PharmaFocus Today – Page 326 – media

After recent troubles, Catalent expands its biologics services platform

Global CDMO giant Catalent, which has been struggling through difficult financial times, added more biologic processes to its OneBio platform, which features capabilities for antibody and recombinant proteins, cell and gene therapies, and messenger RNA.The rollout of the added services is part of the company’s participation at the BIO International Convention taking place in Boston this week, Catalent said in a June 5 press release. The additions come in the wake of the CDMO delaying the release of its earnings report multiple times after admitting in April that it was struggling with “productivity issues” and high costs at three major production sites—including two of its largest. The locations at issue include Catalent’s gene therapy manufacturing site in Harmans, Maryland, as well as its drug product and drug substance plants in Bloomington, Indiana, and Brussels, Belgium. Catalent’s problems may have caused life sciences conglomerate Danaher to shelve plans in April to ...
- Source: drugdu
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European Commission grants two new marketing authorisations for UCB’s Bimzelx

The European Commission (EC) has granted UCB’s Bimzelx (bimekizumab) two new approvals, with the inflammatory disease drug now authorised to treat certain adults with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The marketing authorisations, which follow a pair of recommendations from the European Medicines Agency’s human medicines committee earlier this year, make Bimzelx the first and only IL-17A and IL-17F inhibitor approved in the EU for these two indications. The authorisation for PsA – a type of arthritis that affects some patients with psoriasis – specifically applies to those with active disease who have had an inadequate response or have been intolerant to one or more disease-modifying antirheumatic drugs. The approval was supported by results from two phase 3 trials in which Bimzelx showed improvements over placebo in joint and skin symptoms across biologic naïve and TNF inhibitor-inadequate responder populations. “The approval of [Bimzelx] in PsA provides rheumatologists and dermatologists ...
- Source: drugdu
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Samsung Biologics, Pfizer partner for biosimilars portfolio manufacturing

Samsung Biologics has announced a strategic collaboration with Pfizer for the long-term commercial manufacturing of the latter’s multi-product biosimilars portfolio. Initially, the companies signed a manufacturing agreement in March last year for a Pfizer product. As per the new agreement terms, Samsung Biologics will provide Pfizer with more capacity for manufacturing for the biosimilars portfolio. The portfolio will cover inflammation, oncology and immunology. Samsung will use its new facility, Plant 4, for the products manufacturing. Samsung Biologics president and CEO John Rim said: “We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had previously committed and are on the move for future expansion into our second campus in order to provide our clients with ...
- Source: drugdu
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Astellas Submits New Drug Application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, June 9, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients. “Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer,” said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-Oncology Development, Astellas. “Astellas’ submission ...
- Source: drugdu
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China Approves the World’s First Vaccine against XBB Descendent Lineages of SARS-CoV-2 for Emergency Use

CHENGDU, China, June 8, 2023 /PRNewswire/ — On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities in China. This is the first COVID-19 vaccine in the world approved for EUA against XBB descendent lineages of SARS-CoV-2. It demonstrates that China is leading the world in the development of COVID-19 vaccines. WestVac Biopharma and its subsidiary company WestVac Biopharma (Guangzhou) leveraged the rapid response of the insect cell expression platform on constructing the vector for Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 Cell), which is of high purity and high quality for human use. The subunit vaccine antigen is precisely designed based on the structure of the targeting S-RBD and HR proteins of the COVID-19 subvariants XBB.1.5 and BA.5 and self-assembled into stable trimeric protein particles with ...
- Source: drugdu
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In shift away from toxic ethylene oxide, Colorado firm offers ‘green’ chlorine dioxide sterilization

