The Digest

Pharma news roundup and Larvol updates

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The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – Breast Cancer – May 13, 2019

May 13, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
Pivotal phase II DESTINY-Breast01 trial met primary endpoint, supporting global regulatory submission plan to start in H2 2019 (AstraZeneca Press Release) – May 7, 2019 – P2, N=230; DESTINY-Breast01 (NCT03248492); Sponsor: Daiichi Sankyo, Inc; “The HER2-targeting antibody drug conjugate (ADC) and potential new medicine was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine….The safety and tolerability profile of trastuzumab deruxtecan was also consistent with previous experience. These results are expected to support planned global regulatory submissions, including a Biologics License Application with the US Food and Drug Administration (FDA) anticipated in the second half of 2019.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Interim OS analysis from P3 E2112 trial (NCT02115282) in combination with exemestane for advanced HR+ breast cancer in Q4 2019 (Syndax) – May 7, 2019 – Q1 2019 Results: Final OS analysis in Q2 2020
[Screenshot]

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: NDA submission for advanced HR+, HER2- breast cancer in 2020 (Syndax) – May 7, 2019 – Q1 2019 Results
[Screenshot]

 

Avastin (bevacizumab) / Roche; Tecentriq (atezolizumab) / Roche; Kadcyla (ado-trastuzumab emtansine) / Roche; Venclexta (venetoclax) / Roche, AbbVie; Perjeta (pertuzumab) / Roche; entrectinib (RXDX-101) / Roche
Roche to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Roche Press Release) – May 10, 2019 – “Roche….announced that new data from clinical trials of 17 approved and investigational medicines across 27 cancer types, including hard-to-treat and rare tumours, will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, United States, from 31 May– 4 June, 2019. A total of 155 abstracts that include a Roche medicine will be presented at this year’s meeting.”

 

Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) / Roche, Halozyme Therapeutics; pegvorhyaluronidase alfa (PEGPH20) / Halozyme Therapeutics
Halozyme reports first quarter 2019 results (PRNewswire) – May 7, 2019 – “‘We enjoyed a strong start to 2019 as our first quarter included a new ENHANZE® collaboration with argenx, positive phase III data from Janssen’s COLUMBA study evaluating a subcutaneous formulation of DARZALEX®, and FDA approval of Herceptin Hylecta™’….On ENHANZE® we anticipate regulatory submissions by ENHANZE® partner Janssen for the subcutaneous formulation of DARZALEX®, a new phase 3 trial initiation by one of our ENHANZE® partners and multiple Phase 1 trial initiations. On PEGPH20, we project the announcement of topline results from our HALO-301 pivotal phase 3 trial in pancreas cancer in the second half of the year.'”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports first quarter 2019 financial results (Businesswire) – May 9, 2019 – “…’During 2019, we anticipate the following key milestones for Puma: (i) filing a new drug application for neratinib based on the results of the Phase III trial in third-line metastatic breast cancer in the summer of 2019; (ii) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the summer of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in other countries in the second half of 2019.”

 

Tecentriq (atezolizumab) / Roche; Herceptin (trastuzumab) / Roche; Perjeta (pertuzumab) / Roche
Genentech to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) – May 10, 2019 – P3, N=900; IMpassion130 (NCT02425891); P3, N=808; CLEOPATRA (CLEOPATRA); Sponsor: Hoffmann-La Roche; “Key presentations in breast cancers: Key data to be presented at ASCO include…second interim analysis of overall survival (OS) results, updated safety data and patient-reported outcomes (PROs) from the Phase III IMpassion130 study of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane…) for the treatment of PD-L1-positive, metastatic triple-negative breast cancer (TNBC)…Additional data include an eight-year, end-of-study analysis from the Phase III CLEOPATRA study of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy for first-line treatment of HER2-positive metastatic breast cancer.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports first quarter 2019 financial results (Businesswire) – May 9, 2019 – P3, N=621; NALA (NCT01808573); P2, N=392; SUMMIT (NCT01953926); P2, N=650; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “…’During 2019, we anticipate the following key milestones for Puma: (i) presenting data from the Phase III trial of neratinib in third-line metastatic breast cancer patients in the second quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the second quarter of 2019; and (iii) reporting Phase II data from the SUMMIT basket trial in patients with HER2 mutations in the second half of 2019′.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports fourth quarter 2018 financial results and provides clinical and business update (Syndax Press Release) – May 6, 2019 – P3, N=600; NCT02115282; “The Company continues to anticipate the next interim OS analysis for E2112, its NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, in the second quarter of 2019. Additional interim analyses will be conducted by ECOG-ACRIN approximately every six months until either an OS benefit is observed, or the final target number of events occur. Any positive OS assessment would enable the Company to file for full regulatory approval.”

