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Biogen isn't worried about competing with Eli Lilly as they both attempt to bring an Alzheimer's drug to the market, Biogen's CEO said Tuesday. Researchers argue that the accumulation of amyloid plaque is a crucial first step toward the cognitive decline observed in Alzheimer's disease. Eli Lilly didn't immediately respond to a request for comment. He said that will likely require Eli Lilly and Biogen to roll out maintenance doses that will keep plaque levels low. Biogen is banking on the success of its drug leqembi after the disastrous approval and rollout of its old Alzheimer's drug aduhelm last year.
April 21 (Reuters) - Abortion rights supporters expressed relief on Friday after the U.S. Supreme Court preserved access to a widely used abortion pill but warned of a long fight ahead as a legal challenge to the medication continues. Abortion providers had been stockpiling the abortion pill mifepristone or planning to switch to a new regimen amid the battle over the legality of a drug used in more than half of U.S. abortions. Several providers said late on Friday they would pause plans to change their medication abortion protocol in light of the Supreme Court's order. The Supreme Court did not rule on the merits of the case, however, meaning that mifepristone could still be restricted or banned at a later stage in the case. Several states where abortion remains legal, including California, Massachusetts and Washington, previously said they had begun stockpiling abortion drugs in advance of possible restrictions.
Emergency room doctors have to help patients who have been in lots of different life situations, including life situations that the doctors might not approve of. If treating a patient makes you feel “complicit” in whatever the patient did to come to the emergency room, being an emergency room doctor is not the job for you. And, I’ll add, it’s remarkable that three federal appellate judges gave these plaintiffs a green light. But another portion of the opinion is a specific and special gift to employers who claim that their opposition to Obamacare’s mandatory coverage provision is motivated by religion. The Affordable Care Act “forces these plaintiffs to choose between purchasing health insurance that violates their religious beliefs and foregoing conventional health insurance altogether,” he wrote.
Alejandro Mayorkas, secretary of the U.S. Department of Homeland Security, speaks during a new conference in Brownsville, Texas, U.S., on Thursday, Aug. 12, 2021. WASHINGTON – The Department of Homeland Security will establish a new task force to examine how the government can use artificial intelligence technology to protect the country. DHS Secretary Alejandro Mayorkas announced the task force Friday during a speech at a Council on Foreign Relations event. Mayorkas gave two examples of how the task force will help determine how AI could be used to fine-tune the agency's work. Mayorkas asked Homeland Security Advisory Council Co-Chair Jamie Gorelick to study "the intersection of AI and homeland security and deliver findings that will help guide our use of it and defense against it."
The Justice Department plans to announce charges against more than 24 Mexican drug cartel leaders and members, according to senior law enforcement officials. The announcement is expected on Friday morning and is part of the Drug Enforcement Administration's push to target the Sinaloa and Jalisco New Generation Cartel (CJNG) groups, the officials say. "The Sinaloa cartel and the Jalisco cartel and their affiliates control the vast majority of the fentanyl global supply chain, from manufacture to distribution," DEA Administrator Anne Milgram told Congress last month. The Sinaloa cartel "remains the most powerful" drug trafficking organization in Mexico despite the conviction of El Chapo, experts said. El Chapo's arrest also led to intensification of bloody clashes with the CJNG, which split from the Sinaloa Cartel in 2010.
Attorney General Merrick Garland announced the charges at a news conference in Washington, alongside Drug Enforcement Administration Administrator Anne Milgram and other top federal prosecutors. The fentanyl trafficking, weapons and money laundering charges in three indictments involved a total of 28 defendants: 23 of whom are based in Mexico, four in China and one in Guatemala. A senior administration official on a call with reporters on Friday called the reward offers “unprecedented.”“These targets traffic fentanyl from around the world including from Mexico, (China) and Guatemala. These reward offers are part of a government wide attempt to put a halt to trafficking in illicit fentanyl and its precursor,” they added. And in late March, the US Food and Drug Administration approved an over-the-counter version of the opioid overdose antidote Narcan for the first time.
