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Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Contribution
License Agreement

ACADIA Pharmaceuticals and Neuren Pharmaceuticals Announce Exclusive License Agreement for the North American Development and Commercialization of Trofinetide in Rett Syndrome

PR-M08-18-NI-071
FDA Designation

Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI™ in combination with MEKTOVI® and cetuximab for BRAFV600E-mutant Metastatic Colorectal Cancer

PR-M08-18-NI-070
Pilot Study

Pilot Study Indicates Qualia Mind Improving Reasoning, Episodic Memory, Verbal Ability and Concentration

PR-M08-18-NI-069
Designation

Prometic receives Rare Pediatric Disease Designation from U.S. FDA for small molecule drug candidate, PBI-4050

PR-M08-18-NI-068
FDA Orphan Drug Designation

Pliant Therapeutics Receives FDA Orphan Drug Designation for Lead Program PLN-74809 in Idiopathic Pulmonary Fibrosis

PR-M08-18-NI-058
Phase II Study

Eiger BioPharmaceuticals Announces First Patient Enrolled in Phase 2 LIFT Study of Pegylated Interferon Lambda in Combination with Ritonavir-Boosted Lonafarnib at National Institutes of Health

PR-M08-18-NI-057
FDA

DURECT's Licensee Pain Therapeutics Receives Complete Response Letter from FDA for REMOXY® ER (oxycodone) Extended-Release Capsules CII

PR-M08-18-NI-059
Business

Perrigo to Divest Its Prescription Drug Business

PAO-M08-18-NI-015
Collaboration

Regeneron and bluebird bio Announce Collaboration to Discover, Develop and Commercialize New Cell Therapies for Cancer

PR-M08-18-NI-054
FDA Approval

Alteogen Gets FDA Approval for Orphan Drug Designation with an Antibody-Drug Conjugate for Gastric Cancer

PR-M08-18-NI-052
Collaborative Research Partnership

Mallinckrodt Forms Collaborative Research Partnership with Washington University in St. Louis

PR-M08-18-NI-056
Final Results

Final Results from the Protagonist PROPEL Study Support Further Clinical Development of PTG-100 for the Treatment of Ulcerative Colitis

PR-M08-18-NI-055
Collaboration and Licensing Agreement

Neovasc Announces Collaboration and Licensing Agreement with Penn Medicine and the Gorman Cardiovascular Research Group

PR-M08-18-NI-053
Clinical Trials

Harpoon Therapeutics Treats First Patient with HPN424 in Phase 1 Clinical Trial of Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients

PR-M08-18-NI-051
Partnership

Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium, Imperial Innovations and Oxford Biomedica Announce New Partnership

PR-M08-18-NI-049
Agreement

Glenmark Pharmaceuticals and Harbour BioMed Sign Agreement for Greater China to Develop GBR 1302, a First-in-Class Bispecific Antibody for Treatment of HER2-Positive Cancers

PR-M08-18-NI-050
Collaboration

Regenacy Pharmaceuticals Announces Collaboration with the Charcot-Marie-Tooth Association (CMTA) to Advance Ricolinostat for the Treatment of Hereditary Neuropathy

PR-M08-18-NI-044
Phase 3 Study

Britannia Pharmaceuticals Ltd: Phase 3 TOLEDO Study Shows Apomorphine Infusion Provides Effective Relief of Persistent Motor Fluctuations in Parkinson's Disease

PR-M08-18-NI-043
Clinical Trials

60 Day Window for Clinical Trial Approval Official, says George Clinical, a leading Asia-Pacific CRO

PR-M08-18-NI-123
FDA Clearance

Sensus Healthcare Receives FDA 501(k) Clearance to Market Next-Generation SRT-100+ Superficial Radiation Therapy for Treating Non-Melanoma Skin Cancer and Keloids

PR-M08-18-NI-041
Joint Venture

RegeneRx Licensee GtreeBNT Enters into Joint Venture to Globally Develop RGN-137 for Treatment of Epidermolysis Bullosa

PR-M08-18-NI-039
Clinical Trials

Regenera Pharma Enrolls First Patient in US Phase 3 Study of RPh201 in NAION, Advances Phase 2 Study in Alzheimer's Disease in Canada

PR-M08-18-NI-038
FDA Clearance

Hologic Announces FDA Clearance of the Panther Fusion® GBS Assay

PR-M08-18-NI-042
Clinical Data

MiMedx Announces Publication Of Phase 2B Clinical Trial Efficacy Data For Micronized dHACM In The Treatment Of Plantar Fasciitis In Foot & Ankle International

