Hello, everyone, and how are you today? We are just fine, thank you, despite forecasts of impending doom and the steady rain drenching the Pharmalot campus. After all, as the Morning Mayor would say: “Every brand new day should be unwrapped like a precious gift.” So we must make the most of it. And keeping busy is a good idea. On that note, here are your tidbits. Hope your day is productive and pleasing …
The “Right to Try” movement is spreading to Canada, the Ottawa Citizen reports. A group of patients with terminal illnesses is urging lawmakers to pass legislation that would give dying patients access to potentially lifesaving and life-lengthening treatments and drugs that are not approved by Health Canada. The 28 members of the group all have amyotrophic lateral sclerosis (ALS) or terminal cancer.
Novartis is contemplating the sale of its struggling Alcon eye-care business and such a move would signal the unraveling of a vision to build the drug maker into a diversified health care giant, Reuters informs us. Since former Novartis chief executive Dan Vasella left in 2013, the company has reversed course, focusing on its prescription drug business. Since then, the animal health and vaccines businesses have been sold.
A controversy erupted over how an editorial, based on an embargoed study in the New England Journal of Medicine, made it to Circulation, a competing journal, days before the study was published, MedPage Today explains. The Circulation editorial was critical of the study design and conclusions reached by the investigators. The lead author of the study, Cleveland Clinic cardiologist Dr. Steve Nissen, called it an “inexplicable breach of ethical standards.”
A federal jury in San Francisco decided that a former InterMune executive and a friend in the UK engaged in a $1 million insider trading scheme, Reuters writes. The US Securities and Exchange Commission filed civil charges accusing Sasan Sabrdaran of telling his friend about the progress of a drug for combating a fatal lung disease that was up for regulatory approval in Europe.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Merck’s biosimilar version of Lantus, the Sanofi blockbuster basal insulin product, be approved, PMLive tells us. The drug, which is called Lusduna, is now one step closer to European approval, but is facing a patent infringement lawsuit from Sanofi, which is scrambling to protect its successful product.
Regent Pacific Group is launching Fortacin in the UK for premature ejaculation, PharmaTimes writes, Trial data showed that more than 85 percent of men had delayed ejaculation time of greater than one minute using the spray, and that ejaculation time continued to increase as the drug is used for several months. A rollout in several other European countries is planned for next year.
Uniqure is restructuring its R&D organization in the Netherlands, consolidating manufacturing in the US, refocusing its pipeline and cutting 25 percent of its workforce and save up to $20 million over the next two years.
The Food and Drug Administration rejected Dynavax Technologies’s hepatitis B vaccine for the second time in three years, casting doubts on whether the company can bring its main drug to the market on its own, Reuters says.
A late-stage trial for an injectable treatment for addiction to heroin and other opioids was successful, although full results will not be released until April, the Wall Street Journal reports.
And what defense does an author have against publication of a biased, flawed study in a competing journal? NONE. For those who wish a little edification, we have garbage meisters who pass for Journal Editors at very reputable journals, and if it happens to be a drug study unfavorable to the sponsor get ready for one of these guys to rip you a new one. The only way to beat them to the punch is to get your paper published first. Steve Nissen, infamous secret taper of drug company meetings commenting on ethics? What a freaking joke.
Comments are closed.