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Pharma

October FDA Advisory Committee meeting on Alkermes’ ALKS-3831 has mixed expectations on weight gain data discussion

Alkermes’ schizophrenia/bipolar disorder candidate ALKS–3831 weight gain data will be at the forefront of a 9 October FDA Advisory Committee (AdCom) meeting, but how the panel members will evaluate it is up for debate, as reported by William Newton, Pharma Writer for the Investigative News team at GlobalData, a leading data and analytics company. Newton comments: “The AdCom will question whether ALKS–3831, which is a combination of an opioid antagonist […]
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SGLT-2 inhibitors likely to be primary growth drivers of branded heart failure treatment market, says GlobalData

Eli Lilly and Boehringer Ingelheim’s (BI’s) Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) are expected to drive heart failure (HF) market growth and achieve high uptake as cardiologists become more familiar with the sodium-glucose cotransporter-2 inhibitors (SGLT-2I) class, says GlobalData, a leading data and analytics company. At the recently concluded European Society of Cardiology (ESC) Congress […]
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Amarin’s positive ESC data may boost Vascepa’s EU marketing efforts amid US generic entry threat

Amarin Corporation recently presented final results from the EVAPORATE trial in which Vascepa (icosapent ethyl) reduced patients’ coronary plaque by 17% compared to placebo following 18 months. The newly presented results can be leveraged to reinforce physician education and maximize revenue opportunity in the EU where Amarin is not facing imminent market exclusivity loss, according to GlobalData, a […]
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More public pharma and CMOs took PPP COVID-19 small business loans

At least 99 publicly owned pharma companies and contract manufacturing organizations (CMOs) – many with substantial market value and access to capital markets – were approved to receive PPP loans that were intended to help small businesses in the US to pay workers during the COVID-19 pandemic, a GlobalData analysis of a partial release of information by the Small Business Administration (SBA) shows. PPP (paycheck protection program) loans are a US federal government initiative. Fiona Barry, Associate Editor of GlobalData PharmSource, […]
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Despite crowded CKD-HPT market, Shield Therapeutics remains committed to PT20 following positive Phase IIb results

Phase IIb results were published in July for Shield Therapeutics’ oral iron-based phosphate binder PT20 for the treatment of hyperphosphatemia (HPT) in dialysis-dependent chronic kidney disease (CKD) patients. Although the CKD-HPT market has several marketed treatments available, PT20 has the potential to capture a slice of the HPT market by targeting dialysis-dependent patients who are […]
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Roche’s Ocrevus confirm its strong position of highly efficacious drug in the MS landscape

Following the publication of new positive data from the Phase IIIb CASTING trial of Roche’s Ocrevus (ocrelizumab) in patients with relapsing-remitting multiple sclerosis (RRMS); Alessio Brunello, Managing Pharma Analyst at GlobalData, a leading data and analytics company, offers his view: “Roche’s Ocrevus has several notable clinical attributes that support its strong market uptake, including high […]
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Key players in IBD space engage effectively with Japanese patients through well-established digital strategy, says GlobalData

In Japan, the treatment landscape for inflammatory bowel disease (IBD), comprising Crohn’s disease (CD) and ulcerative colitis (UC), is mature and encompassing many conventional therapies as well as novel therapies including biologics and a small molecule. With the increasing competition from biosimilars and the late-stage pipeline drugs, key players with novel therapies are offering comprehensive […]
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E-pharma set to revolutionize drug market access in India as COVID-19 drives e-commerce growth, says GlobalData

The COVID-19 induced lockdown resulted in an unprecedented rise in e-commerce transactions across India. In line with this, e-pharma sector also witnessed growth despite regulatory challenges. Against this backdrop, e-pharma space is all set to revolutionize drug market access in the country, says GlobalData, a leading data and analytics company. Anupama Mishra, Pharma Analyst at […]
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Few CMOs are equipped to manufacture cell and gene therapies

As more than 7,000 cell and gene therapies progress through the development pipeline and only 152 CMOs have the capabilities to manufacture them, production bottlenecks are the major obstacle to large-scale commercial manufacture once more Advanced Therapy Medicinal Products (ATMPs) are approved, says GlobalData, a leading data and analytics company. Currently, 79 of these cell […]
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