rheumatoid arthritis

Actemra shortage spills over to include Sanofi’s rival Kevzara

Roche’s Actemra has been in high demand since its value in treating severe COVID-19 was established, leading to shortages. Now, Sanofi’s rival therapy Kevzara has also been hit by supply constraints. Sanofi said in a statement that supply of all four formats of Kevzara (sarilumab) – 150 mg or 200 mg pre-filled syringes or auto-injectors …

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FDA firms up JAK inhibitor warnings after Xeljanz review

The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. After looking at the data from Pfizer’s long-term, post-marketing safety study – ORAL Surveillance – the US …

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Trials leave Galapagos’ SIK programme looking under the weather

Galapagos has had to send its SIK inhibitor programme back to the drawing board after its lead compound GLPG3970 has failed two of three clinical trials, adding to a string of disappointments for the Belgian biotech.  Results from a phase 1b study in psoriasis and two phase 2a studies in ulcerative colitis and rheumatoid arthritis …

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Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in P-III CT-P17 3.1 Trial for Rheumatoid Arthritis at EULAR 2021

Shots: The P-III CT-P17 3.1 trial involves assessing Yuflyma (adalimumab, 40mg, high-concentration formulation, low-volume and citrate-free, q2w, up to 24 wks.) vs reference adalimumab in a ratio (1:1) in 648 patients with active RA The one year data demonstrated comparable efficacy of Yuflyma to reference adalimumab in terms of ACR20/50/70 response rates in patients receiving …

Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in P-III CT-P17 3.1 Trial for Rheumatoid Arthritis at EULAR 2021 Read More »

AbbVie Presents Results of Long-Term Efficacy and Safety Analyses for Rinvoq (upadacitinib) in P-III SELECT-COMPARE Study for Rheumatoid Arthritis at EULAR 2021

Shots: The P-III SELECT-COMPARE study evaluates the safety and efficacy of Rinvoq (15 mg, qd) vs PBO and Humira (SC, 40mg, every other week) in a ratio (2:2:1) in adult patients with a mod. to sev. active RA who had an inadequate response to MTX and continued a stable background of MTX The new analysis …

AbbVie Presents Results of Long-Term Efficacy and Safety Analyses for Rinvoq (upadacitinib) in P-III SELECT-COMPARE Study for Rheumatoid Arthritis at EULAR 2021 Read More »

What’s Best for Eczema (Atopic Dermatitis): Coconut Oil vs. Mineral Oil vs. Vaseline

Natural topical remedies for eczema, including licorice root gel, St. John’s Wort cream, and emollients such as coconut oil, mineral oil, and petroleum jelly, are put to the test. Despite the availability of drugs with proven efficacy for eczema, like topical steroids, many patients seek out natural alternatives. Which plant, then, should be used for …

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Biogen Signs a License and Commercialization Agreement with Bio-Thera for BAT1806 (biosimilar, tocilizumab) to Treat Moderate to Severe Rheumatoid Arthritis

Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction is expected to close in Q2’21 Biogen to get exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries excluding China (includes Hong Kong, Macau, and Taiwan) Biogen will …

Biogen Signs a License and Commercialization Agreement with Bio-Thera for BAT1806 (biosimilar, tocilizumab) to Treat Moderate to Severe Rheumatoid Arthritis Read More »

FDA holds back from action over Xeljanz safety study

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post-marketing ORAL Surveillance safety study showed that JAK inhibitor Xeljanz (tofacitinib) was associated with a higher rate of heart attacks and cancer …

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Pfizer Signs a License and Research Agreement with Imcyse to Develop Imotopes for Rheumatoid Arthritis

Shots: Imcyse to receive up front, ~$180M as milestones along with royalties. Pfizer to purchase an equity stake in Imcyse Initially, the companies will collaborate to develop existing lead candidates and further optimize potential molecules. Later, Pfizer will lead clinical development and commercialization activities for the program The Imotope platform is a curative approach to …

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Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

Shots: The Health Canada has granted a NOC which is based on clinical evidence for Remsima/CT-P13 SC vs CT-P13 IV up to 1year in patients with RA. The results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining Remsima SC up to 54wks. The therapy has shown similar …

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Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

Shots: The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 patients in subjects with RA aged ≥ 50yrs. and had at least one additional CV risk factor The primary analyses include 135 subjects with MACE and 164 subjects with malignancies. …

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NICE backs broad use for Gilead/Galapagos arthritis pill Jyseleca

Patients with rheumatoid arthritis (RA) in England will be able to get treatment with Gilead Sciences and Galapagos’ JAK inhibitor Jyseleca, after it was backed by cost-effectiveness agency NICE. Jyseleca (filgotinib) has been recommended for moderate and severe active RA in patients who have responded inadequately to intensive therapy with two or more conventional disease-modifying …

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What White Blood Cell Count Should We Shoot for?

At the start of my video What Does a Low White Blood Cell Count Mean?, you can see what it looks like when you take a drop of blood, smear it between two pieces of glass, and view at it under a microscope: a whole bunch of little, round, red blood cells and a few …

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FDA issues surprise rejection of Gilead, Galapagos rheumatoid arthritis drug

While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.

Analysts question Gilead’s commitment to arthritis drug after FDA setback

The FDA has rejected Gilead and Galapagos’ rheumatoid arthritis (RA) pill filgotinib over concerns that it could damage male fertility, prompting speculation that the big US pharma could become disillusioned with the project. Filgotinib needs to be good: it is the fourth Janus kinase (JAK) inhibitor to market after Eli Lilly’s Olumiant (baricitinib), Pfizer’s Xeljanz …

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Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

Shots: Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage …

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis Read More »

One Way to Treat Asthma and Autoimmune Diseases with Diet

Cutting two teaspoons of salt’s worth of sodium from one’s daily diet can significantly improve lung function in asthmatics In the 1960s and 1970s, a mystery was emerging. Why were childhood asthma rates between 2 to 5 percent in the developed world but as low as 0.007 percent in the developing world? For example, in …

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