FDA ordered to ramp up unannounced foreign inspections

The omnibus spending bill recently signed by President Joe Biden directs the FDA to expand unannounced foreign facility inspections and evaluate them through a new pilot program.

The legislation includes $10 million for the program and a mandate to increase unannounced surveillance inspections of foreign drug establishments, Regulatory Focus reports.

The legislation also directs the FDA to evaluate “the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.”

More specifically, the pilot program will evaluate significant differences between announced and unannounced inspections of foreign drug facilities, with a particular focus on differences in the number and type of violations of the Federal Food, Drug, and Cosmetic Act.

The pilot program will also evaluate, per t…

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Agilent spends $725M to expand manufacturing

Agilent recently announced that it plans to double its manufacturing capacity of therapeutic nucleic acids.

The $725 million investment will go toward the Santa Clara, California–based company’s Frederick, Colorado facility. The Colorado plant will get new Train C and D manufacturing lines. The facility already has a Train B manufacturing line, announced in 2020, that will go live later this year.

The expanded facility will include advanced automation and engineering enhancements such as water reduction and solvent capturing and recycling.

Therapeutic nucleic acids represent a rapidly growing $1 billion market, according to Agilent. In addition, there is strong demand for the company’s high-quality active pharmaceutical ingredients (API). The new lines in Colorado will enable the company to meet growing demand for siRNA, antisense and CRISPR guide RNA molecules. Agilent expects customer shipments from the expansion to start in 2026.

“This in…

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Agilent spends $725M to expand manufacturing

Agilent recently announced that it plans to double its manufacturing capacity of therapeutic nucleic acids.

The $725 million investment will go toward the Santa Clara, California–based company’s Frederick, Colorado facility. The Colorado plant will get new Train C and D manufacturing lines. The facility already has a Train B manufacturing line, announced in 2020, that will go live later this year.

The expanded facility will include advanced automation and engineering enhancements such as water reduction and solvent capturing and recycling.

Therapeutic nucleic acids represent a rapidly growing $1 billion market, according to Agilent. In addition, there is strong demand for the company’s high-quality active pharmaceutical ingredients (API). The new lines in Colorado will enable the company to meet growing demand for siRNA, antisense and CRISPR guide RNA molecules. Agilent expects customer shipments from the expansion to start in 2026.

“This in…

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Baxter may look to sell off BioPharma business

Baxter (NYSE:BAX) today unveiled a strategic roadmap for its future that includes potential plans for its BioPharma Solutions (BPS) business.

The company’s plans include a simplified commercial and manufacturing footprint, according to a news release. The company also intends to improve its capital structure. That includes a review of strategic alternatives for its BioPharma Solutions (BPS) business.

Baxter’s plans for the BPS business include a potential sale or other separation options.

The BPS business provides contract manufacturing services to the pharma and biotech industries. Baxter said it has continued opportunities for growth, but the BPS business holds a limited alignment with the rest of its portfolio. A potential sale or other transaction could help Baxter streamline its focus, it said.

Get the full story at our sister site, MassDevice.

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Making sense of the Adderall shortage

[Image courtesy of Wikimedia Commons]

In the latter part of 2022, a widespread shortage of Adderall (amphetamine and dextroamphetamine) left millions of patients to contend with withdrawal symptoms or find an alternative treatment strategy. 

A Sermo survey found that about half of 348 physicians had encountered patients dealing with the Adderall shortfall.  

More than eight out of ten, 82%, were concerned about the impact of the shortage on adult patients’ quality of life, jobs and relationships. Slightly more, 87% of physicians were worried about the effects of the shortage on children with ADHD and their parents. 

Reasons for the Adderall shortage

Making sense of the situation remains challenging. The Drug Enforcement Administration (DEA), which limits the production of Adderall and its generics, is concerned that aggressive marketing practices contributed to the shortage, according to W…

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Athenex to layoff 92 workers as it closes New York plant

The biotech Athenex (Nasdaq:ATNX) plans to close a facility in Clarence, New York, by March 17, according to a notice from the New York State Department of Labor. It will cut 92 jobs in the process.

The company also noted it would close its 503B sterile compounding business to focus on cell therapy. In the third quarter of 2022, the unit was responsible for roughly 19% of its product sales.

ATNX shares were up 17.90% to $0.17.

On February 5, 2021, its shares traded at $14.00.

Complete response letter from FDA

One factor driving its share price lower was a complete response letter (CRL) from the FDA in March 2022 for its New Drug Application (NDA) for oral paclitaxel with encequidar to treat metastatic breast cancer.

The company’s oral paclitaxel formulation also recently failed to win regulatory approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for metastatic breast cancer as a result of Chemistry, Manufactur…

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10 prominent drugs recalled over nitrosamines

[ProjectManhattan, CC BY-SA 3.0, via Wikimedia Commons]

In recent years, a number of drug companies have carried out prominent recalls of hypertension, heartburn and diabetes medications due to the presence of nitrosamines, organic compounds shown to cause cancer in animal studies.

