Pharmacist Digest

FDA Guidance on Continuous Manufacturing of Drug Substances and Drug Products

Big Molecule Watch

APRIL 24, 2023

In March 2023, the FDA issued a final guidance , titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products” that describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).”

Biosimilars

Why reshoring drug production means embracing continuous manufacturing

pharmaphorum

AUGUST 12, 2022

The COVID-19 pandemic led to skyrocketing demand for some products while simultaneously constraining supplies due to logistical breakdowns and protectionist practices. The logic of outsourcing production to other countries, primarily China, suddenly looked dubious as Western countries struggled to import the drugs they needed.

Packaging

Packaging Drug Development

Advancing OSD: Continuous Production Considerations and Dose-Level Authentication

PharmaTech

SEPTEMBER 29, 2022

Thursday, September 28, 2022 at 11am ET | 10am CT | 8am PT Learn the key benefits of continuous OSD production as well as the importance of authenticating OSD products at the dose-level with experts from Syntegon and Colorcon in this episode of the PharmTech Drug Digest Video Series.

Pharmaceutical Continuous Manufacturing: Right for some products, but not all, and hurdles abound – workshop

Quality Matters

SEPTEMBER 15, 2023

For certain drug substance and drug product manufacturing processes, PCM can bring opportunities to enhance flexibility and efficiency, lower production costs, cut environmental footprints, accelerate scale-up when needed, improve process control, and reduce potential quality issues, workshop participants reported.

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Dosage

STAT+: FDA clears first over-the-counter continuous glucose monitor

STAT

MARCH 5, 2024

For the first time, anyone in the United States will soon be able to buy a continuous glucose monitor without a prescription. The Food and Drug Administration authorized Dexcom on Tuesday to start selling a new product, called the Stelo, to adults who do not use insulin. The product is scheduled to hit the market this summer.

Diabetes

Opinion: As livestock move around the country, so does H5N1. The U.S. needs real-time tracking of livestock movements

STAT

MAY 7, 2024

dairy production, which accounts for 3.5% ’s gross domestic product, had each reported H5N1 cases in dairy cows and continue to do so. By then, H5N1 had likely been circulating among dairy cows for months. Six weeks later, the nine states responsible for more than one-quarter of U.S. of the U.S.’s

Drug Digest: Advancing OSD: Continuous Production Considerations and Dose-Level Authentication

PharmaTech

OCTOBER 5, 2022

Pharmaceutical Technology editors interview oral solid dosage development experts from Syntegon and Colorcon, with discussions centered on continuous OSD production, containment safety, and authentication at the dose level.

Dosage

STAT+: A nonprofit does deals in Brazil and India to make low-cost CAR-T cell therapies widely available

STAT

MAY 8, 2024

“But we’re not offering the same products that are approved for elsewhere. These are novel products, because we have the knowledge to make CAR-T therapies.” ” Continue to STAT+ to read the full story… These are not generic versions. There are no patents protecting anybody from making these.

STAT+: As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’

STAT

MARCH 18, 2024

One such case occurred last year, when a wave of Humira biosimilars entered the market and drug companies slashed the list prices of their insulin products. Continue to STAT+ to read the full story…

Opinion: STAT+: A year in, the U.S. is still not taking advantage of lower-cost biosimilars for Humira

STAT

FEBRUARY 14, 2024

These nine FDA-approved products offer lower-cost alternatives to the world’s bestselling drug, Humira , used to treat rheumatoid arthritis, Crohn’s disease, and other autoimmune disorders. Continue to STAT+ to read the full story… This made 2023 a watershed year for millions of U.S.

Biosimilars

STAT+: FDA investigating whether CAR-T, a treatment for cancer, can also cause lymphoma

STAT

NOVEMBER 28, 2023

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a statement.

Hospitals

STAT+: Why FDA product recalls have spiked in recent years

STAT

DECEMBER 14, 2023

Either American products are getting worse, or scrutiny over their safety is getting tougher. The increase in recalls started in 2019 and continued growing steadily during and after the pandemic, reaching a peak in 2022. That year, more than 600 products were recalled by the two agencies, compared to 280 in 2018.

Large amount of bird flu virus in milk suggests asymptomatic cows are infected with H5N1

STAT

MAY 8, 2024

But in recent weeks, studies have found genetic traces of H5N1 in a large percentage of commercial milk products. All the evidence generated to date indicates that pasteurization is effective at inactivating H5N1 in milk , though the FDA continues to study the issue. Read the rest…

STAT+: Payments by drug and device makers to doctors remain widespread, but also vary considerably

STAT

MARCH 28, 2024

And 94% of those payments were associated with at least one marketed medical product. Among the products for which the most payments were made included blood thinners and a robotic surgical system. Continue to STAT+ to read the full story… billion to approximately 826,300 physicians.

