Hello, everyone, and welcome to another working week. The weekend respite flew by quickly, yes? Well, this is to be expected. That said, we hope it was invigorating, because that all-too-familiar routine of meetings and deadlines and what-not has now returned. To cope, yes, we are quaffing a few cups of stimulation and, as always, invite you to join us. Meanwhile, here is the customary menu of tidbits to help you along. Hope your day goes well and do stay in touch …
Many leading academic institutions, including Stanford University and Memorial Sloan Kettering Cancer Center, have repeatedly failed to comply with a federal law requiring them to register study results with the ClinicalTrials.gov database, STAT reports. The worst offenders disclosed research results late or, in some cases, not at all at least 95 percent of the time since the law began requiring mandatory reporting in 2008.
Five times in the last six years, the Food and Drug Administration has approved the Afinitor cancer medication for additional uses without proof that it extended life, The Milwaukee Journal-Sentinel reports. The Novartis drug is now used to treat advanced breast and kidney cancer, a rare type of pancreatic tumor, and two types of nonmalignant tumors. But Afinitor also comes with a lengthy list of serious side effects.
Eli Lilly will charge about $11,430 per patient per month for its new lung cancer drug in the US, which is more than what some doctors call a fair price reflecting what they say is a modest benefit, The Wall Street Journal tells us. In clinical trials, the Portrazza drug extended survival among patients with squamous non-small cell lung cancer, which has had few new treatment options in recent years.
Under mounting pressure of its pricing and business practices, Valeant Pharmaceuticals has hired specialists to cope with the scrutiny, Reuters reports. The drug maker retained Robert Kelner, a partner at the Covington & Burling law firm, to help respond to congressional inquiries and Vianovo, a boutique crisis public affairs firm run by former political campaign and government aides.
The Indian generic drug industry is increasingly dependent on ingredients made in China, a development that has companies worried, The Economic Times tells us. Last year, National Security Advisor Ajit Doval described the increasing dependence on Chinese suppliers as a “national threat” and urged the government to take specific steps to bolster the local drug industry.
AstraZeneca is in talks that might lead to the acquisition of Acerta Pharma, a potential $5 billion-plus deal designed to build up its cancer drug portfolio, Bloomberg News says.
Horizon Pharma is paying $510 million to buy Crealta Holdings, which makes the only approved drug for chronic refractory gout, a malady that affects about 50,000 Americans, The Chicago Tribune reports.
The FDA alerted compounders of potential particulate matter in an active ingredient sourced from China’s Taizhou Xinyou Pharmaceutical & Chemical, InPharma Technologist says.
Roche was granted accelerated approval for its experimental Alecensa drug for treating people with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, Pharma Times writes.
An FDA advisory committee voted 28-0 to place more restrictions on codeine use in children and also remove the drug from its over-the-counter monograph for cough and cold, MedPage Today reports.
Shire is holding takeover talks with Baxalta as part of its strategy to expand in rare diseases and fend off larger rivals, according to Bloomberg News.
Merck and Eli Lilly are expanding their immuno-oncology alliance to evaluate a combination of abemaciclib, Lilly’s kinase inhibitor, and Merck’s Keytruda PD-1 inhibitor, Pharma Times says.