Search Results for “EC” – Page 210 – media

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
- 93
- 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
- 93
- 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
- 84
- 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
- 58
- August 17, 2024
ICRA

In its recently released research note, rating agency ICRA highlighted the encouraging growth prospects of the Indian active pharmaceutical ingredients (API) industry. ICRA expects the revenues of its sample set of companies to expand at a CAGR of 7-8 per cent between CY2023 and CY2029 from an estimated size of USD 13-14 billion in CY2023. This will be driven by a steady ramp-up in the pharmaceutical formulations industry, which in turn, will be aided by an increasing geriatric population, higher prevalence of chronic diseases, and rising demand for contract manufacturing with global customers looking to diversify their supply chain along with greater focus on domestic sourcing. ICRA forecasts the operating profit margin (OPM) of its sample set of companies to improve mildly in FY2025. Indian API industry players faced considerable volatility in earnings over FY2021-FY2023 on account of multiple headwinds such as rising raw material costs due to elevated crude ...
- Source: drugdu
- 81
- August 17, 2024
Gilead’s PBC therapy Livdelzi bags accelerated approval

Gilead Sciences’ Livdelzi (seladelpar) has received an accelerated approval from the US Food and Drug Administration (FDA) to treat primary biliary cholangitis (PBC). The approval is based on results from the Phase III RESPONSE trial (NCT04620733), which demonstrated Livdelzi to be the first treatment yielding significant reductions in alkaline phosphatase (ALP) normalisation and pruritus—significant markers of PBC progression. ALP levels normalised at 12 months for 25% of Livdelzi-treated patients compared to none on placebo. Change in pruritus score at six months was significantly reduced among Livdelzi-treated patients compared to those taking placebo. Overall, 62% of patients on Livdelzi achieved composite biochemical response at 12 months, achieved by just 20% of placebo patients. With this regulatory nod, Livdelzi enters a space dominated by other approved therapies like Ocaliva (obeticholic acid) and ursodeoxycholic acid. Ocaliva was developed by Intercept Pharmaceuticals, which was acquired by Alfasigma in late 2023. Gilead gained the rights ...
- Source: drugdu
- 64
- August 17, 2024
Vimgreen Completes Enrollment of Its Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson’s Disease

HANGZHOU, China, Aug. 15, 2024 /PRNewswire/ — Vimgreen Pharmaceuticals, a science-driven pharmaceutical company focused on the modulation of adenosine signaling, announced today the completion of enrollment of its Phase 2 clinical trial of VG081821AC, a novel adenosine A2A receptor (A2AR) antagonist that also functions as an inverse A2AR agonist, for the treatment of early-to-mid stage Parkinson’s disease. A total of 150 participants have been enrolled and randomized into one of three cohorts, a high-dose VG081821 group, a low-dose VG081821 group, and a placebo group at a ratio of 1:1:1. The 12-week Phase 2 trial is a multicenter, randomized, placebo-controlled, double-blind study to investigate the safety and efficacy of VG081821 as monotherapy in early-to-mid stage PD patients. The primary endpoint was the difference of change from baseline in movement disorder society-unified Parkinson’s disease rating scale (MDS-UPDRS) part III (motor symptoms) score between VG081821 and placebo over the 12 weeks of administration. ...
- Source: drugdu
- 80
- August 17, 2024
Breas Medical flags risk of formaldehyde exposure in ventilators

Dive Brief Breas Medical started a correction of more than 8,000 ventilators after identifying a risk of formaldehyde exposure, the company said Friday. The notice, which was shared by the Food and Drug Administration, states internal testing of Vivo 45 LS ventilator devices showed the potential for short-term exposure to elevated levels of formaldehyde under specific conditions. Breas, which had not received any related injury reports, has reduced the maximum room air temperature of the ventilators and updated its instructions for new devices to mitigate the risk. Dive Insight The potential for ventilators to expose patients to formaldehyde, a chemical that can harm the lungs and nervous system, has prompted actions by the FDA and companies including GE Healthcare over the past two years. Breas began a nationwide U.S. correction of 8,186 Vivo 45 LS ventilator devices on Aug. 5. Internal testing of the Vivo 45 LS, a small, portable ...
- Source: drugdu
- 84
- August 16, 2024
UroGen Pharma Submits FDA New Drug Application for UGN-102, a Potential Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

By Don Tracy, Associate Editor UGN-102 has the potential to be the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, UroGen says. UroGen has completed its New Drug Application (NDA) submission for UGN-102 (mitomycin) for intravesical solution, suggesting that it has the potential to become the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The NDA submission is supported by results from the Phase III ENVISION trial, which demonstrated that patients treated with UGN-102 had a 79.6% complete response (CR) rate at three months following the first instillation.1 “The completion of the NDA submission for UGN-102 marks a crucial milestone for UroGen and underscores our dedication to advancing this groundbreaking treatment for patients with LG-IR-NMIBC,” said Liz Barrett, president, CEO, UroGen, in a press release. “By providing a viable alternative to repeated surgeries, if approved UGN-102 may offer patients quality of life benefits and clinically ...
- Source: drugdu
- 73
- August 16, 2024
FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year. By Frank Vinluan A Gilead Sciences drug acquired earlier this year in a multi-billion dollar deal is now FDA approved as new treatment for primary biliary cholangitis (PBC), a rare liver disease that can lead to liver failure. The approval announced Wednesday for the drug covers the treatment of adults whose disease is inadequately managed by the standard of care PBC drug as well as those who cannot tolerate that drug. The Gilead therapy, seladelpaar, will be marketed under the brand name Livdelzi. PBC is a rare, progressive autoimmune condition that leads to inflammation and scarring of the liver’s bile ducts. The chronic disorder, which impairs liver function, mainly strikes women over 40 years of age. Gilead estimates that ...
- Source: drugdu
- 70
- August 16, 2024

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