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FDA Grants Accelerated Approval to Gilead’s Livdelzi for the Treatment of Primary Biliary Cholangitis

By Don Tracy, Associate Editor Approval of Livdelzi is based on results from the Phase III RESPONSE study, which demonstrated improved key biochemical markers and reduced pruritus. The FDA has granted accelerated approval to Livdelzi (seladelpar), Gilead’s treatment for primary biliary cholangitis (PBC) in adults who either have an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate it. According to the company, the approval was based on positive results from the Phase III RESPONSE study, where Livdelzi significantly improved key biochemical markers and reduced pruritus, a debilitating symptom of PBC. Accelerated approval was based on a reduction of ALP.1 “More people are being diagnosed with PBC, impacting people of varied ages, gender, race and ethnicity. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night,” said Carol Roberts, president, The PBCers Organization, ...
- Source: drugdu
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- August 19, 2024
【EXPERT Q&A】Why do import and export enterprises have to do AEO certification?

Drugdu.com expert’s response: The necessity for import-export enterprises to undergo AEO (Authorized Economic Operator) certification primarily stems from the following aspects: I. Enhancing International Competitiveness 1.High International Recognition: AEO certification, a globally recognized standard formulated by the World Customs Organization (WCO), carries international mutual recognition. Enterprises with AEO certification are regarded as secure and reliable trading partners in international trade, thereby enhancing their international credibility and reputation. 2.Priority Customs Clearance: AEO-certified enterprises enjoy preferential treatment such as priority processing and reduced inspections, including diminished time and procedures for customs inspections, border controls, and logistics security. This expedites cargo clearance, shortens the dwell time at customs, and improves both export and import efficiency. II. Reducing Costs and Improving Efficiency 1.Lower Inspection and Audit Frequencies: AEO-certified enterprises benefit from reduced inspection rates and audit frequencies during import-export activities, minimizing unnecessary inconveniences and additional expenses. This helps to lower international trade costs, encompassing ...
- Source: drugdu
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- August 19, 2024
CMS Touts First Negotiated Drug Prices, But Greater Impact Expected in Future Rounds

The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
- Source: drugdu
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- August 19, 2024
Pfizer’s RSV vaccine shows benefit in immuno-compromised adults in study

Pfizer said on Monday its respiratory syncytial virus (RSV) vaccine Abrysvo generated a strong immune response in a late-stage study of four groups of adults aged 18 and older with a compromised immune system. A single 120 microgram dose of the vaccine generated strong neutralising antibodies against both subtypes of RSV, called RSV-A and RSV-B, across all groups in the study, Pfizer said. Abrysvo was well-tolerated in the study and showed a safety profile consistent with findings from other studies of the vaccine, it added. The drugmaker plans to submit the data to regulatory agencies for review. The study tested two doses of Abrysvo in 203 adults across four groups – those with a type of lung cancer, end-stage kidney disease, autoimmune inflammatory disorder, and solid organ transplant recipients – all of whom have compromised immunity and are at risk of developing severe RSV-associated disease. Pfizer’s vaccine is currently approved ...
- Source: drugdu
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- August 19, 2024
Novo Nordisk Education Foundation and RNT medical college to establish India’s first ‘Sickle Cell Wellness Hub’

Novo Nordisk Education Foundation (NNEF), a non-profit organisation set up by Novo Nordisk India, signed a Memorandum of Understanding (MoU) with Rabindranath Tagore (RNT) Medical College, Udaipur to establish a ‘Sickle Cell Wellness Hub’ dedicated to people living with sickle cell disease (SCD). The MoU was signed between Dr Vipin Mathur – Principal & Controller, RNT Medical College and Vikrant Shrotriya – Managing Trustee, Novo Nordisk Education Foundation. Also present at the occasion were Dr R L Suman – Medical Superintendent, MB Government Hospital, Udaipur and Dr Lakhan Poswal – Senior Professor & HOD, Pediatrics and Nodal Officer, SCD Centre of Excellence, RNT medical College, Udaipur. This public-private partnership is aligned to the Government of India’s commitment of eradicating SCD from India by 2047 as part of its National Sickle Cell Anaemia Elimination Mission 2023 [1]. According to the statement released, the Sickle Cell Wellness Hub will offer holistic care ...
- Source: drugdu
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- August 19, 2024
Evotec slashes workforce by 400 people in “difficult market”

