Takeda is looking to sell some drugs in Western Europe, just as it nears a final deal to jettison its Latin American business. China's recent regulatory changes have attracted major Indian drugmakers Cipla, Sun Pharma, Aurobindo and Dr. Reddy's to expand their presence in the country. Eisai and partner Sysmex's blood test for Alzheimer's shows correlations between amyloid and cerebrospinal fluid. And more.
1. Still on a cash-raising spree, Takeda shops €1.5B European drug sale: report
Takeda, still looking to raise money to pay down debt, is prepared to sell some consumer and prescription drugs in Western Europe, Reuters reported. The assets could fetch around €1.5 billion ($1.68 billion), and possible buyers include private equity funds interested in healthcare, European biopharma players and Indian or Asian drugmakers looking to expand in Europe, Reuters’ sources said.
2. Top Indian drugmakers expand in China as policy changes trigger opportunity
Cipla is forming a Chinese joint venture with local firm Jiangsu Acebright Pharmaceutical. The new company will set up a manufacturing facility to make respiratory products for the Chinese market. Cipla is among several leading Indian drugmakers that hope to ride the wave of recent regulatory changes to expand their businesses in China.
3. Eisai’s prototype blood test for Alzheimer’s shows links to CSF amyloid in early disease
New research from Eisai showed measurable correlations between amyloid biomarkers in the bloodstream and changes in the cerebrospinal fluid. The finding will help Eisai and Japanese collaborator Sysmex to develop a fully automated blood test for quick diagnosis of Alzheimer’s disease.
4. FDA investigators discover key Strides Pharma quality records in shredding room
At a Strides Pharma plant, FDA investigators found drug testing records in shredders, and some CGMP documents were awaiting shredding without being reviewed by quality control staff. The FDA issued the plant a warning letter, which the company said will delay approvals for 10 pending generic drug applications.
5. Astellas picks up Frequency's regenerative hearing loss med outside U.S. for $80M
Astellas has in-licensed ex-U.S. rights to Frequency Therapeutics’ hearing loss candidate FX-322 for $80 million up front and $545 million in milestones. The therapy, having passed a small phase 1, is a cocktail of small-molecule drugs designed to target dormant cells in the ear to encourage the growth of new hair cells.
6. Indoco caught in maelstrom of FDA concerns as plant hit with warning letter
Indoco Remedies acknowledged it has been slapped with an FDA warning letter for a plant in Goa, India, that makes tablets and other products. A nearby sterile injectables plant operated by the company was hit by a Form 483, which cited serious data integrity and equipment cleaning problems.