2021

Insights+: The US FDA New Drug Approvals in October 2021

The US FDA has approved 4 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 61 novel products in 2021 Additionally, last year in 2020, the US FDA …

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Insights+: The US FDA New Drug Approvals in September 2021

The US FDA has approved 5 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 55 novel products in 2021 Additionally, last year in 2020, the US FDA …

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Pharmashots Interview: X4 Pharmaceuticals’ Paula Ragan Shares Insights on the Data of Mavorixafor in Combination with Ibrutinib Presented at 2021 EHA Annual Congress

In an interview with PharmaShots, Paula Ragan, Ph.D., President, and Chief Executive Officer at X4 Pharmaceuticals shared her views on preliminary efficacy and safety data of Mavorixafor + Ibrutinib in an ongoing P-Ib study to treat waldenström’s macroglobulinemia Shots: The ongoing P-Ib clinical trial evaluates the safety & efficacy of mavorixafor + ibrutinib in patients …

Pharmashots Interview: X4 Pharmaceuticals’ Paula Ragan Shares Insights on the Data of Mavorixafor in Combination with Ibrutinib Presented at 2021 EHA Annual Congress Read More »

PharmaShots Interview: Cue Biopharma’s Anish Suri Shares Insights on the Data of CUE-401 Presented at 2021 FOCIS Annual Meeting

In an interview with PharmaShots, Anish Suri, Ph.D., President, and Chief Scientific Officer at Cue Biopharma shared his views on new preclinical data of CUE-401 for the treatment of autoimmune diseases at the 2021 FOCIS Annual Meeting Shots: The company has reported the preclinical data of CUE-401 which can induce & expand regulatory T cells in …

PharmaShots Interview: Cue Biopharma’s Anish Suri Shares Insights on the Data of CUE-401 Presented at 2021 FOCIS Annual Meeting Read More »

AbbVie Presents Results of AGN-190584 in P-III GEMINI 1 Study for Presbyopia at 2021 ASCRS

Shots: The P-III GEMINI 1 study involves assessing AGN-190584 (pilocarpine 1.25%, qd) ophthalmic solution in 323 patients in a ratio (1:1) with presbyopia for 30days. The study demonstrated that AGN-190584 met both its 1EPs & 2EPs with patients achieving near & intermediate vision gains. In addition, AGN-190584 showed no loss of distance vision, rapid onset …

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Insights+ Key Biosimilars Events of June 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of Jun, Celltrion launched Remsima SC (biosimilar, infliximab) for …

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Insights+ Key Biosimilars Events of May 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of May, Samsung initiated patient enrollment in the P-III …

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Takeda Reports Long-Term Safety and Efficacy Results of its Dengue Vaccine Candidate

Shots: The P-III TIDES study involves assessing two doses of TAK-003 (0.5mL, SC on day 1 & 90) vs PBO to prevent laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 20,000+ children and adolescents Results: @36mos. after the second dose, 62.0% VE against VCD; 65.0% …

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Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR 2021

Shots: The AURORA 2 involves assessing Lupkynis vs control arm in 216 patients who have completed P-III AURORA 1 study for 1 year Results: reduction in UPCR from pre-treatment baseline to year 2 (-3.1 vs -2.1 mg/mg); reduction proteinuria b/w 1 & 2year (1.0 vs 0.6 mg/mg); stable renal function. In general, the interim analysis …

Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR 2021 Read More »

Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021

Shots: The P-III VOYAGE trial involves assessing Dupixent (100/200mg, q2w, based on weight) + SOC asthma therapy in 408 children aged 6-11yrs. with uncontrolled mod. to-sev. asthma with evidence of type 2 inflammation Results: improvement in asthma control @24wks. (1.34/ 1.33 vs 0.88/ 1.00); improvement in ACQ-7-IA; reduction in mean FeNO levels to below the …

Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021 Read More »

Insights+ Key Biosimilars Events of April 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of April, Biocon and Viatris received EC’s approval for …

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Novartis Presents Results of Beovu (brolucizumab -dbll) in P-III KESTREL and KITE Studies for Diabetic Macular Edema at ARVO2021

Shots: The company reported the 1yrs. results from the P-III KESTREL & KITE studies assessing Beovu (6mg) vs aflibercept (2mg) in 926 patients with DME across 36 countries Results: met its 1EPs i.e. non-inferiority in mean change BCVA from baseline @48wks., patients treated with Beovu (6mg) experienced fluid (IRF/SRF) resolution and achieved CSFT levels below …

Novartis Presents Results of Beovu (brolucizumab -dbll) in P-III KESTREL and KITE Studies for Diabetic Macular Edema at ARVO2021 Read More »