 

HLX02 (trastuzumab biosimilar) / Fosun Pharma
Henlius biosimilar HLX02 gets NDA acceptance from NMPA (Biospectrumasia) – May 8, 2019 – “Shanghai Henlius Biotech, Inc., subsidiary of Shanghai Fosun Pharmaceutical Group Co. has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its biosimilar HLX02, a trastuzumab for injection.”

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Weekly Top News – IBD – May 13, 2019

May 13, 2019

Remsima SC (infliximab biosimilar SC) / Celltrion
A Phase 3 Study to Evaluate the Efficacy and Safety of the CT-P13 SC in Patients With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – May 10, 2019 – P3; N=600; Not yet recruiting; Sponsor: Celltrion

 

etrasimod (APD334) / Arena
Etrasimod: Initiation of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis by mid-2019 (Arena) – May 11, 2019 – Q1 2019 Results: Data from P3 trial for ulcerative colitis in 2021

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 10, 2019 – P3; N=372; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

Entyvio (vedolizumab) / Takeda
A Phase 3 Study of Vedolizumab for Induction and Maintenance Therapy in Japanese Patients with Moderate to Severe Crohn’s Disease (DDW 2019) – May 9, 2019 – Abstract #Tu1746; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; P3; “It additionally showed numerically greater clinical remission at Week 60 compared with PBO. VDZ is well-tolerated in induction and maintenance therapy in Japanese pts with moderate to severe CD with a safety profile consistent with non-Japanese studies.”

 

Entyvio (vedolizumab) / Takeda
Vedolizumab Use is Not Associated with Increased Malignancy Incidence: Gemini Long-Term Safety Study Results and Post-Marketing Data (DDW 2019) – May 9, 2019 – Abstract #Su1835; Pres time: May 19, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – San Diego Convention Center; P3; “As observed numbers are small, individual malignancy data should not be over-interpreted, and the limitation that standardization does not correct for other potential confounders (e.g. smoking and body mass index) should be considered. Although limitations of post-marketing safety reports, including incomplete data and voluntary reporting of events, must be considered when interpreting post-marketing data, the number of malignancies with VDZ appeared low.”

 

Entyvio SC (vedolizumab SC) / Takeda
Effects of Subcutaneous Vedolizumab on Health-Related Quality of Life and Work Productivity in Patients with Ulcerative Colitis: Results from the Phase 3 Visible 1 Trial (DDW 2019) – May 9, 2019 – Abstract #Sa1878; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; “Similarly, signifi- cant improvements in work productivity measures were observed among patients treated with vedolizumab SC. Further investigation of the effects of vedolizumab SC on quality of life is needed to validate these findings.”

 

mirikizumab (LY3074828) / Eli Lilly
Efficacy and Safety of Mirikizumab (LY3074828) in a Phase 2 Study of Patients with Crohn’s Disease (DDW 2019) – May 9, 2019 – Abstract #1003; Pres time: May 21, 2019; 10:00 AM – 10:15 AM; Location: Room: 20BCD – SDCC; P2; “Sustained efficacy and safety are currently being evaluated in a maintenance study. S-216AGA”

 

Idacio (adalimumab biosimilar) / Fresenius Kabi
Eye on Pharma: Fresenius Kabi launches biosimilar adalimumab, Idacio (Center for Biosimilars) – May 6, 2019 – “Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.”

 

Stelara (ustekinumab) / J&J
STELARA CD PMS: Post-Marketing Surveillance for Crohn’s Disease Participants Treated With Stelara (Ustekinumab) (clinicaltrials.gov) – May 8, 2019 – P; N=600; Recruiting; Sponsor: Janssen Korea, Ltd., Korea

 

Entyvio SC (vedolizumab SC) / Takeda
U.S. Food & Drug Administration accepts Takeda’s Biologics License Application for a subcutaneous formulation of vedolizumab (Entyvio) for maintenance therapy in moderately to severely active ulcerative colitis (Takeda Press Release) – May 9, 2019 – “Takeda…announced that the U.S. Food & Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a subcutaneous (SC) formulation of vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.”

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Weekly Top News – Psoriasis – May 13, 2019

May 13, 2019

Cosentyx (secukinumab) / Novartis
SUBCUTANEOUS SECUKINUMAB 300MG AND 150MG PROVIDES SUSTAINED INHIBITION OF RADIOGRAPHIC PROGRESSION IN PSORIATIC ARTHRITIS OVER 2 YEARS: RESULTS FROM THE PHASE 3 FUTURE-5 TRIAL (EULAR 2019) – May 10, 2019 – Abstract #LB0006; Pres time: Jun 15, 2019; 08:18 AM – 08:24 AM; Location: Hall 7B; No abstract available.

