Pharmaceutical Processing World Archives - Page 45 of 64

Cardinal Health stock down after Q4 earnings disappoint The Street

Cardinal Health (NYSE: CAH) reported fourth-quarter adjusted earnings today that were only two-thirds of what The Street expected.

The Dublin, Ohio–based health care services company’s stock was down more than –13% to $51.04 apiece in morning trading. Our sister site MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.

State and local opioid lawsuits resulted in $149 million in pre-tax charges in Q4; it was $1.17 billion for the full year. The Pharmaceutical segment’s profit was about the same year-over-year, at $358 million. Sales grew 15% to $38.3 billion.

Get the full story on MassDevice.

Moderna sales increase 64 times in Q2

Moderna (NSDQ:MRNA) posted second-quarter results today that beat the overall consensus on Wall Street.

The Cambridge, Mass.-based company reported profits of $2.8 billion, or $6.46 per share, on sales of $4.4 billion for the three months ended June 30 for a sales growth of 6,398.51% compared with Q2 2020.

Earnings per share were $6.46, 40¢ ahead of The Street, where analysts were looking for sales of $4.28 billion.

“I am proud of the progress our teams at Moderna have made in the past quarter in advancing our development pipeline while addressing a global pandemic and quickly establishing global manufacturing and commercial organizations,” CEO Stéphane Bancel said in a news release. “We now have mRNA candidates in clinical trials across five therapeutic areas including infectious diseases, cardiovascular, oncology, rare disease and autoimmune disorders. We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months, but r…

WHO aims to halt COVID-19 vaccine boosters to spur vaccination in developing world

The World Health Organization (WHO) has called to put plans to distribute booster shots on hold until late September to enable more equitable vaccine access across the world.

At present, only 14% of the world’s population is fully vaccinated, and, in some countries, only a sliver of people have obtained vaccines. However, vaccination rates are flagging in much of the developing world. In Bangladesh, for instance, only 2.7% of people are fully vaccinated, according to Our World in Data. In Niger, 0.7% of the public has reached that milestone.

In a media briefing, the world is understandably concerned about the Delta variant, said Tedros Adhanom Ghebreyesus, director-general of the WHO. “But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected,” he explained.

WHO wants all countries to vaccinate at least 10% of their populations by the end …

Nanoform and Boehringer Ingelheim execute master services agreement

Nanoparticle medicine specialist Nanoform (Helsinki, Finland) and Boehringer Ingelheim (Ingelheim am Rhein, Germany) will collaborate on proof-of-concept studies related to Nanoform’s CESS technology.

The master services agreement enables the two parties to move forward with pre-clinical research related to CESS, an acronym for “Controlled Expansion of Supercritical Solutions.”

CESS has the potential to optimize the bioavailability and solubility of new drug candidates, according to Nanoform, which are central drivers of drug development failures.

“This is the first step toward what we hope will be a long and fruitful partnership between our companies,” said Christian Jones, CCO of Nanoform, in a statement.

Earlier this year, Nanoform struck a deal with Celanese Corp. (NYSE:CE), a specialty materials company. The two companies intend to collaborate on nanoparticle-enabled drug delivery to use Celanese’s copolymer delivery technology for drug-eluti…

COVID-19 vaccination rates ticking up as Delta fuels infections

Image courtesy of Pexels

The rate of vaccination in the U.S. continues to tick upward. On Aug. 1, healthcare workers administered 816,203 doses, marking one of the highest totals in recent weeks.

Vaccination rates have increased about 24% in the past week, according to an estimate from UBS.

If the trend holds, the daily vaccination rate could surpass one million — roughly in line with the pace in late June.

At present, almost 58% of all Americans have received at least one COVID-19 vaccine dose.

In early July, the daily rate of U.S. vaccinations hit its lowest point since the beginning of the year. At that time, health officials administered about 500,000 doses daily.

As a result of the lagging vaccination rate, the U.S. was about a month late in meeting President Biden’s goal to provide at least one vaccine dose to 70% of adults by July 4. Some 60.6% of U.S. adults are fully vacc…

Avantor launches line of robotic tips for applications spanning cell biology and proteomics

The chemicals and materials specialist Avantor (NYSE:AVTR) has debuted J.T.Baker robotic tips for robotic liquid handling and research workstations.

The company says the new tips offer high precision and reliability.

Avantor will employ an independent test lab to verify the robotic tips are free of DNase, RNase, ATP and pyrogens.

The company will offer the robotic tips in two formats.

The first includes conductive tips that support the sampling of small liquid volumes with high precision without contamination. Included in this format are Hamilton- and Tecan-type compatible with a variety of robotic workstations.

J.T.Baker robotic tips

The second format spans clear robotic tips that optimize the performance for sample preparation and drug discovery applications. In addition, the transparency supports the visual recognition of foam to optimize sampling.

Avantor recently acqui…

NIBRT chooses SP fill-finish system to train biopharmaceutical production workers

The National Institute for Bioprocessing Research and Training (NIBRT) center of excellence in Dublin, Ireland, has tapped SP Scientific Products (SP) to install a modular multi-container filling line and isolation system.

