Pharma Still Reeling As House Passes Trade Deal Without Market Exclusivity Provision
The North American trade pact is moving swiftly through Congress. The legislation is noticeably missing a provision that would have granted market exclusivity for biologics for 10 years. The removal of the protection was a big win for Democrats and a huge loss for the pharmaceutical industry. In other news: an Ebola vaccine, nerve drugs, biotech stocks, a subscription model for medication, and more.
The Wall Street Journal:
House Passes North American Trade Pact With Bipartisan Support
The House of Representatives approved President Trump’s amended North American trade pact on Thursday in an overwhelmingly bipartisan fashion, a rare instance of legislative cooperation in an era of intense political divisions. The House approved legislation to implement the U.S. Mexico Canada Agreement, or USMCA, by a 385 to 41 vote, with 193 Democrats and 192 Republicans backing the pact. The Senate is expected to pass the legislation early next year, after which the president would sign it into law. (Mauldin and Andrews, 12/19)
The Associated Press:
North America Trade Pact Deals Rare Setback To Big Pharma
A revamped North American trade deal nearing passage in Congress gives both the White House and Democrats a chance to claim victory and offers farmers and businesses clearer rules governing the vast flow of goods among the United States, Canada and Mexico. But the pact leaves at least one surprising loser: the pharmaceutical industry, a near-invincible lobbying powerhouse in Washington. (Wiseman, Johnson and Freking, 12/19)
South China Morning Post:
U.S. Policymakers Worry About China 'Weaponizing' Drug Exports
One of the biggest national security threats in the U.S.-China trade war could be to the everyday medicines taken by millions of Americans. The U.S. relies on imported medicines from China in a big way. Antibiotics, over-the-counter pain meds and the stuff that stops itching and swelling — a lot of it is imported from China. (Palmer, Zhou and Bermingham, 12/10)
Stat:
FDA Approves An Ebola Vaccine, Long In Development, For The First Time
The Food and Drug Administration announced Thursday it has approved an Ebola vaccine developed by Merck, making it the first for the deadly disease approved in the United States. The vaccine, Ervebo, protects against Zaire ebolaviruses, the species of the virus that has been the most common cause of Ebola outbreaks. Ebola Zaire is the virus responsible for the current long-running outbreak in the Democratic Republic of the Congo. (Branswell, 12/19)
CNN:
FDA Approves First-Ever Vaccine For Prevention Of Ebola Virus
Cases of EVD in the US are very rare and have generally occurred when people already infected with the virus have traveled into the country or when health care workers have become infected treating those sickened by EVD. "While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo," Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, said in a press release. (Erdman, 12/20)
The Associated Press:
FDA Warns Of Breathing Risks With Popular Nerve Drugs
U.S. health regulators are warning that popular nervous system medications can cause dangerous breathing problems when combined with opioids and certain other drugs. The Food and Drug Administration said Thursday it would add new warnings to packaging for Neurontin, Lyrica and generic versions, which are used to treat seizures, nerve pain, restless leg syndrome and other conditions. (Perrone, 12/19)
Reuters:
FDA Grants Accelerated Approval For Astellas, Seattle Genetics' Bladder Cancer Drug
U.S. Food and Drug Administration said on Wednesday it approved Astellas Pharma Inc and Seattle Genetics' experimental drug to treat advanced bladder cancer, about three months ahead of schedule. Shares of Seattle Genetics were up 6% at $119.05 after the bell. The drug, Padcev, is approved in the United States for patients with advanced or metastatic urothelial cancer, the companies said. (Martin, 12/19)
The Wall Street Journal:
Behind The Biotech Stock Rally: New Deals And Easing Political Worries
Shares of biotech companies have surged in recent months, boosted by innovation, a spate of deals and easing worries about political risks. The Nasdaq Biotechnology Index has gained 22% so far this quarter, far outpacing the S&P 500’s 7.7% gain. The recent rally has helped the biotech index recover from a third-quarter decline, bringing its year-to-date performance to 25%, nearly in line with the broader index’s 28% advance. (Langley, 12/20)
Stat:
In A Shift Toward Venture Capital Fundraising, FORMA Brings In $100 Million
After eschewing venture capital for the better part of a decade, Watertown, Mass.-based FORMA Therapeutics is changing its tune. The company, which has a lead drug candidate that takes aim at sickle cell disease, announced Thursday it had raised $100 million in a Series D financing round from a group of venture investors that includes RA Capital, Cormorant Capital, Wellington Management, and Samsara BioCapital, among others. (Sheridan, 12/19)
The Advocate:
National Praise For Louisiana's Health Department Chief For New Hepatitis C Deal
Rebekah Gee, the head of Louisiana’s health department, was recognized by a New York Times columnist as one of five people who “spread hope in 2019” for her work spearheading an innovative deal to pay for hepatitis C treatment in an effort to eradicate the disease in Louisiana. Gee’s health department struck a “Netflix-style” deal with Asegua Therapeutics, a subsidiary of pharmaceutical giant Gilead, whereby the state pays about $58 million a year for unlimited access to Hep C drugs. Medicaid patients and people in the state’s prison system get the drug free through the arrangement. (12/19)