A federal appeals court late on Wednesday blocked part of a ruling issued last week by a Trump-appointed judge that endangers access to the abortion pill mifepristone. The Justice Department can still ask the Supreme Court to intervene in an attempt to completely block Kacsmaryk's ruling. The Justice Department has filed a motion in the federal district court in Washington state, asking for clarification on Friday's ruling. Kacsmaryk's ruling, if allowed to stand, would not mean that access to mifepristone would immediately be cut off nationwide. The agency has broad power to do so, with the Supreme Court in a 1985 ruling saying that such decisions generally cannot be challenged in court.
[1/4] A pack of birth control pills is displayed in this illustration picture taken in Philadelphia, Pennsylvania, U.S., July 11, 2022. REUTERS/Hannah Beier/IllustrationApril 10 (Reuters) - Over 300 biotech and pharmaceutical industry executives, including Pfizer Inc (PFE.N) CEO Albert Bourla, signed an open letter on Monday calling for reversal of a federal judge's decision to suspend sales of the abortion pill mifepristone. Last week's ruling by Judge Matthew Kacsmaryk undermines the FDA's authority, the letter's authors wrote, adding that it ignores decades of scientific evidence and legal precedent. The ruling could open the possibility to the banning of vaccines and contraception for women, said Levin. "It's the single worst threat to the industry in over 50 years."
WASHINGTON, April 10 (Reuters) - A federal judge's decision last week to suspend the U.S. Food and Drug Administration's (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said. The FDA approved mifepristone, part of a two-drug regimen that accounts for more than half of U.S. abortions, over 20 years ago. Banning its sale calls into question the FDA's power to regulate all drugs nationwide, the experts said. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before Kacsmaryk, who is himself a conservative former Christian activist. Plaintiffs are arguing that the FDA in its 2000 approval did not adequately consider the drug's safety when used by girls under age 18 to terminate a pregnancy.
WASHINGTON, March 31 (Reuters) - The U.S. Justice Department is appealing a decision by a Texas judge that blocked Obamacare's mandate that health insurance plans cover preventive care at no cost to patients, the White House said on Friday. U.S. District Judge Reed O'Connor in Fort Worth, Texas, on Thursday blocked the federal government from enforcing requirements that insurance plans cover preventive care, including screenings for certain cancers and pre-exposure prophylaxis against HIV (PrEP). If O'Connor's ruling is not paused or overturned on appeal, insurers will be able to charge patients copays and deductibles for such services in new insurance plans. "The president is glad to see the Department of Justice is appealing the judge's decision," White House Press Secretary Karine Jean-Pierre said in a statement. "Preventive care saves lives, saves families money, and protects and improves our health," she said.
The Biden administration on Friday appealed a Texas federal judge's decision to strike down free Obamacare coverage of preventive health-care services ranging from screenings for certain cancers and diabetes to HIV prevention drugs. HHS estimates that 150 million Americans benefited from the free screenings, counseling, medications and other forms of health care that prevent disease under the Obamacare requirements. Working class Americans will get hit the hardest and might forgo essential health care because they can't afford the cost, Gostin said. O'Connor ruled that Obamacare cannot mandate free coverage of health care recommended by the Preventive Services Task Force because the organization's members were appointed in an illegal manner. They also argued the Preventive Services Task Force was appointed in an unconstitutional manner and therefore its recommendations cannot serve as the basis of an Obamacare mandate.
FRANKFURT, March 24 (Reuters) - Bayer (BAYGn.DE) said the focus of its drug research would shift away from women's health, a traditional pillar of Germany's largest drugmaker, to hone in on neurology, rare diseases and immunology. "When it comes to research and the subsequent clinical phases, we will no longer have an explicit focus on women's health," the head of Bayer's pharmaceuticals unit, Stefan Oelrich, told Reuters on Friday. The shifted focus comes as Bayer is due to have a change at the top in June. Bayer, which acquired a large women's health business under the 2006 takeover of Schering Pharma, will focus drugs research on oncology, cardiovascular disease, neurology, rare diseases and immunology, the company said in a statement. Research efforts in immunology could still yield products in women's health but Bayer's dedicated work on the therapeutic area overall had fallen short of expectations, he said.
