European Pharmaceutical Review

SEPTEMBER 15, 2022

Long-term data from the KEEPsAKE trials shows more than half of adult psoriatic arthritis patients receiving Skyrizi ® (risankizumab, 150mg) achieving a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College of Rheumatology 20 (ACR20) response at 100 weeks.

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Pharmaceutical Technology

AUGUST 2, 2022

The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) ’s Stelara (ustekinumab) to treat paediatric patients aged six years and above with active psoriatic arthritis (PsA).

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European Pharmaceutical Review

NOVEMBER 1, 2022

The proposed restrictions are due to a review of available data, including clinical trial results for Xeljanz and initial findings from an observational study of Olumiant. The PRAC has confirmed that individuals with the following chronic inflammatory disorders should not take JAK inhibitors: Rheumatoid arthritis (RA).

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European Pharmaceutical Review

NOVEMBER 2, 2023

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” Like Stelara, the most serious known side effect of Wezlana is infection.

Biosimilars 91

Biosimilars 91

Pharmaceutical Technology

MAY 25, 2023

Yuflyma is indicated to treat juvenile idiopathic arthritis, hidradenitis suppurativa, Crohn’s disease, plaque psoriasis, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

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Pharmaceutical Business Review

MARCH 12, 2024

Results from the QUASAR programme showed that TREMFYA led to statistically significant and clinically meaningful improvements in UC symptoms. In July 2020, the FDA expanded its indication for the treatment of adults with active psoriatic arthritis.

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European Pharmaceutical Review

MAY 18, 2023

The NICE recommendation is based on data from three Phase III clinical trials, which demonstrated significantly more patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response.

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Immunity Immunization Hospitals 84

European Pharmaceutical Review

SEPTEMBER 11, 2023

The reference medicine Stelara (ustekinumab) is a monoclonal antibody (mAb) treatment to interleukin (IL)-12/23 indicated for autoimmune disorders including Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

Biosimilars 77

Biosimilars 77

PharmaShots

MAY 10, 2023

Shots: The new efficacy & safety data from the P-III study evaluating Tremfya vs PBO in 1064 patients who had an inadequate response or intolerance to conventional and/or advanced therapies The results showed clinical remission (22.6% showed a clinical response (61.5% vs 7.9%) @12wk.; symptomatic remission (22.6% vs 12.9%) @4wk.

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pharmaphorum

SEPTEMBER 2, 2021

The FDA also said the risks seemed to be higher with both higher and lower doses of Xeljanz/Xeljanz XR, whereas an earlier assessment suggested only implicated the higher dose of the drugs, used to treat rheumatoid arthritis and ulcerative colitis. The result?

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Labelling 52

pharmaphorum

DECEMBER 15, 2021

Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transplant (HSCT) used to treat leukaemias and other blood cancers. billion in the first nine months of the year.

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European Pharmaceutical Review

DECEMBER 14, 2022

Clinical studies of Nimbus Therapeutics’ allosteric TYK2 inhibitor. In Phase I studies, NDI-034858 showed a good tolerability profile, a dose-dependent trend in exploratory clinical activity and a pharmacokinetic profile allowing for once-daily solid oral dosing. For $4 billion , Takeda will acquire Nimbus Lakshmi, Inc.,

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European Pharmaceutical Review

JANUARY 24, 2024

It is the first prospective, large-scale, randomised-controlled clinical trial evaluating people of colour across all skin tones with moderate to severe plaque PsO and scalp PsO to objectively measure clearance and other treatment outcomes with Tremfya. percent compared to 37.8 percent versus 33.4

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Safe Biologics

DECEMBER 6, 2023

Wezlana is approved to treat adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis.

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Biosimilars Packaging Labelling Drug Development 130

Pharmaceutical Technology

JUNE 19, 2023

BAT2206 is approved in the country to treat active psoriatic arthritis (PsA) in adults, either as a monotherapy or along with methotrexate. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

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Biosimilars 52

Pharmaceutical Technology

JULY 27, 2022

Clinical remission according to Adapted Mayo Score was the primary endpoint of the studies while secondary endpoints comprised clinical response and mucosal healing among others. According to the findings, the trials met the primary endpoint and all secondary endpoints with statistical significance.

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Immunity Immunization 52

Pharmaceutical Technology

FEBRUARY 10, 2023

Phase III clinical trial of TAK-279 in psoriasis is expected to commence this year. These diseases include psoriatic arthritis, inflammatory bowel disease and systemic lupus erythematosus. With this transaction, Takeda has now acquired TAK-279, formerly known as NDI-034858 at Nimbus.

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Immunity Immunization 52

pharmaphorum

FEBRUARY 5, 2021

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. First approved in 2o12, Xeljanz brought in sales of more than $1.7

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Communication Labelling 78

Express Pharma

JUNE 23, 2023

Mariam Shwea, Healthcare Analyst at GlobalData, comments , “UCB’s Bimzelx is welcomed for its trailblazing nature, as the reported data revealed its superior long-term disease control and significant clinical improvement in the signs and symptoms of PsA and axSpA patients when compared to the respective placebo groups.”

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pharmaphorum

NOVEMBER 25, 2020

Although the drug has lost market share to rivals in psoriasis, there is still more to come from Cosentyx thanks to potential new uses in ankylosing spondylitis, psoriatic arthritis and six new indications. The post Novartis set to overcome $14 billion patent cliff say analysts appeared first on.