PR-M08-18-NI-040
Granted Designation

Selumetinib Granted Orphan Designation in Europe for Neurofibromatosis Type 1

PR-M08-18-NI-037
Acquisition

Intertek Groups Expands Offerings with the Acquisition of Alchemy Systems

PAO-M08-18-NI-012
Collaboration

Secant Group Announces Collaboration between Orgenesis and Atvio Biotech

PR-M08-18-NI-033
Orphan Drug

Trovagene Receives Positive Opinion for Orphan Drug Designation in the European Union for PCM-075, Trovagene's Investigational Cancer Drug

PR-M08-18-NI-032
Clinical Results

Theravance Biopharma Reports Positive Top-Line Four-Week Data from Phase 2 Trial of TD-9855 for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension

PR-M08-18-NI-031
Clinical Trials

Xcovery Announces First Cohort of Patients Dosed in a Phase 1/2 Clinical Trial of Vorolanib

PR-M08-18-NI-035
Collaboration

QIAGEN Creates Collaboration with Japan’s Largest Clinical Laboratory Testing Company, SRL, to Accelerate Launch of Companion Diagnostics

PR-M08-18-NI-034
China

Big Pharma Companies Taking New Drugs to China First

PAO-M08-18-NI-010
Clinical Study

BioLineRx Initiates Phase 1/2a Clinical Study for AGI-134, a Novel Immunotherapy for Treatment of Solid Tumors

PR-M08-18-NI-030
Oncology

Laekna Acquires Exclusive Worldwide Rights to Two Clinical Stage Oncology Assets

PR-M08-18-NI-029
Acquisition

Hologic to Acquire Faxitron Bioptics, Leader in Digital Specimen Radiography, for Approximately $85 Million

PR-M08-18-NI-028
Preliminary Data

Sangamo Announces Preliminary Data From Champions Study Evaluating SB-913

PR-M08-18-NI-027
Partnership

The ALS Association Partners with GNS Healthcare to Apply AI to Accelerate Answer ALS Research

PR-M08-18-NI-026
Acquisition

GI Partners Completes Acquisition and Merger of California Cryobank and Cord Blood Registry

PR-M08-18-NI-065
Innovation

Fresenius Kabi Introduces Four Presentations of Heparin Sodium in freeflex®Containers

PR-M08-18-NI-025
Marketing Authorization

XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for Moderately to Severely Active Ulcerative Colitis

PR-M08-18-NI-024
Clinical Results

180 Therapeutics Announces Positive Results from a Phase 2a Clinical Trial of Anti-TNF Therapy in Dupuytren’s Disease

PR-M08-18-NI-019
Collaboration

QIAGEN and Hamilton Launch New Collaboration to Improve Pre-Analytical Sample Processing for QuantiFERON-TB Gold Plus

PR-M08-18-NI-018
IRB Approval

BioPharmX Receives IRB Approval to Initiate Phase 2 Trial of BPX-04 for the Treatment of Rosacea

PR-M08-18-NI-017
Clinical Data

Blockchain-Based Pilot for Exchange of Clinical Data Announced by Grapevine World in Collaboration With the University of Southampton and Tiani Spirit

PR-M08-18-NI-015
European Approval

Pfizer Receives European Approval for Oncology Biosimilar, TRAZIMERA™ (trastuzumab)

PR-M08-18-NI-014
FDA Approval

United Therapeutics Announces FDA Approval Of The Implantable System For Remodulin®

PR-M08-18-NI-016
FDA Approval

Roche's cobas HPV Test receives FDA approval for first-line cervical cancer screening using SurePath preservative fluid

PR-M08-18-NI-006
FDA Approval

Thermedical Announces FDA Investigational Device Exemption Approval to Begin US Clinical Study of Durablate Catheter for Treatment of Ventricular Tachycardia

PR-M08-18-NI-021
Phase I Trial

Arcus Biosciences Announces Initiation of Phase 1 Trial for AB154, its Anti-TIGIT Antibody

PR-M08-18-NI-012
Drug Application

Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA

PR-M08-18-NI-011
FDA Inspection

WuXi STA’s Jinshan Site Passes Fourth U.S. FDA Inspection

PR-M08-18-NI-013
Engineering Agreement

Abzena Signs Protein Engineering Agreement with NYU Langone Health

PR-M08-18-NI-036
Clinical Data

BRAFTOVI™ (encorafenib) + MEKTOVI® (binimetinib) Receives Positive CHMP Opinion for Advanced BRAF-mutant Melanoma

PR-M08-18-NI-010
EMA

European Medicines Agency Adopts Positive Opinion for KEYTRUDA®(pembrolizumab) Combination with Pemetrexed and Platinum Chemotherapy

PR-M08-18-NI-009
Positive Opinion

Pierre Fabre receives positive CHMP opinion for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in adult patients with advanced BRAF-mutant melanoma

