- The next big thing in pharmacy supply chain: Blockchain (healthcareitnews.com)
With $200 billion lost to counterfeit drugs annually and patient safety issues, a chain-of-custody log that blockchain could enable holds promise...Blockchain has the potential to transform healthcare in general and the pharmacy supply chain in particular...The distributed ledger technology could offer legislative, logistical and patient safety benefits for pharmaceutical supply chain management. From a regulatory perspective in the United States, blockchain technological and structural capabilities, in fact, extraordinarily map to the key requirements of the Drug Supply Chain Security Act...The DSCSA outlines a 10-year timeframe that will require elements including medication track-and-trace, product verification and notification of stakeholders about illegitimate drugs. A shared ledger of information to enable each of these steps is a foundational aspect of blockchain technology...“Logistically, blockchain aligns well with federal efforts like the National Strategy for Global Chain Security,”...“One of the most promising benefits of blockchain from a patient safety perspective is to help stem the tide of the so-called SSFFC medicines – substandard, spurious, falsely labeled, falsified and counterfeit – that continue to plague the pharmaceutical supply chain.”
- FDA lays groundwork for regulating 3D-printed drugs (biopharmadive.com)
The Food and Drug Administration has issued guidance on 3D printing and the role it plays in manufacturing healthcare products...While the guidance focuses largely on medical devices, Commissioner Scott Gottlieb acknowledged in a Monday statement that the innovative technology also holds the potential to disrupt drug development. Already, the agency has approved one medicine crafted with 3D printers, Aprecia Pharmaceutical Co.’s Spritam..."This is likely just the tip of the iceberg given the exponential growth of innovative research in this field," Gottlieb said, referring to the 3D-printed products on the market. "We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs."...The promise of 3D printing, however, could spark new innovation and invention in how drugs, and the devices that deliver them, are formulated and made. In response, the FDA is moving to stay ahead of the technology's advances....
- Cities, counties and schools sidestep FDA foreign drug crackdown, saving millions (washingtonpost.com)
Schenectady County, N.Y., is on track to pay 20 percent less on prescription drugs for its employees this year than in 2003...Flagler County, Fla., expects to save nearly $200,000 in 2017 on brand-name medicines for its 800 workers, thanks to drug costs that have fallen 10 percent since 2016...dozens of cities, counties and school districts have found a solution they say protects their budgets and saves workers money: They are helping employees buy medicines from Canada and overseas, where prices are up to 80 percent cheaper...“We love it. . . . It’s a win-win,” said Anita Stoker, benefits and wellness manager for Flagler County, which has a program enabling its employees to get drugs from pharmacies in Canada, Britain, Australia and New Zealand...The number of municipalities offering this benefit is growing, even though the Food and Drug Administration considers such drug importation to be illegal and this fall began stepping up enforcement against storefronts advertising the same service. In October it raided nine central Florida locations that helped a mostly senior population order drugs from pharmacies in other countries. Investigators warned the stores’ owners that they were operating illegally and could face fines or jail time...Drugs ordered from overseas often come with the same packaging as in the United States. CanaRx, based in Windsor, Ontario, and ElectRx, based in Detroit, say they vet pharmacies to ensure customers get the real product. Counties, cities and schools, plus an increasing number of private companies, contract with one of these businesses for online service.
- Walgreens To Invest $416 Million In Chinese Pharmacy Chain (forbes.com)
Walgreens Boots Alliance said Wednesday it would expand its global retail pharmacy operations by taking a 40% stake in Sinopharm Holding Guoda Drugstores Co. Ltd., a subsidiary of China National Accord Medicines Corporation...Sinopharm GuoDa “operates and franchises retail pharmacies across China,” a market that Walgreens CEO Stefano Pessina has said he wants to tap as the companies looks to faster growing and emerging markets to extend its reach...“It is China’s leading pharmacy chain,”,,,Alliance Boots has had a joint venture in China known as Guangzhou Pharmaceuticals, which is a drug wholesaler in China. The joint venture operates pharmacies under a local brand...
- Kmart to pay $32.3M to settle health care-related whistleblower case (nbcnews.com)
Kmart Corp. has agreed to pay $32.3 million to settle a whistleblower lawsuit alleging its pharmacies overcharged federal health care programs and some private insurers for generic prescription drugs..."Pharmacies that are not fully transparent about drug pricing can cause federal health programs to overpay for prescription drugs," Chad Readler, the acting assistant attorney general of the department's Civil Division, said..."This settlement should put pharmacies on notice that there will be consequences if they attempt to improperly increase payments from taxpayer-funded health programs by masking the true prices that they charge the general public for the same drugs."...The complaint was filed on behalf of former Kmart pharmacist James Garbe. According to the suit, in one case, Kmart had sold a 30-day supply of a generic version of a prescription drug for $5 to customers of its discount program, but then filed for reimbursement from the government for $152 for that same drug for its Medicare customers...Garbe will receive a whistleblower award of $9.3 million, which amounts to 29 percent of the federal government's recovery...
