Category:

Drugmakers currently use the European Medicines Agency as a one-stop-shop to get drugs licensed across Europe, but Britain is likely to drop out of that system if it severs EU ties and leaves the single market in a scenario dubbed "hard Brexit"...An approach to leaving the EU which saw ideological considerations placed above securing the right relationship for the economy and for UK patients would see the UK life sciences sector relegated to a second-tier player...Being cut off from the European system could put British patients at the back of the queue for new medicines because applications for new licenses from Europe...warning comes amid growing concern that Britain's successful pharmaceutical and biotechnology sector could be hit hard...In addition to worries about trade barriers and drug regulation once Britain leaves the EU, industry executives are concerned about their ability to recruit foreign staff and loss of EU science funding...

Drums? What drums?...Yet another foreign company tried to fool the US Food and Drug Administration, but without success...The latest example occurred when Beijing Taiyang Pharmaceutical, an ingredients maker, refused to let FDA inspectors enter a warehouse after noticing drums used for storing chemicals through a window. The next day, the inspectors were allowed in, but saw a "significant" number of drums were gone. But employees would not say where the drums were taken or what had been stored inside them...This sort of behavior...is an ongoing problem for the agency...a big fib. At the time of the November 2015 inspection, Beijing Taiyang told the FDA inspectors they had stopped making a certain ingredient two months earlier. But the inspectors reviewed electronic audit trails on instruments and found the company conducted numerous analyses of the ingredient prior to the inspection...But the FDA remained unconvinced. The agency pointed out that its inspectors noticed that the batch numbers on the recently made ingredients corresponded with a batch numbering system for actual products, according to the warning letter.

As Americans grapple with the rising cost of medicines, a contentious ballot measure in California is being billed as a fix to an intractable national problem...Known as Proposition 61, the proposal would require state agencies to pay no more for prescription drugs than the Department of Veteran Affairs, which receives a federally mandated 24 percent discount from manufacturers. In theory, that would lower drug costs for up to 7 million residents of California who get insurance coverage for their medicines through various state agencies, including low-income residents on the state version of Medicaid...the measure has merits and flaws. Ultimately, the California Drug Price Relief Act is a well-intentioned proposal that clearly sends a strong message to the pharmaceutical industry — but the details should also give us pause...Prop 61 is imperfect and, ideally, pricing should be addressed on a national level. But the measure sends a needed message that the status quo is unsustainable. Until the pharmaceutical industry recognizes this sad reality, there will be more — and better — propositions before voters...

McKesson...reported that revenues for the second quarter...totaled $50 billion, up 2% compared to the year-ago period. On the basis of U.S. generally accepted accounting principles, second-quarter earnings per diluted share from continuing operations was $1.35, compared to $2.65 a year ago...The company is updating its outlook from the previous range of $13.43 to $13.93 per diluted share to a new range of $12.35 to $12.85 per diluted share for the fiscal year ending March 31, 2017...Our updated outlook for fiscal 2017 reflects McKesson’s expectation of a lower profit contribution resulting from recent customer pricing activities and lower operating profit as a result of further moderating branded pharmaceutical pricing trends compared to previous expectations…

Bartell Drugs is making sure that visually impaired customers are able to understand their prescription information. The...drug chain...has started offering three solutions for people with visual impairment who can’t read the print on their prescription drug container labels. Based on their need, these patients can now receive ScripTalk audible labels, ScripView large-print labels or Braille labels...It’s extremely important that patients know and understand the instructions for their medications. This can be challenging for our patients with visual impairments…

ScripTalk features a label embedded with a microchip containing all the printed prescription label data. The patient places the container onto a handheld reader and presses a button to listen to the prescription information, including patient name, drug name and medication instructions, as well as pharmacy contact information, contraindications and more.

ScripView is a large-print, booklet-style label attached to the prescription container that enables patients with low vision to read prescription information more easily. The label contains all the same information as the pharmacy’s regular label but in large print. Pharmacist can edit the font size based on the need of the patient.

Braille label tape can be added to a prescription with basic medication information...