 

Taltz (ixekizumab) / Eli Lilly
IXEKIZUMAB IMPROVES THE SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS REGARDLESS OF SEX, DURATION OF DISEASE, OR BODY MASS INDEX IN TWO RANDOMIZED, PHASE 3 CLINICAL TRIALS (EULAR 2019) – May 10, 2019 – Abstract #FRI0430; Pres time: Jun 14, 2019; No abstract available.

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE, PHASE 2B STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF TILDRAKIZUMAB, A HIGH-AFFINITY ANTI–INTERLEUKIN-23P19 MONOCLONAL ANTIBODY, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (EULAR 2019) – May 10, 2019 – Abstract #LB0002; Pres time: Jun 12, 2019; 05:35 PM – 05:45 PM; Location: Hall 6; No abstract available.

 

Idacio (adalimumab biosimilar) / Fresenius Kabi
Eye on Pharma: Fresenius Kabi launches biosimilar adalimumab, Idacio (Center for Biosimilars) – May 6, 2019 – “Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.”

 

Humira (adalimumab) / Eisai, AbbVie; bimekizumab (UCB4940) / UCB
BE OPTIMAL: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – May 7, 2019 – P3; N=840; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Not yet recruiting –> Recruiting

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Weekly Top News – Breast Cancer – May 6, 2019

May 6, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Updated OS data from P3 IMpassion031 trial (NCT03197935) for TNBC at ASCO 2019 (May 31 – June 4, 2019) (Cantor Fitzgerald) – May 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67171383; Page no: 1; REPORT TITLE: “Cantor daily research highlights”; AUTHOR: Research Department, et al; DATE: 04/24/2019

 

Tecentriq (atezolizumab) / Roche
GeparDouze/NSABP B-59: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy with atezolizumab or placebo in patients with triple negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo (ESMO-BC 2019) – May 5, 2019 – Abstract #122TiP; Pres time: May 3, 2019; 12:15 PM – 01:00 PM; Location: Exhibition area; P3; “…Accrual will be 1,520 randomized patients stratified by region (North America; Europe), tumor size (1.1-3.0 cm; > 3.0 cm), epirubicin or doxorubicin/cyclophosphamide (EC; AC) schedule (q2w; q3w), and nodal status (positive; negative). Patients are randomized 1:1 to receive atezolizumab 1200 mg or placebo IV every 3 weeks concurrently with sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses and every 3 week carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 weeks (per investigator discretion) for 4 cycles…Main secondary endpoints include pCR breast, overall survival, distant disease-free survival, safety and toxicity. GeparDouze is performed as an academic collaboration between NSABP and GBG.”

 

Ibrance (palbociclib) / Pfizer
Ibrance: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in H2 2020 (Pfizer) – Apr 30, 2019 – Q1 2019 Results: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in H2 2020
[Screenshot]

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from P3 KEYNOTE-522 trial (NCT03036488) for TNBC in 2019 (Merck (MSD)) – Apr 30, 2019 – Q1 2019 Results: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in 2019
[Screenshot]

 

Talzenna (talazoparib) / Pfizer
Impact of objective response (OR) on patient-reported outcomes (PRO) in patients (pts) with advanced breast cancer (ABC) and a germline BRCA1/2 (gBRCA) mutation in the phase III EMBRACA trial (ESMO-BC 2019) – May 5, 2019 – Abstract #154O; Pres time: May 2, 2019; 05:20 PM – 05:25 PM; Location: Vienna Hall; “…Background: In EMBRACA, a randomised 2:1 phase 3 open-label study of pts with ABC and a gBRCA mutation, a statistically significant higher OR rate was observed with talazoparib (TALA) (n = 219) vs physician’s choice of chemotherapy (PCT; n = 114) (62.6% vs 27.2%; odds ratio, 5.0; 95% CI, 2.9, 8.8; P < 0.001)… Overall change from baseline and greater delay in TTD in GHS/QoL were observed favouring pts who experienced OR vs those who did not have OR. These results suggest that higher OR rates may lead to better overall improvement from baseline and greater delay in TTD in GHS/QoL in pts with ABC and a gBRCA mutation.”

