Karuna Could Submit Schizophrenia Drug to FDA by Mid-Year
Bipartisan Bills Seek to Overhaul FDA Opioid Regulations
March 1, 2023
by Dan McCue
WASHINGTON — Sens. Joe Manchin, D-W.Va., and Mike Braun, R-Ind., reintroduced a trio of bills Wednesday aimed at reforming how the Food and Drug Administration approves and manages opioid medications.
“In the last year, more than 106,000 Americans and 1,400 West Virginians died from drug-related overdoses,” Manchin said in a written statement.
“It’s far past time for Congress to take comprehensive, meaningful action to address the crisis,” he continued. “I encourage my colleagues on both sides of the aisle, along with FDA leadership, to support these critical, commonsense reforms to combat the drug epidemic that continues to ravage our nation.”
According to the senators, the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act would allow the FDA to deny a new drug application for an opioid analgesic drug on the basis of the drug not being clinically superior to other commercially available drugs.
This would help provide further authority to the FDA so it can review the public health impact of every new opioid medication approval and deny new drug applications even if the pharmaceutical company–sponsored clinical trials apparently show “safety” of the drug, they said.
“These commonsense pieces of legislation would strengthen scientific review throughout the opioid approval process, prioritize public health impacts over pharmaceutical interests and hold the FDA and its leadership accountable for their role in addressing the drug epidemic,” the senators wrote.
“The opioid epidemic continues to devastate communities and tear a hole through the Midwest,” Braun said in a written statement. “I’m proud to join with Sen. Manchin to introduce these three bipartisan bills to overhaul the FDA approval process for opioid medications. Opioid drugs are different from other pharmaceuticals, and carry very different risks, and how we approve and manage these drugs must change as well.”
Dan can be reached at [email protected] and @DanMcCue
A+
a-
In The News
Health
Voting
Prescription Drugs
March 20, 2023
by Dan McCue
Karuna Could Submit Schizophrenia Drug to FDA by Mid-Year
BOSTON — Encouraged by positive topline results from its phase 3 trial for its new therapy for adults with schizophrenia,... Read More
BOSTON — Encouraged by positive topline results from its phase 3 trial for its new therapy for adults with schizophrenia, Karuna Therapeutics announced Monday that it is on track to submit KarXT to the Food and Drug Administration for approval by summer. If that comes to... Read More
March 1, 2023
by Dan McCue
Bipartisan Bills Seek to Overhaul FDA Opioid Regulations
WASHINGTON — Sens. Joe Manchin, D-W.Va., and Mike Braun, R-Ind., reintroduced a trio of bills Wednesday aimed at reforming how... Read More
WASHINGTON — Sens. Joe Manchin, D-W.Va., and Mike Braun, R-Ind., reintroduced a trio of bills Wednesday aimed at reforming how the Food and Drug Administration approves and manages opioid medications. “In the last year, more than 106,000 Americans and 1,400 West Virginians died from drug-related overdoses,”... Read More
December 30, 2022
by Probe: Alzheimer's Drug Approval 'Rife With Irregularities'
Probe: Alzheimer's Drug Approval 'Rife With Irregularities'
WASHINGTON (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as... Read More
WASHINGTON (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed... Read More
December 14, 2022
by Dan McCue
Japanese Pharma Firm to Pay $4B for Single Drug
TOKYO — Japanese Pharma firm Takeda has agreed to pay $4 billion in cash for a single drug invented by... Read More
TOKYO — Japanese Pharma firm Takeda has agreed to pay $4 billion in cash for a single drug invented by Nimbus Therapeutics, a Boston, Massachusetts-based biotechnology company. The drug Takeda is buying (NDI-034858) blocks selective allosteric tyrosine kinase 2 (also known as TYK2), a signaling protein... Read More
December 7, 2022
by Dan McCue
US Seeks to Delay Talks on Extension of WTO COVID Patent Waivers
WASHINGTON — The United States will not support extending a Dec. 17 deadline for waiving intellectual property protection for COVID-19... Read More
WASHINGTON — The United States will not support extending a Dec. 17 deadline for waiving intellectual property protection for COVID-19 tests and treatments, and instead is asking the U.S. International Trade Commission to first investigate market dynamics such as pricing, supply and demand before it chooses... Read More
December 7, 2022
by Speedier Drug Approvals Hit Slowdown as FDA Faces Scrutiny
Speedier Drug Approvals Hit Slowdown as FDA Faces Scrutiny
WASHINGTON (AP) — Expedited drug approvals slowed this year as the Food and Drug Administration's controversial accelerated pathway came under... Read More
WASHINGTON (AP) — Expedited drug approvals slowed this year as the Food and Drug Administration's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the FDA’s drug center... Read More
News From The Well
