PharmaFocus Today – Page 353 – media

As COVID vaccine sales plummet, BioNTech looks for new growth opportunities

After raking in billions with its Pfizer-partnered vaccine, BioNTech is turning to new ventures as its revenues plummet. BioNTech reported first-quarter revenues of €1.27 billion (1.4 billion), a far cry from 2022’s first-quarter haul of €6.37 billion ($7.03 billion). Despite the downturn, the quarter went “fully to our expectations,” CFO Jens Holstein said on a conference call. Sales-wise, the current quarter should be the weakest of 2023, Holstein said. The company’s COVID-19 vaccine revenue guidance for 2023 stands at €5 billion ($5.4 billion), which is “something we can live with,” the CFO added. Meanwhile, BioNTech believes the United States’ transition to a commercial COVID-19 vaccine market could provide new growth opportunities. But as its pandemic-related business struggles, BioNTech is busy advancing its pipeline as it looks for its next big growth driver. The company’s pipeline includes multiple oncology ventures, including an HER2-targeted antibody-drug conjugate (ADC) that it’s working on with ...
- Source: drugdu
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- May 10, 2023
FDA completes inspection of Nexus’ manufacturing facility in US

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards. Equipped with advanced isolator technology, the Pleasant Prairie facility adheres to the highest current good manufacturing practice (CGMP) standards. It is designed to manufacture a broad range of injectable medications and will provide hospitals and clinicians access to affordable, safe, and critical-need medicines. Nexus Pharmaceuticals President and CEO Usman Ahmed said: “We are thrilled to receive the EIR for our Pleasant Prairie facility. “This is a major milestone for our company and reflects our commitments to reshoring sterile pharmaceutical manufacturing to the US. “We are proud of our team’s hard work and focus on achieving a ...
- Source: drugdu
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- May 10, 2023
AI helps create better, simpler hepatitis and COVID-19 tests

Going beyond pregnancy and COVID-19, the world could someday soon come to rely on at-home tests for many diseases thanks in part to AI-fueled improvements. University of Florida scientists have used artificial intelligence tools to simplify a test that works for both hepatitis C and SARS-CoV-2, the virus that causes COVID-19. The simplified test happens in one small test tube in just a few minutes. With further refinement, it could come to doctor’s offices soon and, one day, even home tests that are as easy as a pregnancy test. “We are trying to build a home-based test that is as reliable as a lab-based test,” said Piyush Jain, a UF professor of chemical engineering who led the latest research. “We are trying to make the test simple, eliminate the need for expensive equipment and provide results in just 10 to 20 minutes.” To accomplish those goals, Jain’s group is innovating ...
- Source: drugdu
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- May 10, 2023
New zebrafish model provides insight into how the brain acquires essential omega-3 fatty acids

Researchers at the UCLA David Geffen School of Medicine, the Howard Hughes Medical Institute at UCLA and the National Institutes of Health have developed a zebrafish model that provides new insight into how the brain acquires essential omega-3 fatty acids, including docosahexaenoic acid (DHA) and linolenic acid (ALA). Their findings, published in Nature Communications, have the potential to improve understanding of lipid transport across the blood-brain barrier and of disruptions in this process that can lead to birth defects or neurological conditions. The model may also enable researchers to design drug molecules that are capable of directly reaching the brain. Omega-3 fatty acids are considered essential because the body cannot make them and must obtain them through foods, such as fish, nuts and seeds. DHA levels are especially high in the brain and important for a healthy nervous system. Infants obtain DHA from breastmilk or formula, and deficiencies of ...
- Source: drugdu
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- May 10, 2023
After production problems, Catalent delays earnings and plans to slash guidance

For Catalent, the hits keep coming. After an April communique warning of reduced sales and productivity issues at three separate plants, the CDMO juggernaut delayed the release of its earnings for the third fiscal quarter. The report was originally scheduled to roll out Tuesday. Catalent said in a release Monday it’s now angling to unveil is quarterly report on May 15. Last month, Catalent said manufacturing hurdles at three major production sites—including two of the contract manufacturer’s largest—were expected to put a squeeze on third-quarter earnings and weigh on the company’s outlook for the entire fiscal year, which runs through the first half of 2023. Now, in addition to those “operational challenges,” Catalent says it has “also since identified significant issues with its forecasts over the past year.” With that mix of operational and productivity hangups, plus “prior forecasting challenges,” Catalent expects to “significantly reduce” both its 2023 revenue and EBITDA ...
- Source: drugdu
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Antibiotics, Western diet and higher socioeconomic status may increase IBD risk in children

