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GlobalData

Pharma

Pricing of Outlook Therapeutics’ ONS-5010 will be a crucial factor for its introduction into the wider market, says GlobalData

Outlook Therapeutics recently submitted a Biologics License Application to the US Food and Drug Administration (FDA) for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wAMD). If ONS-5010 is approved, the pricing of the therapy would be significant for its introduction into the wider market, says GlobalData, a leading data and analytics company. […]
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Empagliflozin produces clinical benefits for hospitalized patients with acute heart failure, says GlobalData

Following the results for the EMPULSE trial demonstrating that Boehringer Ingelheim’s (BI) sodium-glucose co-transporter-2 inhibitor (SGLT-2I) empagliflozin (Jardiance) was beneficial at reducing adverse events (AEs) among acute decompensated heart failure (ADHF) patients; Akash Patel, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view: “With the increasing metabolic complexity that cardiovascular and […]
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UK has the most thriving oncology-focused startup and venture capital ecosystem in Europe, says GlobalData

Venture capital (VC) plays a critical role in the identification and commercialization of promising intellectual property, facilitating new therapy development, says GlobalData. The leading data and analytics company notes that the UK has a thriving oncology-focused startup and VC scene, producing successful healthtech startups such as BenevolentAI and Exscientia, both of which have achieved unicorn […]
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Sanctions on Russian investor funding has limited impact on foreign innovator drugs, says GlobalData

The West’s sanctions on Russia, as well as biopharmaceutical companies and venture investment firms halting investment and business with Russian companies, will impact only a few early-stage innovator drugs that involve Russian investors as venture financing from Russian investors in foreign innovator drugs is limited, says GlobalData, a leading data and analytics company. Sharon Cartic, […]
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Big data will play a major role in the pharma value chain as it helps deliver efficiency improvements, says GlobalData

Exploiting big data analytics via emerging technologies such as artificial intelligence (AI) and Internet of Things (IoT) has improved return on investment in the pharma industry by shortening drug development timelines, reducing costs, increasing sales, and improving the likelihood of drug approval. If this continues, big data will transform the pharmaceutical industry in the coming […]
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Triple-negative breast cancer patients in Japan prefer unbranded support, observes GlobalData

The treatment for triple-negative breast cancer (TNBC) in Japan is currently possible only through a combination of immunotherapy (Keytruda or Tecentriq) and chemotherapy. Against this backdrop, both branded and unbranded digital support for TNBC in Japan is being offered by key companies marketing these immunotherapy drugs. However, patients are preferring unbranded support for effective disease […]
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Reduced risk of cardiovascular morbidity and mortality demonstrated in finerenone’s FIDELITY study, says GlobalData

At this year’s American College of Cardiology (ACC) Scientific Session, positive results were presented from Bayer’s FIDELITY analyses of Kerendia (finerenone), providing insight into the drug’s ability to reduce risk of cardiovascular and kidney outcomes in diabetic kidney disease patients. The positive data from the FIDELITY trial will help support the use of finerenone to […]
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Sotagliflozin significantly reduces risk of cardiovascular death in patients with both T2D and CKD, says GlobalData

At the 71st annual American College of Cardiology (ACC) 2022 meeting, results presented for the SCORED trial will likely lead to a large market share for Lexicon Pharmaceuticals’ sodium-glucose co-transporter-inhibitor (SGLT-I) sotagliflozin (Zynquista). The therapy is currently in Phase III in the US, as physicians increasingly prescribe SGLT-2Is for patients with Type 2 Diabetes (T2D) […]
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FDA’s increasing approvals of COVID-19 products and cell therapies will drive high-value pharma contract manufacturing, says GlobalData

The Food and Drug Administration’s (FDA) increasing approvals and Emergency Use Authorizations (EUAs) of COVID-19 vaccines and drugs, as well as cell and gene therapies, continue to provide ample manufacturing opportunities for contract manufacturing organizations (CMOs), says GlobalData, a leading data and analytics company. According to GlobalData’s report, ‘New Drug Approvals and Their Contract Manufacture […]
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BridgeBio’s acoramidis positioned to directly compete against Pfizer’s Vyndaqel for treatment of ATTR-CM if it passes trials, says GlobalData

