Given a paragraph, generate a claim that is supported by the given paragraph. 1) The claim must contain information from within the paragraph. 2) A sentence within the paragraph can be used as a claim. 3) The claim should not have contradictions within the paragraph. 4) The claim should be at most one sentence long.

[Q]: Teva Pharmaceutical Industries Ltd’s rival migraine headache preventer is excluded on one list and patients can pay more for it in some cases on a second list, the note said. As with rival PBMs Express Scripts and CVS Health Corp, OptumRx’s lists of covered drugs, or formularies, cover tens of millions of consumers who receive their healthcare from employers and health insurers. About 39 million Americans suffer from migraine headaches, according to the Migraine Research Foundation, and global migraine drug sales could reach $8.7 billion by 2026, according to analytics firm GlobalData. OptumRx’s decision secures easier access to customers for Lilly’s Emgality at all three of the biggest PBMs - including CVS and Express Scripts - and gives Amgen’s Aimovig a leg up after CVS decided not to include it on its preferred drug list. Teva’s Ajovy only has preferred status at CVS, while Amgen also has it at Express Scripts, part of Cigna Corp.  “We are pleased that all three companies have chosen Emgality to be one of the preferred medications, making it accessible to even more patients suffering from migraine,” Lilly said in an emailed statement. Inclusion on a preferred drugs list by the largest PBMs and health insurers is critically important for sales of new medicines. Increasingly, PBMs are choosing a subset of treatments for their coverage list when there are multiple treatments that are considered equivalent. The three treatments, approved by the U.S. Food and Drug Administration last year, belong to a class of drugs called CGRP inhibitors that have proven effective in helping to prevent migraines. A Teva spokeswoman said the company is committed to increasing access to Ajovy regardless of formulary decisions and is still offering discounts that allow patients to pay nothing in some cases, regardless of insurance. “Since Ajovy injection launched in September, we have experienced strong demand and steady growth, and we continue discussions with payers,” the spokeswoman said. An Amgen spokeswoman said that the company was pleased with the decision and is committed to ensuring affordable access to its drug. Amgen, which shares Aimovig U.S. revenue with Novartis AG, earlier this week reported fourth-quarter sales of $95 million, nearly doubling Wall Street estimates. The OptumRx decision becomes effective Feb. 1. The OptumRx select formulary relegates Teva’s drug to a lower access level that would typically require a higher out-of-pocket cost, it said. PBMs typically extract discounts from drugmakers in return for favorable placement on their preferred list of covered drugs, such as through a low co-payment, or coinsurance payment, for their members. All three migraine drugs have a list price of $575 a month, or $6,900 a year. Those prices do not reflect the rebates and discounts to PBMs, who design and negotiate benefits for employers and insurers. All three drugmakers are providing a limited duration supply of the new drugs at no cost directly to patients in addition to other assistance programs. Amgen’s Aimovig was first-to-market from the new class. But the rivals from Teva and Lilly followed soon after. The three large PBMs together cover the majority of the more than 150 million Americans who receive benefits through their employers. Their clients, including insurers and corporations, may choose not to follow a PBM’s recommendations on coverage, but that typically would cost more. Amgen shares were off 28 cents at $186.63, Lilly was up nearly 1 percent at $120.90 and Teva shares traded in New York  were down nearly 1 percent at $19.69.
[A]: Exclusive: Top U.S. insurer to cover Amgen, Eli Lilly migraine drugs, exclude Teva.


