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Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for Denosumab
Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar to Prolia and Xgeva, moving it closer to potential marketing authorisation in the European Economic Area (EEA).
Roche Reports Positive Results from Phase III evERA Breast Cancer Study
Roche has announced positive results from the phase III evERA study evaluating its investigational oral selective oestrogen receptor degrader (SERD), giredestrant, in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
Vidal Health and SII Collaborate on HPV Vaccine Access
Vidal Health and Serum Institute of India (SII) have partnered to boost cervical cancer prevention, launching from 1 October 2025 a first-of-its-kind cashless platform for HPV vaccination—covering digital bookings, consent, and certification with zero paperwork.
Ionis Experimental Drug Zilganersen Shows Promise in Trial for Alexander Disease
Ionis Pharmaceuticals has reported positive topline results from a pivotal study of its experimental drug zilganersen in patients with Alexander disease, a rare, progressive and often fatal neurological disorder.
US FDA Grants Fast Track Designation to AAV Gene Therapy by Sanofi
The US FDA has granted fast track designation to Sanofi’s SAR446268, an AAV gene therapy for juvenile and adult-onset myotonic dystrophy type 1 (DM1).
Datavant and Indegene Partner to Power More Efficient Clinical Trial Recruitment
By embedding Datavant’s bespoke data enrichment capabilities into Indegene’s NEXT Patient Recruitment platform, the two companies are enabling faster trial enrollment, fewer screen failures and more efficient recruitment processes for biopharmaceutical organisations.
Asia Pacific Leads Global Pharmaceutical Capsule Filling Machines Market
The Asia Pacific region dominated the global pharmaceutical capsule filling machines market in 2024, capturing a 40 percent share, according to a report by Precedence Research.
Jubilant Pharmova Appoints Arun Kumar Sharma as Interim CFO
Jubilant Pharmova has Arun Kumar Sharma as Chief Financial Officer (CFO) and Key Managerial Personnel (KMP) of the company for an interim period, effective October 1, 2025. He will serve in this role until the appointment of a new CFO is finalised.
Qiagen and APAGE Set Regional Consensus on Rapid Molecular Testing for Gastrointestinal Infections
The two-day meeting, held on 20–21 September in collaboration with the Asia-Pacific Association of Gastroenterology (APAGE), convened key opinion leaders from Singapore, Malaysia, Thailand, Indonesia, the Philippines and Australia.
Alkem Launches Pertuzumab Biosimilar Pertuza in India for HER2-Positive Breast Cancer
Alkem Laboratories has introduced Pertuza, a biosimilar of pertuzumab, in India for the treatment of HER2-positive breast cancer. The drug is supplied as a 420 mg/14 mL injection and is developed and manufactured domestically.
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