STAT+: Pharmalittle: We’re reading about FDA dithering on pharma patents, WHO pandemic talks, and more

STAT

MAY 13, 2024

The world, such as it is, continues to spin. For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency registry.

Diabetes

STAT+: J&J sues former employee for allegedly taking thousands of documents to a new job at Pfizer

STAT

MARCH 20, 2024

This unit within J&J is responsible for creating and formulating competitive strategies for J&J’s products through their lifecycle. Continue to STAT+ to read the full story… Brackbill, who joined J&J in the finance department in 1999, joined this group in 2021.

Documentation

STAT+: GSK is replacing its popular Flovent inhaler with authorized generics, raising cost concerns for asthma patients

STAT

JANUARY 5, 2024

Flovent’s manufacturer, GSK, has discontinued both versions of the product — Flovent HFA, an inhalation aerosol, and Flovent Diskus, an inhalation powder — and replaced each with what is known as an “ authorized generic ,” essentially the same product sold under a private label. Prasco, a U.S.

Labelling

Labelling Drug Pricing

STAT+: FDA cracks down on websites that claim to sell chemicals in obesity drugs Wegovy, Zepbound

STAT

FEBRUARY 15, 2024

The Food and Drug Administration is cracking down on websites that claim to sell the underlying chemicals of popular diabetes and obesity drugs like Ozempic, Wegovy, and Zepbound, saying that the websites are selling unapproved and misbranded drug products. Continue to STAT+ to read the full story…

Diabetes

STAT+: Biden invokes Defense Production Act to stem drug shortages

STAT

NOVEMBER 28, 2023

It’s based on a law, the Defense Production Act, that lets the government require private companies to make materials deemed necessary for national defense, in this case essential medicines and medical countermeasures. Continue to STAT+ to read the full story…

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Hospitals

STAT+: Novo Holdings to purchase drug manufacturer Catalent for $16.5 billion, a deal that could expand Wegovy production

STAT

FEBRUARY 5, 2024

billion deal, an acquisition that will give Novo additional sites as it builds up production of its booming obesity and diabetes drugs. Catalent has been involved in the production of Novo’s obesity treatment Wegovy. Continue to STAT+ to read the full story…

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies

STAT+: Lilly’s weekly insulin works as well as daily products, new studies show

STAT

MAY 16, 2024

Eli Lilly reported Thursday that its experimental weekly insulin worked as well as daily basal insulin products in two late-stage studies, paving the way for the drug to compete with a similar weekly insulin developed by Novo Nordisk. Continue to STAT+ to read the full story…

Diabetes

Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability

STAT

FEBRUARY 13, 2024

The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate Division of California Appeals held that companies not only have to defend products they have developed and marketed, but also those they have not. Continue to STAT+ to read the full story…

Drug Development

STAT+: FDA is criticized for taking a ‘ministerial’ role in sorting out some pharma patents

STAT

MAY 13, 2024

For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency registry. Continue to STAT+ to read the full story…

Diabetes

STAT+: Digital tools for diabetes management did not deliver benefits that justify cost, new report finds

STAT

MARCH 21, 2024

Despite finding that some populations may benefit, the report concludes that current evidence doesn’t support broader adoption for most products. Continue to STAT+ to read the full story…

Diabetes

STAT+: Amy Abernethy to step down as Verily’s chief medical officer in latest departure from company

STAT

DECEMBER 19, 2023

Amy Abernethy, the president of product development and chief medical officer at Verily, a health care spinout of search giant Alphabet, will leave the company at the end of the first quarter to start a nonprofit aimed at changing the way the health care system collects data. Continue to STAT+ to read the full story…

STAT+: Software glitch caused Tandem insulin pumps to prematurely shut down, FDA warns

STAT

MAY 8, 2024

The product is made by Tandem Diabetes Care, which sells touchscreen insulin pumps and an accompanying app to help dose the medicine. ” Continue to STAT+ to read the full story… Around 300,000 people use the technology. to a dead pump. “Infuriating,” the user wrote.

Diabetes

Diabetes Communication

STAT+: Can gene therapies make for a profitable business? Keep your eye on Bluebird Bio

STAT

FEBRUARY 1, 2024

Bluebird and the case for gene therapy profits Genetic treatments that are potential cures for inherited diseases are a huge medical advance, but can these transformational (and expensive) products become a profitable business? The other products are Zynteglo for beta thalassemia ($2.8 million), Bluebird sells three gene therapies.

