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Top of the morning to you. And a fine one it is here at the Pharmalot campus, where the shortest of short people has left for the local schoolhouse and the official mascots are snoozing away. Moreover, a warm and shiny sun, a rarity in recent days, is making a welcome appearance. To celebrate, yes, we are downing a cup of stimulation — Blueberry Cobbler is our preference today. Feel free to join us. As always, here are your tidbits. Hope your day goes well …

Several major investment funds met last month with biotech execs in a Boston hotel to urge them to do a better job of defending against criticism of drug pricing and take control of the conversation before lawmakers try to regulate prices, Bloomberg News reports. Among those attending were Fidelity Investments, T. Rowe Price, Third Rock Ventures, and Wellington Management.

Merck and Johnson & Johnson’s Janssen Pharmaceuticals unit last month received civil investigative demands from the United States Attorney’s office in New York related to their contracts with pharmacy benefit managers, according to filings made Monday with the US Securities and Exchange Commission (see page 18). The demands cover January 2006 through the present. The J&J demand was issued in connection with an investigation under the False Claims Act (see page 28).


Food and Drug Administration commissioner Robert Califf told an industry conference last week that Congress must “carefully craft” the 21st Century Cures legislation, Bloomberg News reports. If not, he warned, patients and the FDA could face “significant risk” if products are approved too quickly and end up causing harm or being ineffective. He also emphasized the FDA needs a “stable source of funding” to meet requirements mandated by new laws.

The South African government is negotiating with Roche to reduce the price of its Herceptin breast cancer drug, which costs about $32,700 a year to treat one person and was unaffordable to most women, Health Minister Aaron Motsoaledi told Reuters. “I met the CEO in April and told him women won’t be able to afford this. Let’s talk, maybe something can come out of this.”


The FDA granted a waiver to allow the chair of its Circulatory System Devices advisory panel to hold his position despite a conflict of interest, Regulatory Focus tells us. Later this month, the committee will review a device from St. Jude Medical, which funded clinical trials at the University of Wisconsin, where committee chair Richard Page heads the department of medicine.

Epirus Biopharmaceuticals is overhauling management, cutting 40 percent of its workforce and suspending its lead drug program, the Boston Business Journal reports. The company has enough cash to last through June.

An experimental cancer vaccine developed by NewLink Genetics failed to prolong survival in patients with pancreatic cancer compared to a standard therapy in a late-stage study, TheStreet informs us.

Access to recommended therapies for reducing the risk of stroke varies widely across England, Pharma Times writes, citing a report from the Association of the British Pharmaceutical Industry.

India’s Department of Pharmaceuticals told the national drug price regulator to examine applications filed by various drug makers against fixed ceiling prices that were recently set, PharmaBiz reports.

A former Eli Lilly manager who quit for health reasons and was later dropped from a company disability plan was awarded more than $500,000 by a federal judge, the Indianapolis Business Journal writes.

Cumberland Pharmaceuticals will bring Ethyol, a drug used to treat some side effects from cancer treatment, back to the US under an agreement with Clinigen Group, the Tennessean says.

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