PR-M08-18-NI-008
Positive Opinion

Janssen Receives Positive CHMP Opinion for Darzalex®▼ (daratumumab) as Frontline Treatment for Newly Diagnosed Patients with Multiple Myeloma

PR-M08-18-NI-007
Global Collaboration

ABL Bio and I-Mab Biopharma Announce Global Collaboration on Innovative Bispecific Antibodies

PR-M08-18-NI-005
Clinical Trial

Cerapedics Announces First Patients Enrolled in IDE Clinical Trial of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery

PR-M08-18-NI-004
FDA Approval

FDA Approves PERSERIS™ (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults

PR-M08-18-NI-002
Research Collaboration

Lilly Announces Extension of Cancer Research Collaboration with Dana-Farber Cancer Institute

PR-M08-18-NI-003
Biosimilar

Mylan and Fujifilm Kyowa Kirin Biologics Announce Positive CHMP Opinion for Hulio™, Biosimilar Adalimumab

PR-M08-18-NI-001
Phase II Results

Promising Phase 2 Results for Eye Implant from Genentech

PAO-M08-18-NI-003
Clinical Logistics Services

Marken Offers Unique Clinical Logistics Services In Russia

PR-M08-18-NI-023
Clinical Tria Logistics

Marken Opens Clinical Trial Logistics Hub In Melbourne, Australia

PR-M08-18-NI-022
Clinical Trials

Phase 3 Study Of Subcutaneous Pertuzumab And Trastuzumab Initiated Using Halozyme's ENHANZE® Technology

PR-M07-18-NI-106
Phase I Study

Foresee Pharmaceuticals Announces Results from a Phase 1 Clinical Study

PR-M07-18-NI-105
FDA Approval

INSIGHTEC Receives FDA Approval to Initiate Clinical Study of MR-Guided Focused Ultrasound to Treat Patients With Alzheimer's Disease

PR-M07-18-NI-104
Study Results

Eisai And Biogen Present Detailed Results From Phase II Clinical Study Of Elenbecestat In MCI And Mild To Moderate Alzheimer's Disease

PR-M07-18-NI-103
Global Collaboration

I-Mab Biopharma and ABL Bio Announce Global Collaboration on Innovative Bispecific Antibodies

PR-M07-18-NI-107
Phase I Trial

Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT-1806, a Proposed Biosimilar of Actemra® (Tocilizumab)

PR-M07-18-NI-101
Launch

Asuragen Expands AmplideX® Technology and Product Line with Launch of PCR/CE SMN1 Kit

PR-M07-18-NI-100
Therapy Approval

KEYTRUDA® (pembrolizumab) is the First Anti-PD-1 Therapy Approved in China for Advanced Melanoma

PR-M07-18-NI-098
Care Delivery

Siemens Healthineers Transforms Care Delivery with Innovative New Tests for Diagnosing Heart Attacks Faster

PR-M07-18-NI-097
Advanced Solid Tumors

Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent TP-0184 in Phase 1 Study of Patients with Advanced Solid Tumors

PR-M07-18-NI-096
Phase III Trial

KEYTRUDA® (pembrolizumab) Monotherapy Met a Primary Endpoint in the Phase 3 KEYNOTE-048 Trial

PR-M07-18-NI-093
Phase I Results

Glenmark Pharmaceuticals Announces Encouraging Phase 1 Results Supporting Biosimilarity Criteria for GBR 310

PR-M07-18-NI-091
Manufacturing

WuXi Biologics Announced Successful Completion of the First cGMP Run in MFG3

PR-M07-18-NI-090
Data Publication

PTC Therapeutics Announces Publication of Data Demonstrating the Clinical Differentiated Benefit of Deflazacort

PR-M07-18-NI-088
Phase III Trial

Endoscopy Publishes the Dayb Phase III Trial for Plenvu®(Ner1006), the First One Litre Peg Bowel Preparation[i]

PR-M07-18-NI-089
HIV Diagnoses

Gilead Announces New Data on the Impact of Truvada® for Pre-Exposure Prophylaxis (PrEP) on the Number of HIV Diagnoses in the United States

PR-M07-18-NI-087
Clinical Trials

Celgene Announces Phase III ‘AUGMENT’ Study of REVLIMID® in Combination with Rituximab (R2)

PR-M07-18-NI-085
API Manufacturing

Cambrex to Acquire Halo Pharma, Adding Drug Development and Finished Dosage Capabilities to Global API Manufacturing Network

PR-M07-18-NI-082
Patient Enrollment

Aldeyra Therapeutics Announces First Patient Enrolled in Sjögren-Larsson Syndrome Pivotal Phase 3 Clinical Trial