STAT+: HCA to expand the use of AI tool to automate clinical documentation in ER

STAT

APRIL 24, 2024

“The whole goal here was to develop a product that was affordable so that HCA can deploy it across their entire system, their entire network,” Augmedix CEO Manny Krakaris told STAT. Continue to STAT+ to read the full story…

Documentation

Documentation Hospitals

STAT+: FDA warns medical device makers about rise in fabricated data

STAT

FEBRUARY 20, 2024

The data comes from third-party labs hired by device firms to test the quality of their products. Continue to STAT+ to read the full story… An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning.

STAT+: Abbott’s dissolvable stent, which failed in heart disease patients, may help vascular patients

STAT

MAY 15, 2024

But the company voluntarily pulled the product from the market just over a year later due to “low commercial uptake.” Continue to STAT+ to read the full story… Abbott’s first dissolvable stent, for coronary artery disease, received Food and Drug Administration approval in 2016.

Philips, maker of millions of defective sleep apnea machines, ordered to overhaul manufacturing

STAT

APRIL 9, 2024

WASHINGTON — The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. The company must also continue to replace, repair, or provide refunds to all U.S. Department of Justice. customers who got the defective devices, the department said. Read the rest…

STAT+: Major generic maker Aurobindo cuts production at a key plant amid concerns over shortages

STAT

FEBRUARY 9, 2024

Aurobindo, which is one of the largest generic drug makers, has halted some production at a key facility in India after U.S. 2, prompted Aurobindo to temporarily halt manufacturing on an undisclosed number of production lines. Continue to STAT+ to read the full story… The inspection, which ended on Feb.

STAT+: Drug supplies for millions would be jeopardized by U.S. crackdown on China biopharma industry, trade group says

STAT

MAY 9, 2024

Biotechs hire Chinese CDMOs, as they’re often called, for services that include product manufacturing, development, formulation, packaging, and distribution. Continue to STAT+ to read the full story… federal government.

Packaging

STAT+: As AI marches into medicine, investors eye security, privacy startups

STAT

MARCH 18, 2024

Investors are starting to back startups that offer privacy and security services to bolster health AI products already on the market while they wait for crucial safety and privacy regulations to take shape. Continue to STAT+ to read the full story…

Hospitals

STAT+: FDA’s Peter Marks seems inclined to grant full approval to Sarepta’s Duchenne gene therapy

STAT

JANUARY 9, 2024

“Hypothetically, if you had a product that used an aggregate scale and all of the components of that aggregate scale looked pretty good, or nearly all of them look pretty good, but the aggregate, for various reasons, didn’t come out perfectly. We approved products based on that,” Marks told me.

STAT+: Delay of eye drop recall highlights FDA’s impotence on the issue

STAT

NOVEMBER 21, 2023

WASHINGTON — It took nearly three weeks for a maker of eye drops to recall its products after the Food and Drug Administration requested a recall. FDA inspectors found unsanitary conditions at a facility in India that makes over-the-counter eye drop products that multiple U.S. Continue to STAT+ to read the full story…

STAT+: Gilead gets a boost from California court in a case over slow-walking an HIV drug

STAT

MAY 2, 2024

The argument advanced a novel theory that focused on the behind-the-scenes decision over product development rather than more typical claims that harm from a medicine was due to a side effect. Continue to STAT+ to read the full story…

Documentation

STAT+: Ultima Genomics launching high-end DNA sequencers that can read genome for $100

STAT

JANUARY 30, 2024

The company plans to officially launch the product at this year’s Advances in Genome Biology and Technology meeting, which kicks off in Orlando, Fla., Continue to STAT+ to read the full story…

STAT+: Amid layoffs and a hit to earnings, Bristol’s new CEO shares his vision for the future

STAT

APRIL 25, 2024

billion, meaning product sales did well but the deals hurt earnings more than expected. Continue to STAT+ to read the full story… Its quarterly loss was negatively impacted by costs from the deals, coming in at $5.89 per share according to generally accepted accounting principles, or $4.40 per share, on an adjusted basis.

STAT+: FDA chief scientist to replace Woodcock

STAT

NOVEMBER 29, 2023

The chief scientist works closely with the FDA’s product centers, and Bumpus played a big role in the expansion of the agency’s regulation of cosmetics. Continue to STAT+ to read the full story… Namandjé N. Bumpus was named chief scientist in June of last year.

STAT+: More drug and device patents were invalidated for bad info than those filed by other industries, analysis finds

STAT

NOVEMBER 15, 2023

Of those 36 cases, two-thirds involved 34 patents that covered medical products regulated by the FDA. Overall, there were more invalidated patents for products approved by the FDA than other types of products, such as cable modems, electric lighting, automobile multimedia systems, and magnetic purse clasps.

