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Following the FDA’s approval of Hulio (adalimumab-fkjp), a biosimilar of AbbVie’s Humira that was the highest grossing drug for eight years running with $19.2bn in 2019 global sales, Hulio will be made available in July 2023 for all of Humira’s approved indications that are not protected by orphan exclusivity. Hulio joins five other FDA-approved adalimumab […]
COVID-19 disruption of clinical trials is in decline, says GlobalData
After three months of increasing trial disruptions, the number of disrupted trials began to fall between June and July. Most disruption was caused by the suspension of enrollment, followed by slow enrollment, and delayed initiation, says GlobalData, a leading data and analytics company. Brooke Wilson, Associate Director, Trials Intelligence at GlobalData, comments: “Although the total […]
Cipla continues to expand focus on therapy areas of promising growth through deals, says GlobalData
India-based Cipla has recently entered into a partnership with Boehringer Ingelheim (BI) India Pvt. Ltd. to co-market three new oral anti-diabetics drugs in India, mainly sodium glucose co-transporter-2 (SGLT2) inhibitor Oboravo (empagliflozin), and related combination therapies – Oboravo Met (empagliflozin + metformin) and Tiptengio (empagliflozin + linagliptin). With this, along with recent agreements in the […]
Takeda continues post-Shire selloff to the benefit of Korean biopharma Celltrion, says GlobalData
South Korea-based bio/pharma company Celltrion has recently agreed to acquire a portfolio of 18 prescription pharmaceutical products and over-the-counter medicines across the Asia-Pacific (APAC) region for US$278.3m from Japan-based drug giant Takeda. This acquisition by Celltrion is part of Takeda’s massive divestment program to help release it from its crippling debt from its recent US$62bn […]
As Trump and Biden push to ‘Buy American’, $354m Government award to manufacture COVID-19 medicines in US raises suitability questions, says GlobalData
The US Federal Government’s Biomedical Advanced Research and Development Authority (BARDA) award of $354m to Phlow Corporation for the manufacture of COVID-19 medicines and other essential drugs has been touted by the Trump Administration as bringing pharmaceutical manufacturing back to the US. However, it is questionable why the $354m funding was awarded, seemingly without competition, […]
Hodgkin’s lymphoma market set to reach $2.1bn by 2029 driven by new combination therapies
The Hodgkin’s lymphoma (HL) market is expected to grow from $1.2bn in 2019 to $2.1bn in 2029 across the eight major markets (8MM*) at a moderate compound annual growth rate (CAGR) of 5.5%, according to GlobalData, a leading data and analytics company. The company’s latest report, ‘Hodgkin’s Lymphoma: Opportunity Analysis and Forecasts to 2029’, states […]
Biogen’s aducanumab submission to the FDA could change Alzheimer’s disease landscape
Following Biogen’s submission of a Biologics License Application (BLA) to the FDA of aducanumab; Alessio Brunello, Managing Pharma Analyst at GlobalData, a leading data and analytics company, offers his view: “The potential approval for aducanumab is not likely to be the final treatment for Alzheimer’s disease (AD), but it could open doors for combination research, namely […]
Hodgkin lymphoma diagnosed incident cases set to reach 27,000 in 2029
The burden of diagnosed Hodgkin lymphoma (HL) is expected to increase at an annual growth rate (AGR) of 0.90% from around 25,000 cases in 2019 to 27,000 cases in 2029 in the eight major markets (8MM*), according to GlobalData, a leading data and analytics company. GlobalData’s latest report: ‘Hodgkin Lymphoma: Epidemiology Forecast to 2029’ reveals […]
US diagnosed prevalent cases of AL amyloidosis projected to increase by 36.7% over next decade, says GlobalData
The number of diagnosed prevalent cases of AL amyloidosis is expected to increase from 75,033 in 2019 to 89,637 in 2029 at an annual growth rate (AGR) of 1.95% across the seven major markets 7MM*, according to GlobalData, a leading data and analytics company. Of the 7MM, the US is expected to have the highest […]
Novavax receives $1.6bn from OWS with ambitious vaccine delivery target, says GlobalData
Following the news that US biotech Novavax announced it will receive $1.6bn funding for the development of its COVID-19 vaccine candidate NVX-CoV2373; Philipp Rosenbaum, PhD, Senior Infectious Diseases Analyst at GlobalData, a leading data and analytics company, offers his view: “Even with the Operation Warp Speed’s (OWS’s) support boosting Novavax’s late-stage clinical trials, manufacturing and […]