German life science company Evotec is cutting 400 jobs as the company continues to deal with ‘a more difficult market environment’.” The company’s CEO Christian Wojczewski has announced an accelerated transformation programme for the company, designed to produce cost savings of at least €40m ($44m) next year, he said. One of the reasons cited by Evotec for this challenging environment includes a high fixed cost base for weaker profitability. Nonetheless, the business outlook for FY 2024 involves a slight rise in revenue projections, increasing from €790m to €820m. This is compared to €781m in FY 2023. In May, the company shut down its gene therapy business after its Q1 2024 group revenues were down by 2%. Evotec said its site in Austria will be closed down as part of the restructuring, which affected 40 employees. The company ventured into the gene therapy arena in April 2020, when it teamed up ...
- Source: drugdu
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- August 19, 2024
Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by China’s NMPA

SHANGHAI, Aug. 12, 2024 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials. For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. ...
- Source: drugdu
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- August 19, 2024
Q&A with Michael Abrams

By Mike Hollan Abrams discusses how both new pharma and big pharma are reacting to each other and the current market.The last few years have been a rollercoaster ride for the pharma industry. Michael Abrams, managing partner at Numeroff & Associates, spoke with Pharmaceutical Executive about the current state of the industry and what factors are driving M&A and layoffs at the moment. Pharmaceutical Executive: What is driving layoffs in the Pharma sector? Michael Abrams: Despite hopes that the wave of layoffs in 2023 would mark the peak industry pain point, they have continued well into 2024. For big pharma companies, the language used in press releases varies, but the underlying causes are similar: growing pressure on price from government and private sector payers, combined with patent expirations that threaten to cut into revenue. While these are the main real issues, there is, after the surprise passage of the IRA, ...
- Source: drugdu
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- August 17, 2024
Trends, Drivers, and Implications

Current trends are driven by various strategic and financial considerations from both established pharmaceutical companies and development-stage biotech firms. Understanding the valuation and accounting implications of these transactions are crucial for stakeholders to navigate the complex landscape effectively. By Kristen SeaverThe biotechnology industry has witnessed significant shifts in recent years, particularly in the realm of both mergers and acquisitions (M&A) and collaborative agreements. These trends are driven by various strategic and financial considerations from both established pharmaceutical companies and development-stage biotech firms. Understanding the valuation and accounting implications of these transactions are crucial for stakeholders to navigate the complex landscape effectively. Trends in biotech transactions One of the prominent trends in the biotech sector is the acquisition of clinical-stage companies with compelling clinical development programs. Established pharmaceutical companies are increasingly acquiring development stage companies with promising clinical stage programs to bolster their drug development pipelines and mitigate the risks associated ...
- Source: drugdu
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- August 17, 2024
DKSH extends exclusive distribution agreement with Cosucra in Australia and New Zealand

DKSH’s Business Unit Performance Materials, a leading distributor of specialty chemicals and ingredients, will provide business development, marketing, sales, logistics, and distribution services for Cosucra’s range of dietary fibers and plant-based proteins in Australia and New Zealand. As a global leading producer of pea protein and inulin fibers, Cosucra utilises the properties of two natural raw materials, chicory roots and peas, to develop ingredients for healthy, sustainable, and tasty food products. Cosucra’s naturally produced, trademarked ingredient range includes Fibrulose and Fibruline chicory root fiber, Pisane pea protein isolate range, as well as Swelite pea fibre, and Nastar pea starch. Following a successful partnership in several countries in Europe and Asia, including Germany, Switzerland, and the Philippines, Cosucra has once again entrusted DKSH to grow its natural and healthy food ingredients business in Australia and New Zealand. This is thanks to DKSH’s extensive distribution network, strong capabilities in marketing and sales, ...
- Source: drugdu
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- August 17, 2024

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