Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
|Articles|June 28, 2012
Industry Briefs: June 25, 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
Bristol-Myers Squibb and Pfizer have received a Complete Response Letter from FDA for Eliquis (apixaban), for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Impax Laboratories and Tolmar have entered into a multiproduct agreement for the development, supply, and distribution of generic topical prescription drug products.
FDA has issued Janssen R&D a Complete Response Letter for Xarelto (rivaroxaban) for the reduction of secondary cardiovascular events in patients with acute coronary syndrome
PharmaNet/i3 has launched PharmaNet/i3 Strategic Resourcing, a new provider of staffing and functional service provider services.
Quotient Clinical and Capsugel have announced a collaboration for the development and clinical assessment of lipid-based formulations.
Takeda North America has changed its name to Takeda Pharmaceuticals USA.
WIL Research Company has selected Thermo Fisher Scientific’s Q Exactive mass spectrometer systems to expand its capabilities for regulated bioanalysis, drug discovery, metabolism, and structural identification services.
People News
Takeda has announced a new assignment of directors, the appointment of corporate officers and a change of senior leadership. Key appointments include Masato Iwasaki as director and senior vice-president of Pharmaceutical Marketing, and Deborah Dunsire as director, president, and CEO of the company’s subsidiary Millennium Pharmaceuticals.
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This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
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