Quick Hits: Questions Over Accelerated Approval and Availability of Drugs Under Expanded Access

Quick Hits: Questions Over Accelerated Approval and Availability of Drugs Under Expanded Access

A new study is questioning whether accelerated approvals for cancer drugs have benefitted patients. In 2012, Congress approved legislation that included the Breakthrough Therapy (BT) Program, in which promising drugs for serious or life-threatening diseases receive an expedited review and approval process. Researchers analyzed the efficacy and safety of cancer drugs approved through the […]

Key marijuana drug approval looms as cannabis goes mainstream

Key marijuana drug approval looms as cannabis goes mainstream

By Ben Hirschler LONDON (Reuters) – Evidence that cannabis can ease epilepsy and other conditions is building as a British company counts down to what would be the first U.S. government approval for a prescription drug derived from the marijuana plant. GW Pharmaceuticals <GWPH.O>, which has spent 20 years developing medicines from cannabis, is hoping […]

Recon: Rising Insulin Prices Spark Outrage; Six Biotechs Raise $568M in IPOs

Recon: Rising Insulin Prices Spark Outrage; Six Biotechs Raise $568M in IPOs

Posted 21 June 2018 | By Ana Mulero  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Skyrocketing insulin prices provoke new outrage (The Hill) The ‘Right to Try’ Could Cost Dying Patients a Fortune (Bloomberg) (Endpoints) (Fierce) (STAT) Novo Nordisk’s ‘sema’ whips Merck’s diabetes drug […]

Novo Nordisk Stock Pops Nearly 3% on Positive Diabetes-Drug Results

Novo Nordisk Stock Pops Nearly 3% on Positive Diabetes-Drug Results

Novo Nordisk A/S (NVO) is having one of its best days in more than two months, with shares popping 2.58% — their highest percentage gain since May 2 — shortly after the market opened Thursday. NOV added $1.18 to $46.83 after Novo Nordisk released positive late-stage test results for two drugs designed to treat diabetes. The drugs, […]

California Poised To Expand Access To Hepatitis C Drugs

California Poised To Expand Access To Hepatitis C Drugs

Patrick Garcia wasn’t completely surprised when he learned recently he had hepatitis C. Until a few years ago, he had experimented with numerous drugs, injecting heroin, methamphetamine, cocaine — you name it. “I haven’t lived exactly a perfect life,” said Garcia, 43, whose mouth, hand and back were injured in a motorcycle wreck last year. […]

Here's a plan to fight high drug prices that could unite libertarians and socialists

Here's a plan to fight high drug prices that could unite libertarians and socialists

President Donald Trump and Secretary of Health and Human Services Alex Azar recently introduced American Patients First, a complicated plan intended to make prescription drugs more affordable. It includes many ideas and suggestions, such as requiring drug makers to put the list prices of their products in their advertisements and “working across the administration to […]

Semro column: A very mixed bag on drug prices

Semro column: A very mixed bag on drug prices

This story begins with a broken promise. In 2016, then candidate Donald Trump made the campaign promise to reduce drug costs by allowing Medicare to negotiate prices. It’s a good idea. In 2016, 56.8 million Americans were enrolled in Medicare and 43.2 million were enrolled in Medicare Part D, the prescription drug benefit. That’s a […]

Your Health: The growing case against IV Tylenol, once seen as a solution to the opioid crisis

Your Health: The growing case against IV Tylenol, once seen as a solution to the opioid crisis

In the midst of the opioid crisis, Boston Medical Center added an intravenous version of Tylenol to its arsenal of drugs for pain management. But IV Tylenol was expensive, and after drugmaker Mallinckrodt Pharmaceuticals increased the price, the hospital projected it was on track to spend $750,000 in 2015 on acetaminophen (the active ingredient in […]

Many Drugs Made Available via FDA Expanded Access Programs

Many Drugs Made Available via FDA Expanded Access Programs

Half of meds ID’d in expanded access programs treat cancer; others for metabolic, endocrine diseases. HealthDay News — Over the past 2 decades, close to 100 US Food and Drug Administration (FDA)-approved drugs and biologics were made available before FDA approval through expanded access programs, according to a study published online June 15 in JAMA […]

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