Manasi Vaidya

Associate Editor

Manasi Vaidya joined as a reporter in New York in February 2015 and has covered the drug development space across a number of therapeutic areas, and built an expertise in writing about oncology. While focusing on analysis pieces about ongoing clinical trials, her coverage has also branched out to regulatory issues, pricing and reimbursement and patent litigation. She has covered practice-changing developments from high profile conferences like ASCO and SABC, in addition to FDA regulatory meetings. She previously covered the Asian biotechnology industry for BioSpectrum, a monthly magazine in India, for two years. She has a Masters degree in Science, Health and Environmental Reporting from New York University, and a Masters degree in Biotechnology from Dr. D. Y. Patil University. Her work has appeared in Nature Medicine, Nautilus and Technology Review India.

Lung Cancer, Respiratory Diseases, Ovarian and Breast Cancer, Kidney Cancer, Women and Men’s Health, Gastrointestinal Disorders, Kidney Disease

Investigative Journalism

08 Oct 2020

Fate Therapeutics’ (NASDAQ:FATE) multipronged CAR NK approach could address gaps left by single-target CAR-T therapies in B cell malignancies and chronic lymphocytic leukemia (CLL), experts said. This multiantigen targeted approach could limit antigen escape, which has been implicated in disease relapse, they added.

22 Jul 2020

There is rationale for evaluating antifibrotics in COVID-19 given the SARS-CoV-2 virus’ impact on the lungs, but several unknowns persist on the overlap between idiopathic pulmonary fibrosis (IPF) and COVID-19 related fibrosis, making the therapeutic impact of antifibrotics unclear, experts noted. While Fibrogen’s (NASDAQ:FGEN) idiopathic pulmonary fibrosis (IPF) data is strong enough for pamrevlumab to be considered in Phase II, the potential of Blade Therapeutics’ BLD-2660 is tougher to determine given the existence of only in vitro data for the product, they noted.

09 Jun 2020

Roche’s (SIX:ROG) Phase II tiragolumab/Tecentriq (atezolizumab) combination as a first-line (1L) treatment in non-small cell lung cancer (NSCLC) needs longer-term efficacy data to solidify its potential, experts said. Still, the tolerability profile bodes well in comparison to other 1L therapies, they added.

13 May 2020

Rising reports of thromboembolic cases among COVID-19 patients have prompted physicians and also several trials to evaluate higher doses of heparin than are typically used as an anticoagulant strategy, but experts noted there is still a lack of clarity on the optimal regimen. Additionally, they said, while all hospitalized patients stand to benefit from a prophylactic dose, whether to use the higher therapeutic dose in those patients is an open question.

15 Apr 2020

While COVID-19 data from a China-based study and Pluristem Therapeutics’ (NASDAQ:PSTI) compassionate use program focused on those with acute respiratory distress syndrome (ARDS) is encouraging to continue exploring mesenchymal stem cell (MSC) products, there are also several limitations with interpreting the results, experts noted. Readthrough to trials being planned by three main MSC players—Athersys (NASDAQ:ATHX), Mesoblast (ASX:MSB) and Pluristem—is unclear without more granular data and trial design details, they noted.

07 Apr 2020

An investigator-led Phase III trial studying hydrocortisone for community-acquired pneumonia has been redesigned to also recruit COVID-19 patients, according to a source familiar with the trial. The France-based study has so far recruited about 300 COVID-19 patients and enrolment is estimated to close in two weeks, he added. As of today (7 April), France has 98,984 confirmed cases and 8,911 deaths.

30 Jan 2020

Amag Pharmaceuticals’ (NASDAQ:AMAG) Phase IIb/IIIa success expectations with AMAG-423 (digoxin immune fab) in severe pre-eclampsia are clouded by lack of prior randomized data relevant to the trial’s primary endpoint, experts said.

27 Dec 2019

Seattle Genetics’ (NASDAQ:SGEN) tisotumab vedotin needs to show longer responses in metastatic cervical cancer patients in a Phase II study than those previously seen in Phase I/II data in order to prove clinical significance and potentially support approval, experts said.

07 Oct 2019

ChemoCentryx’s (NASDAQ:CCXI) Phase III avacopan (CCX168) for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis divides experts on whether payers would push back on first-line (1L) use without demonstrating superior efficacy versus corticosteroids. Nonetheless, they agreed optimism is warranted for the Phase III to prove noninferiority on the 26-week remission coprimary endpoint.