PR-M07-18-NI-084
Legal

Novartis Goes to Court Over Gilenya Generics

PAO-M07-18-NI-020
Drug Development

Kite Makes Move on Gadeta

PAO-M07-18-NI-019
FDA Approval

Amneal Announces FDA Approval and Launch of Generic Potassium Chloride Oral Solution

PR-M07-18-NI-081
Opening

DPS Group and TRIA Celebrate Opening of State-of-the-Art cGMP mRNA Clinical Manufacturing Facility for Moderna Therapeutics

PR-M07-18-NI-077
Biosimilar

FDA Issues New Biosimilar Action Plan

PR-M07-18-NI-074
Drug Development

Novartis Kisqali® now first and only CDK4/6 inhibitor indicated in US

PR-M07-18-NI-068
Clinical Trials

Allergan and Molecular Partners Announce Two Positive Phase 3 Clinical Trials

PR-M07-18-NI-067
Research

Researchers Are One Step Closer to Developing Eye Drops to Treat Age-related Macular Degeneration (AMD)

PR-M07-18-NI-066
Announcement

Bryan Zerhusen, Ph.D. Joins Cantor Colburn to Chair its Life Sciences Practice Group

PR-M07-18-NI-072
Opioids

HBI Solutions' Tool Predicts Who Is Likely to Abuse Opioids Using Medical and Social Data

PR-M07-18-NI-064
Collaboration

Vyriad Announces Collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer

PR-M07-18-NI-065
Phase 3

PainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study

PR-M07-18-NI-062
FDA

Safety Concerns Raised about Valsartan from China

PAO-M07-18-NI-013
Clinical Data

Pulmatrix Announces Positive Top-Line Preliminary Results from Part 3 of the 3-Part Phase 1/1b Clinical Trial of Pulmazole

PR-M07-18-NI-058
Research

IDTechEx Research: Long Term In Vivo Performance of Tissue Engineered Heart Valves

PR-M07-18-NI-057
Market Prediction

Biosurgery Market Worth 15.58 Billion USD by 2023

PR-M07-18-NI-059
Opiods

Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder

PR-M07-18-NI-055
Announcement

Court Ruling in Favor of Aquestive Therapeutics Enjoining Dr. Reddy's Laboratories from Launching its Generic Suboxone Product

PR-M07-18-NI-053
Preferred Provider

Leiters and Avanos Medical Announce Preferred Provider Agreement

PR-M07-18-NI-054
Drug Development

Upsher-Smith Launches Vigabatrin For Oral Solution Under The Brand Name Vigadrone™

PR-M07-18-NI-051
Acquisition

AMPAC Fine Chemicals To Be Acquired By SK Holdings

PR-M07-18-NI-050
FDA Approval

FDA approves the first drug with an indication for treatment of smallpox

PR-M07-18-NI-046
FDA Approval

U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

PR-M07-18-NI-047
Antibiotic Resistance

Roche PCT assay cleared for expanded use - Important tool in antibiotic resistance crisis

PR-M07-18-NI-049
Market Prediction

Aseptic Sampling Market Worth 1,247.0 Million USD by 2023

PR-M07-18-NI-050
Announcement

Bausch Health Companies Inc. Completes Name Change

PR-M07-18-NI-048
FDA Approval

Abbott Receives FDA Approval for Next-Generation MitraClip® Device to Treat People with Leaky Heart Valves

PR-M07-18-NI-045
Announcement

Natera Announces Pricing of Follow-On Offering

PR-M07-18-NI-044
New Drug Application

AbbVie Announces Submission of Supplemental New Drug Application to US FDA for Venetoclax

PR-M07-18-NI-041
Clinical Trials

CStone's PD-1 inhibitor CS1003 receives clinical trial approval in China

PR-M07-18-NI-042
Acquisition

Otsuka Pharmaceutical to Acquire Visterra

PR-M07-18-NI-040
Drug Development

SCYNEXIS Reports Positive Results from Phase 2b Dose-Finding Study of Oral SCY-078 in Vulvovaginal Candidiasis

PR-M07-18-NI-039
Announcement

BioCryst Provides Update on Strategy, Pipeline and Outlook

PR-M07-18-NI-037
Cell and Gene Therapy

MedImmune and 4D Molecular Therapeutics Collaborate to Design, Develop and Commercialize AAV Gene Therapy for Chronic Lung Disease

PR-M07-18-NI-038
Pricing

Pfizer Announces it Will Defer Company’s Price Increases

PR-M07-18-NI-036
Acquisition

Medline Announces Acquisition of NeuroGym Technologies

PR-M07-18-NI-035