The problem could cost Big Pharma companies billions of dollars, but proving the cancer-causing role of nitrosamines in drugs may be difficult. (Note: Nitrosamines are also in a host of processed foods, including cured meats.)

Morgan Stanley had estimated that the presence of nitrosamines in Zantac, once the best-selling drug in history, could cost GSK, Sanofi and Pfizer between $10.5 billion to $45 billion in trial judgments. But U.S. District Judge Robin Rosenberg dismissed claims related to the matter, questioning plaintiffs’ reasoning in interpreting the data linking nitrosamines in Zantac with cancer.

Nevertheles…

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Why Servblock is still banking on blockchain for pharma and biotech

In recent years, interest in blockchain distributed ledger technology has crescendoed and crashed. Boosters of the technology proclaimed that it could revolutionize everything from the pharma supply chain to business contracts. However, critics lamented that the technology often appeared like an expensive solution in search of a problem.

“There’s been a lot of false promises around blockchain technology and what it can do,” acknowledged John Ward, CEO of the Dublin-based blockchain company ServBlock focused on the biotech and pharmaceutical sector. “Blockchain is probably not going to save the world,” Ward said.

The recent wave of backlash against cryptocurrency, and by extension blockchain and other distributed ledger technologies, could offer clarity, Ward said. Or, to cite the analyst firm Gartner, the crash of blockchain into the so-called “Trough of Disillusionment” could pave the way for more rational applications…

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HHS to offer Tamiflu doses from national stockpile

[Image courtesy of Wikimedia Commons]

The U.S. Department of Health and Human Services (HHS) has announced that it would provide the prescription flu treatment Tamiflu (oseltamivir phosphate) to jurisdictions with an elevated demand for the antiviral during the flu season.

The move would make millions of treatment courses available.

Roche is the developer of Tamiflu. Several generics are also available for the drug.

The U.S. government stores the antiviral in its Strategic National Stockpile (SNS), containing antibiotics, life-support medications, airway maintenance supplies and other medical items.

HHS notes that jurisdictions will work with the Administration for Strategic Preparedness and Response (ASPR) regional teams, who will evaluate requests for the antiviral.

The news comes as supplies of Tamiflu have dwindled. In addition, the U.S. has also encountered shortages of the AD…

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Scorpion Biological Services changes name to Scorpius BioManufacturing post-expansion

The contract development and manufacturing organization (CDMO) Scorpion Biological Services will adopt the name Scorpius BioManufacturing after unveiling expanded manufacturing capabilities earlier this year. The company opened a new biomanufacturing facility in San Antonio in October. Scorpius will be headquartered in the same city.

A string of companies have also changed their name in 2022.

The smoking cessation firm Respira became Qnovia. Adagio changed its name to Invivy

CytRx became LadRx. Bone Therapeutics turned into BioSenic.

Scorpius opted to adopt a new name that “better defines our focus and full-service offering,” explained David Halverson, Scorpius president, in a news release.

In addition to its CDMO offerings, the biologics-focused company also is a contract research organization (CRO).

The company can “take our clients’ biologic innovations through the clinic to commercialization,” Halverson said.

“We have long…

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Catalent to invest $40M in biologics facility in Durham, North Carolina

Contract manufacturing giant Catalent has announced that it will set up a new biologics analytical center of excellence in North Carolina’s Research Triangle.

The new plant will offer analytical development and testing services for biologics, including cell and gene therapies.

Catalent obtained a Job Development Investment Grant (JDIG) from the North Carolina Economic Investment Committee (EIC) to provide 201 new jobs over the next five years in Durham County.

It anticipates that construction of the facility will be completed by mid-2023.

Catalent also operates a biologics and analytical center of excellence in Kansas City, Missouri. The company has committed $12 million to expand that facility.

Earlier this month, the company announced that it had opened a sizeable commercial-scale cell therapy manufacturing facility in Gosselies, Belgium.

Additionally, it expanded a clinical supply facility in Shanghai while laying off about 600 wo…

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MasterControl raises $100M to support its quality and manufacturing software

MasterControl (Salt Lake City) today announced a $150 million Series A round led by Sixth Street Growth, with a company valuation of $1.3 billion.

The money raised will accelerate the development of its quality and manufacturing software as a service offerings serving life sciences customers. MasterControl’s customers include such giants as Pfizer, Cochlear and Thermo Fisher Scientific. It says it has more than 1,100 customers worldwide, including 50 of the top pharma and medical device customers.

Up until this point, the privately held company had bootstrapped its way up to more than $100 million in annual revenue.

Get the full story on our sister site, Medical Design & Outsourcing.

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