Samsung Bioepis Presents Results of SB11 (proposed biosimilar ranibizumab) at ARVO 2021

Shots: The company reported the results from a study based on the structural and functional analysis of SB11, a proposed biosimilar referencing Lucentis (ranibizumab) The analytical assessment demonstrated that structural, physicochemical characterization i.e. amino acid sequence, post-translational modifications, higher order structure, and size and charge variants of SB11 were similar to Lucentis The SB11 is …

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ViewPoints Interview: Marc Meachem Shares Insight on the ViiV’s 2021 Commitment to the Community

In an interview with PharmaShots, Marc Meachem, Head of US External Affairs at ViiV Healthcare shared his views on the company’s approach towards the community. He also shed light on the grants and funding received for the betterment of HIV patients. Shots: ViiV Healthcare is doubling its community investments in 2021 with the goal of …

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Insights+ Key Biosimilars Events of March 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of March, Samsung Bioepis Initiated P-I Study of SB17 …

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The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US …

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The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US …

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Insights+ Key Biosimilars Events of February 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of Feb, Biocon collaborated with CHAI to expand access …

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What Excites You Most About the Life Sciences Industry in 2021?

We have looked back at some of the biggest advances in 2020, but it’s a new year and time to look ahead, so we asked our Life Sciences team what they are looking forward to in 2021. “Predicting the unknown!” says Thibault Géoui, Senior Director of Discovery Biology & Predictive Risk Management. “We are using …

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Insights+ Key Biosimilars Events of January 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

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The US biosimilar market: Predictions for 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. As we’ve seen over those five years, biosimilars are critical in continuing to provide …

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What we’re expecting in 2021, and beyond…

From telehealth to digital trials, customer engagement to healthcare data, Healthware Group outlines the key trends that are expected to shake up digital health this year. Well, it goes without saying, COVID-19 has resulted in a rapid adoption of digital technologies across all industries, most notably in healthcare. There are several important aspects to these …

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Insights+: Key Deals of JP Morgan Healthcare Conference 2021

This year J.P. Morgan 39th Annual Healthcare Conference was conducted virtually and we witnessed multiple announcements from numerous Biopharma companies An analysis of events and catalysts that were announced at the conference during these days are included in the report. Most of the deals occurred in the first two days of the conference Our PharmaShots …

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Clinical research in 2021: A new era of collaboration and innovation

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. The pandemic has propelled the life science industry toward higher expectations for faster, more responsive and …

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Nine for 2021: Addressing the pandemic legacy

In this second ‘Nine for 2021‘ article, IQVIA’s Sarah Rickwood looks at four issues which will directly impact pharma in 2021: the permanent changes in customer engagement models, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate. …

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Are face-to-face medical meetings a thing of the past?

Everything, from exercise classes to pub quizzes, went online last year – and medical education was no exception. In their droves, congresses, conferences, and masterclasses went virtual in a bid to ensure healthcare professionals were supported, up to date, and socially distanced. But is this change here to stay? Are the days of queuing for …

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2021 – The healthcare changes here to stay

2020 was the year that changed everything, and as the new year begins many are wondering what awaits the world in 2021. Impetus Digital co-founder and CEO Natalie Yeadon reflects on the last 12 months and shares her views on the healthcare, research and digital changes that could be here to stay. I think it …

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Nine for 2021: The COVID-19 legacy

In the first of a two part series, IQVIA’s Sarah Rickwood covers nine key trends and events that will affect the global healthcare and pharmaceutical industries in 2021. One bright spot in an otherwise dreadful year: the pharmaceutical industry has discovered it can do things it never dreamed possible. Anyone who proposed that a novel, …

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How Big Data will accelerate the future of digital medicine in 2021

The pandemic has shed light on inefficiencies in healthcare systems, and provided an opportunity to adjust how we manage care in the future. Jennifer Haas, executive vice president of Noteworth, shares her 2021 predictions surrounding the future of telehealth and big data.  Healthcare providers are grappling with the task of scaling digital care delivery operations …

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PharmaShots Wishes you a Merry Christmas and a Happy New Year

Shots: Thank you for your overwhelming affection and support throughout the year. This year we achieved a massive increase in subscribers PharmaShots mobile app is ready and we planned to launch our PharmaShots mobile app in January 2021 May this holiday season fills your life with happiness and wealth. Wish you a Merry Christmas and …

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AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Shots: AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region The price for the vaccine is not final but it is expected not to exceed $4/ dose. The vaccine will initially supply to all Latin American countries …

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