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Regulatory

Latest Headlines

Latest Headlines

Intercept surges as FDA review hesitates on endorsing OCA data, but doesn't hate it

FDA staffers reviewing Intercept's data on obeticholic acid (OCA) for rare cases of primary biliary cirrhosis noted that the drug clearly hit a key goal in the study after finding the safest dose for patients. But the panel of outside experts scheduled to meet on Thursday will be charged with considering whether its impact on the single biomarker for the disease--a surrogate for transplant-free survival--is sufficient for an approval, with data lacking on another biomarker and lingering concerns about potential liver damage.

Gilead gains next-gen HIV approval from FDA as it looks to beat back competition

Gilead Sciences has notched up yet another HIV therapy approval as touted blockbuster Descovy gains the nod from the U.S. regulator.

UPDATED: Samsung Bioepis aims at AbbVie Humira patents in U.K. lawsuit

Incheon-based Samsung Bioepis has aimed a U.K. lawsuit at AbbVie's Humira patents as it races to bring a slate of biosimilars to the market that includes the blockbuster rheumatoid arthritis therapy in the face of sharp-elbowed competition to do the same.

Rusan plant in India remains under EU ban due to persistent GMP problems

Four years after U.K. regulators issued a ban on products from a Rusan Pharma site in India, inspectors found that nothing has changed, or at least not enough for the company to escape the manufacturing suspension imposed in 2012.

Startup wins PMA approval for direct-visualization, endoscopic ablation for afib

CardioFocus has nabbed an approval from the FDA for its HeartLight Endoscopic Ablation System to treat paroxysmal atrial fibrillation.

Strimvelis to be the start of a whole new gene therapy platform for GSK and partners

GlaxoSmithKline and its Italian research partners are plotting major new European research hubs with future growth in gene therapies and beyond after the CHMP recommended its new "bubble boy" drug for approval in Europe on Friday.

Drugmakers see no marketing leverage from FDA biosim guidelines

Drugmakers had high hopes for the FDA's biosimilars labeling guidance; both reference-product drugmakers and copycats figured they might be able to use biosimilar labeling to their marketing advantage, depending on the language. But no dice, the FDA said late last week.

GSK promises 'bubble boy' gene therapy will not break the bank as new pricing model revealed

GlaxoSmithKline has only just received a thumbs-up from a European Medicines Agency committee for its groundbreaking new gene therapy treatment--but it's already thinking about pricing as it gears up for a final European approval in the coming months.

PwC: Biopharma must turn to tech to address surge in data integrity violations

Over the past few years, regulators have frequently found fault with data integrity at manufacturers and CROs, which have been accused of everything from logging discrepancies in uncontrolled Excel files to the duplicating of electrocardiogram results. In response, PricewaterhouseCoopers is calling for adoption of technologies to identify and prevent fraudulent activities.

Alibaba Health drops China online pharmacy plans, blames complex regulatory environment

Exactly one year after Alibaba announced it wanted to integrate its pharmacy business into its health unit and sell more drugs online, the Chinese e-commerce giant has now dropped its plans citing growing concerns over its country's healthcare landscape.