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Poor sales trajectory, check. Scale-back in marketing effort, check. What’s next for Valeant’s Addyi and its maker, Sprout? An impairment charge...and a big one, at that...David Maris expects to see a whopper charge on the carrying value of Sprout--as in, as much as 90% or more...And he expects to see it "with next quarter’s results, if not sooner...Valeant has already warned in a regulatory filing of a potential impairment...sales of Addyi (flibanserin) --the controversial female libido drug that Valeant shelled out $1 billion to gain access to--are dismal. In July, they had reached just $696,235, Maris wrote, citing IMS data--a far cry from the $100 million to $150 million the Canadian drugmaker forecast for this year...when the "overdue" impairment does finally come, investors will feel the burn...the write-off cut into 2017 EPS and beyond by 14 cents per share, though that’s not necessarily even the worst part…

Walgreens Boots Alliance said U.S. antitrust regulators are requiring a divestiture of between 500 and 1,000 retail stores if its acquisition of Rite Aid will be approved...In the Walgreens-Rite Aid deal, it’s the Federal Trade Commission that is evaluating the transaction and demanding divestitures if the deal is going to win approval...Despite the large divestiture of stores, Walgreens expects the deal to still close in the second half of this year leaving the company with more than 11,700 U.S. stores. Walgreens has 8,200 U.S. stores and Rite Aid has 4,500. Even a divestiture of up to 1,000 stores would make Walgreens larger than CVS Health and its 9,600 pharmacies ...Walgreens chief executive officer Stefano Pessina has vowed to be a consolidator in a U.S. market he sees as facing more government control of pricing thanks in part to broader health coverage under the Affordable Care Act. The U.S. also has a growing population of aging baby boomers gaining Medicare coverage.

After years of anticipation, the Food and Drug Administration will hold a public, two-day meeting in November to review the extent to which so-called off-label information about medicines may be disseminated to physicians...the FDA has taken a firm stance toward the issue. A key concern is that public health could be jeopardized if a company were to distribute information about an unapproved use that had not been proven to be safe and effective, a standard for regulatory approval...drug makers have argued that conveying certain types of information is protected by the First Amendment...drug makers and their supporters have grown impatient and fear that various court rulings might become a de facto standard. Last winter, an independent review panel was floated as a way to address the issue. Last May, two lawmakers accused the Department of Health and Human Services of delaying new rules and issued a draft bill that would allow companies to market products for unapproved uses...

...the US Food and Drug Administration filed an annual report to Congress about citizen's petitions that can be used to ask the agency to refrain from approving a generic drug or a biosimilar...FDA officials reiterated complaints that many petitions generally do not raise valid scientific concerns and appear to have been filed to delay approval of competing medicines...Congress...requires the FDA to respond to most petitions within 150 days. And as far as the FDA is concerned, this creates an unnecessary problem...agency officials are concerned that most petitions are merely a competitive ruse, and they wrote Congress that they are forced to redirect efforts at the expense of completing the other work of the agency...The concerns expressed by FDA officials largely mirror a forthcoming analysis...The analysis found that brand-name drug makers filed 92 percent of such citizen petitions between 2011 and 2015...Citizen petitions represent a hidden tool in (the brand-name drug maker's) toolkit of entry-delaying activity, all to the detriment of consumers forced to pay high drug prices...the analysis concludes.

A US senator is urging the US Federal Trade Commission to accelerate its antitrust investigation into a drug maker that sells Suboxone (buprenorphine/naloxone), a medicine used to treat addiction to opioids and narcotics...The appeal by Senator Edward Markey comes less than a week after 35 states filed an antitrust lawsuit against Indivior (Reckitt Benckiser), accusing the company of engaging in a scheme to block generic competition. In doing so, the company "drove up prices and deprived states and consumers of lower costs," Markey wrote in his letter on Tuesday to FTC…Reckitt raised the price of its pill while lowering the price of the newer film version. And the patent on the new version does not expire until 2023. This is a pharmaceutical industry tactic known as forced switching, since patients and physicians have little choice but to consider a newer, higher-priced version...Markey also pointed out that the manufacturer has "significantly impeded the FTC investigation by attempting to deny the FTC access to thousands of pages of documents that are integral to the investigation." However, he also noted that the federal court overseeing the matter later ordered the company to produce the documents...So will the FTC step on the gas?

