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US FDA Approves Accord BioPharma's ENNUMO Pegfilgrastim Biosimilar
The US Food and Drug Administration (FDA) has approved Accord BioPharma’s ENNUMO (pegfilgrastim-pccg), expanding its US biosimilar portfolio and strengthening access to G-CSF therapies for cancer patients.
Novo Nordisk Brings World's First Once-Weekly Basal Insulin Awiqli to India
Novo Nordisk India has launched Awiqli, the world's first once-weekly basal insulin, offering adults with diabetes a more convenient treatment option with fewer injections.
AstraZeneca, Ionis' Wainua Misses Phase 3 Primary Endpoint in ATTR-CM Trial
AstraZeneca and Ionis reported that Wainua (eplontersen) missed the primary endpoint in the phase 3 CARDIO-TTRansform trial for ATTR-CM, while maintaining a consistent safety profile.
Evonik Invests USD 100 Million to Expand US Drug Manufacturing
Evonik is investing USD 100 million to upgrade its US drug substance Contract Development and Manufacturing (CDMO) facility, expanding manufacturing capacity to meet growing demand for US-based pharmaceutical outsourcing.
UK Life Sciences Attracts Investment to Create Jobs and Faster Patient Treatments
The UK life sciences sector has attracted over £3 billion in public-private investment in the past year, accelerating innovation, creating jobs, and improving patient access to new treatments.
Orchid Pharma Partners with Pharmasyntez to Commercialise Exblifep in Russia
Orchid Pharma has signed an exclusive licensing and supply agreement with Pharmasyntez JSC for Exblifep in Russia. The partnership is expected to strengthen access to advanced antimicrobial therapies while addressing the growing challenge of antibiotic resistance.
Cipher Pharmaceuticals Secures pCPA Agreement to Expand Public Access to Epuris Across Canada
Cipher Pharmaceuticals has completed negotiations with the pan-Canadian Pharmaceutical Alliance, securing a Letter of Intent for Epuris (isotretinoin). The agreement represents a significant step toward expanding public drug plan coverage and improving patient access to severe acne treatment across Canada.
Dr. Reddy's Delays Semaglutide Supplies Following API-Related Quality Issue
Dr. Reddy's Laboratories announces a temporary delay in commercial supplies of semaglutide after identifying an API-related quality issue affecting certain batches. The company is investigating the root cause and has confirmed that patient safety and existing global regulatory filings remain unaffected.
Merck Wins US FDA Breakthrough Therapy Designation Status for Enpatoran in Lupus
Merck has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for enpatoran in lupus patients with active skin manifestations, advancing a potential first approved treatment for cutaneous lupus.
Vivani Medical has entered into an agreement with Novo Nordisk to evaluate NPM-139, its ultra long-acting semaglutide implant for chronic weight management. The implant aims to offer a convenient once- or twice-yearly treatment option, with Phase 1 clinical trials expected to commence in mid-2026.
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