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GlobalData

Pharma

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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IPOs expected to return in 2022 after an increase in SPAC M&As in 2021, says GlobalData

An unforeseen rise in special purpose acquisition company (SPAC) mergers and acquisitions (M&As) as a quicker route for biopharmaceutical companies to enter the public capital markets was witnessed during the COVID-19 pandemic, says GlobalData. However, the leading data and analytics company found that, as economic markets slowly try to rebuild post-pandemic, it is doubtful that […]
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Civica’s insulin initiative will provide strong competition to lower the cost of insulins, says GlobalData

To help combat the nationwide insulin affordability crisis, Civica, a nonprofit generic pharmaceutical company, has launched its Insulin Initiative with the JDRF. The initiative aims to drive affordability and accessibility for all Americans, regardless of insurance status. GlobalData, a leading data and analytics company, found that by entirely changing the production and pricing model, Civica […]
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ARV-110’s Phase II data demonstrates clinical value of PROTACs, a next-generation drug class, says GlobalData

Arvinas’ proteolysis targeting chimeras (PROTACs), bavdegalutamide (ARV-110), which is being investigated as a new therapy for metastatic castration-resistant prostate cancer (mCRPC) in the Phase I/II ARDENT study, has recently shown promising efficacy and safety data for treating mCRPC, providing a huge win for the company, says GlobalData. The leading data and analytics company notes that […]
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Omicron subvariant, BA.2, poses a serious threat to the efficacy of current therapies, says GlobalData

More research is required to determine whether current Omicron treatments are effective against BA.2—the most transmissible of the Omicron subvariants, says GlobalData. The leading data and analytics company notes that vaccines and therapies should be tested specifically against BA.2 to better prepare for challenges that may lay ahead. BA.2 contains numerous unique mutations compared to […]
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Newly approved rare blood cancer drug Vonjo promising for patients with both low and moderate platelet counts, says GlobalData

Not only has CTI BioPharma’s drug Vonjo (pacritinib) already broken new ground by being the first treatment approved for intermediate and high-risk myelofibrosis patients with low platelet counts (below 50×109 per liter of blood), key opinion leaders interviewed by GlobalData note that the drug has promise as a treatment for patients with moderate platelet counts […]
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Chinese immune checkpoint inhibitors to face big hurdles for approval in West, says GlobalData

The development of immune checkpoint inhibitors (ICIs) has been a strong focus of China’s R&D strategy, with these costly agents being used across an increasing number of oncology indications. Multiple domestically developed ICIs have now obtained approval from the National Medical Products Administration, and several more are in the pre-registrational phase, awaiting regulatory approval. However, […]
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European Commission withdraws MA for Pfizer’s Staquis, causing uncertainty for ‘mild to moderate’ AD treatment, says GlobalData

The European Commission (EC) withdrew the marketing authorisation (MA) for Pfizer’s topical phosphodiesterase-4 (PDE4), Staquis (crisaborole) in the EU (known as Eucrisa in the US). This highlights a gap in the market for the treatment of ‘mild to moderate’ atopic dermatitis (AD), one that has yet to be filled by an effective topical therapy. Although […]
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International Women’s Day puts spotlight on Endometriosis, says GlobalData

International Women’s Day commemorates the political, social, economic, and cultural achievements of women throughout history. This important day also creates space to discuss issues that disproportionately affect women—one example of which being gynaecological conditions, such as endometriosis. Despite affecting nearly 10% of women globally, endometriosis lacks proper research, funding, and disease awareness. As a result, […]
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Diagnosed prevalent cases of atopic dermatitis set to reach 42.25 million in 2030 across 7MM, finds GlobalData

The 12-month diagnosed prevalent cases of atopic dermatitis (AD) across the seven major markets (*7MM) are projected to increase from 42.13 million in 2020 to nearly 42.25 million in 2030, with an annual growth rate (AGR) of 0.03%, according to GlobalData, a leading data and analytics company. GlobalData’s latest report: ‘Atopic Dermatitis – Epidemiology Analysis […]
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Cassava’s simufilam still has further hurdles to face in securing a solid position in the Alzheimer’s disease market, says GlobalData

Cassava Sciences recently announced that the Food and Drug Administration (FDA) had denied a Citizen Petition and associated supplements filed by investors questioning the credibility of positive data from the company’s Phase IIb trial (NCT04079803) of late-stage Alzheimer’s disease (AD) asset, simufilam. Despite this win for the company, simufilam still has further hurdles to face […]
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