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Reata Pharmaceuticals’ (NASDAQ:RETA) Phase II trial of RTA408 (omaveloxolone) in primary mitochondrial myopathy (MM) has triggered expert efficacy optimism based on the drug’s Phase II success in...

Ra Pharmaceuticals’ (NASDAQ:RARX) potential Phase III trial of C5 inhibitor RA101495 in paroxysmal nocturnal hemoglobinuria (PNH) patients should have a switching design in patients demonstrating...

Pfizer’s (NYSE:PFE) Sutent (sunitinib) will find low uptake in adjuvant renal cell carcinoma (RCC) setting, but approval could still come through despite a split Oncologic Drug Advisory Committee...

AstraZeneca’s (LON:AZN) Tagrisso (osimertinib) Phase III data in first-line EGFR mutant non-small-cell lung cancer (NSCLC) has oncologists noting it will likely be the new standard of care (SOC)...

Pfizer (NYSE:PFE) and Merck KGaA’s (ETR:MRK) Phase III first-line advanced renal cell carcinoma (RCC) JAVELIN 101 study of PD-L1 inhibitor Bavencio (avelumab) in combination with Pfizer’s Inlyta (...

Allergan’s (NASDAQ:AGN) efforts to have inter partes review (IPR) disputes dismissed through transferring Restasis (cyclosporine ophthalmic emulsion) patents to a Native American tribe may uncover...

Cascadian Therapeutics’ (NASDAQ:CASC) ONT-380 (tucatinib) for HER2+ colorectal cancer (CRC) needs to reach 30-40% in its Phase II primary endpoint of objective response rate (ORR) to be considered...

AstraZeneca’s (LON:AZN) PACIFIC Phase III of Imfinzi (durvalumab) results in unresectable Stage III non-small-cell lung cancer (NSCLC) following concurrent chemoradiotherapy will trigger immediate...

Resverlogix's (TSE:RVX) apabetalone for reducing cardiovascular disease (CVD) event risk has experts debating whether its targeting of diabetic patients with impaired kidney function could...

Artificial intelligence/machine learning (AI/ML) advances that allow clinical trial sponsors to create synthetic control arms (SCAs) -- instead of enrolling patients on active comparators – are...

AstraZeneca’s (LON:AZN) Phase III study of Tagrisso (osimertinib) requires at least a 22-month progression-free survival (PFS) in order to be clinically viable in first-line EGFR mutant non-small-...

United Therapeutics’ (NASDAQ:UTHR) Phase III FREEDOM-EV design and resulting label for Orenitram (oral treprostinil) allowing only one background therapy will significantly hamper uptake in...

Global Blood Therapeutics’ (NASDAQ:GBT) GBT440 has a mixed Phase II outlook in idiopathic pulmonary fibrosis (IPF) patients due to challenges in recording accurate improvements in oxygen...

Roche’s (VTX:ROG) Tencentriq (atezolizumab)/chemotherapy combination arm in the Phase III IMpower150 first-line non-small-cell lung (NSCLC) trial faces a difficult challenge to show a significant...

Johnson & Johnson’s (NYSE:JNJ) Tremfya (guselkumab) for moderate-to-severe psoriasis is likely to be in formulary tier 3 or 4, due to a crowded market and its potentially high price, experts...

AnaptysBio’s (NASDAQ:ANAB) Phase II study with its anti-IL33 antibody ANB020 has encouraging preclinical data offering a sound rationale for Phase II efficacy, experts said. However, long-term...

Merck’s (NYSE:MRK) enrollment pause triggered by deaths in its Phase III studies for Keytruda (pembrolizumab) in multiple myeloma (MM), has left experts perplexed as to the cause of the deaths,...

Coherus’ (NASDAQ:CHRS) latest motion to stay legal proceedings with Amgen (NASDAQ:AMGN) for its Neulasta (pegfilgrastim) biosimilar faces an unclear court decision -- on which the company hinges...

