Pharmaceutical Processing World Archives - Page 7 of 64

HHS awards more than $1 billion to advance next-gen COVID-19 vaccines and therapeutics

The U.S. Department of Health and Human Services (HHS) has awarded $1.4 billion to support vaccine clinical trials to test new, more effective and longer-lasting COVID-19 vaccines. In all, Project NextGen is a $5 billion initiative from Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the program is to identify and address strengths and weaknesses of current COVID-19 therapies and vaccines, as well as the back the development of next-gen COVID-19 vaccines and therapies

The latest funding announcement announced allots $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody and another $100 million to spark innovation of novel vaccine and therapeutic technologies.

Towards next-gen COVID-19 vaccines and therapies

Regeneron alone received $326 million under the program, dubbed Project NextGen. The funding for the Tarrytown, New York–bas…

Biopharma talent wars heat up as openings spike in 2023

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The biopharma industry had a lull in job opening growth from late 2022 and into early 2023. At that time, some early stage companies struggled to secure funding, while larger firms adopted a more cautious posture, according to recent research from the global real-estate firm JLL. Madeline Holmes, a senior research analyst at the company, noted, “Job Openings was something that we looked into as a metric of potential future growth.”

While biopharma layoffs remain a common occurrence, a turnaround could be underway — at least for bigger well-heeled players. The appetite for life sciences talent has ramped up since March of this year. June 2023 marked the sixth highest number of biopharma job openings in any month on record, in line with peaks in 2022. Year-over-year, June postings rose 11%.

Holmes provided some geographical context, noting that Massachusetts saw the most b…

Arizona Senator Sinema champions Phoenix Medical Quarter

Kyrsten Sinema (left) with Sharon Harper (right), CEO and co-founder of Plaza Companies, at a Creighton University/Phoenix Medical Quarter event. Harper’s firm specializes in developing and managing properties for medical and bioscience facilities, among others. Both Sinema and Harper are champions of healthcare and bioscience growth in Arizona.

Arizona has launched the Phoenix Medical Quarter, a 100-acre hub of medical research in midtown Phoenix. Education and patient care are primary objectives for the new hub, which aims to compete with top medical centers worldwide while cementing Arizona’s leadership in biosciences.

Independent Arizona senior Senator Kyrsten Sinema, who has championed the state’s healthcare and biosciences sectors, also announced more than $2 million in Senate appropriations for the Creighton and Barrow Neurological Institute, which are integral parts of the Phoenix Medica…

Lilly wraps up acquisition of Versanis, marking the fifth largest pharma deal of 2023

Top 5 biggest M&A deals in the pharmaceutical industry as of August 14, 2023: Pfizer/Seagen ($43B), Biogen/Reata Pharmaceuticals ($7.3B), Astellas Pharma/Iveric Bio ($5.9B), Merck & Co./Prometheus Biosciences ($10.8B), Eli Lilly/Versanis ($1.93B).

Eli Lilly just wrapped up its acquisition of Versanis Bio in a $1.9 billion deal, the pharma giant announced today. The deal marks Lilly’s latest move to build up its pipeline of potential obesity and diabetes treatments, which promises to be a notable growth area for the company. Lilly recently completed its submission of tirzepatide for chronic weight management to the FDA.

The company reported positive Phase 3 results from the SURMOUNT-3 and SURMOUNT-4 studies, showing the highest levels of weight loss observed so far in the SURMOUNT program.

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1…

Regeneron agrees to spend up to $213M to acquire Decibel Therapeutics

To date, 2023 is shaping up to be a relatively brisk year for M&A deals. A recent case in point is Regeneron’s acquisition of Decibel Therapeutics. The centerpiece of the deal is DB-OTO, a gene therapy intended for patients with otoferlin-related hearing loss. The drug is in its first clinical trial. Regeneron agreed to pay $4.00 per share for Decibel stock with the potential to pay up to $3.50 per share in cash if Decibel hits agreed-upon regulatory milestones for DB-OTO in a specified time frame, bringing the total value of the deal to roughly $213 million.

Last year, Decibel touted DB-OTO’s ability to support otoferlin expression for several weeks before it plateaued. The company said the data for the drug were in line with earlier preclinical research in which mice achieved a functional recovery.

Involved in transmission of sound signals in the inner ear, the protein otoferlin is essential for hearing. Deficiency or mutations in the gene that produces o…

Single-use technologies gain wide adoption in biomanufacturing

The G3 Electronic Fieldbus Platform complements Emerson’s AVENTICSSeries 501 Pneumatic Valve Manifold. The graphic display for configuration and diagnostics is compatible with various communication protocols, such as Ethernet IP, ProfiNet and DeviceNet. Photo courtesy of Emerson.

With the rise of biologics and personalized medicine, the biopharmaceutical industry is adding single-use technologies (SUTs) to their manufacturing options. Manufacturers are realizing the benefits of being agile, and many are adopting SUTs to turn over smaller batches of new products quickly and efficiently. Single-use technologies use disposable bioprocessing equipment, such as bags and flexible tubing, instead of conventional, permanent stainless steel systems. By eliminating the time-consuming clean-in-place (CIP) and steam-in-place (SIP) processes between batches, SUTs speed up the changeover time and greatly reduce the costs of ener…

Decade-plus review of drug recall trends from 2011 to 2023

Earlier this year, we took a look at the most common causes of drug-related recalls in 2022 and the first quarter of 2023. Now, we are expanding our lens to examine drug-related FDA recalls from 2011 to 2023.

