMPA of China for registration as an API used in marketed formulations. Ziprasidone mesylate is primarily used to treat acute agitation symptoms in patients with schizophrenia. According to the announcement, SSY Group has built a leading second-generation antipsychotic HPAPI platform in China, covering blonanserin, lurasidone, ziprasidone hydrochloride, and the newly approved ziprasidone mesylate. Source: https://finance.eastmoney.com/a/202609163876154835.html
- Source: drugdu
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- September 17, 2026

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