Zynerba Pharmaceuticals' (NASDAQ:ZYNE) ZYN002 cannabinoid (CBD) in fragile X syndrome (FXS) has prompted expert uncertainty over whether preclinical efficacy will translate to clinical efficacy in...

The Medicines Company’s (NASDAQ:MDCO) Vabomere (meropenem-vaborabactam) will chiefly be used as a second-line option for complicated urinary tract infection (cUTI) following expected FDA approval...

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...

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...

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...

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...

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...

• 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

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...

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...

Ionis Pharmaceuticals’ (NASDAQ:IONS) inotersen garners continued physician enthusiasm for its overall safety profile even with a patient death in the Phase III familial amyloid polyneuropathy (FAP...

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...

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...

Roche’s (VTX:ROG) slim benefit with Perjeta (pertuzumab) in the APHINITY trial in Her2+ breast cancer has experts predicting a smaller than anticipated market use in the adjuvant setting including...

Faster drug approval for cell therapies and a clearance of the backlog of generic approval applications are the expected positive outcomes for the drug industry following the appointment of FDA...

The prevalence of hyperprogressive disease (HPD) among patients receiving PD-1/PD-L1 checkpoint inhibitors and its relationship to MDM2 amplification underscores the need for caution with...

Puma Biotechnology's (NASDAQ:PBYI) neratinib FDA advisory committee (AdCom) review and approval chances in the extended adjuvant setting will unlikely be impacted by Roche's (VTX:ROG) Phase III...

Eli Lilly's (NYSE:LLY) Cyramza (ramucirumab) will likely have limited uptake issues in most patients if it shows positive Phase III results in first-line gastric cancer due to clinicians'...

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,...

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...

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...

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...

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...

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...

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...

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...

Cidara Therapeutics’ (NASDAQ:CDTX) suggested future Phase III trial design investigating intravenous (IV) CD101 for candidiasis is well-designed to demonstrate noninferiority compared with...

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...

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...

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...

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...

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...

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...

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...

Two patients out of 10 have dropped out of Catalyst Pharmaceuticals’ (NASDAQ:CPRX)-financed, investigator-sponsored Phase II/III trial of Firdapse (amifampridine phosphate; 3,4-DAP) in the...

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...

Lexicon Pharmaceuticals’ (NASDAQ:LXRX) LX1032 (telotristat ethyl) for carcinoid syndrome has a positive FDA approval shot due to its encouraging Phase III data, which shows statistical significant...

Seattle Genetics’ (NASDAQ:SGEN) FDA hold on its vadastuximab talirine studies left experts hesitant about using the drug in the allogeneic stem cell transplant (alloSCT) setting of acute myeloid...

Advanced Accelerator Application (NASDAQ:AAAP) has switched to CRO Brightech to handle data management for Lutathera’s (lutetium Lu177 dotatate) approval package for gastroenteropancreatic...

Ipsen’s (EPA:IPN) Phase III SPINET trial investigating Somatuline Autogel/Depot (lanreotide) for lung neuroendocrine tumours (NETs) has enrolled under 30% of its 216 subjects, a trial investigator...

Kite Pharma (NASDAQ:KITE) has delicate logistics and physician education hurdles to overcome if it is to be successful in launching axicabtagene ciloleucel (axi-cel) for aggressive non-Hodgkin’s...

Capricor Therapeutics’ (NASDAQ:CAPR) CAP-1002’s cardiac stem cell mechanism of action has unclear efficacy projections in its Phase I/II cardiomyopathy secondary to Duchenne muscular dystrophy (...

AstraZeneca’s (LON:AZN) Lynparza (olaparib) is not exhibiting an alarming level of secondary malignancies, said experts based on an FDA adverse events (AEs) document this news service obtained...

Human longevity drugs may still face labelling and reimbursement challenges should they demonstrate evidence of extending a healthy life span, according to experts. As ageing is not considered a...

Drug trials targeting human longevity will likely have endpoints focused on the accumulation of age-related diseases rather than survival to demonstrate an extended life span and improvements in...

