Product Development

Fibrogen could face IPF strategic conundrums to keep post-Phase IIb pamrevlumab pursuit viable - experts

Fibrogen (NASDAQ:FGEN) faces hurdles to advance pamrevlumab in idiopathic pulmonary fibrosis (IPF) beyond its Phase IIb results, experts said. Fibrogen may struggle to execute a robust randomized trial and may be hoping for acquisition interest after releasing Phase IIb data, a source said, while a pulmonologist who was familiar with company strategy pointed to its struggles after the 2014 approvals of...

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Roche’s emicizumab’s Phase III trial in haemophilia A has most experts questioning drug overall safety profile, clinical future unclear

Roche’s (VTX:ROG) report of a patient death in its Phase III ACE910 (emicizumab) HAVEN 1 study in haemophilia A had experts question a trial investigator’s claim the death occurred independently of the drug.

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Cidara's Phase III candidiasis trial primed for approval; CD101 uptake triggers largely positive expert feedback

Cidara Therapeutics’ (NASDAQ:CDTX) suggested future Phase III trial design investigating intravenous (IV) CD101 for candidiasis is well-designed to demonstrate noninferiority compared with standard of care (SOC), experts said. CD101’s superior dosing schedule is likely to see it take a significant slice of the existing antifungal market, most added.

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Amgen’s high LDL-C drug Repatha’s Phase III CVOT success has uncertain clinical and payer relevance ahead of full trial read outs – experts

Unclear clinical relevance remains for Amgen’s (NASDAQ:AMGN) Phase III of its high LDL-C drug Repatha's (evolocumab) cardiovascular outcomes trial (CVOT), experts said, despite the company calling the study a success with a significant reduction in CV events.

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Spark has experts envisioning an amortized payment plan for voretigene in RPE65-mediated IRDs

Spark Therapeutics’ (NASDAQ:ONCE) voretigene neparvovec will most likely see an amortized payment plan from payers if approved regardless of its label, experts said. Analysts have stated that Spark’s therapy has shown promising four-year durability from the Phase I study, which could support a one-time upfront cost and wide uptake, with global sales of USD 573 million expected in 2023.

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AstraZeneca’s durvalumab/tremelimumab strikes Phase III efficacy optimism for unselected first-line NSCLC patients with data, MOA rationale- experts

AstraZeneca’s (LON:AZN) durvalumab/tremelimumab combination for first-line non-small-cell lung cancer (NSCLC) has a good chance of beating standard-of-care (SOC) chemotherapy in a Phase III trial, most oncologists said. Based on past data and the mechanism of action, the addition of tremelimumab is likely to increase the objective response rate (ORR) in an unselected population, which increases survival prospects, they explained.

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Roche’s emicizumab has largely uncertain haemophilia A approval forecasts after undetailed Phase III safety read outs – experts

Despite positive efficacy results, Roche’s (VTX:ROG) ACE910’s (emicizumab) Phase III outcomes lack sufficient detail to gauge the drug’s safety profile and subsequent approval prospects in haemophilia A, three experts agreed.

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Mylan’s Advair generic approval hinges on solidity in meeting FDA guidelines; true equivalence a hurdle – experts

Mylan's (NASDAQ: MYL) bid for approval of MGR001—generic of GlaxoSmithKline’s (LON:GSK) Advair (fluticasone/salmeterol) inhaler—is within reach but dependent on the data-package’s precision to specific FDA guidelines introduced in 2013, said experts.

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Stealth BioTherapeutics’ planned Phase III trial divides physicians over potential elamipretide protocol length, functional endpoints desired

Stealth BioTherapeutics’ planned Phase III trial of elamipretide in genetically-confirmed mitochondrial myopathy has drawn physician debate over whether Stealth’s proposed 4-week protocol is long enough to capture relevant efficacy and safety data.

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Gilead’s bictegravir faces tough HIV market but TAF combo attractive enough to drive use over Viiv’s Tivicay – experts

Gilead Sciences’ (NASDAQ:GILD) bictegravir faces tough HIV space dominated by Viiv’s Tivicay (dolutegravir), but a fixed dose combination comprising tenofovir alafenamide (TAF) could give it an edge, said experts.

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