- Bumper crop of new drugs fails to lift big pharma R&D returns (reuters.com)
It is shaping up to be a bumper year for drug approvals, with U.S. officials clearing twice as many novel medicines as in 2016, yet returns on research investment at leading pharmaceutical companies are down...In fact, projected returns at 12 of the world’s top drugmakers have fallen to an eight-year low of only 3.2 percent...The disconnect reflects the rising cost of developing new drugs, meager peak sales expectations for individual products and the fact that younger biotechnology companies are accounting for a growing proportion of new products...So far this year, the Food and Drug Administration...has approved 41 novel drugs compared with 22 for the whole of 2016...It’s been a great year for approvals in 2017...But for the giants of the pharma world...things are not so rosy. This decade has seen shrinking profitability in their research labs, with the average internal rate of return down sharply from 10.1 percent in 2010 to 3.2 percent this year...A separate group of four large biotech companies are projected to enjoy an IRR nearly four times higher at 11.9 percent. The calculations are based on long-term sales forecasts...The biotech companies are seeing more success...biotechs typically had a leaner cost structure...
- Charity Delays Giving New Aid After U.S. Faults Pharma Ties (bloomberg.com)
A medical charity that lost a crucial stamp of approval from the U.S. government because it had worked too closely with its drug-company donors said it will decide in January whether it can continue to help patients pay for their prescriptions...the Caring Voice Coalition, one of the biggest patient-assistance charities in the U.S., said it is delaying offering patients financial help for 2018 until it decides what to do...“We are very concerned that we may not be able to remain as a long-term viable resource for individuals with chronic illness,”...the Office of Inspector General of the Department of Health and Human Services rescinded its favorable advisory opinion of the Caring Voice Coalition, in part because the charity had provided drugmakers with data that could help them see if their contributions were helping their own customers. That could potentially give drug companies greater power to raise prices, the HHS said. It was the first time the HHS has rescinded a favorable advisory opinion for a patient-assistance charity.
- Teva CEO tells PM no bending on mass redundancy plan (ynetnews.com)Teva workers: 'We'll stop distributing drugs for serious diseases' (ynetnews.com)
Despite personal attempts by Netanyahu and government ministers to persuade pharmaceuticals giant's chief to reduce number of planned layoffs, Kåre Schultz doubles down, insisting any compromise will only result in 'further redundancies and the closure of more factories,' notes program represents a ‘small part’ of cost slashing spree around the world...Prime Minister Benjamin Netanyahu failed to convince...Teva CEO Kåre Schultz to reduce the number of Israeli layoffs he intends to execute in the pharmaceuticals giant in a plan that has sparked outrage and triggered multiple protests.
- Artificial Intelligence: will it change the way drugs are discovered? (pharmaceutical-journal.com)
The pharmaceutical industry is beginning to invest in artificial intelligence (AI), with many large pharmaceutical companies partnering with AI start-ups in 2017 in order to develop better diagnostics or biomarkers, to identify drug targets and to design new drugs. But when will the first AI-designed drugs reach the market and will AI permanently change the pharmaceutical industry and the way drugs are discovered?...Harnessing the power of modern supercomputers and machine learning will enable us to develop medicines more quickly, and at a reduced cost...The technology has just taken off recently and primarily that’s due to the advances in deep learning that have demonstrated superhuman accuracy in image recognition and autonomous driving...We are starting to see AI can outperform humans when analysing very complicated datasets for high content, phenotypic drug discovery...The [AI] technology is allowing us to explore a much bigger design space and discover these rare molecules that have properties beyond what we would get if we just ran a traditional high throughput screen...We can benefit from computer modelling but we still need to conduct real experiments and there will still be an element of serendipity...
- Rx precision medicine tool latest to be integrated into clinical workflow (healthcareitnews.com)
Translational Software recently became the latest in a growing number of health IT vendors creating systems to advance precision medicine with its debut of its PGx pediatric platform. Another precision medicine player stepped into the market...with a product designed to be integrated smack dab in the middle of a physician’s clinical workflow. 2bPrecise, a cloud-based precision medicine platform vendor and an Allscripts company, launched a pharmacogenomics (PGx) system to bring crucial data to the clinical workflow...2bPrecise Pgx...makes pharmacogenetic information accessible so physicians can make better informed treatment decisions based on a patient’s unique genetic makeup...The 2bPrecise PGx system plugs into an EHR’s native workflow and can integrate content from Translational Software (a genomic data-based clinical decision support system) and other knowledge sources to enable precision medicine-based decision making at the point of care. 2bPrecise’s PGx system is part of its larger precision medicine platform, built to capture and store genomic data from a range of sources, enabling the harmonization of clinical knowledge and genomic research to extract patient-specific insights.