The numerous biosimilars for AbbVie’s (NYSE:ABBV) Humira (adalimumab) are unlikely to reach the market prior to Amgen’s (NASDAQ:AMGN) approved biosimilar, Amjevita, and certainly not before 2020,...

• PAH portfolio an undeniable value driver with Opsumit and Uptravi
• Phase III C-Diff and MS drugs face market penetration hurdles
• Phase II pipeline lacks clinical evidence to back...

The Medicines Company (NASDAQ:MDCO)/Alnylam Pharmaceuticals’ (NASDAQ:ALNY) Phase II PCSK9 inhibitor inclisiran’s biannual dosing potential could substantially boost its hypercholesterolemia uptake...

Novartis' (VTX:NOVN) Phase II JULIET study of tisagenlecleucel-T in diffuse large B-cell lymphoma (DLBCL) is now closed for enrollment due to a large backlog of enrolled patients waiting to enter...

Alkermes’ (NASDAQ:ALKS) ALKS-5461 is likely to require an additional Phase III major depressive disorder (MDD) trial based on previous mixed clinical results before regulators will approve the...

Sponsors like AstraZeneca (LON:AZN) and Merck Serono, the biopharma division of Merck KGaA (ETR:MRK), are increasingly seeking patient input throughout the clinical trial process, even as early as...

Agios’ (NASDAQ:AGIO) AG-120 has generated cautious expert optimism following minor responses (MR) and stable disease (SD) responses in recent Phase I data for low-grade gliomas.

BioMarin Pharmaceutical’s (NASDAQ:BMRN) BMN 270’s Phase I/II haemophilia A drug has most experts agreeing its interim factor VIII (FVIII) level increases may cause thrombosis in Phase I/II’s next...

A recent publication of two fatal cases of myocarditis with Bristol Myers Squibb’s (NYSE:BMY) combination of Opdivo (nivolumab) and Yervoy (ipilimumab) has oncologists downplaying concerns...

Kite Pharma’s (NASDAQ:KITE) use of prophylactic levetiracetam to control severe neurotoxicity associated with the chimeric antigen receptor T-cell (CAR-T) therapy KTE-C19 has valid rationale but...

Daiichi Sanyko’s (TYO:4568) mirogabalin is reporting high adverse rates (AEs), including suicidal ideation and liver function, in an open-label portion of its Phase III fibromyalgia program, said...

Capricor Therapeutics’ (NASDAQ:CAPR) Phase I/II HOPE and ALLSTAR trials investigating CAP-1002 for cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) and myocardial regeneration,...

Karyopharm’s (NASDAQ:KPTI) Phase II/III SEAL study (NCT02606461) of selinexor in dedifferentiated liposarcoma has been slow to recruit at some centers and may encounter accrual challenges due to...

Roche’s (VTX:ROG) lampalizumab has generated guarded optimism for its Phase III chances, and while hailed as a potential breakthrough for geographic atrophy (GA) associated with dry age-related...

Biogen (NASDAQ:BIIB) and Ionis Pharmaceuticals' (NASDAQ:IONS) Phase III trial of nusinersen in later-onset spinal muscular atrophy (SMA Type 2) should hit its primary endpoint based on past data...

AveXis’ (NASDAQ:AVXS) Phase I/II trial of its gene therapy, AVXS-101, in Type 2 spinal muscular atrophy (SMA) will include around 20 patients across 12 sites, according to a source familiar with...

NewLink Genetics (NASDAQ:NLNK) Phase I/II combination trial of indoximod with Bristol-Myers Squibb’s (NYSE:BMY) Yervoy (ipilumumab) in metastatic melanoma is expected to present a better safety...

Akari Therapeutics' (NASDAQ:AKTX) coversin Phase II trial in paroxysmal nocturnal hemoglobinuria (PNH) has cautious expert optimism after full complement ablation was achieved at the same dose in...

