Hello, everyone, and how are you today? We are just fine, thank you, despite a spot of rain descending on the Pharmalot campus. Our spirits, in fact, remain as sunny as ever. After all, as the Morning Mayor once said: Every brand new day should be unwrapped like a precious gift. So while you tug on the ribbon, you can also peruse the tidbits assembled below. Have a grand day and do keep in touch …
Eli Lilly may cut staff now that a closely watched drug candidate for treating Alzheimer’s disease failed a late-stage trial, the Indianapolis Star reports. Wall Street analysts estimate Lilly spent hundreds of millions of dollars developing the drug in hopes of earnings billions in sales. Instead, the results “will cause us to reevaluate staffing decisions made in anticipation of positive results,” a Lilly spokeswoman tells the paper.
Pfizer canceled plans to build a $425 million, five-story manufacturing plant in Ireland after the clinical failure of its cholesterol-lowering candidate bococizumab, the Irish Times writes. The drug maker had planned to employ an additional 350 people and make the drug at its Grange Castle site, where it currently produces two of its largest selling drugs — the Enbrel arthritis treatment and the Prevnar vaccine.
A World Health Organization working group recommends using the word “falsified” instead of “counterfeit” to describe spurious medicines, PharmaBiz reports. The draft report states that any concern related to intellectual property rights does not fall within this definition and that medical products should not be considered as falsified solely on the grounds that they are unauthorized for marketing in any given country.
Japan will overhaul its prescription drug pricing system, according to the Nikkei Asian Review. The main focus will be to create an annual review of prices instead of every-other-year reviews. A public health insurance program covers a large portion of medical bills and drug prices are set by the government, which hopes the shift toward more frequent price reviews will reflect downward market trends and lead to lower government-set pricing.
Amicus Therapeutics faces an extended delay of at least two years before a regulatory filing for its Fabry disease drug Galafold will be ready, TheStreet tells us. The Food and Drug Administration rejected a request to seek accelerated approval for Galafold based on existing kidney biomarker data. Instead, the agency told Amicus to conduct another clinical trial to gather new gastrointestinal symptom data in Fabry patients.
Roche agreed to sell an API plant in South Carolina to Patheon for a nominal amount in a deal that will save about 200 jobs at the plant, WRAL TechWire reports.
European Union and Japanese regulators plan to share details of active pharmaceutical ingredient manufacturing facility inspections, InPharmaTechnologist says.
An Indian court will hear arguments in a case challenging $400 million damages given to Daiichi Sankyo after the Singh family was found to have concealed information about Ranbaxy Laboratories, the Economic Times says.
Momenta Pharmaceuticals said its experimental biosimilar version of Humira met the main goal in a late-stage trial involving patients with a form of psoriasis, according to Reuters.
The owner of Rid Pharmaceuticals and four other employees were acquitted in a case in which at least 28 children died across Bangladesh in 2009 after consuming Paracetamol syrup made by the company, BDNews24 says.
The Korean antitrust regulator ordered Boehringer Ingelheim and Sanofi to sell animal health care assets in the country as a condition of their $25 billion asset swap, the Korea Times reports.