Daiichi Sankyo’s Turalio becomes the first FDA-approved TGCT treatment, after receiving breakthrough therapy, priority review and orphan drug designation.
Heptares Therapeutics has entered into a drug discovery and licensing agreement with Daiichi Sankyo – providing further validation of the company’s structure-based drug design approach, says CEO.
The former owners of Indian drugmaker Ranbaxy have been ordered to pay Daiichi Sankyo $385m for concealing quality problems across its manufacturing network before selling the business.
Closure of its Benicar intermediates plant was prompted by impending US patent loss and a decision to focus on large molecule drugs says Daiichi Sankyo.
Japanese drug firms eyeing international investments should not be put off by Daiichi Sankyo’s turbulent ownership of Ranbaxy according to an Indian delegation in Tokyo last week to seek collaborations.
Regulatory compliance will be the number one focus for Sun Pharma, the company says, following its $3.2bn (€2.3bn) takeover of Indian generics firm Ranbaxy.
Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.
Saltigo has won a manufacturing contract with Daiichi Sankyo under it which it will provide custom synthesis services for one of the Japanese drugmaker’s pipeline candidates.
Ranbaxy Laboratories is putting all of its weight behind a quality push following its admission of manufacturing adulterated drugs, and just as its parent company Daiichi Sankyo is pursuing legal action.
in-PharmaTechnologist.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceuticals, including news from Daiichi Sankyo, Galenea and Lannett.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including a reshuffle at Daiichi Sankyo and appointments at Fate Therapeutics and 3-V Biosciences.
Two approvals in a week for drugs made at Ranbaxy’s New Jersey OHM Laboratories subsidiary have eased the generics firm’s North American regulatory woes and strengthened its position in the expanding US market.
The Indian pharmaceutical and biotech sectors may see more M&A activity this year with rumours that GSK, Sanofi Aventis and Merck KGaA are on the look out for potential deals.
Ranbaxy has claimed that a pharmaceutical company is making a
concerted effort to depress the company's share price by initiating
the accusations that the generics manufacturer falsified data to
achieve compliance.
The US Food and Drug Administration has resorted to a legal
challenge against India's Ranbaxy Laboratories in an ongoing
investigation into the sale of substandard drugs.
Japan's Eisai has inked a deal with Accenture to have it provide it
with global clinical data management services from India, and
becomes the first big Japanese pharma firm to take such a step.
Japan's number two pharma firm has elected to set up significant
operations in India - the first Japanese pharma company planning to
plant itself in the country on such a scale.
The rumours of a marriage between Japanese drugmakers Sankyo and
Daiichi Pharmaceutical were confirmed on Friday, when the two
companies officially announced their intention to merge in a stock
deal valued at around Y 813.0 billion...