Product Development

CMS’ Medicare Advantage step edits in Part B likely to have muted impact on biosimilar uptake due to influence of similar challenges with commercial plans, experts say

Increased autonomy awarded to Medicare Advantage (MA) plans by the Centers for Medicare and Medicaid Services (CMS) to introduce step edits for Part B therapies is unlikely to have a major impact on biosimilar uptake due to similar financial challenges as seen with commercial payers, said experts.

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Karyopharm’s interim Phase IIb selinexor data in later-line DLBLC draws reserved expert interest for full results, but durable response would stimulate enthusiasm

Karyopharm Therapeutics’ (NASDAQ:KPTI) Phase IIb SADAL trial investigating selinexor in refractory or relapsed (r/r) diffuse large B-cell lymphoma (DLBCL) draws cautious expert optimism for delivering clinically significant full results.

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Coherus BioScience’s Udenyca and CH-1420 biosimilars for Amgen’s Neulasta and AbbVie’s Humira have market uptake concerns despite likely approvals, experts say

Coherus BioSciences’ (NASDAQ:CHRS) biosimilars Udenyca, formerly known as CHS-1701 (pegfilgrastim), and CH-1420 (adalimumab) have US uptake concerns despite likely FDA approval expectations, experts said.

Despite analysts’ expectations that market penetration will happen at the expense of respective originator products, Amgen’s (NASDAQ:AMGEN) Neulasta (pegfilgrastim) and AbbVie’s (NYSE:ABBV) Humira (adalimumab), due to low biosimilar price tags, experts are more sceptical.

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Allergan’s abicipar generates reports of SAE hemorrhagic vasculitis in neovascular AMD Phase III program, investigators say

Allergan’s (NYSE:AGN) abicipar pegol may have cases of hemorrhagic vasculitis in its pivotal Phase III studies CEDAR and SEQUIOA in neovascular age-related macular degeneration (AMD), said three trial investigators.

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Inventiva’s addition of PPAR gamma to lanifibranor’s targets has unclear value in NASH, triggering uncertainty over Phase II success, experts say

Inventiva Pharma’s (EPA:IVA) lanifibranor has drawn expert reservations for Phase IIb NATIVE trial success in nonalcoholic steatohepatitis (NASH). Although adding PPAR gamma as a target is an attractive hypothesis, preclinical evidence of PPAR gamma’s value in NASH is foggy, they explained. Real-world experience with PPAR gamma therapies in diabetes, on the other hand, triggered mixed reviews on NASH relevance.

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Pfizer/Eli Lilly’s long-term Phase III for tanezumab in osteoarthritis still draws RPOA caution despite amendments and positive data, experts say

Pfizer (NYSE:PFE)/Eli Lilly’s (NYSE:LLY) tanezumab for osteoarthritis (OA) of the hip and knee may face hurdles to clear long-term efficacy and safety benchmarks, experts said.

While positive Phase III (NCT02697773) data announced on 18 July is encouraging, prior safety signals from tanezumab’s Phase II proof-of-concept trial (NCT00394563) – released in 2009 – has experts still cautious of incidences of rapidly progressive osteoarthritis (RPOA).

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Akcea's AKCEA-APO(a)-LRx needs Phase III Lp(a) measurements, CV risk specifics before CVOT initiation; positive Phase IIb trial expectations, experts say

Akcea Therapeutics (NASDAQ:AKCA) should first plan for a Phase III study for AKCEA-APO(a)-LRx to determine the exact levels of lipoprotein Lp(a) reduction and cardiovascular (CV) risk before proceeding to a cardiovascular outcome trial (CVOT), experts said.

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Achillion’s Phase II C3 glomerulopathy trial of ACH4471 likely to be impacted by slow recruitment though experts optimistic about final results

Achillion Pharmaceuticals’ (NASDAQ:AHCN) 14-day Phase II ACH-4471 trial for complement (C3) glomerulopathy (C3G) is likely to face patient enrollment hurdles, affecting an on-time readout, experts said. Nonetheless, they earmarked the study for success, considering ACH-4471’s more targeted and upstream approach to modulating the complement system.

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Gilead/Spring Bank’s Phase II inarigivir/Vemlidy combo logical for HBV but inarigivir's modest data and unclear mechanism draws expert reservations

Gilead Sciences (NASDAQ:GILD) and Spring Bank Pharmaceuticals’ (NASDAQ:SBPH) Phase II trial investigating inarigivir in combination with Gilead’s nucleoside analogue Vemlidy (tenofovir) for hepatitis B virus (HBV) infection has a promising rationale due to the combination’s synergistic antiviral approach. However, inarigivir’s monotherapy efficacy impact is still unclear, drawing uncertainties to its potential contribution in a combination setting, some noted.

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Novartis’ CVOT and postmarket trial for Entresto likely to meet primary safety, NT-proBNP endpoints but expense will continue to curb access, experts say

Novartis’ (VTX:NOVN) heart drug Entresto (sacubitril/valsartan) will likely lead to a reduction in cardiovascular (CV) mortality events for a successful Phase III CV outcomes trial (CVOT), experts said, despite analyst misgivings of a hypotension risk. Experts said they also expect Entresto to lead to a reduction in NT-proBNP in the postmarket PIONEER-HF study due to significant data for heart failure (HF) patients with preserved ejection fraction (HFpEF) in the Phase II PARAMOUNT trial.

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