Battle Heats Up Between Hunter Biden and the GOP
  + stars: | 2023-03-18 | by ( C. Ryan Barber | ) www.wsj.com   time to read: 1 min
Hunter Biden filed suit against a computer-repair-store owner over dissemination of his personal information. The Washington skirmishing between Hunter Biden and the GOP escalated this week as congressional Republicans ramped up their investigation into his business dealings and the president’s son followed with a lawsuit against a computer-repair-shop owner who said in a court filing that he disseminated a copy of the contents of Mr. Biden’s electronically stored data. The moves by both sides could draw greater attention to a difficult period in Hunter Biden’s life, when he has acknowledged a serious drug problem. GOP lawmakers are seeking to discover whether the younger Mr. Biden’s various business arrangements with wealthy foreigners involved his father, President Biden.
Companies Bayer AG FollowNEW YORK, March 9 (Reuters) - Bayer AG (BAYGn.DE) plans to spend $1 billion on drug research and development in the U.S. this year as it works to double its sales in the country by the end of the decade, Bayer's top U.S. pharmaceutical executive told Reuters. "It's time for us to double down on the U.S.," Guth said, noting that Bayer plans to sell the drugs it is developing itself in the country, rather than partner with U.S. companies like it has in the past. Bayer is looking to build up its portfolio of new drugs as it hopes to improve share prices, which have been hit by concerns over litigation surrounding weedkiller Roundup and a lack of trust in the company's leadership. Guth said he expects peak sales of 12 billion euros from cancer drug Nubeqa, kidney medication Kerendia, and two of its top pipeline assets, experimental stroke drug asundexian and experimental women's health drug elinzanetant. Reporting by Michael Erman; Editing by David GregorioOur Standards: The Thomson Reuters Trust Principles.
Two Marion directors were "out of the country and will be arrested as soon as they land in India," senior police official Ram Badan Singh told Reuters. Uzbekistan in December said the children died after consuming Marion's cough syrups. The same toxin was found in cough syrups exported to Gambia by another Indian company, Maiden Pharmaceuticals. India in October suspended production at Maiden for violations of manufacturing standards after the World Health Organization said four of its cough syrups may have killed dozens of children in Gambia. The deaths in Gambia and Uzbekistan have dented the image of the $41 billion pharmaceutical industry in India, which is known as the "pharmacy of the world."
12 Democratic-led states challenge restrictions on abortion pill
  + stars: | 2023-02-25 | by ( ) www.cnbc.com   time to read: +3 min
Twelve Democratic-led states have sued the Food and Drug Administration to challenge certain federal restrictions imposed on the distribution of the abortion pill mifepristone, saying those limits are not supported by evidence. Mifepristone, in combination with the drug misoprostol, was approved in 2000 by the FDA for medication abortion in the first 10 weeks of pregnancy. The decision enabled more than a dozen Republican-led states to adopt new abortion bans. The FDA's special restrictions on mifepristone are imposed under a safety program meant to minimize the risk of potentially dangerous drugs. After last year's Supreme Court ruling, President Joe Biden directed federal agencies to expand access to medication abortion.
Companies U.S. Food and Drug Administration FollowFeb 24 (Reuters) - Twelve Democratic-led states have sued the U.S. Food and Drug Administration to challenge certain federal restrictions imposed on the distribution of the abortion pill mifepristone, saying those limits are not supported by evidence. Mifepristone, in combination with the drug misoprostol, was approved in 2000 by the FDA for medication abortion in the first 10 weeks of pregnancy. The decision enabled more than a dozen Republican-led states to adopt new abortion bans. The FDA's special restrictions on mifepristone are imposed under a safety program meant to minimize the risk of potentially dangerous drugs. After last year's Supreme Court ruling, Democratic President Joe Biden directed federal agencies to expand access to medication abortion.
