Prescription Drugs

2023-11-28 15:54:36
by Dan McCue
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors

WASHINGTON — The Food and Drug Administration on Tuesday approved Ogsiveo tablets for adult patients with progressing desmoid tumors, a... Read More

WASHINGTON — The Food and Drug Administration on Tuesday approved Ogsiveo tablets for adult patients with progressing desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive, invading surrounding structures and organs,... Read More

Obesity Drug Wegovy Cut Risk of Serious Heart Problems by 20%, Study Finds

The popular weight-loss drug Wegovy reduced the risk of serious heart problems by 20% in a large, international study that... Read More

The popular weight-loss drug Wegovy reduced the risk of serious heart problems by 20% in a large, international study that experts say could change the way doctors treat certain heart patients. The research is the first to document that an... Read More

Mind-Altering Ketamine Becomes Latest Pain Treatment, Despite Little Research

WASHINGTON (AP) — As U.S. doctors scale back their use of opioid painkillers, a new option for hard-to-treat pain is taking... Read More

WASHINGTON (AP) — As U.S. doctors scale back their use of opioid painkillers, a new option for hard-to-treat pain is taking root: ketamine, the decades-old surgical drug that is now a trendy psychedelic therapy. Prescriptions for ketamine have soared in recent years,... Read More

2023-11-01 18:27:47
by Dan McCue
FDA Approves Biosimilar for Treatment of Multiple Inflammatory Diseases

WASHINGTON — The Food and Drug Administration on Tuesday approved Wezlana, a biosimilar interchangeable with Stelara for the treatment of... Read More

WASHINGTON — The Food and Drug Administration on Tuesday approved Wezlana, a biosimilar interchangeable with Stelara for the treatment of multiple inflammatory diseases. The agency said its approval of Wezlana, which is manufactured by Amgen, was based on a comprehensive... Read More

STUDY: Drug Used in Diabetes Treatment Mounjaro Helped Dieters Shed 60 Pounds

The medicine in the diabetes drug Mounjaro helped people with obesity or who are overweight lose at least a quarter... Read More

The medicine in the diabetes drug Mounjaro helped people with obesity or who are overweight lose at least a quarter of their body weight, or about 60 pounds on average, when combined with intensive diet and exercise, a new study... Read More

Rite Aid Seeks Chapter 11 Bankruptcy Protection as It Deals With Lawsuits and Losses

Rite Aid has filed for bankruptcy protection and plans to sell part of its business as it attempts to restructure... Read More

Rite Aid has filed for bankruptcy protection and plans to sell part of its business as it attempts to restructure while dealing with losses and opioid-related lawsuits. The drugstore chain said late Sunday it also has obtained $3.45 billion in... Read More

2023-10-03 20:15:31
by Dan McCue
Pharma Firms Agree to Participate in Medicare Price Negotiations

WASHINGTON — The White House announced Tuesday that all 10 drug companies whose products were selected for price negotiations with... Read More

WASHINGTON — The White House announced Tuesday that all 10 drug companies whose products were selected for price negotiations with Medicare have agreed to participate in those talks. The companies, which include Bristol Myers Squibb, the maker of Eliquis, Boehringer... Read More

2023-09-20 19:23:53
by TWN Staff
DHS Homeland Security Investigations Releases Strategy to Combat Illicit Opioids

WASHINGTON — The Department of Homeland Security’s Homeland Security Investigations on Tuesday released the Strategy for Combating Illicit Opioids, an... Read More

WASHINGTON — The Department of Homeland Security’s Homeland Security Investigations on Tuesday released the Strategy for Combating Illicit Opioids, an intelligence-driven approach to disrupting and dismantling transnational criminal organizations and keeping dangerous substances, like illicit fentanyl driving the overdose epidemic,... Read More

Biden's Medicare Price Negotiation Push Is Broadly Popular. He's Not Getting Much Credit

WASHINGTON (AP) — President Joe Biden is trumpeting Medicare's new powers to negotiate directly with drugmakers on the cost of prescription medications — but... Read More

WASHINGTON (AP) — President Joe Biden is trumpeting Medicare's new powers to negotiate directly with drugmakers on the cost of prescription medications — but a poll shows that any immediate political boost that Biden gets for enacting the overwhelmingly popular policy may be limited.... Read More

2023-09-11 17:27:51
by Dan McCue
CDC Awards $279M to 49 States, DC to Prevent Drug Overdoses

ATLANTA — The Centers for Disease Control and Prevention awarded $279 million to 49 states, the District of Columbia and... Read More

ATLANTA — The Centers for Disease Control and Prevention awarded $279 million to 49 states, the District of Columbia and 40 local health departments to help stem the tide of overdoses within their communities.  The agency announced the awards on... Read More

Biden Targets Diabetes Drug Jardiance and Nine Others for Medicare Price Talks

WASHINGTON (AP) — The Biden administration is targeting the blood thinner Eliquis, diabetes treatment Jardiance and eight other medications for... Read More

WASHINGTON (AP) — The Biden administration is targeting the blood thinner Eliquis, diabetes treatment Jardiance and eight other medications for Medicare's first-ever drug price negotiations as it seeks to lower medical costs for Americans. The administration on Tuesday released a list... Read More

2023-07-26 20:54:47
by Dan McCue
House Dem Leaders Intro New Drug Price Legislation

WASHINGTON — A trio of House Democrats introduced legislation Wednesday that would extend the savings garnered by the federal government... Read More

WASHINGTON — A trio of House Democrats introduced legislation Wednesday that would extend the savings garnered by the federal government from negotiating prescription drug prices to all who are covered by private health plans. The bill, called the Lowering Drug... Read More