[Q]: Calyxt Inc, an eight-year-old firm co-founded by a genetics professor, altered the genes of a soybean plant to produce healthier oil using the cutting-edge editing technique rather than conventional genetic modification. Seventy-eight farmers planted those soybeans this spring across 17,000 acres in South Dakota and Minnesota, a crop expected to be the first gene-edited crop to sell commercially, beating out Fortune 500 companies. Seed development giants such as Monsanto, Syngenta AG and DowDuPont Inc have dominated genetically modified crop technology that emerged in the 1990s. But they face a wider field of competition from start-ups and other smaller competitors because gene-edited crops have drastically lower development costs and the U.S. Department of Agriculture (USDA) has decided not to regulate them. Relatively unknown firms including Calyxt, Cibus, and Benson Hill Biosystems are already advancing their own gene-edited projects in a race against Big Ag for dominance of the potentially transformational technology. “It’s a very exciting time for such a young company,” said Calyxt CEO Federico Tripodi, who oversees 45 people. “The fact a company so small and nimble can accomplish those things has picked up interest in the industry.”  Gene-editing technology involves targeting specific genes in a single organism and disrupting those linked to undesirable characteristics or altering them to make a positive change. Traditional genetic modification, by contrast, involves transferring a gene from one kind of organism to another, a process that still does not have full consumer acceptance. Gene-editing could mean bigger harvests of crops with a wide array of desirable traits - better-tasting tomatoes, low-gluten wheat, apples that don’t turn brown, drought-resistant soybeans or potatoes better suited for cold storage. The advances could also double the $15 billion global biotechnology seed market within a decade, said analyst Nick Anderson of investment bank Berenberg. The USDA has fielded 23 inquiries about whether gene-edited crops need regulation and decided that none meet its criteria for oversight. That saves their developers years of time and untold amounts of money compared to traditional genetically modified crops. Of those 23 organisms, just three were being developed by major agriculture firms. The newly competitive landscape could foster more partnerships and licensing deals between big and small firms, along with universities or other public research institutions, said Monsanto spokeswoman Camille Lynne Scott. Monsanto - which was recently acquired by Bayer AG - invested $100 million in startup Pairwise Plants this year to accelerate development of gene-edited plants. North Carolina-based Benson Hill, founded in 2012 and named after two scientists, mainly licenses crop technology to other companies. But it decided to produce its own higher-yielding corn plant because of the low development costs, said Chief Executive Matt Crisp. Calyxt plans to sell the oil from its gene-edited soybeans to food companies and has a dozen more gene-edited crops in the pipeline, including high-fiber wheat and potatoes that stay fresh longer. Developing and marketing a traditional genetically modified crop might easily cost $150 million, which only a few large companies can afford, Crisp said. With gene-editing, that cost might fall as much as 90 percent, he said. “We’re seeing a huge number of organizations interested in gene-editing,” Crisp said, referring to traditional crop-breeding companies, along with technology firms and food companies. “That speaks to the power of the technology and how we’re at a pivotal point in time to modernize the food system.”  Supporters of gene-editing say it allows a higher level of precision than traditional modification. With CRISPR, one popular type of gene-editing technology used by Syngenta, scientists transfer an RNA molecule and an enzyme into a crop cell. When the RNA encounters a targeted strand of DNA inside the cell, it binds to it and the enzyme creates a break in the cell’s DNA. Then, the cell repairs the broken DNA in ways that disrupt or improve the gene. (For a graphic on how the Syngenta process works, see: tmsnrt.rs/2KJmtxr )  Biotech firms hope the technology can avoid the “Frankenfood” label that critics have pinned on traditional genetically modified crops. But acceptance by regulators and the public globally remains uncertain. The Court of Justice of the European Union ruled on July 25 that gene-editing techniques are subject to regulations governing genetically modified crops. The ruling will limit gene-editing in Europe to research and make it illegal to grow commercial crops. The German chemical industry association called the decision “hostile to progress.”   U.S. Agriculture Secretary Sonny Perdue blasted the ruling for enacting unnecessary barriers to innovation and stigmatizing gene-editing technology by subjecting it to the EU’s “regressive and outdated” regulations governing genetically modified crops. The USDA also has no current plans to regulate gene-editing in animal products, according to a document provided by the agency. The U.S. Food and Drug Administration, however, plans to regulate gene-editing in both plants and animals, FDA Commissioner Scott Gottlieb wrote in a June blog post. The agency is developing an “innovative and nimble” approach to regulating gene-editing, he wrote, that will aim to ensure its safety for both humans and animals while allowing companies to bring beneficial products to market. The USDA, by contrast, chose not to regulate gene-edited crops because the process typically introduces characteristics that are “indistinguishable” from those created through traditional plant breeding, which take much longer, USDA Secretary Perdue said in a March statement. Although there has been no widespread consumer resistance to gene-editing, activists who have long opposed genetically modified crops remain suspicious of any sort of tinkering with DNA. The new technique raises risks of creating undesired changes in the food supply and warrants increased regulation, said Lucy Sharratt, coordinator of the Canadian Biotechnology Action Network. That kind of opposition is why agribusiness giant Cargill Inc [CARG.UL] is pursuing gene-edited technology with caution, said Randal Giroux, the firm’s vice-president of food safety, quality and regulatory affairs. Cargill announced in February that it would collaborate with Precision BioSciences to develop healthier canola oil, but is proceeding slowly on agreements to store and transport other companies’ gene-edited crops pending clarity from regulators, Giroux said. “We really do want to see gene-editing evolve in the marketplace,” Giroux said. “We’re watching to see how consumers adopt these products and react to these products.”  SECRET FIELD-TESTING  Other major agriculture biotech firms are moving more aggressively, hoping to take advantage of lighter regulation to speed development. A gene-edited crop may take five years to move from development to commercialization in the United States, compared with a genetically modified crop that could take 12 years, said Dan Dyer, head of seeds development at Syngenta. The firm is working on better-tasting tomatoes that take longer to spoil and hopes to launch a gene-edited crop in the mid-2020s, said Jeff Rowe, Syngenta’s president of global seeds. DowDuPont - at a secret location in the U.S. Midwest - is field-testing waxy corn, a variety grown for industrial purposes that has been edited for higher yields. The company plans a commercial launch next spring. Smaller firms will be nipping at the heels of these massive companies in the race to bring the next generation of genetically engineered foods to market, said Robert Wager, a biology faculty member at Vancouver Island University. “The lack of USDA-regulated status is a huge game-changer,” he said, “for universities and small startups to enter the market.”