28 Aug 2019

Lexicon Pharmaceuticals (NASDAQ:LXRX) and Sanofi’s (EPA:SAN) Zynquista (sotagliflozin) has experts reserving judgement on the drug’s value without a direct comparison to SGLT2 inhibitors following topline data in type 2 diabetes (T2D) patients with chronic kidney disease (CKD).

31 Jul 2019

Boosting the number of cells in Adaptimmune Therapeutics’ (NASDAQ:ADAP) lead T-cell receptor (TCR) therapies in ongoing Phase I oncology trials is unlikely to form the basis of enhancing its efficacy potential, experts said. While there is early positive data for both ADP-A2M4 (formerly MAGE-A4 TCR) and ADP-A2M10 (formerly MGE-A10 TCR), interpreting results across tumor types is challenging, they noted.

21 Jun 2019

Improving patient identification tools will be key to getting full market traction for Merck KGaA’s (ETR:MRK) tepotinib and Novartis’ (SIX:NOVN) capmatinib after an expected approval in non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping mutations, experts said. Presentations at ASCO earlier in June on initial Phase II data for both drugs were impressive, however, with experts citing interest in using the drug in the first-line (1L) setting.

07 Jun 2019

Amgen’s (NASDAQ:AMGN) Phase I/II AMG510 efficacy data in non-small cell lung cancer (NSCLC) improves expert outlook on its KRAS G12C inhibition mechanism’s potential as a single agent, experts said. However, some expert caution remains due to currently poor colorectal cancer (CRC) data in the same trial, and overall low patient numbers for both indications.

14 Mar 2019

Pfizer’s (NYSE:PFE) Xeljanz (tofacitinib) safety alert in rheumatoid arthritis (RA) patients could lead to exclusion of riskier ulcerative colitis (UC) patients from receiving the 10mg BID dose, some experts said, while others noted the need for more data to influence treatment decisions.

15 Feb 2019

An upcoming UK parliamentary select committee hearing on 7 March regarding reimbursement of Vertex Pharmaceuticals’ (NASDAQ:VRTX) cystic fibrosis (CF) drug Orkambi (lumacaftor/ivacaftor) is likely to reveal confidential pricing negotiations, which could impact Vertex’s other European payer agreements and subsequent rare disease drug reimbursement negotiations.

15 Feb 2019

A new US Department of Health and Human Services (HHS) proposal to curb rebates will increase biosimilar competitiveness, and positively impact low-cost and generic alternatives in the hepatitis C (HCV) and diabetes spaces, experts said. The latter are currently given lower formulary priority compared to high-cost branded alternatives in Medicare Part D plans, they explained.

25 Jan 2019

Reata Pharmaceuticals’ (NASDAQ:RETA) Phase II pursuit of bardoxolone in focal segmental glomerulosclerosis (FSGS) may be thwarted given proteinuria increases seen in other kidney disorder trials, said nephrologists.

18 Jan 2019

Roche’s (SIX:ROG) cobas EGFR Mutation Test v2 liquid biopsy diagnostic used with and after initial treatment with its own drug Tarceva (erlotinib) is becoming increasingly redundant as more physicians choose AstraZeneca’s (LON:AZN) Tagrisso (osimertinib) for first-line (1L) treatment of EGFR mutant non-small cell lung cancer (NSCLC).

14 Dec 2018

Eli Lilly’s (NYSE:LLY) Verzenio (abemaciclib) usage within its three labelled indications in hormone receptor-positive (HR+) breast cancer has been approximately 20% as a late-line monotherapy, 30% as an initial therapy in combination with anastrozole, and 40% in combination with AstraZeneca’s (LON:AZN) Faslodex (fulvestrant), said Alex Horn, global development leader for Abemaciclib, Eli Lilly, Indianapolis.

27 Sep 2018

Bristol-Myers Squibb’s (NYSE:BMY) bid for Opdivo (nivolumab) and Yervoy (ipilimumab) as a maintenance therapy following chemotherapy in small cell lung cancer (SCLC) will likely be thwarted by the expected addition of Roche’s (SIX:ROG) Tecentriq (atezolizumab) to the first-line (1L) setting, experts said.

27 Aug 2018

AstraZeneca (LON:AZN) is unlikely to find a distinct spot for Imfinzi (durvalumab) combined with tremelimumab in the highly coveted first-line (1L) non-small-cell lung cancer (NSCLC) space due to competition with immunotherapy(IO) combinations with chemotherapy and a lack of biomarker or toxicity advantages over other IO-only combinations, said experts.

Merck’s (NYSE:MRK) Keytruda (pembrolizumab) is the frontrunner, with an estimated 80% market share in the 1L NSCLC space and NSCLC revenues potentially reaching USD 8.5bn by 2022.