 

Kadcyla (ado-trastuzumab emtansine) / Roche
FDA approves Genentech’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (Roche Press Release) – May 3, 2019 – “Genentech…announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin® (trastuzumab)-based treatment…The FDA rapidly reviewed and approved the application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs…This approval is based on results of the Phase III KATHERINE study…”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: Data from P2 monarcHER trial (NCT02675231) in metastatic breast cancer at the end of 2019 (Eli Lilly) – May 1, 2019 – Q1 2019 Results

 

capecitabine / generics; Avastin (bevacizumab) / Roche
Continuous chemotherapy improves outcomes and quality of life in advanced breast cancer [ESMO press release] (ESMO.org) – Apr 30, 2019 – P3, N=420; Stop&Go (NCT01935492); “The phase III study randomised 420 patients with advanced HER2-negative breast cancer to either an intermittent schedule (four cycles – ‘treatment holiday’ – another four cycles) or a continuous schedule comprised of the same eight cycles administered consecutively. Both first line treatment (paclitaxel plus bevacizumab) and second line treatment (capecitabine or non-pegylated liposomal doxorubicin) followed these schedules….Patients who started second line treatment (n=270; 131 vs. 139 in intermittent vs. continuous arms) demonstrated a median PFS in second line of 3.5 vs. 5.0 months respectively, with a hazard ratio (HR) of 1.04 (95%CI 0.69-1.57).”

 

Tecentriq (atezolizumab) / Roche
IMpassion031: A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) – Apr 29, 2019 – P3; N=324; Recruiting; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Recruiting; N=204 –> 324; Trial completion date: Sep 2021 –> Jan 2023; Trial primary completion date: Mar 2019 –> Sep 2020

 

Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
A pragmatic, randomised, multicentre trial comparing 4-weekly vs. 12-weekly administration of bone-targeted agents (denosumab, zoledronate or pamidronate) in patients with bone metastases (ESMO-BC 2019) – May 5, 2019 – Abstract #LBA3; Pres time: May 2, 2019; 04:30 PM – 04:35 PM; Location: Vienna Hall; P4; “The findings of this trial are consistent with those previously reported for de-escalating ZA. This trial also included pts receiving de-escalated DN and PAM. While the results of the REDUSE trial are awaited, the data presented would suggest that de-escalation of commonly used BTAs is a reasonable treatment option.”

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Weekly Top News – IBD – May 6, 2019

May 6, 2019

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Data from P2 SERENITY trial (NCT02891226) for Crohn’s disease at DDW (May 18- 21, 2019) (Eli Lilly) – Apr 30, 2019 – Q1 2019 Results
[Screenshot]

 

Stelara (ustekinumab) / J&J
GENERAL HEALTH STATUS IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS RECEIVING USTEKINUMAB: RESULTS FROM THE PHASE 3 UNIFI INDUCTION AND MAINTENANCE STUDIES (DDW 2019) – May 2, 2019 – Abstract #Sa1887; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Stelara (ustekinumab) / J&J
EFFECTS OF USTEKINUMAB INDUCTION THERAPY ON ENDOSCOPIC AND HISTOLOGIC HEALING IN THE UNIFI PHASE 3 STUDY IN ULCERATIVE COLITIS (DDW 2019) – May 3, 2019 – Abstract #Tu1735; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Xeljanz (tofacitinib) / Pfizer
ANALYSIS OF HEMATOLOGICAL CHANGES IN TOFACITINIB-TREATED PATIENTS WITH ULCERATIVE COLITIS ACROSS PHASE 3 INDUCTION AND MAINTENANCE STUDIES (DDW 2019) – May 3, 2019 – Abstract #Tu1752; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Xeljanz (tofacitinib) / Pfizer
MEASURING THE MEDIATING EFFECTS OF MAYO SCORE COMPONENTS FOR TOFACITINIB ON DISEASE-SPECIFIC QUALITY OF LIFE IN ULCERATIVE COLITIS: DATA FROM THE OCTAVE PROGRAM (DDW 2019) – May 2, 2019 – Abstract #Sa1873; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Entyvio (vedolizumab) / Takeda
EFFECTS OF INTRAVENOUS VEDOLIZUMAB ON HEALTH-RELATED QUALITY OF LIFE AND WORK PRODUCTIVITY IN PATIENTS WITH CROHN’S DISEASE: RESULTS FROM THE PHASE 3B VERSIFY TRIAL (DDW 2019) – May 2, 2019 – Abstract #Sa1881; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Entyvio (vedolizumab) / Takeda
A PHASE 3 STUDY OF VEDOLIZUMAB FOR INDUCTION AND MAINTENANCE THERAPY IN JAPANESE PATIENTS WITH MODERATE TO SEVERE CROHN’S DISEASE (DDW 2019) – May 3, 2019 – Abstract #Tu1746; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Alofisel (darvadstrocel) / Takeda
Drugmaker Takeda to introduce value-based pricing in Europe (Nikkei) – Apr 29, 2019 – “Takeda is looking to adopt the pricing mechanism for a stem cell therapy called Alofisel for a complication of Crohn’s disease. Because of the complex production method that involves cell cultivation, the drug is expected to carry a price tag of an estimated 60,000 euros ($67,000)….The drug is expected to go on sale by the end of fiscal 2019 in the U.K. and elsewhere in Europe.”

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