Understanding the recall landscape

In recent decades, prominent incidents like the Tylenol poisonings in 1982 have underscored the need for attentive tracking, swift reaction and careful mitigation measures when facing possible hazards to health. To get a sense of the current landscape of pharmaceutical recalls, we analyzed an FDA dataset spanning from 2011 to 2023. The data, which includes an array of drugs and recall reasons, found that lack of assurance of sterility continues to be far and away the most common reason for pharmaceutical recalls.

Sterility issues continue to clearly be the most common reason for FDA drug recalls. Data source: FDA

While FDA recalls of drugs have fluctuated widely…

Gilead wins ruling against alleged counterfeiters in HIV drug case

A federal judge ruled against two defendants accused of selling counterfeit HIV medications, denying their motions to lift existing asset freezes obtained by pharmaceutical company Gilead Sciences in the ongoing lawsuit. Judge Ann M. Donnelly of the United States District Court for the Eastern District of New York converted the temporary asset freezes into preliminary injunctions, allowing Gilead to preserve funds for a potential award in the still undecided case. The judge had frozen the assets in 2022.

Gilead alleges the defendants were part of a counterfeiting ring that sold fake versions of its HIV medications. In the Gilead HIV drug case, the company obtained asset freezes against defendant Scripts Wholesale, a drug distributor and defendant Peter Khaim, a supplier.

Scripts and Khaim moved to lift the freezes. The court denied both motions. On Scripts’ motion, Judge Donnelly found Gilead showed a likelihood of success on its Lanham Act claims that Sc…

FDA approves another over-the-counter Naloxone nasal spray

The RiVive over-the-counter naloxone nasal spray. [Image from Harm Reduction Therapeutics]

Harm Reduction Therapeutics announced that it received FDA approval for its over-the-counter RiVive naloxone nasal spray.

Pittsburgh-based HRT designed the 3 mg naloxone HCl nasal spray for the emergency treatment of opioid overdose. Approval helps make free or low-cost OTC nasal spray widely available in the U.S.

The FDA first approved Narcan 4 mg OTC naloxone nasal spray in March of this year. A different opioid overdose therapeutic, the Opvee nalmefene hydrochloride nasal spray from Opiant Pharmaceuticals, received approval in May.

RiVive uses an easy-to-use standard dose unit system. Each nasal spray device contains one dose. HRT plans to offer it exclusively in twin packs containing two single-dose devices.

“We are grateful that FDA granted RiVive approval so we can now achieve what most thought i…

New HHS initiatives put spotlight on long COVID

The U.S. Department of Health and Human Services (HHS) recently announced two major initiatives to shed light on long COVID, a condition affecting millions. First, the agency plans to establish the Office of Long COVID Research and Practice. HHS is also set to launch new long COVID-19 clinical trials through its RECOVER initiative. Jointly, the long COVID drug development efforts highlight the need for therapies and create openings for pharmaceutical companies to drive research and drug development related to the condition.

HHS has earmarked $1.15 billion for the RECOVER Initiative to explore novel therapies for the condition estimated to have affected between 7.7 and 23 million Americans. To date, the RECOVER Initiative has enrolled more than 24,000 participants in observational studies on long COVID. New clinical trials, beginning enrollment in summer 2023, will test experimental therapies across five focus areas to identify therapies that can alleviate symptoms and…

Court rejects Johnson & Johnson bankruptcy gambit over talc suits

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A U.S. bankruptcy judge in New Jersey has dismissed a Johnson & Johnson-created company’s bankruptcy filing to resolve talc-related lawsuits.

Judge Michael Kaplan’s ruling on July 28 was similar to a U.S. Court of Appeals for the Third Circuit ruling months ago, which failed to find immediate financial distress over the lawsuits. As recounted in media reports, Kaplan said: “In sum, this court smells smoke, but does not see the fire.”

Johnson & Johnson plans to appeal Kaplan’s ruling. It was previously seeking U.S. Supreme Court review of the Third Circuit ruling.

JNJ shares were down nearly 4%, at $167.58 apiece, by the afternoon today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down about 1%. The company’s financial performance has been somewhat volatile in r…

Timeline: Navigating Johnson & Johnson’s talc lawsuits and their stock performance impact

Johnson & Johnson continues to face legal challenges over allegations that its talcum powder causes cancer. Recently, a judge dismissed the company’s latest attempt to settle thousands of lawsuits through bankruptcy, marking the second time J&J’s bankruptcy strategy has been rebuffed. We take a look at the timeline of the talc litigation below.

Johnson & Johnson is planning on spinning off its consumer unit, which will be known as “Kenvue.” The separation of the unit could happen later this year.

The company’s talc-related troubles started in 2009 when the first lawsuit was filed against J&J alleging its talc products caused a woman’s ovarian cancer. By 2016, J&J suffered its first significant legal defeat with a $72 million verdict. In 2018, a jury ordered the company to pay $4.69 billion to cancer victims.

Johnson & Johnson began selling its Baby Powder brand of talcum powder in 1894.

N…