Immunomedics’ (NASDAQ:IMMU) Phase I/II Sacituzumab govitecan (IMMU-132) carries further development and market promise in triple-negative breast cancer (TNBC) due to a targeted approach with fewer...

Ophthotech’s (NASDAQ:OPHT) combination of Fovista (anti-PDGF) and anti-VEGF therapies has triggered expert guardedness on its potential for Phase III success in wet age-related macular...

Rigel Pharmaceuticals' (NASDAQ:RIGL) fostamatinib disodium has a poor treatment position in the idiopathic thrombocytopenic purpura (ITP) landscape versus its main competitor, thrombopoietin (TPO...

Kite Pharma’s (NASDAQ:KITE) ZUMA-1 study of KTE-C19 in aggressive non-Hodgkin’s lymphoma (NHL) is mandating prophylaxis with levetiracetam in an effort to prevent seizures, a source familiar with...

Pfizer’s (NYSE:PFE) inotuzumab ozogamicin faces an uncertain path to FDA approval in acute lymphoblastic leukemia (ALL) following mixed Phase III trial results, experts said.

Novo Nordisk’s (CPH:NOVO-B) subcutaneous (SC) semaglutide has sound future approval projections in diabetes despite demonstrating significant diabetic retinopathy in its Phase III SUSTAIN 6 trial...

Stem-cell transplants in multiple sclerosis will not threaten the current drug therapeutic market despite the extraordinary efficacy observed in a recent trial, neurologists said on the side lines...

Teva Pharmaceuticals (NYSE:TEVA) SD-809 (deutetrabenazine) is showing tolerability improvements over tetrabenazine after patients are switched to SD-809 in a Phase III extension study, according...

Eli Lilly’s (NYSE:LLY) Taltz (ixekizumab) for psoriatic arthritis (PsA) is likely to see treatment paradigm positioning comparable to Novartis’ (VTX:NOVN) anti-IL-17 Cosentyx (secukinumab),...

The proposed US REGROW bill that has elicited concern from many cell therapy developers is unlikely to pass in Congress’s current session, but has success potential postelection, said political...

Genmab (CPH:GEN) and Johnson & Johnson’s (NYSE:JNJ) Phase Ib trial of subcutaneous Darzalex (daratumumab) for multiple myeloma (MM) will need to demonstrate noninferior efficacy and toxicity...

Pfizer's (NYSE:PFE) Sutent (sunitinib) may face uptake barriers in the adjuvant setting for renal cell carcinoma (RCC) due to its side-effect profile despite the Phase III S-TRAC study reaching...

Despite targeting cancer drugs for the first time, trickle-down effects of pharmacy benefit managers' (PBMs') 2017 exclusion lists will not likely have a major impact on prescribing and coverage...

Zogenix’s (NASDAQ:ZGNX) ZX008 (fenfluramine) is facing enrolment challenges in its North American Phase III Dravet syndrome study, said a source familiar with the situation. The trial,...

Eli Lilly’s (NYSE:LLY) Trulicity’s (dulaglutide) Phase III cardiovascular outcome trial (CVOT) excited expert debate on whether its similar long-acting formulation to Novo Nordisk’s (CPH:NOVO-B)...

The quest to develop and commercialise a CRISPR therapy will likely involve numerous stages of scientific and regulatory hurdles for developers as they race to dose the first human, agreed...

Roche's (VTX:ROG) Perjeta (pertuzumab) spurs confidence in experts about its success in the adjuvant setting APHINITY trial for HER2-positive (HER2+) breast cancer but with a pause due to...

Coherus Biosciences’ (NASDAQ:CHRS) adalimumab biosimilar CHS-1420 may have scope to tap into a new population of previously uncovered psoriasis patients due to the high price of AbbVie’s (...

Gilead Sciences’ (NASDAQ:GILD) hepatitis C (HCV) drug Epclusa’s (sofosbuvir/velpatasvir) appealing pricing to US payers could affect Bristol-Myers Squibb (NYSE:BMY) Daklinza’s (daclatasvir...