19 Jul 2018

Novartis’ (VTX:NOVN) outcome-based contracts (OBCs) for reimbursing its CAR-T therapy Kymriah (tisagenlecleucel) for acute lymphoblastic leukemia (ALL) remain a viable option for treatment centers, despite recent conflicting media reports saying otherwise, experts said. But private payer enthusiasm for engaging in OBCs and how the arrangement can overall reduce healthcare costs is unclear in light of nebulous financial logistics, they noted.

13 Jun 2018

Immunomedics’ (NASDAQ:IMMU) Phase I/II sacituzumab govitecan hormone receptor positive (HR+) Her2-negative breast cancer data may not be enough for an accelerated approval despite showing clinically significant responses in a heavily pretreated population and a similar path adopted in triple-negative breast cancer (TNBC), experts said.

30 May 2018

AstraZeneca’s (LON:AZN) Fasenra (benralizumab) failures in chronic obstructive pulmonary disease (COPD) could be due to the antibody’s activity being limited to only those patients with an asthma-COPD overlap syndrome (ACOS) phenotype, where the drug’s use could be further explored, said experts.

26 Apr 2018

Novartis’ (VTX:NOVN) Phase III MONALEESA-3 trial is rational in combining Kisqali (ribociclib) with AstraZeneca’s (LON:AZN) Faslodex (fulvestrant) in first- and second-line HR+Her2-negative advanced metastatic breast cancer due to Faslodex’s efficacy advantage over aromatase inhibitors (AIs) that are commonly used in first-line disease, experts said. They added the trial is expected to be a positive study.

24 Apr 2018

Jounce Therapeutics’ (NASDAQ:JNCE) JTX-2011 mechanism as an inducible T-cell co-stimulator (ICOS) agonist holds promise to spur immune responses in gastric and breast cancer, experts said. However, the absence of validated clinical data draws pause on forecasting Phase I/II trial success, they noted.

23 Mar 2018

Pfizer’s (NYSE:PFE) biosimilar antitrust claim against Johnson & Johnson (NYSE:JNJ) could be strong enough to reach the discovery stage of litigation but will survive only if the latter company's exclusionary tactics for Remicade (infliximab), beyond just lowered prices and bundling deals, are proven, said experts.

31 Oct 2017

AstraZeneca’s (LON:AZN) benralizumab will likely have a dosing advantage over competitors in severe eosinophilic asthma, but may struggle to reach optimal market expectations, experts said. Convincing some physicians that it offers a superior efficacy profile for the majority of patients will be the major challenge, experts said.

29 Sep 2017

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 (ODAC) vote, experts said.

On 19 September, the FDA’s ODAC voted 6-6 for the use of Sutent as an adjuvant RCC treatment following a nephrectomy.

26 Sep 2017

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 (axitinib) met its initial recruitment target of 583 patients in summer 2017, said a source familiar with the trial.

29 Aug 2017

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 pulmonary arterial hypertension (PAH), experts said. Dosing and titration challenges compared to competitors will also likely deter widespread use, they added.

29 Aug 2017

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 saturation and clinical translation of such changes, expert said.

15 Aug 2017

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 safety data in humans will be needed to allay major concerns, they added.

Some analysts have noted the ‘blockbuster potential’ ANB020 could make potentially USD 2.8bn in 2027, but others have also pointed out that it is lagging in development compared to Phase III competitors from Aimmune Therapeutics (NASDAQ:AIMT) and DBV Technologies(NASDAQ:DBVT).

31 Jul 2017

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 financially -- but may find favor if the court decides to conserve resources, said experts.

Experts said it is not clear if courts will accept Coherus’ recent motion to stay, filed last week, on its prior motion to dismiss Amgen’s patent infringement case —a bid to conserve funds until a final approval.

11 Jul 2017

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.

30 Jun 2017

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.

09 Jun 2017

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.

06 Jun 2017

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 the more hopeful higher risk subset.

Roche had earlier announced the trial reaching its primary endpoint on 2 March, leading to an upward share price movement of 6.5% and expectations of Perjeta being added to the standard of care -- Roche’s (VTX:ROG) Herceptin (trastuzumab) and chemotherapy -- for adjuvant therapy in Her2+ patients.

12 May 2017

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 Perjeta (pertuzumab) data in the adjuvant setting for Her2+ breast cancer, said experts.

However, during the 24 May AdCom review, Puma will face questions on data integrity of its Phase III pivotal ExteNET study (NCT02400476), since the trial design was changed through the course of the study and because of its Grade 3 diarrhea side-effect profile, said experts.

30 Mar 2017

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.

13 Mar 2017

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...

