FDA looks at incentives, manufacturing ‘interventions’ to solve drug shortages

The FDA will consider creating a list of “essential drugs” and financial incentives to drugmakers that manufacture them as it continues to grapple with the drug shortages that plague U.S. hospitals and caregivers.

Responding to lawmakers’ entities to find new solutions to an old problem, FDA Commissioner Scott Gottlieb, M.D., last week announced the formation of a new Drug Shortages Task Force and named Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives to lead it.

“I’m charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge,” Gottlieb said. “The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages.”

FDA

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Mylan Exelon generic drug has been approved to reduce the burden of Parkinson’s disease

Mylan announced the U.S. launch of Rivastigmine Transdermal System, 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, a generic version of Novartis’ Exelon® Patch. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer’s disease and the treatment of mild to moderate dementia associated with Parkinson’s disease.

mylanMylan President Rajiv Malik said,  “The launch of generic Exelon® Patch is another example of the investment Mylan is continuing to make into products that are difficult to develop and manufacture, particularly in transdermal drug-delivery systems. The launch of this product also strengthens the company’s growing central nervous system portfolio, which is a therapeutic area of continued focus for Mylan as we strive to provide better health for a better world.”

See more details on Mylan.

Gilead’s Kite taps Eisai cancer vet Amoroso to lead the charge for CAR-T sales

Just one month after naming a new head of corporate development, Gilead is beefing up its top management team again—this time plucking an oncology vet to head up its entrance into the burgeoning market for CAR-T cancer treatments.

Gilead unit Kite, which won FDA approval for the CAR-T drug Yescarta last year, has hired Michael Amoroso as SVP and head of worldwide commercial efforts in cell therapy. He’ll oversee sales and marketing, doctor and patient services, and “market access”—aka payer negotiations—Kite said in a Monday statement. Underscoring the Yescarta rollout’s importance, Amoroso will report directly to Gilead CEO John Milligan.

Gilead

HATU

HATU(2-(7-Aza-1H-Benzotriazole-1-yl)-1,1,3,3-TetramethyluroniumHexafluorophosphate) is a reagent used in peptide coupling chemistry to generate an active ester from a carboxylic acid. HATU is used along with Hünig’s base (N,N-diisopropylethylamine, DIPEA) to form amide bonds. Generally DMF is used as solvent, although other polar organic solvents can also be used.

CAS# 148893-10-1

Structure:

HATU
HATU

 

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Child ingests antipsychotic drug, leading Novartis to recall packages that don’t meet child safety rules

Novartis and its generics unit Sandoz are voluntarily recalling nearly half a million packages of medications after a child opened a “child-proof” blister pack and ingested a tablet of antipsychotic medication haloperidol.

The recall of 470,000 packages of a variety of drugs was announced Friday by the Consumer Product Safety Commission, which said, “The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.”

It didn’t say how, or if, the child was affected. A Novartis logo is pictured on its headquarters building in Mumbai

3,4,5-trichloro-pyrrole-2-carboxylic acid

Name: 3,4,5-trichloro-pyrrole-2-carboxylic acid

CAS# 1111085-36-9

Structure:

3,4,5-trichloro-pyrrole-2-carboxylic acid
3,4,5-trichloro-pyrrole-2-carboxylic acid

PLEASE NOTE:

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online

FDA Director Scott Gottlieb said in a statement that the Internet, although not the only channel for illegal prescription drug sales, has the most profound impact and poses unique challenges for technology companies, law enforcement agencies and the FDA. In the future, FDA will use big data solutions and artificial intelligence technologies to grasp the channels and locations for illegally selling prescription drugs through the Internet.

A crisis of this magnitude requires broad, collaborative and creative approaches. We’re especially aware that as we take more actions to curb the lawful prescribing of prescription opioids, our actions will inevitably push more and more people to obtaining opioids from illicit sources. And we know that digital drug dealers and other criminals are increasingly selling their illicit opioids through the internet, including social media and illegal online pharmacies. This activity is contributing to the public health emergency of opioid-related overdose deaths that have ripped apart families and communities. We (FDA) aim to confront these new threats.

See more details on U.S. Department of Health and Human Services