[1/4] Cast member Fan Bingbing attends a news conference during the promotion of 'Green Night' at the 73rd Berlinale International Film Festival in Berlin, Germany, February 23, 2023. Her reappearance also spotlighted the return of Chinese-language film to the international stage, as mainland China and Hong Kong have eased zero-COVID policies, allowing for international travel. Featuring both Mandarin and Korean dialogue, the film is one of several from China and Hong Kong receiving world premieres at the Berlinale. In "Green Night", Fan plays the role of Jin Xia, a Chinese immigrant working as a security guard at Seoul airport. Chinese cinema is showing signs of thriving in Berlin, Fan said.
An effort to legalize marijuana in Mexico has stalled after several years of debate by lawmakers. But Mexican cartels and independent growers are still preparing to cater to a new domestic market. The Sinaloa Cartel in particular is drawing business lessons from marijuana dispensaries in the US. At the current price for weed, Margarita gets roughly $25 a kilo. A marijuana legalization activist smokes marijuana in front of the San Lazaro Legislative Palace in Mexico City in October 2022.
Hong Kong CNN —Two years ago, cannabidiol was booming in Hong Kong. CBD cookies at the Found cafe in Hong Kong on August 11, 2022. And while CBD products could avoid this trace amount by using a pure form of CBD, most manufacturers mix other compounds for higher potency. From 2019 to early 2022, Hong Kong authorities launched nearly 120 “operations” seizing and testing CBD products from restaurants and shops to warehouses, Secretary for Security Tang Ping-keung said last year. Now “there’s less choice for consumers in Hong Kong.
Under the guidelines proposed on Friday, gay and bisexual men who are in monogamous relationships would be allowed to donate blood. The FDA had imposed a lifetime ban on men who have sex with men donating blood during the AIDS crisis in the 1980s. The agency had eased the ban in 2015, allowing gay and bisexual men to donate blood if they had not had sex in the previous year. The American Medical Association had criticized the FDA's restrictions on gay men donating as discriminatory. Those taking injections to prevent HIV would not be allowed to donate blood for two years following their most recent injection.
Mark Cuban has invested in the online pharmacy Truepill, he confirmed to Insider. It works with Cuban's other healthcare bet Mark Cuban Cost Plus Drug Co.Mark Cuban's interest in breaking into the healthcare industry is heating up. In November, he backed the online pharmacy Truepill through its funding round, Cuban confirmed to Insider in an email. He's played an active role in his drug-pricing startup, which launched as the Mark Cuban Cost Plus Drug Co. in 2021. When asked about the delays, Cuban said Cost Plus Drugs' volume exceeded both companies' expectations.
Biopharma CEOs say his company Cost Plus Drugs could remove costs from the distribution system. Cuban told Insider in an email that he believed the company's pricing transparency was "an absolute positive for patients." The company started its pharmacy services last year and quickly racked up over 1 million accounts, Cuban told Insider recently. Cost Plus Drugs is focused on bringing down the price of generic medications, which no longer have patent protections but can still be expensive. Cuban told Insider that EQRx was in a "different business" than what he's attempting to build out.
Amazon is adding a prescription drug discount program to its growing health care business. The retail giant said Tuesday that it will launch RxPass, a subscription service for customers who have Prime memberships. Amazon Prime members can now receive all of their eligible generic medications for just $5 a month and have them delivered free to their door. Last year, the company shuttered its hybrid virtual, in-home care service called Amazon Care after it failed to get traction from employers. And Haven, a company Amazon created in collaboration with JPMorgan and Berkshire Hathaway to improve health costs, dissolved a year earlier than that.
Mark Cuban has invested in the online pharmacy Truepill, he confirmed to Insider. Truepill works with healthcare startups to send medications through the mail. It works with Cuban's other healthcare bet Mark Cuban Cost Plus Drug Co.Mark Cuban's interest in breaking into the healthcare industry is heating up. In November, he backed the online pharmacy Truepill through its funding round, Cuban confirmed to Insider in an email. He's played an active role in his drug-pricing startup, which launched as the Mark Cuban Cost Plus Drug Co. in 2021.
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