The FDA and DEA are warn­ing pa­tients to toss drugs pur­chased from two un­reg­is­tered phar­ma­cies ac­cused of il­le­gal­ly sell­ing Adder­all on­line.

Kubapharm.com and Pre­mi­um­lightssup­pli­er.com were both ac­cused of sell­ing am­phet­a­mine drugs mar­ket­ed as the AD­HD drug Adder­all with­out a pre­scrip­tion, ac­cord­ing to an FDA state­ment on Tues­day. The agency al­so claims the phar­ma­cies (which failed to reg­is­ter with the DEA) sold the med­ica­tion with­out the prop­er la­bel­ing.

As Adder­all has a high abuse po­ten­tial and “should on­ly be used un­der the su­per­vi­sion of a li­censed health­care pro­fes­sion­al,” the FDA re­quires the med­ica­tion to be sold with a black box warn­ing out­lin­ing the risks.

So far in 2022, the FDA has is­sued six warn­ing let­ters to var­i­ous on­line phar­ma­cies for the un­law­ful sale of drugs over the in­ter­net. How­ev­er, these two warn­ings were specif­i­cal­ly for the sale of Sched­ule II drugs — drugs des­ig­nat­ed by the DEA to have high po­ten­tial for abuse. Adder­all abuse, es­pe­cial­ly among stu­dents and young adults, has been a wide­spread is­sue for the past two decades.

As a re­sult of the Covid-19 pan­dem­ic, on­line phar­ma­cies grew sub­stan­tial­ly, and rogue phar­ma­cies fol­lowed. These il­le­git­i­mate phar­ma­cies ex­ploit­ed cus­tomers by sell­ing pur­port­ed Covid-19 treat­ments among oth­er med­ica­tions.

Out­side of Adder­all, both sites claim to sell var­i­ous oth­er drugs, in­clud­ing anx­i­ety med­ica­tion Xanax. Con­sumers should toss any med­ica­tions pur­chased from these sites, the FDA said.

“The il­le­gal sale of pre­scrip­tion drug stim­u­lants on­line puts Amer­i­cans at risk and con­tributes to po­ten­tial abuse, mis­use and over­dose,” FDA Com­mis­sion­er Robert Califf said in the press re­lease. “These par­tic­u­lar types of on­line phar­ma­cies al­so un­der­mine our ef­forts to help con­sumers safe­ly pur­chase le­git­i­mate pre­scrip­tion med­i­cines over the in­ter­net.”

The let­ters were is­sued on March 30, and ac­cord­ing to the FDA, the web­sites will have 15 days to re­spond with spe­cif­ic steps for ad­dress­ing their vi­o­la­tions.

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.