Hello, everyone, and how are you today? We are just fine, thank you, especially since a shiny sun and cool breeze are enveloping the Pharmalot campus this morning. Nothing like a pleasant start to the day, yes? This calls for a cup of stimulation and, as always, you are invited to join us. Remember, no prescription is required. And of course, here are some items of interest for you. Have a smashing day and do keep us in mind when something interesting occurs …
Valeant Pharmaceuticals slashed its guidance again, as investors wonder whether the company can deliver sufficient profits without big acquisitions and price hikes, the Wall Street Journal reports. For the quarter that ended March 31, Valeant posted a loss compared with a profit a year earlier. The financial report arrives ahead of a July 31 deadline required for the company to avoid defaulting on debt agreements.
In a note to investors titled “Worse Than Feared,” Wells Fargo analyst David Maris wrote that, “in many key business areas, Valeant is underperforming consensus.” He also questioned whether Valeant has sufficient cash to avoid problems with debt holders. “If the business stays the way it is, or continues to deteriorate, we believe Valeant will be challenged in making those debt payments.”
Samsung, South Korea’s biggest family-run conglomerate, is betting that its deep pockets and a long-term commitment can place it ahead in the biosimilars market, Reuters tells us. And the company is counting on speed, as well, by assigning 300 researchers to run 1,500 experiments to cut down on development time for its copy of Amgen’s Enbrel treatment. And about 100 bioreactors were also dedicated to the effort.
A study found Pfizer’s Ibrance and another drug helped women live almost twice as long without their breast cancer worsening as those on standard treatment, but UK women fear the med will not be available, says the Express. “We’re really concerned about this getting through the appraisal system because what we’ve seen over the last seven years is that new breast cancer drugs are just not getting through the process,” says Delyth Morgan of Breast Cancer Now.
Martin Shkreli pleaded not guilty Monday to a new conspiracy charge filed by federal prosecutors, who accused him of plotting to defraud the Retrophin drug company, the Wall Street Journal writes.
European regulators next month will release a revised concept paper on first-in-human trials as they review a French Phase I trial in which one volunteer died in January, Outsoucing Pharma informs us.
A late-stage study of Alexion Pharmaceuticals’s Soliris drug to treat a rare neuromuscular disease failed to meet its primary goal, according to the Wall Street Journal.
A simple solution for lowering drug prices is for Medicare to be allowed to negotiate with drug makers, writes WBB Securities analyst Stephen Brozak in the Star-Ledger of New Jersey.
The National AIDS Trust in the UK is going to court to fight a decision by NHS England to remove the PrEP prophylactic HIV treatment from the official NHS commissioning process, Pharma Times writes.
The US Food and Drug Administration warned consumers about the risk of serious bleeding when using over-the-counter, aspirin-containing antacid drugs to treat heartburn and acid indigestion.
A Novartis trial of two drugs used for combating an aggressive lung cancer shows promise for broadening their use beyond melanoma, Reuters reports.
India’s National Pharmaceutical Pricing Authority plans to lower fixed-ceiling prices for 56 important medicines, according to the Economic Times.
A Phase II study of Merck’s Keytruda found high response rates in heavily pre-treated patients with relapsed or refractory classical Hodgkin lymphoma, Pharma Times tells us.
The FDA approved Allergan’s treatment for high blood pressure, a fixed-dose combination of two existing drugs, Nebivolol and Valsartan, Reuters notes.