- Cashing in on DNA: race on to unlock value in genetic data (reuters.com)
How much is your DNA worth? As millions of people pay for home tests to check on ancestry or health risks, genetic data is becoming an increasingly valuable resource for drugmakers, triggering a race to create a DNA marketplace...GlaxoSmithKline’s decision to invest $300 million in 23andMe and forge an exclusive drug development deal...crystallizes the value locked up in genetic code...Firms like EncrypGen, Nebula Genomics, LunaDNA and Zenome are using blockchain...to secure sensitive DNA records and create a transaction ledger. The new players all have slightly different models, with most simply provide data platforms, where people are rewarded for providing data...For drugmakers...access to this data offers a way to accelerate drug development, since finding a drug target linked to a human genetic variant doubles the chance of producing a new medicine.
- Opioid Lawsuit Links Counties in Fight Against Big Pharma (bloomberg.com)
Mike Papantonio, senior partner at Levin Papantonio, discusses a class-action lawsuit against pharmaceutical companies over the U.S. opioid crisis. He speaks with Bloomberg's Kevin Cirilli on "Bloomberg Markets: Balance of Power." (Source: Bloomberg)
- Cooking Pots and Household Power Tools: FDA Warns California Drugmaker (raps.org)
Food and Drug Administration’s...warning letter for BioDiagnostic International featured an odd note about halfway down the CGMP violations: “You use kitchen cooking pots and household power tools to manufacture your drug product used for biopsy procedures.”...The surprising detail – part of one of four CGMP violations cited – comes as an FDA investigator further found an employee food prep station within its Brea, CA-based drug manufacturing area “with no separation between open manufacturing equipment, cooking utensils, and personal-use items.”...Parts of the facility to manufacture product...were also “open to the outdoors,” which FDA said increases “the likelihood of your drug products becoming contaminated.”...
- Nebraska lawmaker urges Pfizer to sue over use of its drugs in lethal injection procedure (fiercepharma.com)
Pfizer protested the use of its drugs in lethal injection procedures last year, asking states to return the drugs for a refund. But not all of them have, and with an execution planned for Aug. 14 in Nebraska, a state senator is urging Pfizer to sue to halt use of its drugs..."Time is of the essence," Nebraska state Sen. Ernie Chambers said in a letter...to Robert Jones, J.D., Pfizer vice president of U.S. government relations...A Pfizer representative said the company's "records do not show any sales of any restricted products to the Nebraska Department of Corrections. We are again asking the Nebraska DOC to return any Pfizer restricted product.”...Pfizer's position is that its drugs are to "enhance and save the lives of the patients we serve." The company "strongly objects" to the use of its drugs as lethal injections...As Chambers noted in his correspondence, Alvogen recently blocked the use of its drugs in a Nevada execution through the courts.
- China drug scandals highlight risks to global supply chain (cnbc.com)
The drug safety scandals...have underlined the risks to international consumers posed by weak oversight in China, the world's largest supplier of active pharmaceutical ingredients...The European Medicines Agency and the US Food and Drug Administration issued alerts over a cancer-causing ingredient used in a blood pressure medication, supplied by Chinese company Zhejiang Huahai, resulting in a recall of affected drugs...Then Beijing announced that hundreds of thousands of substandard vaccine doses had been sold in China, prompting a public outcry. Senior executives were arrested at the pharma company, Changsheng Biotech, which was also accused by authorities of forging data during the production of rabies vaccines...China is home to thousands of API producers, with exports worth $29bn last year...its producers supply ingredients for generic drugmakers such as Teva Pharmaceutical and multinationals including Johnson & Johnson and Novartis. About 80 percent of APIs used in the US come from China and India…Warnings to Chinese companies published by the FDA and EMA in recent years show that dozens have violated standards, mainly relating to record-keeping during the manufacturing process. In several cases the exporters shipped large volumes of product before the infractions were discovered...