Anthera (NASDAQ:ANTH) has most experts uncertain over chances for blisibimod's Phase III success in systemic lupus erythematosus (SLE), contrary to rheumatologists' sentiments about the...

Ultragenyx Pharmaceutical's (NASDAQ:RARE) Phase II study of UX007 (triheptanoin) in glucose transporter type-1 deficiency syndrome (Glut1 DS) with the seizure phenotype (NCT01993186) has...

Ionis Pharmaceuticals (NASDAQ:IONS) IONIS-TTRrx and Alnylam Pharmaceuticals' (NASDAQ:ALNY) patisiran have experts debating their long-term safety profiles as well as potential points...

Otsuka Pharmaceutical's (TYO:4578) Dacogen (decitabine) may expand the range of tumors that can be targeted with anti-NY-ESO-1 immunotherapies given its ability to induce NY-ESO-1 tumor...

Merck’s (NYSE:MRK) monoclonal antibody Zinplava (bezlotoxumab) for recurrent Clostridium difficile infection (RCDI) is likely to encounter significant reimbursement obstacles with a...

Off-label prescribing and drugs used for multiple oncology indications will complicate efforts to consolidate billing codes under Medicare Part B per recommendations from a legislative-branch...

Gilead Sciences' (NASDAQ:GILD) GS-5745 (matrix metalloproteinase-9 [MMP-9] inhibitor) is struggling to recruit Crohn's patients into its Phase II study (NCT02405442) following strict...

Novo Nordisk's (CPH:NOVO-B) Xultophy (liraglutide and Tresiba [insulin degludec]) and Sanofi's (EPA:SAN) iGlarLixi's (lixisenatide and Lantus [insulin glargine]) will likely have similar labels...

Exelixis’ (NASDAQ:EXEL) Cabometyx (cabozantinib) would need at least a 30% progression-free survival (PFS) improvement to justify first-line use in metastatic renal cell cancer (mRCC) over...

On 7 July, Ablynx's (EBR:ABLX) stock jumped some 12% after releasing top-line data from its monotherapy Phase IIb ALX-0061 (vobarilizumab) study in rheumatoid arthritis (RA). Top-line results from...

Liquid biopsies in development have oncologists encouraged for their future usage in non-small-cell lung cancer (NSCLC). However, their application may be limited to specific scenarios with tissue...

Ganymed's Phase II IMAB362 data in first-line advanced gastric cancer patients have experts particularly intrigued over its potential in patients with high Claudin18.2 expression. While some...

Clovis Oncology's (NASDAQ:CLVS) scope with rucaparib may be limited to use in ovarian cancer patients with BRCA mutations, said experts, though rucaparib investigators were less pessimistic....

Small contract manufacturing organisations (CMOs) may be forced to close shop if next year’s Generic Drug User Fee Amendments (GDUFA) continues to charge inspection fees at the same rates or...

Amgen’s (NASDAQ:AMGN) AMG 416’s (etelcalcetide) Phase III results for secondary hyperparathyroidism (SHPT) inspires FDA approval after statistically significant parathyroid (PTH) and phosphorus...

Infinity Pharmaceuticals (NASDAQ:INFI) and AbbVie's (NYSE:ABBV) Phase III duvelisib study in relapsed/refractory chronic lymphocytic leukemia (CLL) may show improved progression-free survival (PFS...

AbbVie's (NYSE:ABBV) Rova-T (rovalpituzumab tesirine) has generated excitement among experts for its future in small-cell lung cancer (SCLC) following Phase I results presented at ASCO. Wall...

Ampio Pharmaceuticals' (NYSEMKT:AMPE) osteoarthritis (OA) of the knee drug, Ampion, has experts guardedly positive on the drug's chances for approval despite failure of one Phase III. The ongoing...

Medivation's (NASDAQ:MDVN) talazoparib has breast cancer experts closely watching whether the drug's high potency will set it back in the chemo-combination space. Talazoparib's potency...

