Rise and shine. Another busy day is on the way, which is largely true here at the Pharmalot campus, where one of the short people has left for a summer activity, while another sleeps in. As for us, we are pursuing our usual routine, helped along by a few cups of stimulation. Feel free to join us. Meanwhile, here are a few items of interest to get you going. Hope you have a smashing day and do keep us in mind when you run across something interesting …
Novartis cautioned that its profit may decline this year as the company increases spending to market its new Entresto heart failure drug, Reuters reports. The drug maker plans to spend another $200 million to promote the medicine, although analysts say the move should have come sooner. The drug has failed to gain traction in the US, where the company has started to sign deals with payers that tie cost of the treatment to patient outcomes.
Celgene executive vice president of corporate affairs Rich Bagger has taken a leave of absence to work on Donald Trump’s transition team, BioCentury reports. The move was not confirmed, though. Before joining Celgene, Bagger was chief of staff to New Jersey Governor Chris Christie, and served as both a New Jersey state senator and assemblyman.
Drug makers are exploring new ways to persuade people to participate in clinical trials, the Wall Street Journal writes. Some companies are sifting through lab records to identify people with certain diseases who may qualify for studies. Others are monitoring how people discuss diseases in online forums in hopes of developing effective recruitment approaches. One company uses Lyft to take patients to and from a trial for an Alzheimer’s drug.
Global AIDS researchers see expanded funding and new gene-based therapies creating opportunities for finding a cure to the disease within the next decade, the Washington Post says. The optimism comes as 18,000 people gather this week in Durban, South Africa, for the 21st International AIDS Conference, just one month after the United Nations committed to action to end the AIDS epidemic by 2030.
The FDA published a 46-page document detailing the performance and procedural goals for fiscal 2018 to 2022 as part of the sixth iteration of the Prescription Drug User Fee Act, Regulatory Focus tells us. The document presents the agency’s plan on user fees, lists deadlines for pilot projects and guidance documents, as well as views on patient input on the regulatory process.
Celgene agreed to pay as much as $2.3 billion to work with Jounce Therapeutics on jointly developing drugs that stimulate the immune system to fight tumors, the Boston Globe writes.
Regulators on both sides of the Atlantic agreed to review Bristol-Myers Squibb’s Opdivo to treat patients with an aggressive form of head and neck cancer, PMLive notes.
GlaxoSmithKline is using Apple’s ResearchKit to run a rheumatoid arthritis study, marking the first time the tool has been used in clinical research, Quartz tells us.
European regulators agreed to review Samsung’s biosimilar version of AbbVie’s Humira, which is the world’s best-selling drug, according to PharmaTimes.
Two Chinese and two Indian companies have been banned from importing pharmaceutical ingredients to the US, according to InPharma Technologist.
Abbott, the second-largest drug maker in India, is hunting for a buyer to sell its low-margin brands, the Economic Times reports, noting that Abbott paid $3.7 billion to Piramal Healthcare in 2010 for its generic business.
A second case of a patient with an antibiotic-resistant infection could provide a big boost to Cempra, which is developing a new treatment to combat superbugs, TheStreet says.
The only way Entresto will succeed is if it is adopted as first line therapy, which is an impossibility since 98% of CHF patients can be successfully treated with an ACE inhibitor or ARB and the other 2% can be treated with generic digitalis. Of the 5.8 million patients with heart failure only 2%, or approximately 117,000 have an ejection fraction under 40%, which was the cohort in the PARADIGM study. The median survival benefit was six months. At an annual cost of $4500/patient, if EVERY eligible patient were to be treated with Entresto the sales would only be about $255,000,000/year, about the amount that Novartis is spending on promotion alone. They never found a successor to Diovan, and this ain’t gonna be the savior.
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