- Drug development crisis linked to bad technology choices, experts argue (worldpharmanews.com)When Quality Beats Quantity: Decision Theory, Drug Discovery, and the Reproducibility Crisis (journals.plos.org)
The search for new medicines is becoming unsustainably expensive despite huge technological advances because researchers are using the wrong methods, experts say. They say drug discovery should focus on 'validity' - how well the results of experiments predict results in sick people. Instead, it has focused on methods that are easy to industrialize or methods that are academically fashionable...Jack Scannell...and...Jim Bosley approach drug discovery using mathematical tools that are used by economists to study decision making. They show that the chance of discovering an effective drug is surprisingly sensitive to the validity of the experimental methods. Small changes in validity can have a bigger effect than running 10 or even 100 times more experiments...There is a nasty puzzle at the heart of modern biomedical research. On one hand, the technologies that people think are important have become hundreds, thousands, or even billions of times cheaper. On the other hand, it costs nearly 100 times more to bring a drug to market today than it did in 1950. New drugs can be very expensive, yet the industry is closing labs and firing scientists. Our work goes some way towards explaining the puzzle. Governments, companies, and charities should focus on identifying and funding predictive methods, even if they don't match current scientific fashion...
- Indian alliance tries to calm U.S. concerns over IP protections (fiercepharmaasia.com)FDA warns another Indian drug maker for a laundry list of problems (statnews.com)Keep India on list of bad patent players, pharma urges Obama administration (statnews.com)India drug monitoring program struggles to grow fast enough (reuters.com)
Coming just a few days after the U.S. Pharmaceutical Research and Manufacturers of America called laws in India governing intellectual property "weak," a report out from the subcontinent says the Indian Pharmaceutical Alliance is making moves to assuage concerns from the U.S. Trade Representative over its IP laws...The Indian group hopes to keep the USTR from downgrading the country's status to "priority foreign country" from its current "watch list" status so it can continue to enjoy certain trade preferences...The IPA...told the USTR that collaboration between Indian and U.S companies is on the rise, that India is removing "procedural hurdles" in the industry and that it is "sharing data" with U.S. reps to bridge "the gulf" between the two countries when it comes to IP protection for drugs...India plans to clear a backlog of patent applications that has been a concern to U.S. companies and said the country would hire 500 patent and design examiners to cut the time it took to process a patent application to one year...
- Lilly suffers stinging defeat in EU patent battle over Alimta (fiercepharma.com)
Eli Lilly suffered a crushing defeat in the U.K. over patents for its lung cancer blockbuster Alimta (pemetrexed) as the U.K. High Court ruled in favor of Actavis' plan to market copycat versions of the med...The High Court's decision also applies to Actavis' generics in France, Italy and Spain...The company has a separate compound patent for the drug that expires in 2017. But certain patents for Alimta expire in 2021, and the latest ruling could throw a wrench in Lilly's plans to hold on to sales...Lilly is not pleased with the High Court's decision. "We strongly disagree with the ruling by the U.K. High Court" and "we plan to seek permission to appeal this ruling,"…The company has fared better with Alimta in the U.S., though. In August, a federal court ruled in favor of Lilly and granted the company 5 more years of U.S. exclusivity for the med. The court found that generic meds proposed by Teva Pharmaceutical Industries would infringe on Lilly's method patent for Alimta in combination with vitamins, allowing Lilly to hold on to the patent until 2022...
- Theranos Files Plan to CMS for Fixing California Lab Problems (bloomberg.com)
Theranos Inc. filed a plan to U.S. regulators to fix serious deficiencies at the company’s blood-testing lab in Newark, California, as founder Elizabeth Holmes works to regain credibility for her struggling startup...The company submitted the proposed plan of correction...to the Centers for Medicare and Medicaid Services...Theranos also confirmed the filing, though it didn’t release details of the plan...CMS said in late January that Theranos’s violations of federal regulations posed "immediate jeopardy" to patients’ health and safety...Walgreens Boots Alliance Inc. and...Capital BlueCross have said they’re curtailing use of Theranos’s tests while the shortcomings identified by CMS are addressed. Theranos has hired a new lab director and said it’s working quickly to correct other problems, including personnel issues, along with the defects tied to blood testing...
- Dreaded U.S. FDA Form 483s in the spotlight in China (fiercepharmaasia.com)
While much of the news in recent months on warnings issued by the Food and Drug Administration centered on alerts issued to Indian pharmaceutical manfacturers, active pharmaceutical ingredient and drug manufacturers in China have also received their own set of alerts under the FDA's Form 483 regime, according to a report by the Regulatory Affairs Professionals Society... 41 pharmaceutical manufacturing sites in China and 5 in Hong Kong are currently included on the agency's import alert list and are banned from shipping drugs to the United States, compared to the 42 sites listed as banned in India...RAPS found that in 2015 more than 80 Form 483s were issued to Chinese manufacturers after 132 inspections...the FDA conducted 203 inspections at Indian facilities...Some of the findings of the FDA reports include data manipulation at several companies where computer files were altered or deleted, missing logbooks, contamination issues and other serious failures in good manufacturing practices...