Children and adolescents face greater risk of inflammatory bowel disease (IBD) when exposed to antibiotics or a Western diet at early ages, or when their family has higher socioeconomic status, according to a study being presented today at Digestive Disease Week® (DDW) 2023. “Pediatric IBD cases are rising globally, and approximately 1 in 4 of all IBD cases are now diagnosed before age 21,” said Nisha Thacker, the study’s lead author and a gastrointestinal dietitian. A unique concern about pediatric IBD is the impact that the inflammation has on a child’s growth and the progression of puberty, so parents should be aware of this condition and the modifiable factors that influence it. As a part of her PhD studies, at The University of Newcastle in Australia, she conducted a meta-analysis of 36 observational studies representing approximately 6.4 million children. Thacker found that any exposure to antibiotics before age 5 was ...
- Source: drugdu
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- May 10, 2023
Study identifies link for depression, physical conditions requiring hospitalization

For individuals with depression, the most common causes of hospitalization are endocrine, musculoskeletal, and vascular diseases, according to a study published online May 3 in JAMA Psychiatry. Philipp Frank, Ph.D., from University College London, and colleagues examined the association between depression and physical conditions requiring hospitalization in a prospective multicohort study. The primary analysis was based on data from the U.K. Biobank (130,652 individuals), and analyses were repeated in an independent dataset of two cohorts in Finland (109,781 individuals). The researchers found that severe/moderately severe depression was associated with the incidence of 29 nonoverlapping conditions requiring hospital treatment during five years of follow-up in the main analysis. After adjustment for confounders and multiple testing, 25 of these associations remained (adjusted hazard ratio range, 1.52 to 23.03) and were confirmed in the independent dataset. The highest cumulative incidence was seen for endocrine and related internal organ diseases, musculoskeletal diseases, and diseases of the circulatory system and blood (245, ...
- Source: drugdu
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- May 9, 2023
EU countries lay out framework for combating drug shortages

After the European Commission proposed a massive overhaul to the EU’s drug legislation, a group of 19 European countries is launching an effort to reduce the bloc’s supply chain reliance on outside countries. The position paper (PDF) urges the EU to “take more drastic steps” to improve the security of Europe’s supply of medicines. Belgium is leading the charge, and 18 other countries such as France, Germany and Spain are on board. In 2019, more than 40% of global active pharmaceutical ingredients came from China, the countries point out. That, coupled with other factors such as the fact that “almost all API producers depend on China for intermediate inputs,” make Europe and the rest of the world dependent on “a few manufacturers for a large bulk of their medicines supply,” according to the paper. The proposed European Critical Medicine Act would follow in the footsteps of similar acts such as the Critical Raw Materials Act ...
- Source: drugdu
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- May 9, 2023
AI model shows promise in detecting lung cancer earlier

Lung cancer accounts for more than 20% of cancer deaths in the UK A new UK study has revealed the potential of using artificial intelligence (AI) to help doctors diagnose lung cancer earlier. LIBRA, which was led by researchers from the Royal Marsden NHS Foundation Trust, the Institute of Cancer Research, London, and Imperial College London, used data from the CT scans of nearly 500 patients with large lung nodules – abnormal growths – to develop an AI model. The Royal Marsden Cancer Charity, the National Institute for Health and Care Research, RM Partners and Cancer Research UK also supported the study. To assess how effective the new model was at predicting cancer, the team used a measure called the area under the curve (AUC). An AUC of one would indicate a perfect model, while 0.5 would be expected if the model was randomly guessing. The results, which have ...
- Source: drugdu
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- May 9, 2023
Researchers evaluate the dual-therapeutic effect of gene therapy in mouse model of osteosarcoma

Reviewed by Lily Ramsey, LLM Investigators at Brigham and Women’s Hospital and collaborating institutions evaluated the dual-therapeutic effect of gene therapy in a clinically relevant model for common form of bone cancer. With a worldwide incident rate of 3.4 cases per million people per year, osteosarcoma is one of the most common bone cancers affecting children and adolescents. The current gold standard treatment option requires extensive surgical intervention and chemotherapy that leads to a poor prognosis and decreased quality of life. Due to the aggressive nature of the disease, the surgical intervention usually involves total reconstruction of the limbs or, in most cases, amputation. Researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, in collaboration with investigators at University College Dublin (UCD), Massachusetts Institute of Technology (MIT), and Trinity College Dublin (TCD), have identified a potential therapeutic target and developed a unique delivery ...
- Source: drugdu
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- May 9, 2023

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