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Roche’s Genentech enters $765m autoimmune disease partnership with Repertoire

2 days ago | pmlive.com | Emily Kimber

Roche’s Genentech unit and Repertoire Immune Medicines have entered into a partnership worth $765m to discover and develop T cell-targeted immune medicines for an undisclosed autoimmune disease. The collaboration and licence agreement centres around Repertoire’s DECODE platform, which will be used to generate target discoveries that Genentech will further optimise and translate into new drugs.
Biogen’s Skyclarys granted MHRA approval for rare movement disorder Friedreich’s ataxia

2 days ago | pmlive.com | Emily Kimber

Biogen’s Skyclarys (omaveloxolone) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as the first treatment for patients aged 16 years and older with the rare neurodegenerative movement disorder Friedreich’s ataxia (FA). FA is the most common inherited ataxia, a group of disorders affecting coordination, balance and speech, affecting at least one in every 50,000 people in the UK.
Gilead shares promising phase 3 results for Trodelvy plus Keytruda in aggressive breast cancer

2 days ago | pmlive.com | Emily Kimber

Gilead Sciences has shared positive top-line results from a late-stage study evaluating its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) with Merck & Co’s anti-PD-1 therapy Keytruda (pembrolizumab) in triple-negative breast cancer (TNBC) patients.
Pfizer’s Hympavzi granted MHRA approval to treat haemophilia A and B

3 days ago | pmlive.com | Emily Kimber

Pfizer’s Hympavzi (marstacimab) has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to treat haemophilia A or B in adult and paediatric patients. The drug has been authorised to prevent or reduce bleeding episodes in patients ages 12 years and older who weigh at least 35kg and have severe haemophilia A without factor VIII inhibitors or severe haemophilia B without factor IX inhibitors.
BMS receives NICE recommendation for immunotherapy combination in colorectal cancer

3 days ago | pmlive.com | Emily Kimber

Bristol Myers Squibb (BMS) has announced that its dual immunotherapy combination has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line treatment for a subset of colorectal cancer patients.
AstraZeneca/Daiichi Sankyo’s Enhertu shows promise in first-line HER2-positive breast cancer

3 days ago | pmlive.com | Emily Kimber

AstraZeneca (AZ) and Daiichi Sankyo have shared positive results from a late-stage study of their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-positive metastatic breast cancer. The phase 3 DESTINY-Breast09 study has been evaluating the drug in combination with pertuzumab as a first-line treatment for this patient population. Up to 20% of patients with metastatic breast cancer are affected by HER2-positive disease.
Tackling the antibiotic resistance crisis

3 days ago | pmlive.com | Emily Kimber

Bacteria are rapidly developing resistance to the antibiotics they are exposed to. Alexander Fleming discovered penicillin in 1928, and during his Nobel lecture on 11 December 1945, he had already warned about the potential dangers of antibiotic resistance, saying: “It is not difficult to make microbes resistant to penicillin in the laboratory by exposing them to concentrations not sufficient to kill them, and the same thing has occasionally happened in the body.
Sanofi/Regeneron’s Dupixent granted FDA approval for chronic spontaneous urticaria

4 days ago | pmlive.com | Emily Kimber

Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) for chronic spontaneous urticaria (CSU). The drug has been authorised to treat the inflammatory skin disease in adults and adolescents aged 12 years and older who remain symptomatic despite histamine-1 (H1) antihistamine treatment.
GSK’s Blenrep combinations approved by MHRA to treat multiple myeloma

4 days ago | pmlive.com | Emily Kimber

GSK’s Blenrep (belantamab mafodotin) combinations have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat multiple myeloma in adults. The drug has been authorised alongside bortezomib plus dexamethasone (BVd) to treat patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) to treat those who have received at least one prior therapy including lenalidomide.
FDA approves pre-filled syringe version of argenx’s immune disorder drug Vyvgart

4 days ago | pmlive.com | Emily Kimber

The US Food and Drug Administration (FDA) has approved a pre-filled syringe version of argenx’s Vyvgart, giving generalised myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) patients the option to self-inject the immune disorder drug at home.