- The Elective Rotation with Pharmacy Joe – Pharmacy Podcast (pharmacypodcast.com)
"Pharmacy Joe", is the host of The Elective Rotation – A Critical Care Pharmacy Podcast. He is a Critical Care Pharmacist, Preceptor, and Board Certified Pharmacotherapy Specialist who has been in practice for over 15 years. (podcast 20:20)
- UK fines Glaxo $54 million over pay-to-delay deal with generic rivals (statnews.com)
In the latest government effort to penalize unfair competition among drug makers, the United Kingdom fined GlaxoSmithKline $54.5 million for illegally colluding with generic rivals to delay marketing lower-cost versions of the Paxil antidepressant...the UK Competitions and Market Authority found that between 2001 and 2004, Glaxo made payments totaling about $72 million to several generic companies. The deals were reached as part of a settlement to end patent litigation that was filed by Glaxo against the generic drug makers...Such settlements are known as pay-to-delay, since a brand-name drug company pays cash or transfers something else of value to a generic rival, which agrees to delay launching a copycat medicine. In 2001, Paxil was a blockbuster with sales in the UK exceeding $130 million...In this instance, the agreement deferred competition and potentially deprived the UK’s National Health Service of a lower-cost generic Paxil. UK authorities noted that when a generic version of Paxil eventually became available at the end of 2003, average prices fell by more than 70 percent in two years...Cracking down on these practices is essential to protect consumers, to encourage legitimate business activity that such practices stifle, and to stimulate innovation and growth...
- Burwell says HHS is considering ‘march-in’ on skyrocketing drug prices (fiercepharma.com)
Last month, a group of lawmakers urged the National Institutes of Health and the U.S. Department of Health and Human Services to take "extraordinary" action to fight rising drug prices. HHS Secretary Sylvia Burwell responded this week that her agency got the lawmakers' message and is considering rolling out new guidelines to counter skyrocketing prices...The...letter from Doggett and his colleagues asked HHS to issue guidelines for "march-in rights" to address "price gouging" by pharma companies. March-in-rights give the agency the power to skirt patent protections for pricey meds developed with federal funding, effectively opening them up to generic competition...HHS has never used this tactic since the law was enacted in 1980, contending that it is an "extraordinary remedy" that should only be rolled out in extreme situations...Congressional reps contend that the recent price hikes, some of which have run to 5,000%, constitute immediate grounds for action by the agency. "Too many families and providers are facing an extraordinary challenge from unreasonably priced pharmaceuticals" and "too many drugs are not 'available to the public on reasonable terms," the lawmakers said in their letter.
- AstraZeneca and Daiichi Sankyo field backlash over Super Bowl OIC awareness ad (fiercepharma.com)
A Super Bowl commercial paid for by AstraZeneca and Daiichi Sankyo to stimulate awareness of opioid-induced constipation continues to draw controversy...days after the big game. Since Sunday, a parade of politicians, physicians and pundits have criticized the ad, linking the campaign to the opioid prescription drug addiction problem...and forcing AZ and Daiichi, which market...Movantik (naloxegol), to defend it...Vermont Governor Peter Shumlin..."In the midst of America's opiate and heroin addiction crisis the advertisement was not only poorly timed, it was a shameful attempt to exploit that crisis to boost your companies' profits."...U.S. Pain Association..."In the current health care landscape, chronic pain patients are continually forced to 'prove' their pain. They face backlash and ridicule instead of compassion and help. U.S. Pain Foundation collaborated on this ad with other organizations to spread awareness and information...The goal--for all involved on this project--was to make sure people living with OIC do not feel embarrassed or alone...Did the pharmas get their money's worth, reported at $5 million per 30 seconds this year?...so far the ad has been mentioned more than 38,000 times on social media...in the past few days, according to real-time TV tracker iSpot.tv. It also had a 50% positive Tweet rating and has been viewed more than 2 million times online...
- Express Scripts Giving ‘Extra Scrutiny’ to Valeant Prescriptions (bloomberg.com)
Express Scripts Holding Co. is carefully scrutinizing prescriptions for products made by Valeant Pharmaceuticals International Inc., making sure the pharmacy manager’s rules are being followed...We are looking at every single claim for their products...They are getting extra scrutiny...Valeant last year was accused of working with a network of pharmacies to boost sales of its drugs and get them reimbursed by health insurers and pharmacy benefit managers like Express Scripts, even when there were cheaper generics available...Express Scripts reviews prescription claims to ensure that the manufacturer and pharmacies are operating in a manner consistent with its contracts and in the best interests of its clients and patients...The reviews ensure that patients and payers aren’t spending more on the products than necessary...