[A]: Gene-editing startups ignite the next 'Frankenfood' fight.


[Q]: Families of the victims of Heparin reactions testify during a House Energy and Commerce subcommittee hearing on Heparin imports from China on Capitol Hill, April 29, 2008. REUTERS/Jim Young Leroy Hubley said his wife, Bonnie, and son, Randy, had undergone kidney dialysis at an Ohio clinic and were given heparin that was later recalled by Baxter International Inc. Both had reactions to the blood thinner and died within one month of each other. “Now I am left to deal not only with the pain of losing my wife and son, but anger that an unsafe drug was permitted to be sold in this country,” Hubley, who frequently choked back tears and wiped his eyes, told a U.S. House of Representatives subcommittee hearing. A U.S. Food and Drug Administration probe found a contaminant in some batches of Baxter’s heparin. Officials said tests showed the chemical could have caused the reactions reported in 81 deaths of patients treated with some brand of heparin since January 2007. Lawmakers questioned Baxter and its ingredient supplier, Scientific Protein Laboratories LLC (SPL), about why they failed to detect the heparin contamination. Both companies said it appeared the chemical was deliberately added before either company received the ingredients. Baxter, which had supplied about half of the U.S. heparin market, recalled most of its heparin products in February. The action followed a string of U.S. recalls linked to China last year, ranging from tainted pet food and toothpaste to excessive lead in paint that swept millions of toys from stores. The heparin contaminant has been detected in 13 countries, FDA officials have said, but only the United States and Germany have seen reports of an increase in allergic reactions. The FDA says all heparin imported into the United States is now tested for contamination and the current supply is safe. Hubley and other relatives of heparin victims urged new steps to keep medicines free of contamination. “I want to know what is going to be done to rectify the matter. I want to know if my daughter, Dawn, and the millions of others who continue to receive dialysis are safe,” Hubley said. Baxter Chief Executive Robert Parkinson said the company was “alarmed that one of our products was used, in what appears to have been a deliberate scheme, to adulterate a life-saving medication, and that people have suffered as a result.”   “We deeply regret that this has happened, and I feel a strong sense of personal responsibility for these circumstances,” he said. Heparin — used in dialysis and some surgeries to prevent blood clots — is derived from pig intestines and often collected from small, mostly unregulated farms in China. FDA tests found the recalled drug contained an altered form of chondroitin sulfate that mimics raw heparin. Chinese officials have said the chemical was present but is not to blame for the reactions or deaths. Rep. Bart Stupak, a Michigan Democrat, said it remained uncertain whether the contamination was intentional or accidental. He said both companies should have done more to assure their products were safe. “Both Baxter and SPL have failed the American public,” said Stupak, chairman of the House of Representatives Energy and Commerce Committee’s oversight and investigations panel. Using the contaminant would be about 100 times cheaper than real heparin, said committee investigator David Nelson. Lawmakers attacked the FDA for failing to inspect SPL’s plant in Changzhou, China, before approving Baxter’s heparin. Agency inspectors found a series of manufacturing problems during a visit in February, after Baxter’S recall. Baxter officials audited the facility five months earlier and said they found acceptable conditions, Nelson said. “I’m really baffled by that. How is it you can have two divergent findings from the same plant?” Stupak asked. Baxter’s Parkinson said the visits happened at different times, and the drug maker’s audit was routine while the FDA visit was in response to a specific problem. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the agency needed more tools and better technology to hold companies accountable. “FDA needs the help of Congress to make sure that a tragedy like this does not happen again,” Woodcock said. Woodcock said it would cost about $225 million annually for the FDA to inspect, every other year, all pharmaceutical plants around the world that supply the U.S. market. Lawmakers are considering legislation that would charge drug and device makers fees to boost inspections.
[A]:
Families tell U.S. lawmakers of heparin deaths.