Australia’s TGA approves Vifor’s Tavneos for ANCA-associated vasculitis
Pharmaceutical Technology
by Hasini Devarasetti
14h ago
Australia’s Therapeutic Goods Administration (TGA) has granted approval for Vifor Fresenius Medical Care Renal Pharma’s (VFMCRP) Tavneos (avacopan) along with a rituximab or cyclophosphamide-based regimen to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The orally administered small molecule Tavneos is a selective inhibitor of the complement C5a receptor C5aR1. It blocks the ability of those cells that do damage in response to the activation of C5a, which is known to be an inflammation driver. The TGA has also granted orphan drug designation to Tavneos, which is ..read more
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UK MHRA approves Takeda’s dengue vaccine Qdenga
Pharmaceutical Technology
by Hasini Devarasetti
19h ago
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes. It is designed to protect against any of the four serotypes. Qdenga is claimed to be the only dengue vaccine approved in the UK to pre ..read more
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US FDA accepts Sandoz’s BLA for biosimilar denosumab
Pharmaceutical Technology
by Hasini Devarasetti
23h ago
The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. Denosumab will be used to treat several conditions, including osteoporosis in postmenopausal women and in men with high fractures risk, treatment-induced bone loss. The BLA covers all indications which are covered by Prolia (denosumab) and Xgeva (denosumab) reference medicines. It also includes indications to prevent skeletal-related complications in cancer that spread to the bone, and its giant cell tumour and to treat hypercalcemia of malignancy refractor ..read more
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Pliant snags $287.5 million in oversubscribed public offering amid market uncertainty
Pharmaceutical Technology
by Akosua Mireku
1d ago
In the midst of tough predictions for 2023 due to inflation and a difficult funding environment, Pliant Therapeutics closed an oversubscribed $287.5 million public offering to boost its rare disease pipeline. On January 24, Pliant Therapeutics announced its upsized underwritten public offering of 8,333,334 shares of common stock for $30.00 per share. The company predicted the aggregate gross proceeds for the offering would total a sum of $250 million, before deductions. On January 27, the company announced it had exceeded this target with overall aggregate gross proceeds from the offering addi ..read more
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Feinstein Institutes researchers discover new protein for sepsis treatment
Pharmaceutical Technology
by Hasini Devarasetti
2d ago
Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis. Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections. It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy. These anti-pCTS-L monoclonal antibodies may help in providing effective treatments for human sepsis as well a ..read more
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Range anxiety: Will using predictive technology solve one of the core challenges of EVs? 
Pharmaceutical Technology
by Fi Forrest
2d ago
For EV drivers, range anxiety – the fear that an EV will run out of available battery charge before reaching its destination – is one of several pain points for the industry. For private car drivers, the most convenient solution is an onboard API (Application Programming Interface) service that tells you not only where the next charge point is, but also if it is working and available at the time you need it.  With sales of EVs doublingi in 2021 from the previous year, hitting 6.6 million worldwide, the amount of public charging infrastructure that has been announced may be insufficient to ..read more
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Qurient partners with TB Alliance to develop telacebec
Pharmaceutical Technology
by Hasini Devarasetti
2d ago
South Korean biotechnology company Qurient has entered a licence agreement with TB Alliance for the development and commercialisation of telacebec (Q203). Under the deal, TB Alliance will have the exclusive global license to develop and market telacebec except in Russia, South Korea, and the Commonwealth of Independent States (CIS) countries. The first-in-class orally available investigational drug, Telacebec blocks Mycobacterium tuberculosis growth by inhibiting cytochrome bc1 complex. It will be developed to treat tuberculosis (TB) and other non-tuberculosis mycobacteria (NTM) infections. In ..read more
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FDA grants approval to Gilead Sciences’ breast cancer therapy
Pharmaceutical Technology
by Hasini Devarasetti
2d ago
The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients. Trodelvy has been approved for HR+/HER2- breast cancer adult patients who have previously received endocrine-based therapy and a minimum of two additional systemic therapies in the metastatic setting. A first-in-class Trop-2 directed antibody-drug conjugate, T ..read more
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Price point is a key factor for wider market adoption of Amgen’s Amjevita in the US
Pharmaceutical Technology
by GlobalData Healthcare
5d ago
Biologic therapies are a mainstay in the management of various immunology indications, including rheumatoid arthritis (RA), psoriasis (PsO), axial spondyloarthritis (axSpA), atopic dermatitis (AD), Crohn’s disease (CD), and ulcerative colitis (UC), and serve as the key growth drivers in terms of commercial value in these indications. AbbVie’s Humira (adalimumab) has been a blockbuster drug on this front across several of the aforementioned diseases. However, after almost seven years of staving off competitors through patents and litigation, Humira’s market-leading position in the US will be af ..read more
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Modernizing cell culture processes for the next wave of genomic medicine
Pharmaceutical Technology
by Miranda McLaren
5d ago
The field of genomic medicine has reached a true turning point. With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting. Researchers have relentlessly worked through the barriers to create lifechanging treatments for patients in need. “As opposed to other ther ..read more
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