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GlobalData
GlobalData

Pharma

FDA and EMA designations for Acceleron’s Sotatercept highlight potential to differentiate in PAH space

Acceleron Pharma’s sotatercept, was granted priority designation by the European Medicines Agency for pulmonary arterial hypertension (PAH) in May 2020. This further signifies the drug’s major advantages over existing treatments, and will provide enhanced support for its development for targeting underlying disease progression in PAH, according to GlobalData, a leading data and analytics company. The […]
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AstraZeneca’s speedy trial restart splits experts, while Pfizer’s study primed for fast data readout but Moderna may edge it out on detail, says GlobalData

With the European Medicines Agency (EMA) announcing today that it will also initiate a rolling review of the COVID-19 vaccine developed by Pfizer and BioNTech besides just AstraZeneca’s asset; Reynald Castañeda, Pharma Writer for the Investigative News team at GlobalData, offers his view: “After interviewing ten experts, there is clearly a split in terms of […]
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Invokana may experience moderate rebound from decreasing US sales trend following FDA backtracking on boxed warning

The FDA has removed a boxed warning concerning the risk of leg and foot amputations for Janssen’s sodium glucose co-transporter (SGLT) inhibitor, Invokana (canagliflozin) – including its combination varieties Invokamet (canagliflozin + metformin) and Invokamet XR (canagliflozin + metformin extended-release). With the removal of the boxed warning, it is expected that Invokana will experience a […]
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Oral GnRH antagonists could have market potential in female health space beyond endometriosis-related pain and uterine fibroid indications

Oral GnRH antagonists have off-label potential in the female infertility space, beyond the indications of endometriosis-associated pain and uterine fibroids, which constitute the main development focus for companies competing in the space, says GlobalData, a leading data and analytics company. Due to their novel oral formulation, the company notes that GnRH antagonists could replace subcutaneous […]
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Bausch Health looks to Allegro to create long-term value

Bausch Health recently announced that it had entered into an agreement with Allegro to acquire an option to purchase all of the latter’s ophthalmology assets. This transaction will be a significant step for Bausch Health in its strategy to create a long-term growth opportunity, says GlobalData, a leading data and analytics company. Vinie Varkey, MSc, […]
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Competition intensifies in SMA market with new Evrysdi two-year data

Following the news that Roche has announced new positive two-year data for Evrysdi (risdiplam) in infants with spinal muscular atrophy (SMA); Philippa Salter, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view: “Having been approved earlier this year, Roche’s Evrysdi now reaches the market – albeit a whole four years behind […]
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PAH patients to benefit amid telemedicine regulatory changes

Following President Trump’s announced executive order directing the Department of Health and Human Services (HHS) to issue rules ensuring that specific regulatory changes to telemedicine will remain in place once the COVID-19 pandemic ends, HHS will need to healthcare access to rural areas and to create a novel value-based payment model to improve reimbursement, according […]
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Bispecific antibodies will start maturing after 2021 with estimated sales in oncology of $6bn by 2025

The clinical success of Amgen’s Blincyto has amplified the intensive pace of development for bispecific antibodies in oncology. According to GlobalData’s drugs database, there are 106 bispecific antibody molecules – with various targets – currently in the pipeline. Furthermore, there are 263 ongoing/planning to enroll clinical trials involving a bispecific antibody. Sakis Paliouras, PhD, Oncology […]
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Crohn’s disease set to reach 1.6 million cases in 8MM by 2029

The diagnosed prevalent cases of Crohn’s disease (CD) in the eight major markets (*8MM) are projected to increase from 1,339,543 cases in 2019 to 1,629,940 cases in 2029, equating to an annual growth rate (AGR) of 2.17%, according to GlobalData, a leading data and analytics company. The natural course of CD, with low mortality, as well […]
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