- The FDA just approved the first app for treating substance abuse (cnbc.com)
Federal regulators...approved the first mobile app to help treat substance use disorders...The app, developed by a start-up called Pear Therapeutics, is designed to be prescribed by clinician and used alongside counseling...Pear's technology digitizes a form of talk therapy called cognitive behavioral therapy, or CBT, which focuses on "examining the relationships between thoughts, feelings and behaviors...Pear Therapeutics is part of a burgeoning category of health start-ups known as digital therapeutics. The idea is that software can improve a person's health, without the same cost and side effects of medical treatment...Pear's app has not been approved to treat opioid dependence, but...the company has developed a version of the software that is currently under submission. It's designed to be used alongside opioid replacement therapies.
- How to Protect a Drug Patent? Give it to a Native American Tribe (nytimes.com)Allergan and Saint Regis Mohawk Tribe Announce Agreements Regarding RESTASIS® Patents (srmt-nsn.gov)Mylan says Allergan misusing tribal sovereignty in patent dispute (reuters.com)Prevnar 13 among blockbusters industry watchers peg as tribal licensing candidates (fiercepharma.com)
The drugmaker Allergan announced...that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug from a patent dispute...Under the deal, which involves the dry-eye drug Restasis, Allergan will pay the tribe $13.75 million. In exchange, the tribe will claim sovereign immunity as grounds to dismiss a patent challenge through a unit of the United States Patent and Trademark Office. The tribe will lease the patents back to Allergan, and will receive $15 million in annual royalties as long as the patents remain valid...The surprising legal move rippled quickly through the pharmaceutical world...setting off speculation about whether other drug companies would soon follow suit in order to protect their patents from challenges through a patent-review process that the industry despises...If Allergan succeeds in holding onto its patents, “we will probably see multiple branded companies housing their patents with Indian tribes...
- Novartis charged much more in the U.S. for some drugs than in other countries (statnews.com)
An axiom in the overheated debate about prescription drug pricing is that Americans are often charged more than what is paid by people in other countries...the pharmaceutical industry argues that prices are set to fund research for discovering and developing new medicines. This makes sense, of course. But as Americans increasingly complain about rising prices, there has been accompanying angst about the extent to which higher prices in the U.S. are used to essentially subsidize what people pay elsewhere...the U.S. has a hodgepodge of government agencies and private insurers negotiating for medicines, and government health care systems are required to cover so many drugs. In most other countries, the central government is the primary gatekeeper for cost-conscious coverage decisions, which concentrates purchasing and often forces drug makers to lower prices...higher prices may not necessarily reflect higher costs...A higher price doesn’t mean the company had more expenses in the U.S. It will be the rationale they give, but it doesn’t mean they have the cost accounting to back it up."..."Their internal transfer prices are same as the wholesale acquisition cost, or list price, and are based on the amount of revenue they expect to get in each country. These prices tell me that this is what they’re using internally to charge (country) units, but the price isn’t driven by cost to make it in the factory. It’s what they know they can get in that market…This just reflects the U.S. does not have an effective market for evaluating and buying drugs, because when you have a drug that is required to be covered, you don’t have leverage to negotiate."...
- Law firm drops suit alleging CVS gouged generic consumers, plans to refile (fiercepharma.com)
The plaintiff in a proposed class action lawsuit against CVS dropped her claims...After making a series of allegations that pharmacy giant CVS was gouging generic drug consumers who paid with insurance, the plaintiff in a proposed class action lawsuit dropped her claims...Megan Schulz alleged she paid more through insurance to get a generic drug than if she’d just paid cash. The suit also alleged pharmacy "copays" were really payments to pharmacy benefit managers, set up by confidential deals. CVS refuted the allegations and said in a statement...that it’s pleased the suit has been dismissed..."The complaint contained numerous demonstrably false assertions that a reasonable pre-filing investigation by the law firm would have discovered,"..."As such, we are pleased that the suit has been voluntarily dismissed.",,,"We plan to refile the lawsuit against CVS related to its generic drug pricing scheme promptly,"..."Our case against Walgreens was not dismissed and will remain on file until we achieve a just outcome for consumers."
- Martin Shkreli’s new jailhouse home is ‘not where you want to be’: Defense lawyer (cnbc.com)
Shkreli is expected to be locked up...for four months...Martin Shkreli's new home in a Brooklyn, New York, federal jail is definitely not the kind of place "where you want to be,"…Metropolitan Detention Center Brooklyn...Shkreli...was thrown into the MDC...after a Brooklyn federal court judge revoked his $5 million release bond...Judge Kiyo Matsumoto ruled that Shkreli represented a danger to the community because of a bizarre $5,000 bounty he offered to Facebook followers who grabbed samples of Hillary Clinton's hair for him...Shkreli, who previously ran two pharmaceutical companies and several hedge funds...A jury convicted him in August of three securities fraud charges...