31 Jan 2017

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.

27 Jan 2017

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.

29 Dec 2016

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 through a Freedom of Information Act (FOIA) request.

The risk for secondary malignancies developing due to Lynparza treatment was a concern for the Advisory Committee that reviewed the drug’s maintenance treatment approval application.

11 Oct 2016

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 side effects, said experts.

31 Aug 2016

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 its primary endpoint, said experts.

In the absence of any approved adjuvant therapies, the S-TRAC trial' (NCT00375674) improving disease-free survival (DFS) is significant, said experts. It is nonetheless surprising, they noted, since the previous NCI-led Phase III ASSURE trial (NCT00326898) of Sutent as an adjuvant therapy did not reach its DFS primary endpoint.

26 Aug 2016

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 decisions, experts said.

Two of the largest PBMs, CVS Health's (NYSE:CVS) Caremark division and Express Scripts (NASDAQ:ESRX), released their 2017 formulary exclusion lists earlier this month. While Express Scripts did not target cancer, CVS added Astellas Pharma (TYO:4503) and Medivation's (NASDAQ:MDVN) prostate cancer drug Xtandi (enzalutamide).

15 Aug 2016

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 statistical complexities.

Neoadjuvant trials are said to be largely predictive of success in the adjuvant setting, according to an analyst report. While experts agreed they also cautioned against extrapolating neoadjuvant results, owing to the complexity of large trials.

28 Jul 2016

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 antigen expression, experts said.

19 Jul 2016

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 agency, experts said.

Under recommendations issued in a 15 June report by the Medicare Payment Advisory Commission (MedPAC), cancer drugs will be disproportionately affected by the consolidation, they explained. Nonetheless, other drugs covered under Part B for indications like autoimmune diseases, chronic obstructive pulmonary disease (COPD) and others will also be impacted, they noted.

12 Jul 2016

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 approved tyrosine kinase inhibitors (TKIs) considering its toxicity profile, said experts. The company is discussing the next steps with regulatory authorities for Cabometyx’s first-line use, said an Exelixis spokesperson

23 Jun 2016

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.

The change in the cutoff for loss of heterozygosity (LOH) led to a subdued outlook for identifying non-BRCA responders, as was earlier envisioned with the development of the LOH assay, several experts noted. However, Ariel2 investigators emphasized that that the intent of the preplanned analysis was to develop a better tool to identify responders, and refining the LOH score allowed that.

31 May 2016

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 differentiates it from other PARP inhibitors in BRCA mutated metastatic breast cancer, experts agreed. But that could also affect its potential for a combination approach, which other PARP inhibitors are working toward, said several experts. Coupling a PARP inhibitor with a chemotherapy in metastatic breast cancer could expand the patient population, experts noted.

13 May 2016

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 ongoing Phase III EMBRACA trial, said an investigator.

29 Apr 2016

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-class Ibrance from Pfizer (NYSE:PFE) since its accelerated approval in 2015 was reiterated by physicians who were not receptive to making a switch unless ribociclib or any other CDK4/6 inhibitor was significantly less toxic while having comparable or higher efficacy than Pfizer's Ibrance.

07 Apr 2016

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 hold a hearing to address its price. Most doubted the government agency would weigh in on the controversial topic whilst others said it's possible in an election year.

31 Mar 2016

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 secondly, various value-based pricing tools would be implemented in 2017.

30 Mar 2016

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, said experts. Targeting the PI3K pathway as buparlisib does would cause significant side effects, since it is involved in a number of cellular functions, experts said. The number of patients that discontinued treatment due to side effects adversely affected the drug's risk-benefit profile, they added.

16 Mar 2016

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 was noteworthy, physicians said it is largely manageable, making lucitanib an attractive candidate for targeted therapy.

23 Feb 2016

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 arm would be clinically significant. Yet the slew of failed trials in this space warrants caution regarding Phase III success, they added.

02 Feb 2016

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 receptor, as does a PD-1 inhibitor. However, due to several challenges in isolating the B7-H3 receptor, others noted targeting the ligand was a worthwhile tactic nonetheless.

19 Oct 2015

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, said experts.

23 Sep 2015

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 said.

31 Aug 2015

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 agreed.

12 Aug 2015

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, according to experts. Drug prescription limits could be another option to limit costs considering the longer and thus possibly more expensive treatment duration versus its current approval as a fourth-line drug in germline BRCA mutation (gBRCA) patients, they explained.

11 Jun 2015

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 investigator. Speaking to this news service at the recent 2015 American Society of Clinical Oncology meeting, he noted the study will recruit approximately 200 patients.