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Food and Drug Administration...moved to revoke approval of a drug used to treat certain conditions in pigs because it could leave a cancerous residue that may affect human health...The drug, carbadox, is made by Teaneck, New Jersey-based Phibro Animal Health and is used to control swine dysentery and bacterial enteritis...It has also been used to promote weight gain in pigs...Potential cancer risks are based on an assumed lifetime of consuming pork liver or other pork products containing carbadox residues...adding that it is not recommending that people change their food choices while it works to remove the drug from the market...The FDA said it asked Phibro for additional information about the safety of carbadox but the company has not submitted any proof that there is a safe way to use it...Three antibiotics made by Phibro contain the drug: Mecadox Premix 10, Banminth/Mecadox; and Mecadox/Terramycin...

Pfizer’s abandoned deal leaves all sides tainted. The U.S. Treasury looks bad for changing the rules on Monday to kill the $160 billion merger with Allergan. Lawmakers’ inaction encouraged such tax-driven transactions. But Pfizer and Chief Executive Ian Read bear the most responsibility for wasting time and resources pushing an overpriced, risky deal...Monday’s new standards directly target Pfizer’s deal, as they disregard U.S. assets acquired in the past three years. That eliminates Allergan and its low Irish tax rate as a target. It’s unclear if the Treasury Department has overstepped its authority. But purposefully and rapidly mutating laws, especially when applied retroactively, are bad for business and legal authority...Lawmakers emerge covered in tar, too. They could have stopped inversions cold by adopting a territorial tax system. This would have stopped U.S. companies having to pay an extra levy to Uncle Sam on cash earned overseas if local taxes are lower than the U.S. statutory rate. Their fecklessness encouraged Pfizer and other firms to pursue complicated deals where the main payoff is tax avoidance...

Doctors are wildly overdiagnosing asthma, dispensing steroid inhalers like lollipops and possibly putting kids at risk...the prevalence of asthma more than doubled from the 1980s to the mid-1990s, and has stayed around a historical high of 8.3 percent of children and 7 percent of adults... Trouble is, the wrong people are being told they have asthma...So-called cough variant asthma, whose only symptom is a chronic cough, is especially likely to be overdiagnosed...reason for concern about overdiagnosing asthma is that inhaled corticosteroids — the ubiquitous puffers — can have side effects...the diagnosis of asthma has been trivialized, and inhalers [are] dispensed for no good reason … [becoming] almost a fashion accessory."... gold-standard pulmonary tests keep finding that many people diagnosed with asthma don’t have it...The percentage of children falsely labeled asthmatic can be as high as 90 percent...There is strong evidence, from several countries and different age groups, that a large fraction of people who are diagnosed with asthma do not have it.

Valeant Pharmaceuticals International Inc. has terminated the sales force for the female libido pill that it acquired last year for $1 billion...after the drug, Addyi, failed to gain traction in its first six months on the market...Valeant plans to relaunch its sales effort for Addyi with an internal team it will build in the coming months...Along with the 140 contract workers that make up the Addyi sales force, Valeant is firing about 140 employees across its dermatology, gastrointestinal and women’s health divisions, with dermatology taking the biggest hit...The cuts to Addyi’s sales force come after a sluggish start for the drug, which is the first of its kind for women suffering from a low libido. Insurers have been denying or limiting coverage for the pill and many prescriptions written by doctors aren’t getting filled...Valeant...failed to successfully commercialize the treatment by setting the price too high and neglecting to market it...

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The New England Journal of Medicine is arguably the best-known and most venerated medical journal in the world. Studies featured in its pages are cited more often, on average, than those of any of its peers. And the careers of young researchers can take off if their work is deemed worthy of appearing in it...But following a series of well-publicized feuds with prominent medical researchers and former editors of the Journal, some are questioning whether the publication is slipping in relevancy and reputation. The Journal and its top editor, critics say, have resisted correcting errors and lag behind others in an industry-wide push for more openness in medical research. And dissent has been dismissed with a paternalistic arrogance...

A new algorithm may take the guesswork out of medicating patients with cancer, bacterial infections, organ transplants, and other conditions that require very precise drug dosing...Individual differences can alter patient response to medications...Metabolism, body type, ethnicity, other illnesses, and genetics can play a role in how patients respond to drug treatment...The researchers call their method parabolic personalized dosing, or PPD. They gave patients medication and then observed the dosages which brought positive responses...the dosage could be reduced or increased based on how much medication was in the patient’s blood, with the successful doses added to the parabola. The researchers called the parabola "a robust map that identifies drug doses (inputs) that ensure that a patient will stay in a target range."...Establishing a patient’s parabola still requires administering drugs and then observing the response, something doctors already do. "This allows us to make a better guess,"...In the age of big data, algorithms could play a helpful role in integrating a lot of patient information to make dosing decisions.

China and India are causing a "tsunami" in the drug substance market – yet significant hurdles may bring fine chemical outsourcing back to the West...Without the drug substance there would be no drug…While the value of a drug is known, and fiercely debated, the value of drug substances are far more ethereal...there (is) no easy way to determine their value, for one because hardly any data exist on sales or value at the drug sub API level, due to extreme fragmentation in the industry...The combined markets of China and India...dubbed "Chindia," has the highest output at $27bn, and a demand of $10bn. This output is driven by 1,500 merchants in China and 2,300 merchants in India...over the years China has become "the center of gravity for several kinds of APIs," forcing many Western producers out of the market...This...is due in part to capacity build up and the increasing hurdles imposed in the west on local producers, which are driving up costs...No comparable such hurdles face Chinese and Indian players...there are some "rays of hope" for Western producers. These include, the strength of the US dollar, questions surrounding the reliability of "Chindia" as a supply source, and the realization that "penny wise may be dollar stupid" – as potential damage associated with supply disruptions more than offsets cost savings...Ultimately...it would be short sighted to discount vendors in these two countries, regardless of the uncertainties.

Walgreens Boots Alliance reported improving profits as it cuts costs in its U.S. pharmacy business ahead of its Rite Aid acquisition that executives expect to close in the second half of this year. Walgreens growth continues to be hampered by slowing U.S. retail pharmacy sales due in part to reimbursement pressures and a weaker-than-expected flu season with far fewer reported cases across the country. Walgreen U.S. pharmacy sales, which account for 65% of the U.S. division sales, were up just 3.2% in the company’s second quarter...compared to the year-ago period...Walgreens still reported a 14.4% increase in net earnings as the company continued to cut costs and improve margins amid the ongoing integration with Alliance Boots. Total sales were up 13.6% to $30.2 billion, "largely due to the full consolidation of Alliance Boots."...Walgreens executives say they continue their "integration planning," assuming the Rite Aid deal will close in the "second half of calendar 2016."

Pfizer Inc and Allergan Plc walked away from their $160 billion merger on Wednesday, a major win for President Barack Obama, who has been pushing to curb deals in which companies move overseas to cut taxes...Pfizer said the decision was driven by new U.S. Treasury rules aimed at such deals, called inversions. The merger would have allowed New York-based Pfizer to cut its tax bill by an estimated $1 billion annually by domiciling in Ireland, where tax rates are lower…Allergan Chief Executive Brent Saunders said...that the new Treasury rule would not stop the company from doing other stock-based acquisitions as soon as this fall...It really looked like they did a very fine job at constructing a temporary rule to stop this deal and obviously it was successful…