- Gottlieb vows to shake up the FDA, backing a trend toward faster drug development (endpts.com)
FDA commissioner Scott Gottlieb has sounded a crystal clear warning over the high — and growing — cost of drug development. And in a speech to regulatory execs...Gottlieb committed the FDA to backing up more efficient drug development programs with new measures to clear the regulatory path for developers barreling ahead to relatively swift pivotal data in search of an accelerated OK...Gottlieb started by outlining a bleak picture in drug R&D, noting that the economic model for drug development is broken. It costs too much to develop a drug so it can be approved for marketing. And costs are swelling fast at the discovery end of the business, which will help swamp a system that already doesn’t work particularly well...Gottlieb held up some of the rapid-fire clinical trials we’ve been seeing in the cancer field as a model for what can work, paving the way to the accelerated approval pathway at the FDA. And he believes...that moving drug development into the fast lane can reduce R&D costs and thereby allow biopharma companies to pass on savings to patients through lower costs.
- Why the Biosimilar Drug Revolution Hasn’t Arrived (bloomberg.com)
In a word: patents...The Biologics Price Competition and Innovation Act (2010) was...part of the Affordable Care Act. Its essential goal was to infuse competition and lower the prices of drugs that were made from living cells -- so-called biologics...Until the 2010 law, biologics had no fear of competition -- there was no legal way to introduce generic versions into the market -- so they were able to maintain their monopoly price even after their patents expired. The BPCIA was intended to establish mechanisms within the Food and Drug Administration, the Patent and Trademark Office, and the courts that would allow the introduction of "biosimilars." These drugs weren't exact replicas of biologics, but were similar enough, and safe enough, to be used instead of the brand-name drugs...Here we are seven years later. Guess how many biosimilars have made it to market?..Two...companies are forced to fight through thickets of patents to get a biosimilar to market, a law that was supposed to save the U.S. billions will continue to do just the opposite: make it easy for biologic makers to maintain unwarranted monopolies...
- Allergan recruits Deion Sanders to get men to use Botox (mmm-online.com)
Allergan has enlisted football legend Deion Sanders to encourage men to use Botox. The drugmaker announced...that Sanders would be the brand ambassador for the wrinkle-erasing injection, specifically targeting men with moderate-to-severe frown lines and crow's feet...Allergan developed two videos with Sanders, one in which he discusses how turning 50 prompted him to seek a cosmetic answer to the crow's feet forming around his eyes. In the other, two men at a bar see Sanders sitting behind them and attempt to take a selfie with Sanders in the background. After looking at the picture they've taken, one man notices the crow's feet forming around his eyes. Deion then approaches them and tells them he has used Botox...Allergan has not shied away from using high-profile celebrities to promote its products in the in the past. In the last two years alone, the company developed partnerships with actors Lea Michele and Kate Bosworth, and reality-TV personality Khloé Kardashian. Michele worked with Allergan on its women's health campaign Actually She Can, while Kardashian kicked off the Live Chin Up campaign for Kybella, a chin-fat injection. Bosworth helped promote acne treatment Aczone.
- 7 Medical Conditions That Will Be Lining Big Pharma’s Pockets by 2020 (fool.com)
Big pharma stands to make hundreds of billions of dollars from a handful of medical conditions.
- No. 7: Viral hepatitis - $45 billion and $55 billion will be spent globally on drugs that treat viral hepatitis by 2022...around 257 million have chronic hepatitis B virus infection and 71 million people have chronic hepatitis C virus infection.
- No. 6: Respiratory diseases - treating respiratory diseases are expected to generate between $53 billion and $56 billion in sales by 2020. The most common respiratory diseases include asthma, allergies, and chronic obstructive pulmonary disease.
- No. 5: Autoimmune diseases - Autoimmune disease medications could make big pharma companies between $55 billion and $65 billion by 2020
- No. 4: Cardiovascular diseases - cardiovascular disease drugs will rack up sales between $73 billion and $76 billion by 2020...Cardiovascular drugs include treatments for hypertension, heart disease, and cholesterol.
- No. 3: Pain - Pain medications are projected to be the third-biggest moneymaker by 2020, with sales of $82 billion to $85 billion...drugs includes treatments for musculoskeletal pain, arthritis, anesthesia, analgesics (both narcotic and non-narcotic), and migraine.
- No. 2: Diabetes - diabetes drugs are expected to be near the top in spending, with projected global sales between $107 billion and $113 billion by 2020
- No. 1: Cancer - The top medical condition that will likely line big pharma's pockets by 2020 is cancer…sales of cancer drugs will be between $100 billion and $120 billion
- PhRMA and BIO Initiate Litigation to Challenge Unconstitutional Provisions of Nevada’s SB 539 (phrma.org)
The Pharmaceutical Research and Manufacturers of America the Biotechnology Innovation Organization today initiated litigation in the United States District Court for the District of Nevada challenging provisions of SB 539, a Nevada law that would violate patent rights and negate trade secret protection for designated diabetes medicines in a way that would harm patients and chill future biomedical innovation...PhRMA and BIO seek a declaration from the Court that the challenged provisions of SB 539 are preempted by federal law and violate several provisions of the United States Constitution...also seek an injunction prohibiting the implementation or enforcement of these challenged provisions...The Complaint alleges that provisions of SB 539 violate the Constitution in at least four ways:
- by interfering with federal patent law;
- by interfering with federal trade secret law;
- by violating the Takings Clause of the Fifth Amendment of the United States Constitution which prohibits government from taking property without just compensation; and
- by violating the dormant Commerce Clause of the United States Constitution, which prohibits Nevada from impeding commerce in other states.