Vertex Pharmaceuticals’ Orkambi for cystic fibrosis (CF) has generated lacklustre physician reviews since its July 2015 US launch. They noted lung function (FEV1) improvements were mediocre and...

Chimeric antigen receptor T-cell (CAR-T) therapies in acute lymphoblastic leukemia (ALL) may not require randomized confirmatory studies if they win accelerated FDA approval, experts said.

Dermira's (NASDAQ:DERM) topical wipe DRM04 could garner strong physician support due to a clear need for simple and cost-effective hyperhidrosis treatments, experts agreed. Whilst DRM04 may not be...

Rigel Pharmaceuticals’ (NASDAQ:RIGL) fostamatinib disodium has experts questioning Phase II autoimmune haemolytic anaemia (AIHA) outcomes despite positive immune thrombocytopenia (ITP) read outs....

Aurinia Pharmaceuticals' (TSE:AUP) Phase IIb with voclosporin for the treatment of lupus nephritis (LN) has experts skeptical that it will achieve its primary endpoint of complete remission. They...

Medivation's (NASDAQ: MDVN) Phase II ABRAZO trial with talazoparib in metastatic gBRCA mutant breast cancer patients was closed for enrollment before it reached its target, to allow focus on the...

The drug development race in nonalcoholic steatohepatitis’ (NASH) has no clear frontrunner as future standard of care (SOC), given varying mechanisms tackling a disease with multiple targets,...

Shire's (LON:SHP) lifitegrast is likely to have a strong foothold on the dry eye market but will not displace Allergan's (NYSE:AGN) Restasis (cyclosporine ophthalmic emulsion), experts noted....

The shift towards using remote monitoring digital devices in clinical trials could threaten traditional CRO service offerings, experts said. But while site monitoring work is set to drop, there...

Novartis' (VTX:NOVN) ribociclib faces a tough space as the second or third CDK4/6 inhibitor to hit the market for advanced breast cancer patients, said experts. The wide acceptance of first-in-...

Bristol-Myers Squibb (NYSE:BMY) and Merck (NYSE:MRK) are actively planning large scale “strategic” trials to determine the optimal sequence of chemotherapy and immunotherapy in non-small-cell lung...

Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) has potential to win FDA approval in classical Hodgkin's lymphoma (cHL) based on a Phase II study, experts said. Nonetheless, the lack of...

Johnson and Johnson (NYSE:JNJ)/Janssen Biotech’s Stelara (ustekinumab) has questionable Crohn’s Disease uptake prospects as experts debate the extent of anti-TNF therapy refraction and failure....

AstraZeneca’s (LON:AZN) AZD6244 (selumetinib) has oncologists reserved about Phase III efficacy predictions in KRAS-mutant non-small-cell lung cancer (NSCLC) due to past failures in this patient...

Chimeric antigen receptor T-cell (CAR-T) therapies have drawn expert uncertainty about their potential place in non-Hodgkin's lymphoma (NHL) treatment. They pointed to factors like a highly...

Recent successful inter partes review (IPR) challenges against Acorda Therapeutics (NASDAQ:ACOR) by The Coalition for Affordable Drugs has attorneys debating on how refiling IPRs could be a...

Astellas Pharma (TYO:4503)/Medivation's (NASDAQ:MDVN) prostate cancer drug Xtandi (enzalutamide) has drawn debate from Capitol Hill experts on whether the National Institutes of Health (NIH) will...

On 8 March, the Centers for Medicare and Medicaid Services (CMS) announced reimbursement changes to Medicare Part B, noting the current reimbursement rate will be lowered later this year and...

Novartis' (VTX:NOVN) buparlisib faces an uphill battle in improving overall survival (OS) in the BELLE-2 Phase III breast cancer trial to an extent that it would justify its side-effect profile,...

Portola Pharmaceutical's (NASDAQ:PTLA) andexanet alfa for factor Xa inhibitor anticoagulation reversal, faces high pricing hurdles, yet unmet need supports low-quantity purchasing, experts said....

