As the issues of the Roe V. Wade ruling continue to ripple through various circles, including the biotech world, a manufacturer seeks to push back against state law.
According to a report by Bloomberg BNN, Mifepristone maker GenBioPro is seeking to challenge a Mississippi anti-abortion law set in motion by the U.S. Supreme Court’s overturning of Roe v. Wade, stating that this decision prevents his product from selling.
While Mississippi’s trigger law pledged to ban most abortions, it includes abortions that rely on FDA-approved pills such as mifepristone.
GenBioPro is now amending its 2020 lawsuit it filed in Mississippi with the state to address the trigger law. The case attempts to push back on Mississippi’s mifepristone restrictions, which were in effect before the Roe V. Wade ruling, contradict FDA regulations on the pill.
The company argues that the FDA’s dispensing and prescribing regulations for the pill prevent state requirements, including having a licensed physician prescribe the drug in person.
North Carolina-based API maker to expand capabilities
Pisgah Laboratories, a pharmaceutical manufacturer and a subsidiary of India’s Ipca Laboratories, will invest $55 million to expand its manufacturing product line and create 57 new jobs in eastern North Carolina.
According to the North Carolina governor’s office, the site initially began producing x-ray film dyes and agrochemicals. The company received FDA approval to manufacture APIs in 2002 before exclusively developing pharmaceuticals in 2005. Pisgah manufactures the active ingredients for painkillers and the treatment of disorders and diseases, such as Alzheimer’s disease and fibromyalgia.
The expansion will also add sterile injectables, liquid filling operations and a quality control lab, warehouses and microbiological labs.
“Our parent company, Ipca Laboratories Limited, is investing heavily in the future of Pisgah. Carving out a place in the highly competitive pharmaceutical market is no easy task, but we welcome the challenge and intend to see many years of business growth, job creation and business opportunities. education for Pisgah Labs and western North Carolina,” said site manager Dani Bailey.
The site also received a $50,000 performance-based grant from the One North Carolina Fund, which provides financial assistance to local governments to help attract economic investment and create jobs. Businesses do not receive upfront money and must meet job creation and capital investment goals to be eligible for payment.
Indian pharmaceutical companies recall products in the United States due to manufacturing problems
Sun Pharma and Glenmark, two generic drug makers, issued a recall for manufacturing issues.
According to a report by Ferocious Pharma, On June 21, Sun Pharma initiated a voluntary recall of 50,680 testosterone cypionate injection vials due to a “water leak” at a factory in Gujarat, India.
Glenmark has recalled more than 98,307 packets of mometasone furoate topical solution, a lotion that treats skin conditions such as eczema, psoriasis, allergies and rashes. Glenmark initiated the recall on June 16.
The problem for Glenmark was faulty packaging at its factory in Himachal Pradesh, India.
Precision NanoSystems and Replicate Bioscience enter licensing agreement to develop genomic drug manufacturing
Precision NanoSystems (PNI) and Replicate Bioscience seek to enter into a licensing agreement to accelerate the creation, scale and delivery of self-replicating RNA (srRNA) therapies.
The agreement will see PNI provide lipid nanoparticle solutions for scaling and manufacturing of up to 15 replicated rRNA therapies. The terms include aggregate milestone fees, royalties and sub-licensing for revenue sharing, but the company remained mum on the broader details.
“I have confidence in PNI’s delivery technology and in our working relationship. With this agreement, Replicate aims to significantly expand our portfolio of rRNA therapies beyond our lead candidates which are expected to enter human trials next year,” said Andy Geall, Chief Development Officer of Replicate.
The agreement will also allow Replicate to explore more drug candidates in areas beyond the company’s core programs, which address resistance to hormone therapy in breast cancers, resistance to immunotherapy in solid tumors and possibly future pandemics.