Second Alzheimer's Drug in Pipeline Can Slow Disease but With Safety Risk

WASHINGTON (AP) — Another experimental Alzheimer’s drug can modestly slow patients’ inevitable worsening — by about four to seven months,... Read More

WASHINGTON (AP) — Another experimental Alzheimer’s drug can modestly slow patients’ inevitable worsening — by about four to seven months, researchers reported Monday. Eli Lilly and Co. is seeking Food and Drug Administration approval of donanemab. If cleared, it would... Read More

2023-06-23 17:29:41
by Dan McCue
FDA Issues First Draft Guidance on Clinical Trials With Psychedelic Drugs

WASHINGTON — The Food and Drug Administration on Friday published a new draft guidance on what researchers should consider when... Read More

WASHINGTON — The Food and Drug Administration on Friday published a new draft guidance on what researchers should consider when investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders.  The first-of-its-kind... Read More

2023-06-21 19:06:28
by Dan McCue
PhRMA Sues Administration Over Medicare Drug Price Negotiation Rules

WASHINGTON — PhRMA, the pharmaceutical industry’s largest lobbying group, sued the Biden administration on Wednesday asserting provisions of the Inflation... Read More

WASHINGTON — PhRMA, the pharmaceutical industry’s largest lobbying group, sued the Biden administration on Wednesday asserting provisions of the Inflation Reduction Act that allow Medicare to start negotiating the prices of certain drugs are unconstitutional. The 59-page complaint, in which... Read More

2023-06-13 18:41:04
by Dan McCue
Health Leaders Urge More Be Done to Prevent Overdose Deaths

WASHINGTON — Top officials at the National Institutes of Health and the Food and Drug Administration are urging that more... Read More

WASHINGTON — Top officials at the National Institutes of Health and the Food and Drug Administration are urging that more be done to advance the development of rapid drug-testing tools to stem the rising tide of overdose deaths in the... Read More

Hormone Patches or Creams for Menopause Symptoms May Have Lower Blood Pressure Risk Than Pills

WASHINGTON (AP) — Women often use hormone therapy to relieve hot flashes and other menopause symptoms — and new research... Read More

WASHINGTON (AP) — Women often use hormone therapy to relieve hot flashes and other menopause symptoms — and new research suggests patches or creams may be safer for their blood pressure than pills. As women's bodies produce lower levels of... Read More

2023-05-31 17:36:11
by Dan McCue
FDA Proposes New, Easy-to-Read Medication Guide for Patients

WASHINGTON — The Food and Drug Administration wants to make it easier for patients to understand why they’ve been prescribed... Read More

WASHINGTON — The Food and Drug Administration wants to make it easier for patients to understand why they’ve been prescribed specific medications and how to ensure they don’t suffer any preventable adverse reactions when taking them. Toward that end the... Read More

2023-05-25 15:32:28
by Dan McCue
Administration Floats New Rules for Drug Cost Transparency

WASHINGTON — The Biden administration has proposed using new tools to monitor costs associated with prescription drugs so it can... Read More

WASHINGTON — The Biden administration has proposed using new tools to monitor costs associated with prescription drugs so it can hold pharma manufacturers accountable for what Medicaid programs pay for them. The Notice of Proposed Rule Making was made through... Read More

2023-05-15 17:28:13
by Dan McCue
Justices Refuse to Hear 'Skinny Label' Drug Patent Case

WASHINGTON — The Supreme Court on Monday declined to review a 2020 decision by the U.S. Circuit Court of Appeals... Read More

WASHINGTON — The Supreme Court on Monday declined to review a 2020 decision by the U.S. Circuit Court of Appeals for the Federal Circuit that resulted in Teva Pharmaceuticals being found liable for $235 million for infringing on a GlaxoSmithKline... Read More

Dying Patients Protest Looming Telehealth Crackdown

At age 93, struggling with the effects of a stroke, heart failure and recurrent cancer, Teri Sheridan was ready to... Read More

At age 93, struggling with the effects of a stroke, heart failure and recurrent cancer, Teri Sheridan was ready to end her life using New Jersey's law that allows medically assisted suicide -- but she was bedbound, too sick to... Read More

Abortion Pill Rulings in Conflict: What Happens Next?

WASHINGTON (AP) — The Texas case that could cut off access to the most commonly used abortion medication has started... Read More

WASHINGTON (AP) — The Texas case that could cut off access to the most commonly used abortion medication has started on a path through the legal system that could quickly lead to the Supreme Court. The drug, mifepristone, was approved... Read More

2023-04-03 20:11:43
by Dan McCue
Bill Aims to Protect Patient Access to Medication Information

WASHINGTON — A bill introduced by Rep. Jared Golden, D-Maine, aims to ensure that rural Americans and senior citizens have... Read More

WASHINGTON — A bill introduced by Rep. Jared Golden, D-Maine, aims to ensure that rural Americans and senior citizens have access to information about their prescription medications — even without internet access. “Many rural Mainers and seniors don’t have reliable... Read More

2023-03-20 20:55:40
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... Read More

2023-03-01 20:12:09
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... Read More

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... Read More

2022-12-14 20:48:42
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... Read More

2022-12-07 15:57:54
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,... Read More

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... Read More

2022-11-03 16:53:16
by Tom Ramstack
CVS, Walgreens and Walmart Settle Opioid Lawsuits for $13B

Drugstore retailers CVS Pharmacy and Walgreens on Wednesday announced a $10 billion settlement of thousands of state and local lawsuits... Read More

Drugstore retailers CVS Pharmacy and Walgreens on Wednesday announced a $10 billion settlement of thousands of state and local lawsuits accusing the companies of mishandling their sales of opioid painkillers. Walmart has tentatively agreed to pay another $3 billion to... Read More

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