Dive Brief Boulder Sterilization is introducing contract chlorine dioxide sterilization services this summer to provide medical device manufacturers with an alternative to ethylene oxide (EtO). The rollout of the service will make Boulder Sterilization, a division of Boulder iQ, part of a small group of companies to offer medtech sterilization using the gas and, it claims, the only provider to offer both EtO and chlorine dioxide services. Boulder Sterilization’s addition of chlorine dioxide capabilities comes as the industry races to find alternatives to EtO ahead of restrictions on the use of the carcinogenic gas. Dive Insight Interest in using chlorine dioxide to sterilize medical devices dates back decades. A patent filed in 1982 described the use of chlorine dioxide to “sterilize surfaces, especially the gas impermeable surfaces of implements commonly employed in the medical sciences.” Yet, while some sterilization companies such as ClorDiSys Solutions have deployed the approach, EtO has ...
- Source: drugdu
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Exploring the viability of a new treatment for vascular dementia

Researchers from The University of Texas at El Paso’s School of Pharmacy will explore the viability of a new treatment for vascular dementia, thanks to a $2.2 million grant from the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS). The grant builds on work that’s previously been done by the team and their collaborators. Vascular dementia -; the second most common type of dementia worldwide -; is caused by reduced or blocked blood flow in the brain. Similar to Alzheimer’s disease, vascular dementia causes memory loss and cognitive problems such as confusion, slowed thinking, and difficulty with problem solving and speaking. Mohammad Iqbal Bhuiyan, Ph.D., assistant professor in the UTEP School of Pharmacy, is the project’s principal investigator. His NINDS-funded research will focus on better understanding the biological triggers behind vascular dementia and investigating a new candidate drug, known as “ZT-1a,” to counteract the condition. ...
- Source: drugdu
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Pfizer taps Samsung Biologics in long-term biosimilar production deal worth $411M

South Korea’s Samsung Biologics has captured a $411 million contract to manufacture biosimilars for pharma giant Pfizer.Under the deal, Samsung has pledged “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.” The company described the deal as a “long-term” arrangement. Pfizer’s biosimilar portfolio features copycats to Roche’s cancer trio of Rituxan, Avastin and Herceptin plus biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Neupogen. The Samsung partnership will likely also include production of Pfizer’s biosimilar to AbbVie’s Humira, The Korea Herald reports, citing industry experts. AbbVie recorded $21.24 billion in sales of Humira last year. Amgen is already marketing a Humira copycat, but Pfizer and many other players are set to enter the market this year. In a financial filing, Samsung Biologics put the value of the Pfizer deal at $411 million, making it the biggest of its nature for the company and ...
- Source: drugdu
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After nationwide deal, Teva reaches $193M opioid settlement with holdout Nevada

When Teva proposed its sweeping $4.25 billion opioid settlement to resolve thousands of claims across the country, all U.S. states except for Nevada and New Mexico jumped on board. Now, the company has worked out a separate $193 million deal with one of the holdouts.Under the deal, the generics giant will make annual payments to Nevada on a sliding scale starting next July and lasting through July 2043. The payouts will start at $7 million and rise to $9 million through 2037, then increase to $27 million in 2042. The cash will be divvied between Nevada and members of the One Nevada Agreement on Allocation of Opioid Recoveries, a group formed to distribute opioid-related funds to local governments. The deal also includes injunctive relief to put a stop to opioid misuse in the state. For one example, Teva is required to halt the promotion of opioid products, according to a ...
- Source: drugdu
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AstraZeneca to stop post-marketing study of Andexxa following early success

AstraZeneca (AZ) has announced that it will stop its post-marketing study of bleeding reversal agent Andexxa (andexanet alfa) after the trial met its primary endpoint earlier than planned. The phase 4 ANNEXA-I study has been assessing the safety and efficacy of the drug versus standard care in more than 450 patients experiencing an intracranial haemorrhage who have received oral Factor Xa-inhibitor treatment, including apixaban and rivaroxaban. Results from a planned interim analysis of the trial showed that Andexxa-treated patients experienced superior haemostatic efficacy – the ability to limit the expansion of a potentially life-threatening bleed in the brain – compared with the control arm, leading the data monitoring board to recommend that the study be ended. Millions of people worldwide depend on Factor Xa inhibitors to manage their risk of blood clots developing, but these medicines carry a small but significant risk of an acute major bleed. AZ reports that ...
- Source: drugdu
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