The government has pushed the pause button on plans to implement a 6 percent cut to community pharmacy funding from October...In a speech to the Royal Pharmaceutical Society's Annual Conference, Pharmacy Minister David Mowat explained that the delay is to "make sure that we are making the correct decision and that what we do is going to be right for you, right for the NHS and right for the public."...Earlier this year, the Local Government Association - which represents more than 370 councils – warned that community pharmacies are at risk of going out of business because of planned budget cuts, which could potentially pull the plug on a vital lifeline for many elderly and vulnerable patients...Sandra Gidley, Chair of the RPS English Pharmacy Board, also welcomed the Minister's speech, noting: "I am heartened that a second look is being taken at the proposed community pharmacy cuts and that the Minister has recognised the strength of public feeling on the issue"...Around 1.6 million people visit pharmacies every day for treatment and advice, and there is widespread belief that the service could play a much greater role in helping to address some of the NHS' current challenges...

U.S. regulators said...that AstraZeneca will pay $5.52 million to resolve a foreign bribery probe into improper payments by its sales and marketing staff to state-employed healthcare officials in China and Russia...The U.S. Securities and Exchange Commission detailed the settlement with the London-based drug company in an order instituting an administrative proceeding arising out of violations of provisions in the Foreign Corrupt Practices Act...AstraZeneca, which cooperated with the probe, neither admitted nor denied wrongdoing…SEC said that AstraZeneca through at least 2010 failed to devise and maintain a system of internal accounting controls relating to its subsidiaries' interactions with Chinese and Russian government officials...Sales and marketing staff in those countries...provided gifts, conference support, travel, cash and other benefits to the state-employed healthcare providers to buy or prescribe the company's products...

The Department of Health and Human Services issued its final rule on submitting registration and summary results to clinicaltrials.gov. In a nutshell, the new guidelines define which clinical trials must be registered and when, how results should be reported (and when) and potential penalties for non-compliance...The rule seeks to clarify the Food and Drug Administration Amendments Act of 2007, which left significant room for interpretation...Enhancing access to clinical trial information means more useful data for patients and scientists. People who have exhausted their treatment options may have more access to experimental therapies. Scientists can build on trial success and avoid failures...Overall, the rule is getting good reviews for its effort to increase transparency and respond to systemic flaws...It reflects that we have this learning healthcare system, which is what we want...We want laws that learn, that take feedback and are able to understand what is working and what is not working and be amended in order to work better...

Celator Pharmaceuticals proudly displayed a large poster touting its experimental Vyxeos (CPX-351) medication as an effective salve for treating acute myeloid leukemia. The poster was, in fact, one of countless placards featured prominently on the exhibit floor at the American Society of Clinical Oncology meeting…the Celator poster managed to stick out...Vyxeos has not yet been approved to treat AML...Celator reported positive clinical trial results for the drug...But that’s not the same thing as having clearance to market a product. Unfortunately, that’s the impression regulators had after looking at the poster…As far as the Food and Drug Administration is concerned, Celator was, effectively, promoting a drug that was misbranded. And so the FDA sent the company (now Jazz Pharmaceuticals)...a letter to complain about its promotional behavior...From a public health perspective, these claims and presentations are concerning because they include representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA...

In March and April, 56 people in the Sacramento area were hospitalized after taking Norco brand hydrocodone pills. Fifteen died...But, as we discovered, these pills were not pharmaceutical hydrocodone at all. They were counterfeits containing fentanyl that were purchased on the street. Fentanyl is an opioid far more powerful than hydrocodone...the distribution of illicitly manufactured fentanyl has risen to unprecedented levels...These...substances are generally formulated to look like others drugs – heroin or oxycodone tablets…These entirely synthetic, illicitly made "designer drugs" are designed to work on the same receptors in the body as drugs like marijuana, methamphetamine or heroin. The adulteration of counterfeit pharmaceuticals and street drugs with synthetic opioids is arguably the most worrying new trend...