Good morning, everyone, and how are you today? We are just fine, thank you, and as busy as usual as we stare at the overwhelming to-do list. No doubt, you can relate. So time to fight back with a few cups of stimulation. Our flavor today is Southern Pecan, which was in short supply for a distressing while. And now, on with the show. Here are a few items of interest to help you along. Hope you have a smashing day and, of course, do keep in touch …
The overall likelihood that an early-stage biotech drug will get approved is barely 10 percent, according to a new study from the BIO industry trade group. And for all indications, other than cancer, the odds are 12 percent. Of the 14 major disease areas studied, hematology had the best approval odds at 26 percent, while cancer meds have only a 5 percent chance.
Joe Papa, the new Valeant Pharmaceuticals chief executive, will receive compensation that is tied to a so-called “vesting accelerator,” TheStreet tells us. The rewards, which were outlined in a regulatory filing, will reflect progress on issues such as government and customer relations and succession planning. The idea is this approach will make a “significant change” in re-establishing the trust of patients and hospitals.
A day after Sanofi (SNY) stepped up its pursuit of Medivation, Celgene (CELG) and Gilead Sciences (GILD) may make their own bids for the drug maker, Bloomberg News reports. So far, Sanofi is the only company to go public with an offer, although Medivation has rebuffed the $9.3 billion bid. A few other drug makers are believed to be interested in Medivation, including Pfizer (PFE), Amgen (AMGN), AstraZeneca (AZN), and Novartis (NVS).
The FDA Office of Prescription Drug Promotion issued just two letters in this year’s first quarter, maintaining last year’s pace, which also marked a record low in annual enforcement, the Eye on FDA blog tells us. “The drop in enforcement naturally raises questions,” blogger Mark Senak writes. “Has industry gotten really really good with compliance? Has OPDP lost interest?”
Walgreens (WBA) agreed to place Theranos blood-testing centers in thousands of its stores without fully validating the technology, because the retailer worried Elizabeth Holmes would balk if it pushed too hard, the Wall Street Journal writes. The relationship fell apart, but the paper suggests the episode is a good case study of what can go wrong when an established company, which craves growth, bets on an unproven startup.
Two former Sigma Pharmaceuticals executives were each fined $25,000, but avoided immediate jail time, for falsifying company accounts, according to the Sydney Morning Herald. Former chief executive Elmo de Alwis and his chief financial officer Mark Smith also pleaded guilty to additional charges relating to misleading the company’s auditors and board of directors.
Sanofi’s once-a-day shot for diabetes that combines two drugs was recommended by a regulatory panel Wednesday, Bloomberg News tells us. A similar drug from Novo Nordisk (NVO) also received support from the panel on Tuesday.
Deborah Dunsire, who once ran Millennium Pharmaceuticals, is no longer chief executive of Forum Pharmaceuticals, and her departure follows clinical setbacks, Xconomy reports.
Eli Lilly and Pfizer plan to seek regulatory approval by 2018 for a new type of pain drug that could be an alternative to opioids for osteoarthritis, chronic back pain, and cancer pain, Reuters says.
Astellas Pharma (ALPMY), Daiichi Sankyo, and Takeda (TAK) will collaborate on a biomarker database taken from healthy patients to compare with those involved in preclinical and clinical research, according to PMLive.