BridgeBio’s acoramidis, an orally administered small molecule transthyretin, is currently being assessed in Phase II and Phase III trials and if it passes, it will be fighting against Pfizer’s Vyndaqel (tafamidis) for a share of the transthyretin amyloidosis cardiomyopathy (ATTR-CM) and ATTR-polyneuropathy (ATTR-PN) market, observes GlobalData, the leading data and analytics company. Samisha Khangaonkar, Pharma […]
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Combination of recent and anticipated therapy approvals expected to widen interest in the age-related macular degeneration market, says GlobalData

A flourish of activity in the wet age-related macular degeneration (wAMD) market, coupled with anticipated approvals of other products—particularly biosimilars—is expected to widen interest in the AMD market among stakeholders, says GlobalData, a leading data and analytics company. Vinie Varkey, Pharmaceutical Analyst at GlobalData, comments: “The wAMD market is on the precipice of a wave of new products. GlobalData’s Pharmaceutical Intelligence […]
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Medical device companies operating in Russia continue to provide lifesaving healthcare services whilst pausing all non-essential business, says GlobalData

Medical device and pharmaceutical companies are taking a similar approach to global retailers by withdrawing their activities from Russia where possible, however they continue to maintain sales and deliveries of certain medical devices and pharmaceuticals as it would be detrimental to the health of Russian citizens, and therefore unethical to do otherwise, observes GlobalData, the […]
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Sanofi’s Dupixent likely to see label expansion to young eosinophilic esophagitis patients soon after approval in adults, says GlobalData

Following the news that Sanofi and Regeneron announced that the Food and Drug Administration (FDA) accepted a Priority Review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in patients ages 12 years and older with eosinophilic esophagitis (EoE), a chronic allergic inflammatory disease of the esophagus; Mandana Emamzadeh, PhD, Healthcare Analyst at GlobalData, […]
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Eli Lilly and Boehringer Ingelheim’s Jardiance will become a leader in the heart failure market following EU approval, says GlobalData

With Eli Lilly and Boehringer Ingelheim (BI)’s Jardiance now approved to address both indications of heart failure (HF), GlobalData expects the drug to become a leading Sodium-Glucose Co-Transporter-2-Inhibitor (*SGLT2-I) in the HF market. The leading data and analytics company notes that Jardiance could potentially overtake AstraZeneca’s Farxiga (dapagliflozin) as the leading HF therapy and will […]
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Doubts remain over COR388’s efficacy despite new biomarker data, says GlobalData

At the AD/PD 2022 International Conference on Alzheimer’s disease (AD) and Parkinson’s disease (PD), Cortexyme presented new data from its COR388* (atuzaginstat) clinical program, highlighting positive numerical trends seen with the treatment and key biomarkers of AD, including amyloid-beta (Aβ) and tau protein. GlobalData notes that both proteins are hallmark pathologies of AD, so while […]
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Negative AdCom vote for Amylyx’s AMX0035 narrows its chances of an FDA approval, says GlobalData

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (AdCom) voting against the new drug application of Amylyx’s AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS) patients is extremely disappointing for the ALS community, but not entirely surprising, says GlobalData, a leading data and analytics company. Sarah Elsayed, Neurology Analyst at GlobalData, comments: […]
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Covovax will help Serum Institute of India to enter adolescents COVID-19 vaccine market, says GlobalData

The Drugs Controller General of India (DCGI) has recently granted emergency use authorization for Novavax‘s protein-based COVID-19 vaccine for adolescents aged 12 to 18 years. Novavax’s partner Serum Institute of India (SII) will market it under the brand name Covovax. This move will help SII enter the adolescents’ COVID-19 vaccine market in India, says GlobalData, […]
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Corium’s Adlarity faces a fiercely competitive space for symptomatic treatment of Alzheimer’s disease, says GlobalData

Corium’s Adlarity (donepezil hydrochloride) has recently received FDA approval as a treatment for patients with mild, moderate, or severe dementia of Alzheimer’s disease (AD).  However, as Adlarity is the fourth cholinesterase inhibitor product to launch in the US market, it enters a fiercely competitive space for the symptomatic treatment of AD finds GlobalData. According to the […]
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Sobi Gamifant approval in China will pave way for targeted haemophagocytic lymphohistiocytosis treatment, says GlobalData

The China National Medical Products Administration (NMPA) has recently approved Swedish Orphan Biovitrum’s (Sobi) Gamifant (emapalumab) for the treatment of primary haemophagocytic lymphohistiocytosis (pHLH) in adult and pediatric (newborn and older) patients. Its approval in China will pave the way for targeted treatment of the debilitating disease, says GlobalData, a leading data and analytics company. […]
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