Biocon says it has won EMA manufacturing approval for a $275 million plant in Malaysia where it will make insulin for export to the EU.
China’s 3SBio, in a joint venture with CPE Funds, seeks to buy Canadian CDMO Therapure Biomanufacturing for $290 million pending shareholder approval.
Clinical care experts and patient advocacy organizations call attention to why better patient understanding shapes the best integrated approach to orphan drug…
After issuing a warning letter to India’s Mahendra Chemicals, the agency has followed up by putting its API operation after finding a data and document…
The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.
Brought to you by the publisher of FierceBiotech and FiercePharma, the Fierce Innovation Awards Life Sciences Edition identify and showcase outstanding…
Samsung inked a novel drug R&D pact with Takeda, GSK China partnered with Alibaba on HPV vaccination, Gland is revising its M&A deal with Fosun.
India-based Alembic Pharmaceuticals is selling its formulation manufacturing plant in Baddi to Scott Edil Pharmacia for an undisclosed amount.
A fire disrupted production last week at an Algerian-based generics plant, according to Indian drugmaker Alembic Pharma.
Sun Pharma has been stung by a decade-old pay-for-delay lawsuit, one of a of a host of issues that contributed to a 74% profit slide.
Sun's quarterly U.S. sales dropped 42%, BeiGene offers a public offering of $175 million and the FDA sent a Form 483 to Biocon.
The Biocon sterile manufacturing plant that got spanked by European and FDA regulators earlier this year has taken another whipping by the FDA.