Dr Reddy’s takes lead in COVID-19 treatment with both favipiravir and remdesivir in portfolio, says GlobalData
Following the news that Indian pharmaceutical giant Dr. Reddy’s Laboratories (Dr Reddy’s) has signed tripartite agreement with Tokyo-based FUJIFILM Toyama Chemical and Dubai-based Global Response Aid (GRA) for the development, manufacturing and sales of favipiravir innovator brand Avigan; Anupama Mishra, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view: “This is […]
More than half of non-alcoholic steatohepatitis cases go undiagnosed, says GlobalData
In the seven major pharmaceutical markets (7MM*), less than half of non-alcoholic steatohepatitis (NASH) cases were diagnosed in 2019, says GlobalData, a leading data and analytics company. Increased physician awareness and the implementation of systematic screening programs that are more widely received will likely help to close the gap between diagnosed and undiagnosed cases. The […]
Long-term complications for COVID-19 patients could place a strain on the healthcare system, says GlobalData
Long-term complications arising in COVID-19 patients after recovering from the initial illness are expected to increase healthcare costs in the long-term. Complications such as stroke, intensive care unit delirium, post-traumatic stress disorder (PTSD), lung and heart damage and neurological issues may see a rise, as well as the development of long-term lung damage and fibrosis […]
Zeposia could help solve the unmet need of more oral drugs for moderate to severe CD and UC patients, says GlobalData
Following Bristol Myers Squibb’s positive topline results from its pivotal Phase III TRUE NORTH trial, it is possible that oral sphingosine1‐phosphate (S1P) Zeposia could have an impact on the treatment paradigm for ulcerative colitis (UC) due to its oral route of administration. If priced competitively, the drug could be used before biologic therapy, says GlobalData, […]
COVID-19 should not distract UK Government from reaching Brexit agreement for sake of pharmaceutical industry, says GlobalData
As the world continues to brace for a COVID-19 triggered economic downturn and with the Brexit transition period extension deadline ending on 30 June; Urte Jakimaviciute, Senior Director of Market Research at GlobalData, shares her views on how the UK’s departure from the EU may affect the UK’s pharmaceutical sector: “The UK is now set […]
67.3% of clinical trials disrupted by COVID-19 are due to enrollment suspension
Since early March, over a hundred companies have publicly announced disruptions to planned and ongoing clinical trials in their press releases, SEC filings, as well as on social media. Companies have delayed the initiation of planned trials or withdrawn these completely, as well as suspended enrolment in ongoing trials or terminated these trials. GlobalData, a […]
Big bio/pharma companies sales bolstered by COVID-19, says GlobalData
The COVID-19 pandemic has led to temporarily increased drug sales for biggest bio/pharma companies in the first quarter (Q1) of 2020. This increase over sales forecasts for Q1 2020 was due to COVID-19-related purchases, as people stockpiled in preparation for reduced medical access in the lockdown, says GlobalData, a leading data and analytics company. Madeleine […]
COVID-19 impacting patients with Hodgkin lymphoma and other cancers, says GlobalData
COVID-19 could be causing patients with Hodgkin lymphoma and other cancers to delay seeking care, which in turn could delay those patients from receiving a cancer diagnosis. The pandemic may result in a slight decrease in one- to two-year cancer survival, a slight drop in the short-term diagnosed incidence rates, and a shift towards cancer […]
FDA’s Emergency Use Authorization benchmarks for COVID-19 vaccines remain ill-defined despite announcing approval requirements, says GlobalData
Following the US FDA’s issuance of its guidance document; Reynald Castañeda, Pharma Writer for the Investigative News team at GlobalData, offers his view: “The US Food and Drug Administration’s (FDA’s) vaccine guidance mirrors the World Health Organization’s (WHO’s) prior statement on minimal prerequisites for approval, including at least 50% protection, but the US agency’s comments […]
Remdesivir production limitations mean non-US patients to wait until October 2020 at earliest
Following the news that the US secured virtually all available short-term stock of remdesivir; Brian Hicks, Medical Devices Analyst at GlobalData, a leading data and analytics company, offers his view: “The US Government’s latest purchase will have wide-ranging implications for its own citizens, as well as for the broader global community. Firstly, as six doses […]