Product Development

Tau-targeting drugs hold rationale for AD, however concerns including optimal approach and patient selection remain – experts

Tau-targeting drugs have sparked debate for their potential to treat Alzheimer's disease (AD) with experts weighing up strong pathological rationale with concerns regarding scant clinical data, patient selection and whether antibody or vaccines are the best approach.

Continue reading →
Celgene’s marizomib sees Phase I/II recurrent GBM study on hold pending protocol amendment to expand enrollment – sources

Celgene's (NASDAQ:CELG) Phase I/II study of marizomib in combination with Roche's (VTX:ROG) Avastin (bevacizumab) in recurrent glioblastoma (GBM) is awaiting a protocol amendment to allow expansion of 40 additional patients, two sources said. The current study is on hold, added one source, despite the trial being listed as recruiting on

The current enrollment target is 66 patients, according to the trial's (NCT02330562) page, which was last updated on 4 January and shows a July 2017 primary completion date.

Continue reading →
Gilead’s Phase II NASH drug expected to prove safe but limited data draws caution, MOA rationale for early efficacy signals – experts

Gilead Sciences' (NASDAQ:GILD) Phase II trial investigating GS-0976 for nonalcoholic steatohepatitis (NASH) has drawn cautious safety optimism from experts. Whilst available 10 subject data is too small to draw conclusions, GS-0976 mechanism does not elicit safety concerns, they added. But one expert noted the drug's downstream target could lead to side effects related to elimination of fat in the liver.

Continue reading →
GSK’s closed triple in COPD faces pulmonologist resistance on ICS use but GP generous prescribing to drive market

GlaxoSmithKline’s (LON:GSK) closed triple FF/UMEC/VI combination carries dampened enthusiasm for use in chronic obstructive pulmonary disease (COPD)with questionable risk/benefit profile of the inhaled corticosteroid (ICS), experts said.

The closed triple is a once-daily inhaler with an inhaled corticosteroid (ICS)/long acting muscarinic antagonist (LAMA)/ long acting beta agonist (LABA) combination of GSK’s Flovent (fluticasone), Incruse (umeclidinium) and vilanterol, respectively.

Continue reading →
BioMarin’s pegvaliase for PKU will likely remain second to Kuvan at initial launch, eventual uptake certain with unmet need, diet noncompliance – experts

BioMarin Pharmaceutical's (NASDAQ:BMRN) PEG-PAL (pegvaliase) if approved has most experts noting that it will initially remain second-line as an option for adult standard of care (SOC) for phenylketonuria (PKU) versus Kuvan (sapropterin). Kuvan’s preferable side-effect profile and physician experience, among other reasons, will have it maintain its first-line status, they said.

Continue reading →
AstraZeneca’s KESTREL head and neck cancer study has decent chance of positivity for durvalumab/tremelimumab – experts

AstraZeneca’s (LON:AZN) Phase III KESTREL study of durvalumab/tremelimumab has potential to show extended survival in patients with first-line recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), experts said.

Phase I durvalumab monotherapy data lends confidence in the combination’s ability to improve survival over the SOC regimen of Eli Lilly’s (NYSE:LLY) Erbitux (cetuximab)/5-FU/platinum chemotherapy (EXTREME), albeit with some reservations about potential toxicity, experts said.

Continue reading →
Legislation to force payer coverage of abuse-deterrent opioids faces resistance due to cost barriers; limited data to support benefit– experts

Proposed legislation across 23 US states to force payers to increase reimbursement of abuse-deterrent (AD) opioids will likely face significant resistance due to state cost implications, most experts said. The state payer- Medicaid- and private payers alike will likely argue that AD opioids do not currently have enough evidence to support the idea that they prevent abuse and addiction, experts added.

Continue reading →
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...

Continue reading →
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.

Continue reading →
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.

Continue reading →