Eli Lilly’s (NYSE:LLY) decision to alter the primary endpoint in an ongoing Phase III trial of solanezumab in Alzheimer’s disease (AD) has drawn expert debate on the rationale and expectations on...

Valeant Pharmaceuticals' (TSE:VRX) interim CEO's recommendation that US law could be changed to allow drug companies to offer patient co-pay assistance to those on government programs is more...

Cel-Sci’s (NYSE MKT: CVM) impending lawsuit against CRO InVentiv Health Clinical for Phase III enrolment failure may trigger sponsors and vendors to re-examine current and future contracts, legal...

Clovis Oncology's (NASDAQ:CLVS) lucitanib has experts optimistic on Phase II breast cancer results given previously demonstrated response rates and a manageable safety profile. While hypertension...

Novartis' (VTX:NOVN) midostaurin will likely win EMA approval in FLT3 mutation-positive acute myeloid leukemia (FLT3+ AML) based on results of the Phase III RATIFY study, experts said. The drug's...

The possibility and viability of so-called "authorised biosimilars" in the next few years has drawn mixed legal expert sentiment. Some noted that while there are no technical legal obstacles to...

The Medicines Company (MedCo) (NASDAQ:MDCO) has a debatable success rate in having its Angiomax (bivalirudin) patents reinstated in an en banc (entire bench) hearing, legal experts said. A 2015...

Novartis' (VTX:NOVN) PKC412 (midostaurin) is likely to win North American approvals for frontline FLT3 mutation-positive acute myeloid leukemia (FLT3+ AML) in younger patients based on the Phase...

Immunomedics' (NASDAQ:IMMU) clivatuzumab exhibits potential as a third-line therapy in pancreatic cancer, experts said, while noting that an overall survival (OS) of two months over the control...

AbbVie's (NYSE:ABBV) Humira (adalimumab) patents have drawn legal expert debate on whether they could stave off biosimilar competition for at least the next few years. Experts debated the patents...

Gilead (NASDAQ:GILD) and Johnson & Johnson/Janssen's (NYSE:JNJ) HIV-1 combination drug rilpivirine/emtricibine/tenofovir alafenamide (R/F/TAF) is likely to have pricing pushback even with a...

Sanofi's (EPA:SAN) SAR650984 (isatuximab) could face challenges gaining multiple myeloma market traction after the approval of Genmab (CPH:GEN) and Johnson & Johnson's (NYSE:JNJ) Darzalex (...

Macrogenics' (NASDAQ:MGNX) enbolituzumab' B7-H3 ligand targeting strategy has some experts saying the ligand-directed approach may not be as effective as generating an antibody against its...

Dermira's (NASDAQ:DERM) DRM01 against acne vulgaris will likely hit its Phase IIb primary endpoint but its magnitude of effect has some experts doubting its overall clinical significance. The...

• 6MWT mainly appropriate for younger patients with higher baseline scores

• Complications in executing tests introduces inter-site variability

• Dystrophin measurement useful, yet...

The crowded psoriasis market will prove a burdensome barrier to new drugs with strong clinician reluctance to move away from established safe and efficacious treatments, experts said. New drugs...

ZS Pharma's (NASDAQ:ZSPH) hyperkalaemia drug ZS-9 has elicited expert conflict on its FDA approval prospects following interim Phase III safety data. Physicians questioned its safety/efficacy...

Celldex's (NASDAQ:CLDX) Phase III study of Rintega (rindopepimut) has potential to show an overall survival (OS) benefit in newly diagnosed EGFRvIII-positive glioblastoma (EGVRvIII+ GBM), though...

The Indian CMO sector could see a boost in international business if a government initiative providing monetary support to get facilities complying with WHO GMP standards is passed, experts said....

Exelixis' (NASDAQ:EXEL) Cometriq (cabozantinib) faces uptake challenges due to competition with existing drugs and investigational immunotherapy, but may find a niche in smaller patient subsets,...