The technology will complement the training of professionals working on pharmaceutical production fill-finish processes requiring high cleanliness levels to prevent contamination from human contact or airborne germs.

NIBRT will use a SP i-Dositecno robotic filling and stoppering system for pre-sterilized vials, syringes and cartridges in a nested format and a vial capper. NIBRT plans to install the technology in Spring 2022.

The NIBRT global center of excellence in Dublin, Ireland.

NIBRT offers hands-on training in an environment based on advanced industrial bioprocessing facilities.

“We are proud to be recognized and selected by such a respected institute to contribut…

High-performance ion mobility spectrometry is an efficient technique for cleaning validation

Image courtesy of Covalent Bonds

The rigorous cleaning of manufacturing equipment via well-defined standard operating procedures (SOPs) is one of the pharmaceutical industry’s primary defenses against contamination and adulteration. Cleaning validation confirms the efficacy of such procedures but can present challenges, generating large numbers of samples for analysis and potentially keeping equipment offline for too long, compromising productivity.

This article examines high-performance ion mobility spectrometry (HPIMS) as a technique for cleaning validation, comparing it with conventional alternatives. Experimental data illustrate the linearity, reproducibility, and detection limits of HPIMS for relevant compounds, which offers rapid, inexpensive, high sensitivity, at-line measurement for cleaning validation.

Meeting regulatory requirements for cleaning validation

FDA regulations provide a clear and…

AbbVie dips despite Street-beating Q2, raised guidance

AbbVie (NYSE:ABBV) shares took a hit today despite second-quarter results that topped the consensus forecast.

The North Chicago-based company posted profits of $769 million, or 42¢ per share, on sales of $14 billion for the three months ended June 30, 2021, marking a massive bottom-line gain from losses of -$739 million last year on sales growth of 33.9%.

Adjusted to exclude one-time items, earnings per share were $3.11, 2¢ ahead of Wall Street, where analysts were looking for sales of $13.6 billion.

“AbbVie delivered another strong quarter and our business continues to perform extremely well across the portfolio, with AbbVie’s new immunology assets contributing more than $1 billion of combined sales in the quarter,” AbbVie chairman & CEO Richard A. Gonzalez said in a news release. “The Allergan integration also continues to track exceptionally well, with both the neuroscience and aesthetics portfolios delivering double-digit …

Kaiser files lawsuit against Merck over cholesterol drugs

The managed care consortium Kaiser Permanente is suing Merck (NYSE: MRK) over alleged pay-to-delay agreements to withhold the production of generic drugs for Zetia and Vytorin.

Zetia (ezetimibe) is a cholesterol absorption inhibitor while Vytorin combines ezetimibe with simvastatin, an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. FDA drugs treat high cholesterol levels.

The lawsuit also names Glenmark, a manufacturer of generics of Zetia and Vytorin. It alleges that Merck’s plan to delay the introduction of generics for those drugs had cost Kaiser hundreds of millions of dollars, according to a report from the San Francisco Business Times.

The Oakland, Calif.–headquartered Kaiser Foundation Health Plan first filed the suit in San Francisco Superior Court. That court, however, transferred the case to the U.S. District Court in San Francisco.

FDA first approved Zetia in October 2002.

FDA approved Vytorin in July 20…

Biden offers $100 incentives to spur COVID-19 vaccination

Image courtesy of Pexels

With COVID-19 transmission continuing to accelerate, President Biden called for state and local governments to offer financial incentives for vaccination.

Speaking at a White House briefing dedicated to the novel coronavirus, Biden offered to draw such funding from the $1.9 trillion American Rescue Plan.

“People are dying and will die who don’t have to die,” he said in the announcement. “If you’re out there unvaccinated, you don’t have to die.”

Biden also said the government would reimburse small- and medium-size businesses that support vaccinating their employees.

He has also called for federal employees to be fully vaccinated or face regular testing and masking restrictions indoors.

Biden acknowledged that the plan might seem unfair for people who are already fully vaccinated but said the initiative could help beat back the spread of the virus.

Ju…

Merck results miss in Q2

Merck (NYSE: MRK) posted second-quarter results today that missed the consensus forecast on Wall Street, though the company expects up to 14% sales growth this year.

The Kenilworth, N.J.–based pharmaceutical giant reported profits of $1.213 billion, or 48¢, off $11.402 billion in sales, nearly halving its bottom line while boosting sales 19% from Q2 2020. Merck adjusted earnings and revenue to take into account its June 2021 spinoff of Organon, which brought Merck a $9 billion windfall.

Adjusted to exclude one-time items, earnings per share were $1.31, 13¢ behind The Street, where analysts looked for EPS of $1.44 on sales of $11.54 billion.

Related: FDA approves Merck’s Keytruda to treat certain types of breast cancer

“We are encouraged by the strong momentum of our underlying business led by our key growth drivers as the impact of the pandemic on our performance lessens,” said Merck CEO Rob Davis said in a news release. “We are confident that we …