IBM Watson Health tries to do what no pharma company has done: solve the drug-safety puzzle...Big Blue has found yet another business application for its precocious cognitive computing system. IBM Watson Health is collaborating with the biopharmaceutical company Celgene to develop a new platform for evaluating the safety of drugs—both before and after they hit the market—the two companies are announcing this morning. The new offering, "Watson for Patient Safety," will gobble up anonymized medical records, claims data, and millions of electronic submissions to the FDA about potential drug side effects (known as individual case safety reports) to see if it can learn about the hidden dangers of medicines before they become too costly...The problem is one of the toughest in drug development...

It looked like a surefire way to make billions...A year ago, two new drugs (Repatha and Praluent) that used a novel mechanism to drive down cholesterol levels came on the market, and were promptly crowned as blockbusters in waiting. Analysts estimated sales at more than $3 billion a year...But the two drugs have been commercial flops, in part due to a complicated reimbursement system that has frustrated doctors, confused patients, and left the biotech industry worried about the implications for other high-priced drugs in the pipeline...The failures could send a chill through the still-booming biotech business, which relies on the idea that the risky, expensive process of developing new drugs can one day pay off big... some doctors are hesitant to prescribe them until there’s more information...Another hurdle: Getting insurers to pay for the drugs, which both have list prices of about $14,000 a year...the squabble over cost, access, and availability is unlikely to end any time soon. And the fear among biotech insiders is that the commercial disappointment of PCSK9 therapies will imperil new cardiovascular therapies...

Though the vast majority of specialty physicians know what biosimilars are, their knowledge about these emerging medications falls short, according to a survey by the Biosimilars Forum...Of 1,201 U.S. physicians polled, 76.8% had heard the term biosimilars within the previous month...Yet respondents exhibited five key gaps in knowledge: defining biologics, biosimilars and biosimilarity; understanding the biosimilar approval process and the Food and Drug Administration’s use of totality of evidence to assess biosimilars; appreciation that biosimilars’ safety profile is expected to be the same as that of the originator biologic; understanding how the FDA makes decisions for extrapolation of indications; and defining interchangeability and the related rules regarding pharmacy-level substitution...With four biosimilars approved by the FDA and more than 60 in development, the survey highlights the need for greater biosimilars education for physicians and health care professionals...

Seventy-five years after the original insulin patent expired — a point at which drug prices usually decline — three companies have made incremental improvements to insulin that generate new patents and profits, creating a family of modern insulins worth billions of dollars...The history of insulin captures one of the mystifying complexities of the pharmaceutical market — how long-standing drugs become more expensive with time and competition fails to hold down prices. Companies point to improvements in their drugs, but medical experts say some of those changes are simply a strategy to keep prices high with new patent protections. They question how much the molecular tweaks to insulin really improve patients’ health...Patients who were once called "living skeletons" on starvation diets can now live normal lives, thanks to drugs that are being constantly tweaked. But they feel like they’re being held captive to an ever-rising price tag on their lives…

Memo to biopharma executives: when talking to shareholders, take care to tell the whole truth and nothing but the truth...That’s the message delivered this week to Arena Pharmaceuticals after a federal appeals court ruled...that shareholders can proceed with a lawsuit alleging the company deliberately withheld crucial information about a potential problem with a widely anticipated diet drug...At issue was a series of statements Arena executives made in 2009 about the progress they were making in winning Food and Drug Administration approval for the Belviq (lorcaserin) diet pill... company executives made or issued statements expressing confidence that the pill would be approved, because safety and effectiveness had been demonstrated through clinical trials and animal studies. Here’s the rub: while the reference to animal studies mentioned the need to ensure there was no risk that cancer seen in rats could develop in humans, Arena did not disclose a dispute about study results with the FDA...Whether the shareholders prevail remains to be seen...The ruling only means that the shareholders get to fight another day. But the court is sending a signal that if drug makers are going to describe trial results and discussions with the FDA, they should not dress up information, a common predilection in a world where exciting investors is a high priority.