Radius Health's (NASDAQ:RDUS) abaloparatide has most experts confident it will occupy a niche on the osteoporosis treatment market. Abaloparatide shows promise for patients who have had recent...

Sunesis Pharmaceuticals (NASDAQ:SNSS) has potential to win EMA approval for Qinprezo (vosaroxin) in relapsed/refractory acute myeloid leukemia (AML) but is likely to face regulatory hurdles,...

Tracon’s (NASDAQ:TCON) TRC105 combination with Pfizer’s (NYSE:PFE) Inlyta may have potential in 2nd line RCC but possible emerging therapies will likely displace the combo to later lines, experts...

Pfizer's (NYSE:PFE) Xeljanz (tofacitinib) is likely to be approved in moderate-to-severe plaque psoriasis but market uptake will be poor due to competition from other drugs and pricing, experts...

Emergent Biosolutions (NYSE:EBS) is developing a preclinical Alzheimer's disease (AD) immunotherapy drug candidate, according to a source familiar with the situation. The company did not respond...

Valeant Pharmaceuticals (TSX:VRX)/ Sprout Pharmaceuticals' Addyi (flibanserin) should see rapid initial uptake as the first ever female sexual dysfunction (FSD) drug, experts said. An unmet...

Eli Lilly's (NYSE:LLY) presentation of delayed-start trial data for solanezumab in Alzheimer's disease (AD) should be met with caution and should not be over interpreted, experts said. The results...

AstraZeneca's (LON:AZN) Lynparza (olaparib) will most likely experience payer pushback through prior authorization or step edits if it is FDA-approved for the maintenance setting in ovarian cancer...

Autifony Therapeutics’ AUT00063, a potassium channel modulator, has a strong rationale behind its mechanism of action for age-related hearing loss focused on the diminished ability to discriminate...

Synthetic Biologics' (NYSEMKT: SYN) SYN-010 for constipation-predominant irritable bowel syndrome (IBS-C) has physicians cautious on the likelihood of meeting its Phase II primary endpoint. While...

Celgene’s (NASDAQ:CELG) Revlimid (lenalidomide) study in chronic lymphocytic leukemia (CLL) likely experienced site terminations because newer drugs challenged recruitment, while previously strict...

Verastem's (NASDAQ:VSTM) VS-6063 (defactinib) has strong mechanism rationale for Phase II efficacy in KRAS mutant non-small cell lung cancer (NSCLC), however, questions remain over the optimal...

Novartis' (VTX:NOVN), Juno Therapeutics' (NASDAQ:JUNO) and Kite Pharma's (NASDAQ:KITE) chimeric antigen receptor T-cell (CAR-T) therapies have become more predictable in terms of toxicity, but...

Bristol-Myers Squibb's (NYSE:BMY) share price decreased 7% post a presentation at the American Society of Clinical Oncology (ASCO) on Checkmate057 showing higher PD-L1 expression in non-squamous...

Bristol-Myers Squibb (NYSE:BMY) will start enrolling patients in January 2016 in the Phase II part of the Phase I/II Opdivo (nivolumab) trial in hepatocellular carcinoma (HCC), said an...

The US FDA's 15 April drug safety communication requiring testosterone labelling changes which narrows approved uses and warns of cardiovascular (CV) risk, has experts questioning the necessity...

Biogen's (NASDAQ:BIIB) Phase II trial of Tysabri (natalizumab) in stroke will not report results until autumn, according to a source familiar with the situation. The study was originally due to...

Johnson & Johnson's (NYSE:JNJ) subsidiary Janssen Biotech will most likely be in patent office and legal wrangling until at least 2018 over a key patent for its Remicade (infliximab), legal...

The Roswell Park Cancer Institute, based in Buffalo, New York, hopes to facilitate a partnership to develop Centro de Inmunologia Molecular’s (CIM’s) Cimavax lung cancer vaccine in the next 12-18...