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Biosimilars Hospitals 120

pharmaphorum

MAY 12, 2022

AbbVie’s would-be blockbuster Rinvoq has notched up another positive trial in Crohn’s disease, showing that it can achieve clinical remission over a full year when used as a maintenance therapy. ” For AbbVie, the results could unlock sales of $1.3 Rinvoq made $1.65

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Hospitals 65

PharmaShots

JUNE 9, 2023

Quell Therapeutics Signed an Exclusive Option and License Agreement with AstraZeneca to Develop, Manufacture and Commercialize Engineered Treg Cell Therapies Date: June 09, 2023 | Tags: Quell Therapeutics, AstraZeneca, Engineered Treg Cell Therapies, Type 1 Diabetes, Inflammatory Bowel Disease, Biotech, Treg cell engineering modules Astellas and the (..)

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Biosimilars Diabetes 40

PharmaShots

JUNE 27, 2023

Food and Drug Administration (FDA) have accepted the Marketing Authorization Application and the abbreviated Biologics License Application (aBLA), respectively, for BIIB800 in Q4 2022 with the Phase 3 trial being conducted in rheumatoid arthritis (RA) patients. Smriti: Can we talk about BIIB800, a tocilizumab biosimilar?

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Biosimilars Diabetes Immunity Immunization 40

Pharmaceutical Technology

JUNE 5, 2023

Izokibep is under clinical development by Acelyrin and currently in Phase II for Panuveitis. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Izokibep LoA Report.

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Pharmaceutical Technology

NOVEMBER 23, 2022

A substantially higher proportion of subjects who received Skyrizi attained the co-primary endpoints of clinical remission (per SF/AP) and endoscopic response in all the trials. In the European Union, Skyrizi also received approval to treat adults with psoriasis and psoriatic arthritis.

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Pharmaceutical Technology

OCTOBER 26, 2022

The Phase II MajesTEC-1 clinical trial comprised multiple myeloma patients who had received a median of five lines of therapy previously. In August, Janssen received FDA approval for Stelara (ustekinumab) for the treatment of paediatric patients aged six years and above with active psoriatic arthritis.

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Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

FEBRUARY 26, 2024

Clinical data showed approximately 60 percent reductions in plasma NfL concentrations in patients given Qalsody compared to placebo. After 12 weeks, patients treated with danicopan had a clinically-relevant increase in haemoglobin (an average of 2.35 This indicated reduced neuronal injury, EMA noted.

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Generic Medicine Vaccines Pharmaceutical Companies Pharmaceutical Companies 92

pharmaphorum

FEBRUARY 19, 2021

Rigel’s clinical-stage R552 is the main asset in the deal – which also includes $835 million in development, regulatory, and commercial milestones – but Lilly has also taken rights to preclinical-stage follow-ups that can cross into the brain and may have potential in central nervous system disorders.

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Compounding Immunity Immunization Drug Development 52

Big Molecule Watch

NOVEMBER 20, 2023

The CHOMP recommendation is based on positive results from the PULSAR clinical trial in nAMD and the PHOTON trial in DME. The final decision from the European Commission is expected in the coming months. Aflibercept 8 mg was jointly developed by Bayer and Regeneron.

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Biosimilars Diabetes 62

pharmaphorum

JANUARY 6, 2023

a Los Angeles area-based, late-stage clinical biopharma, with additional operations in the San Francisco Bay area, has announced it is acquiring privately held ValenzaBio – which develops therapies for autoimmune and inflammatory diseases – in an all-stock transaction. ACELYRIN, Inc.,

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Labelling 59

pharmaphorum

APRIL 12, 2021

While the headline figure looks significant the UK biotech will receive only €7 million up front, reflecting the fact that the drug has not yet begun clinical testing. If it succeeds in the clinic the drug could offer a more convenient oral alternative to injected IL-17 drugs, such as Novartis’ blockbuster Cosentyx (secukinumab).

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Safe Biologics

JANUARY 1, 2023

Exemptions will be considered for patients in certain clinical circumstances on a case-by-case basis in consultation with their health care provider. It is expected to launch in the US in July 2023 as self-administered prefilled syringes and self-administered prefilled pens (autoinjectors).

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pharmaphorum

MAY 24, 2022

remained in clinical remission after a year’s follow-up compared to 25.1% Earlier, results of the LUCENT-1 study showed that 24% of patients treated with mirikizumab were in clinical remission at 12 weeks – meaning inflammation of the colon is controlled or resolved – compared to 13% of the placebo group. of those on placebo.

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Biosimilars 59

PharmaShots

APRIL 6, 2023

Jennifer Davidson: The new data from the Phase 2b QUASAR Induction Study 1 in adults with moderately to severely active ulcerative colitis (UC) with inadequate responses to previous treatments showed an overall clinical response rate of approximately 80 percent in patients who were randomized to TREMFYA® (guselkumab). A mean of 52.1

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Immunity Immunization 40

pharmaphorum

SEPTEMBER 7, 2022

Clinical trial results showed a significant reduction in symptoms when people took ozanimod, as compared with a placebo. Clinical experts recommend that TNF-alpha inhibitors be used alongside thiopurines for maximum efficacy. Normally, this is a tumour necrosis factor (TNF)-alpha inhibitor (usually, infliximab).

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Dosage Documentation Immunity Immunization 52

PharmaShots

MAY 26, 2023

Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer Date: May 26, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Regulatory, Priority Review, US, FDA Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19 Date: (..)

Biosimilars 40

Biosimilars 40

pharmaphorum

JUNE 20, 2022

Crohn’s the third indication for Skyrizi after psoriasis and psoriatic arthritis, and a key step in AbbVie’s aim to grow the drug – already one of its top sellers with sales of almost $3 billion last year, and $940 million in the first three months of 2022.

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Biosimilars Immunity Immunization 65