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Japan awards AbbVie's Skyrizi with first approval, in 4 psoriasis indications

AbbVie has announced that its interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) has been awarded approval in Japan from the nation’s Ministry of Health, Labour and Welfare (MHLW), marking its first-ever approval in any region worldwide, in the treatment of plaque psoriasis, generalised pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies.

Marketing authorisation was given based on Phase 2 and 3 data evaluating the drug’s efficacy in Japanese patients in the approved indications.

FDA puts multiple myeloma trial on hold after patient deaths

The FDA has placed a partial clinical hold on studies of multiple myeloma treatment Venclexta/Venclyxto (venetoclax) following a number of patient deaths in a late stage study.

AbbVie who are developing the drug with Roche said the hold should not affect any of the approved indications such as in chronic lymphocytic leukaemia (CLL) and acute myeloid leukaemia (AML).

The FDA made the decision after seeing data from the Phase 3 BELLINI trial in patients with relapsed and refractory multiple myeloma.

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HIV hit the headlines this week after it was announced that a British man known only as the ‘London Patient’ had been cured of HIV after receiving a bone marrow transplant from a donor with natural resistance to the immunodeficiency virus. Meanwhile Gilead offered positive results with HIV drug Biktarvy.

The news comes as sources told Reuters OxyContin drugmaker Purdue Pharma was exploring bankruptcy as a get out for the lawsuits they face over their role in manufacturing the opioid crisis.

AbbVie's Skyrizi scoops up CHMP recommendation for moderate to severe plaque psoriasis

AbbVie’s interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) has secured recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP), it has emerged.

Specifically, the drug has been recommended for the treatment of moderate to severe plaque psoriasis in adults who are eligible for systemic therapy.

Imbruvica combo scores expanded FDA approval in most common adult form of leukaemia

It’s big news for Janssen and AbbVie as it emerged that their jointly-developed Bruton's tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) has been awarded expanded indication by the FDA when used in combination with obinutuzumab. The combo is now approved for the treatment of the most common form of adult leukaemia, chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL), in treatment-naïve patients.

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While American firm AbbVie gained approval for leukaemia drug Venlytxo, the NHS defeated the US multinational thus week in court, after the firm challenged NHS England’s hep C drug procurement process, calling it ‘unfair’.

Meanwhile Sir Philip Hampton stepped down from his position as chairman of GSK while Vertex were prompted to oust current COO Ian Smith citing ‘personal behaviour’.

AbbVie's case against the NHS thrown out of court

A judge has thrown US multinational AbbVie’s case against NHS England’s hepatitis C procurement process, out of court.

Mr Justice Choudhury, a judge at the Technology and Construction Court, dismissed AbbVie’s case against the NHS, after the US firm alleged that NHS England’s procurement process for curative drugs for Hepatitis C (HCV) was unfair.

The Judge rejected the arguments of the Illinois-based multinational, after the firm launched a legal challenge against NHS England’s £1 billion procurement of drugs for HCV.

Abbvie's chronic lymphocytic leukaemia drug Venclytxo scores greenlight from NICE

A new recommendation from NICE means that thousands of patients in England and Wales will be able to receive Abbvie’s Venclyxto (venetoclax) in combination with Genentech’s Rituxan (rituximab) on the NHS as a treatment for relapsed or refractory chronic lymphocytic leukaemia (CLL) following one prior therapy.

AbbVie records an estimated $4billion in impairment charges after failure of cancer drug Rova-T

US firm AbbVie has said that it will record an estimated $4 billion in impairment charges related to the abandonment of the company’s once much anticipated investigational cancer treatment Rova-T.

Having purchased the rights to Rova-T through its high profile acquisition of Stemcentrx, AbbVie announced in December that it would ‘stop enrolment’ into Phase 3 trials for the second-line therapy for advanced small-cell lung cancer.

AbbVie's Venclyxto combo beats standard of care in chronic lymphocytic leukaemia

AbbVie has taken the opportunity at the American Society of Hematology (ASH) Annual Meeting 2018 to reveal new data on venetoclax (Venclyxto) in combination with rituximab (VenR), in which it demonstrated “continued substantial benefit” in the treatment of relapsed/refractory chronic lymphocytic leukaemia (R/R CLL) compared to a standard of care regimen of bendamustine plus rituximab (BR).  

The findings showed that VenR achieved a progression-free survival rate of 71.4% in 130 patients over 36 months, compared to 15.2% for those taking BR.

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