Hello, everyone, and how are you this morning? We are just fine, thank you, despite the cloudy skies hovering over the Pharmalot campus. As always, our spirits remain sunny. After all, as the morning mayor used to say: Every brand new day should be unwrapped like a precious gift. So go ahead and tug on the ribbon before digging in to the tidbits assembled below. Hope your day is productive and do drop us a line when something interesting arises …
Endo International is holding talks with private equity firms about selling assets in order to pay down more than $8 billion in debt, according to Reuters. The move comes following a 77 percent drop in its stock price this year and investor concerns that downward pressure on drug prices could undercut its reliance on acquisitions and subsequent price hikes for sales growth.
AstraZeneca is trying to thwart generic competition to its Crestor cholesterol pill by seeking approval to treat a rare disease, the New York Times writes. In an unusual legal argument, the drug maker claims Crestor is entitled to seven years of additional market exclusivity under the Orphan Drug Act, because it won approval to treat children with a rare form of high cholesterol. But critics say the company is abusing the law.
Mayne Pharma Group will pay $652 million for three dozen generic drugs from Teva Pharmaceutical and Allergan, as those companies sell assets to facilitate Teva’s purchase of Allergan’s generics business, Bloomberg News says.
The Bipartisan Policy Center issued a report urging the FDA to clarify how real-world evidence can support clinical trials, label expansions, new indications, and new drug approvals, Regulatory Focus reports.
US and European regulators accepted a marketing application from Roche for a new multiple sclerosis medicine, which received priority review in the US, suggesting a faster approval, Reuters writes.
Medtronic is paying $1.1 billion to buy HeartWare International and add more heart-treatment products to its portfolio, the Wall Street Journal reports.
New York University’s medical school closed eight studies at its psychiatric research center and parted ways with a top researcher after discovering violations in a study of an experimental drug from Pfizer, the New York Times says.
A federal bankruptcy judge late last week approved a settlement between KaloBios Pharmaceuticals and former chief executive Martin Shkreli that restricts his future involvement with the company.
Horizon Pharma hired Bank of America to help explore selling a significant equity stake to an investor in order to bolster its balance sheet, Reuters tells us.
Pfizer plans to invest $350 million in eastern China for a manufacturing plant for biologics, which will be completed by 2018.
The US Food and Drug Administration awarded Bristol-Myers Squibb’s Opdivo immunotherapy its sixth breakthrough therapy status, this time for its potential in treating bladder cancer, PharmaTimes says.
The Indian government capped prices of 42 essential medicines in hopes of bringing down costs by almost 15 percent, the Economic Times writes.
Forum Pharmaceuticals is going out of business following a failed trial of its lead candidate for schizophrenia, Xconomy informs us.