STAT+: Diabetes treatments have improperly listed patents that should be removed, analysis finds

STAT

FEBRUARY 5, 2024

As a result, the researchers contend the patents may be unfairly used to preclude competition from companies that may want to market lower-cost generic products. A total of 188 patents were examined for 10 combination products that include a delivery device and a medicine known as a GLP-1.

Diabetes

Opinion: STAT+: Continuous manufacturing can help pharma companies save time, money, and more

STAT

JANUARY 6, 2023

I’m talking about continuous manufacturing. Continuous manufacturing produces a drug product from start to finish through a nonstop, integrated assembly. Continue to STAT+ to read the full story…

Drug Development

Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

PharmaTech

MARCH 6, 2023

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

FDA Guidance on Continuous Manufacturing of Drug Substances and Drug Products

Why reshoring drug production means embracing continuous manufacturing

Trending Sources

Advancing OSD: Continuous Production Considerations and Dose-Level Authentication

Pharmaceutical Continuous Manufacturing: Right for some products, but not all, and hurdles abound – workshop

STAT+: FDA clears first over-the-counter continuous glucose monitor

Opinion: As livestock move around the country, so does H5N1. The U.S. needs real-time tracking of livestock movements

Drug Digest: Advancing OSD: Continuous Production Considerations and Dose-Level Authentication

STAT+: A nonprofit does deals in Brazil and India to make low-cost CAR-T cell therapies widely available

STAT+: As Humira biosimilars take over the market, CVS has created a new ploy: the drug ‘rebate credit’

Opinion: STAT+: A year in, the U.S. is still not taking advantage of lower-cost biosimilars for Humira

STAT+: FDA investigating whether CAR-T, a treatment for cancer, can also cause lymphoma

STAT+: Why FDA product recalls have spiked in recent years

Large amount of bird flu virus in milk suggests asymptomatic cows are infected with H5N1

STAT+: Payments by drug and device makers to doctors remain widespread, but also vary considerably

STAT+: Pharmalittle: We’re reading about FDA dithering on pharma patents, WHO pandemic talks, and more

STAT+: J&J sues former employee for allegedly taking thousands of documents to a new job at Pfizer

STAT+: GSK is replacing its popular Flovent inhaler with authorized generics, raising cost concerns for asthma patients

STAT+: FDA cracks down on websites that claim to sell chemicals in obesity drugs Wegovy, Zepbound

STAT+: Biden invokes Defense Production Act to stem drug shortages

STAT+: Novo Holdings to purchase drug manufacturer Catalent for $16.5 billion, a deal that could expand Wegovy production

STAT+: Lilly’s weekly insulin works as well as daily products, new studies show

Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability

STAT+: FDA is criticized for taking a ‘ministerial’ role in sorting out some pharma patents

STAT+: Digital tools for diabetes management did not deliver benefits that justify cost, new report finds

STAT+: Amy Abernethy to step down as Verily’s chief medical officer in latest departure from company

STAT+: Software glitch caused Tandem insulin pumps to prematurely shut down, FDA warns

STAT+: Can gene therapies make for a profitable business? Keep your eye on Bluebird Bio

STAT+: HCA to expand the use of AI tool to automate clinical documentation in ER

STAT+: FDA warns medical device makers about rise in fabricated data

STAT+: Abbott’s dissolvable stent, which failed in heart disease patients, may help vascular patients

Philips, maker of millions of defective sleep apnea machines, ordered to overhaul manufacturing

STAT+: Major generic maker Aurobindo cuts production at a key plant amid concerns over shortages

STAT+: Drug supplies for millions would be jeopardized by U.S. crackdown on China biopharma industry, trade group says

STAT+: As AI marches into medicine, investors eye security, privacy startups

STAT+: FDA’s Peter Marks seems inclined to grant full approval to Sarepta’s Duchenne gene therapy

STAT+: Delay of eye drop recall highlights FDA’s impotence on the issue

STAT+: Gilead gets a boost from California court in a case over slow-walking an HIV drug

STAT+: Ultima Genomics launching high-end DNA sequencers that can read genome for $100

STAT+: Amid layoffs and a hit to earnings, Bristol’s new CEO shares his vision for the future

STAT+: FDA chief scientist to replace Woodcock

STAT+: More drug and device patents were invalidated for bad info than those filed by other industries, analysis finds

STAT+: Diabetes treatments have improperly listed patents that should be removed, analysis finds

Opinion: STAT+: Continuous manufacturing can help pharma companies save time, money, and more

Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products

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