Biohaven's treatment for Lou Gehrig's disease fails to win FDA nod
(Reuters) - Biohaven Pharmaceutical Holding Co Ltd said on Friday the U.S. health regulator failed to approve its treatment for amyotrophic lateral sclerosis, or Lou Gehrig's disease, sending its shares down nearly 6% in extended trading.
(Reuters) - Biohaven Pharmaceutical Holding Co Ltd
The company said the Food and Drug Administration issued a complete response letter, raising concerns related to an active pharmaceutical ingredient (API) used in a 2017 study that was made by Apotex Pharmachem India Pvt Ltd between 2014 and 2016.
Biohaven said that the API is now being sourced from another supplier, with which there are no chemistry, manufacturing, and control issues that have been identified.
Amyotrophic lateral sclerosis is a rare neurologic disease, which mainly affects the nerve cells responsible for controlling voluntary muscle movement such as walking or talking.
(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Anil D'Silva)
This story has not been edited by Firstpost staff and is generated by auto-feed.
By Robin Emmott and John Irish | BRUSSELS/PARIS BRUSSELS/PARIS France and Germany will agree to a U.S. plan for NATO to take a bigger role in the fight against Islamic militants at a meeting with President Donald Trump on Thursday, but insist the move is purely symbolic, four senior European diplomats said.The decision to allow the North Atlantic Treaty Organization to join the coalition against Islamic State in Syria and Iraq follows weeks of pressure on the two allies, who are wary of NATO confronting Russia in Syria and of alienating Arab countries who see NATO as pushing a pro-Western agenda."NATO as an institution will join the coalition," said one senior diplomat involved in the discussions. "The question is whether this just a symbolic gesture to the United States
BEIJING Chinese President Xi Jinping on Wednesday called for greater efforts to make the country's navy a world class one, strong in operations on, below and above the surface, as it steps up its ability to project power far from its shores.China's navy has taken an increasingly prominent role in recent months, with a rising star admiral taking command, its first aircraft carrier sailing around self-ruled Taiwan and a new aircraft carrier launched last month.With President Donald Trump promising a US shipbuilding spree and unnerving Beijing with his unpredictable approach on hot button issues including Taiwan and the South and East China Seas, China is pushing to narrow the gap with the U.S. Navy.Inspecting navy headquarters, Xi said the navy should "aim for the top ranks in the world", the Defence Ministry said in a statement about his visit."Building a strong and modern navy is an important mark of a top ranking global military," the ministry paraphrased Xi as saying.