Rise and shine, everyone, another busy day is on the way. This is especially true on the Pharmalot campus, where the short person has long since left for the local schoolhouse and the official mascots have tired of chasing chipmunks and squirrels. As for us, we are quaffing cups of stimulation to cope and are mixing Cinnamon Dolce with Hazelnut Creme, who track this sort of behavior. Meanwhile, here are your tidbits. Go ahead and conquer the world and, of course, keep in touch …
India’s Central Drugs Standard Control Organization has classified more than 200 drug makers as high-risk, the Business Standard reports. Names were not disclosed, but sources tell the paper that authorities want to follow the model set by the US Food and Drug Administration in cracking down on companies that violate compliance norms. This is also the first time that CDSCO has worked with state regulators to conduct risk-based assessments.
Arrowhead Pharmaceuticals is discontinuing the development of three leading compounds to fight liver diseases and cutting 30 percent of its staff, the Wisconsin State Journal reports. The move comes after the FDA earlier this month placed a clinical hold on the tests because of the deaths of an undisclosed number of animals in a separate trial involving one of the drugs.
With patent expirations looming in a few years, Astellas Pharma is trying to find another big-selling drug to replicate the success of the Xtandi blockbuster prostate cancer treatment, Bloomberg News writes. “We are just focusing on proprietary innovative medicines,” Chief Executive Officer Yoshihiko Hatanaka tells the news service. Of course, he wouldn’t let on about specific targets being considered.
Anti-vaxxers apparently feel emboldened now that Donald Trump will become president, according to STAT. “For the first time in a long time, I feel very positive about this, because Donald Trump is not beholden to the pharmaceutical industry,” movement leader Andrew Wakefield says in a phone interview. The hope is to promote the belief that there is a link between vaccines and autism.
Sanofi received its first set of drug compounds from its Warp Drive Bio partnership with a Harvard University scientist and his venture backers with the goal of sparking discovery of new medicines, the Wall Street Journal writes.
Pfizer and Merck KGaA moved closer to bringing the fourth checkpoint inhibitor to the US market after the FDA granted priority review for the drug to potentially treat Merkel cell carcinoma, PMLive reports.
Johnson & Johnson raised its $26 billion takeover offer for Actelion, although the new price could not be confirmed, according to Bloomberg News.
Novo Nordisk said its new Tresiba insulin has about the same risk of serious heart problems as Sanofi’s Lantus but offers lower risk of dangerously low blood sugar in people with type 2 diabetes, the Wall Street Journal says.
The American College of Physicians adopted a new policy against cold calls in which companies solicit patients, often by phone, to consider medical products.
The FDA sent a warning letter to Dongying Tiandong Pharmaceutical, noting the company does not do enough to ensure the crude heparin it uses does not contain a potentially lethal contaminant.
Cancer Research UK committed about $235 million over the next five years for its network of 13 centers to accelerate the pathway for developing cutting-edge treatments, PharmaTimes informs us.
CytRx plans to seek FDA approval of its sarcoma treatment, even though the data is based more on “hocus-pocus” than credible science, TheStreet wants us to know.
South Africa’s auditor general found that 63 percent of public health facilities failed to record patient details‚ resulting in a lack of accounting for dispensed medication, the Times tells us.