In what some are calling a long overdue move, the FDA has proposed a rule that would require drug makers to report the amount of antibiotics that are sold for use in different types of food-producing livestock. By collecting such data, the agency hopes to better understand exactly how the medicines are used by farms that raise hogs, cattle, chickens or turkeys for human consumption.

The heated battle between drug makers and patient advocates over patents and access to medicines is moving to a new venue. The latest clash is taking place in Peru, where several consumer groups are urging the government to issue a compulsory license for an HIV medicine sold by Bristol-Myers Squibb.

The dispute is yet another example of the rising tension between the pharmaceutical industry and some governments over the prices for prescription medicines. In response, a growing number of countries have been pressing drug makers for discounts or, in some cases, issuing compulsory licenses. Read More »

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say ‘Every brand new day should be unwrapped like a precious gift.’ To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Remember, a prescription is not required. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch…

CVS Health agreed to buy Omnicare, the big nursing home pharmacy, in a deal valued at $12.7 billion; Sanderson Farms, which is one of the largest U.S. chicken companies, is refusing to cut back on the use of antibiotics in its production; an Express Scripts unit agreed to pay $7.9 million to the federal government to settle allegations of accepting kickbacks from AstraZeneca; and Richmond Pharmacology, which runs clinical trials for drug makers, has gone to court to challenge a reform proposed by the U.K. government to require registration of all such studies. Read More »

As drug makers jockey for their share of the fast-growing hepatitis C market, the deal between Johnson & Johnson and Achillion Pharmaceuticals has Wall Street analysts rethinking forecasts. The deal calls for J&J to invest $225 million and assume responsibility for development costs. Ultimately, the value of the agreement could reach $1.1 billion.

For J&J, the move may help reposition the company as a player in the hepatitis C market. And for Achillion, the collaboration provides a deep-pocketed partner for a company that some saw as a buyout target. But to what extent will this transform the hepatitis C market and what are the implications for the other drug makers? Here are what some of the wags are saying… Read More »

As a Congressional committee readies legislation designed to jump start medical innovation, executives representing more than 500 hospitals are urging Congressional leaders not to make changes to a prescription drug program that serves indigent patients and bolsters their own bottom lines.

At issue is the 340B Drug Discount program that requires drug makers to offer discounts of up to 50% on all outpatient drugs – for everything from AIDS to diabetes – to hospitals and clinics that are known as safety net hospitals, because they serve indigent populations. Read More »

Several advocacy groups have filed patent challenges to the blockbuster Sovaldi hepatitis c drug in a bid to widen access to patients in some of the world’s largest countries. The challenges were filed over the past two weeks in Russia, China, Argentina, Brazil and Ukraine, which the activists say are home to large numbers of infected patients who are unable to afford the medicine.

Hello, everyone, and nice to see you again. We were away the past few days on what amounted to a long holiday weekend with one of our short people. Besides taking a needed break, creating memories can be important, yes? Now, though, we have returned to the usual routine of deadlines, meetings and the rest. And we cannot envision tackling all this without our ritual cup of stimulation. After all, there is a great deal to do. So please join us as we play a bit of catch up. Meanwhile, here are some tidbits. Hope you have a lovely day…

Sarepta Therapeutics stock surged in after-hours trading yesterday after the drug maker disclosed it can begin a rolling submissions process for FDA approval of its treatment for Duchenne muscular dystrophy; Johnson & Johnson has agreed to pay $7.75 million to the state of Arkansas, which had filed a lawsuit accusing the drug maker of improperly marketing its Risperdal antipsychotic and concealing its risks; and a top FDA official says the long lists of scary prescription drug side effects at the end of television ads are a waste of time for patients. Read More »

Good morning.  Ed Silverman is away from the Pharm one more day and we can only wonder what he’s brewing this morning.  We’re pouring French roast at the alternate campus where it is rainy and foggy, but where a bluebird on the feeder has already brightened the day.  Ed returns tomorrow. He appears to have taken much of the Pharma news with him, but we have scoured the landscape to find these goings-on in Pharmalot this morning. Read More »

Good morning, everyone.  Pharmalot CEO Ed Silverman is away from the campus today, so we’re filling in.  Here’s a look at what’s happening out there:

Endo International PLC is buying Par Pharmaceutical Holdings from a private equity firm for about $8 billion in cash and stock, The Wall Street Journal reports. The deal will help boost Endo’s generics business and comes just months after the Dublin-based company completed a $2.6 billion acquisition of Auxilium Pharmaceuticals. Endo is part of a new generation of lesser-known pharmaceutical companies attempting to bulk up through acquisitions. Read More »

Good morning. Ed Silverman got a jump on the weekend and is away today, but we still have coffee and headlines to carry you through. Drug maker Actavis PLC has booked a “contingent liability” and held discussions with the Justice Department about resolving an investigation into the marketing tactics its Warner Chilcott division, including allegations [...] Read More »