- FDA seals loophole that allowed some drugmakers to avoid pediatric clinical trials (medcitynews.com)
PREA loophole had allowed companies to receive orphan drug designations for diseases common in adults...The Food and Drug Administration moved...to close a loophole that had inadvertently excused some drugmakers from having to conduct clinical trials in children for drugs to treat diseases that commonly affect adults...the FDA announced that it had finalized a draft guidance...intended to close a loophole in the Pediatric Research Equity Act that allowed drug companies making medicines for non-orphan diseases in adults – meaning those affecting more than 200,000 patients – to get pediatric subpopulation designation. Consequently, companies were exempt from conducting the clinical trials in children that PREA would normally have required...“Addressing the inadequate testing of drugs in pediatric populations has been a priority for the FDA, the medical community and Congress and has led to important laws to ensure this important, vulnerable population is not overlooked,” FDA Commissioner Scott Gottlieb said...
- More drugmakers build Brexit stockpiles as EU agency faces exodus (reuters.com)
Sanofi and Novartis said...they planned to increase stockpiles of medicines in Britain in preparation for potential disruption if the UK crashes out of the European Union without a deal...the European Medicines Agency...warned of bigger than expected staff losses and cuts in some activities as a result of having to move from London to Amsterdam due to Brexit...Supplies of thousands of medicines are at risk of disruption if Britain leaves the EU without a deal, forcing manufacturers to prepare duplicate product testing and licensing arrangements to ensure their drugs stay on the market...The European Medicines Agency...expressed “serious concerns” over the availability of some 108 medicines that are manufactured exclusively in the UK.
- Antianxiety drugs — often more deadly than opioids — are fueling the next drug crisis in US (cnbc.com)
Today more than 40 million adults in the United States suffer from anxiety, and it is the most common mental illness in the United States...Overdose deaths involving benzodiazepines — such as Xanax, Librium, Valium and Ativan, drugs commonly used to treat anxiety, phobias, panic attacks, seizures and insomnia — have quadrupled between 2002 and 2015...The trend is being fueled by a 67 percent rise in prescriptions...The market for...(benzodiazepines)...is expected to reach $3.8 billion in the U.S. by 2020...many mental health experts are sounding the alarm, claiming that benzodiazepine addiction is an epidemic as frightening and serious as the opioid crisis...
- Ugandan hospitals hit by shortages of drugs, other supplies (reuters.com)
Public hospitals in Uganda have been hit by shortages of essential medicines and supplies needed for emergency care…The shortages are affecting the East African country’s main Mulago Hospital, which handles serious cases referred to it from other facilities, Uganda Medical Association said...UMA President Ekwaro Obuku...said government hospitals were experiencing serious shortages of basic medicines for emergency care such as vaccines and other drugs, syringes, gloves, catheters, gauze and others...Vivian Nakaliika Serwanjja, health ministry spokeswoman, said shortages had been caused by financial disruption at the government agency responsible for procurement of medical supplies...the scarcities are not widespread,” she said, adding only a few hospitals were affected and supplies had started being delivered...
- Mental health providers concerned about proposed limits on therapy sessions for Medicaid patients without prior approval (thenevadaindependent.com)Nevada Medicaid shift could impact continuity of mental health care (reviewjournal.com)
Nevada Medicaid will decide next month whether to impose additional requirements for patients to undergo therapy on an ongoing basis, a move the state says will increase accountability and ensure people are getting the care they actually need...mental health providers across the state are decrying as yet another barrier to access to mental health care for a vulnerable population...The Division of Health Care Financing and Policy...to decide whether to require psychologists, therapists and other mental health professionals to provide written documentation demonstrating medical necessity and receive prior approval to continue providing talk therapy or neurotherapy…State officials describe the policy as an effort to be both fiscally and socially responsible, ensuring that providers are only getting paid for services that are actually necessary and that patients are receiving the right treatment for their condition...opponents...argue that it will damage an already-thin safety net for patients by imposing additional administrative burdens on providers…