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Alder Submits BLA to U.S. FDA for Eptinezumab

Alder BioPharmaceuticals Inc. announced the submission of a Biologics License Application (BLA) to the U.S. FDA for eptinezumab for migraine prevention targeting the calcitonin gene-related peptide (CGRP).

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FDA Approves Novo Nordisk Hemophilia A Treatment

Denmark-based Novo Nordisk snagged approval from the U.S. FDA for a new treatment for hemophilia A, though Esperoct will not be available in the United States until 2020.

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Japan approves test of iPS cells for spinal injuries

Japanese scientists will test the use of human-induced pluripotent stem cells (iPS) to treat spinal cord injuries, a health ministry panel that approved the research project said.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

“We have been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development,” says FDA Commissioner Scott Gottlieb, M.D.

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Sarepta announces FDA acceptance of golodirsen NDA

The Food and Drug Administration accepted Sarepta Therapeutics Inc.’s New Drug Application seeking accelerated approval for golodirsen (SRP-4053), with a regulatory action date of Aug. 19, 2019.

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Motif Bio Receives Complete Response Letter from the FDA

Motif Bio plc announced today that the clinical-stage biopharmaceutical company received a complete response letter from the U.S. Food and Drug Administration regarding the new drug application for iclaprim for the treatment of acute bacterial skin and skin structure infections.

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FDA’s Real World Evidence Guidance Gains Industry Support, but With Slight Modifications

After the U.S. Food and Drug Administration took a hard line on the use of real-world evidence in clinical trials, industry leaders are beginning to back the idea, but with some minor changes.

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Agenda 2019 Special Feature: Hungry AIs

Artificial intelligence generated plenty of chatter amongst the pharma marketing intelligentsia in 2018. Will 2019 be the year when the industry fully embraces it as more than just a tactic?

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Top 10 Pipelines To Watch: 2019 Annual Report

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

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Johnson & Johnson’s nasal spray for depression wins FDA panel backing

A U.S. FDA advisory panel voted in favor of J&J’s experimental nasal spray esketamine, which has a compound similar to often-abused ketamine, bringing the drug closer to approval.

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February 2019 Focus: Agenda 2019, Top 10 Pipelines To Watch, Value Of Pharmaceuticals, and more!

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