The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
|Articles|July 5, 2012
Industry Briefs: July 2, 2012
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.
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Company News
Arena Pharmaceuticals and Eisai have received FDA approval for a new molecular entity, Belviq (lorcaserin hydrochloride), for treating chronic weight management.
Astellas Pharma has received approval for a new molecular entity, Myrbetriq (mirabegron) extended-release, for treating adults with overactive bladder.
Biogen Idec and Isis Pharmaceuticals have announced a global collaboration for an antisense program targeting myotonic dystrophy.
Encap Drug Delivery has invested $2 million to expand its facilities, for equipment for product mixing and capsule-filling.
GEA Pharma Systems has agreed to supply a continuous manufacturing line for solid-dose products to an undisclosed pharmaceutical company.
Janssen-Cilag, a Johnson & Johnson subsidiary, has completed the acquisition of Corimmun, a privately held German-based drug-development company.
Takeda Farmacêutica Brasil, a subsidiary of Takeda Pharmaceutical has completed its acquisition of Multilab.
People News
Alnylam Pharmaceuticals has expanded its management team. The company has appointed Oved Amitay as vice-president, head of commercial; Akshay Vaishnaw as executive vice-president and chief medical officer; Jared Gollob as vice-president of clinical research; and Lubomir Nechev as vice-president of process sciences.
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Related to this article
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Christy Owings, Thermo Fisher, explains clinical trial supply chain risks in Latin America, importer-of-record strategy, AI, and eCOA delays.
PharmTech AI Pulse Check debuts: pharma experts tackle GxP 'slop,' multi-agent validation risk, OCR document mining, personalized mRNA cancer therapy.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into pharmaceutical development.
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