Product Development

Eli Lilly (NYSE:LLY) has increased the doses of solanezumab in both the A4 and DIAN studies of Alzheimer’s disease (AD), according to two sources familiar with the studies. The A4 study duration has also been extended by one and a half years, they added.

The sources did not comment on the new dose being used in the A4 study. The doses on both ClinicalTrials.gov pages are still listed as 400mg and have not been updated since the alleged protocol amendments. 

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Kite Pharma’s (NASDAQ:KITE) Phase I/II ZUMA-4 study of axicabtagene ciloleucel (axi-cel) in pediatric acute lymphoblastic leukemia (ALL) has a protocol amendment that allows patients who have previously received Amgen’s (NASDAQ:AMGN) Blincyto (blinatumomab) to enter the study, a source said.

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Novartis (VTX:NOVN) temporarily encountered manufacturing problems at its European chimeric antigen receptor T-cell (CAR-T) manufacturing facility, forcing at least one site in the Phase II JULIET trial of tisagenlecleucel-T in diffuse large B-cell lymphoma (DLBCL) to go through the US facility, a source with knowledge of the situation said. The logistical issue occurred after the European sites’ activation and resulted in lengthening the time between apheresis and reinfusion, the source added. 

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Merck’s anacetrapib trial design could become standard for future CETP inhibitor trials in hypercholesterolemia; PCSK9 data potential success bar– experts

Merck’s (NYSE:MRK) Phase III anacetrapib REVEAL results have triggered expert discussion about potential optimal future CETP inhibitor hypercholesterolemia trial design options in order to be competitive with PCSK9 inhibitors. They noted CETP inhibitors needed to match the 14% benefit seen for PCSK9 inhibitors, whilst noting that similar patient numbers and trial length to REVEAL would likely be required and ideal LDL levels should fall between 61 and 100 in the inclusion criteria. 

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Versartis’ Phase III paediatric growth hormone trial primed for FDA approval, efficacy success but long-term safety risks possible – experts

• Same MOA as Genotropin provides efficacy reassurance
• GHD false positives will not impede efficacy read-outs
• Long half-life could bring IGF peaks, gives safety pause

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Vertex’s Phase II triple combos spurs optimism for F508del homozygous CF patients, heterozygous group draws pause - experts

Vertex Pharmaceutical’s (NASDAQ:VRTX) triple combinations of a CFTR potentiator and two correctors elicited expert optimism for Phase II due to encouraging preclinical rationale for F508del homozygous and F508del/minimal CFTR function heterozygous patients, albeit with caution in the latter.

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Revance’s Phase II RT002 has three cervical dystonia patients still responding at 36 weeks; potential reduction in clinic visits major breakthrough – source

Revance Therapeutics’ (NASDAQ:RVNC) RT002 (daxibotulinumtoxin a) is still demonstrating efficacy in three cervical dystonia patients after 36 weeks in an open-label Phase II trthat three ial, said a source familiar with the situation. The company recently presented positive 24-week efficacy/safety data and noted it would be measuring efficacy up to 36 weeks.

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HRD testing finds favor among experts for ovarian cancer PARP inhibitors despite broad labels, potential impact on market penetration - experts

Despite the broad label received in recent ovarian cancer approvals, experts said they are still considering using homologous recombination deficiency (HRD) tests to whittle down eligible patients before treatment.

Tesaro’s (NASDAQ:TSRO) Zejula (niraparib) was the first PARP inhibitor to be given a broad label for second-line ovarian cancer maintenance therapy, while Clovis Oncology’s (NASDAQ:CLVS) Rubraca (rucaparib) is also anticipated to have a similar label.

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TherapeuticsMD’s TX-004HR for postmenopausal dyspareunia CRL could be resolved with postmarketing study, label expansion possible – experts

Despite TherapeuticsMD’s (NYSEMKT:TXMD) FDA Complete Response Letter (CRL) for its TX-004HR (estradiol vaginal capsule) for postmenopausal dyspareunia, it still runs a good chance of approval for its lower doses without an extra, postmarketing 12-month study, experts said. If the study is done, it could be open-label, and is expected to show an excellent safety profile via endometrial biopsies, they said.

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DBV and Aimmune likely to claim individualized slices of peanut allergy pie, DBV’s patch may sway risk averse parents – experts

DBV’s (EPA:DBV) and Aimmune (NASDAQ:AIMT) respective peanut allergy products will see individual preferences affect uptake, experts said. However, DBV’s Viaskin Peanut could appeal more strongly to parents who may be willing to compromise on efficacy for better safety, they added.

While Viaskin Peanut is an epicutaneous immunotherapy that delivers increasing doses of the allergen through the skin with a patch, AR101 is an oral immunotherapy that uses standardized doses of peanut preparations.

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