GlaxoSmithKline’s Avandia woes continue: FDA announced Friday that it was putting the one-time blockbuster diabetes drug through another round of reviews over cardiovascular risk data. The regulator dialed back access to the drug in 2010 and imposed a REMS program that first consisted of a medication guide. Those conditions were expanded to include REMS requirement a year later that restricted distribution for Avandia, Avandamet and Avandaryl. As noted by the Wall Street Journal, the restrictions were prompted by concerns back in 2009 that GlaxoSmithKline had not adequately shared heart-risk information and concluded it undercounted the number of heart attacks among clinical trial patients. GSK’s Avandia problems have not been limited to clinical trial issues, and the company paid $90 million in 2012 over its marketing practices. That’s in addition to today’s news that the Supreme Court is allowing insurer Humana to pursue its case against the drug maker to recoup expenses for healthcare costs it alleges it paid out among its Avandia patients, according to the Wall Street Journal. FDA is set to discuss the drug in June.
A study published in Nature Clinical Pharmacology and Therapeutics indicates that the best way to uncover adverse events may be by combing through patient files, reported MedicalNewsToday. The study said looking at patient files as opposed to relying on drug-specific databases or insurance reports could highlight potential problems at an earlier stage. The researchers created a computerized method “to sift through the content of clinical notes in electronic medical records” and used the data to track the frequency of drug and disease mentions.
Royalty Pharma has upped its uninvited bid to take over Elan, which rebuffed the February offer, saying that it wouldn’t dismiss a credible offer and was also interested in exploring life as a company that pursues acquisitions instead of being the subject of one. Royalty Pharma’s most recent offer nears $7.3 billion, reported Bloomberg, which also said today’s number was a “firm, fully financed offer.” Monday’s offer is an increase from the initial $6.5 billion proffer. Jefferies analyst Corey Davis noted in his Monday research note that the final offer depends on how Elan’s share buyback shakes out – if Elan raises the minimum price, Royalty Pharma’s offer drops. Davis also wrote that shareholder confidence requires Elan show what it has in mind in terms of acquisitions. He wrote that there is a sense Elan has several possible deals in play but “nobody knows what ELN is going to buy.”
Roche has sealed a development deal for experimental hepatitis C treatment danoprvir with Ascletis, reported Reuters. Under the deal the China-based biotech will develop and commercialize the drug in China, Taiwan, Hong Kong and Macau.
FDA has fast-tracked Otsuka’s kidney disorder drug tolvaptan, reported PharmaTimes. The drug is being reviewed for autosomal dominant polycystic kidney disease, with a Sept 1 target date.
