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Immunotherapy

New Nature Medicine Study Demonstrates Ability of The Guardant360 Assay to Predict Patient Response to Immunotherapy in Advanced Gastric Cancer Patients

PR-M07-18-NI-070

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

FDA

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA Approval

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

FDA Approval

Janssen Announces U.S. FDA Approval of SYMTUZA™ (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection

PR-M07-18-NI-061

Collaboration

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

PR-M07-18-NI-065

Announcement

Cook® Regentec Announces First U.S. Clinical Use of Advance® CS Coronary Sinus Infusion Catheter to Deliver a Therapeutic in Heart Failure Patients

PR-M07-18-NI-063

Phase 3

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

PR-M07-18-NI-062

Drug Development

Appeals Board Rules in Favor of Novartis and its Multiple Sclerosis Drug Gilenya

PAO-M07-18-NI-014

FDA

Safety Concerns Raised about Valsartan from China

PAO-M07-18-NI-013

FDA Approval

Xtandi Gets FDA Second Cancer Therapy Approval

PAO-M07-18-NI-012

Industry Trend

China Turning to Indian Drug Manufacturers in Response to Trade War with US

PAO-M07-18-NI-011

Acquisition

Locus Biosciences acquires EpiBiome's high-throughput discovery platform to enhance its global leadership in CRISPR-engineered phage therapeutics

PR-M07-18-NI-060

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

Clinical Data

Eisai Inc. Announces Positive Topline Results from CAMELLIA-TIMI 61, a Large-Scale Cardiovascular Outcome Trial for the Anti-Obesity Agent BELVIQ®

PR-M07-18-NI-056

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

FDA

FDA Committee Gives Nod to New Treatment for Plasmodium Vivax Malaria

PAO-M07-18-NI-010

Drug Development

New Antibiotic to be Tested against Potential Bioweapons

PAO-M07-18-NI-009

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 Discovery

Peptron Announces Published Data Showing a New Sustained-Release Exendin-4 Formulation Prevents Neurodegeneration in a Parkinson's Disease Model

PR-M07-18-NI-052

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

Advertising

Digital Ad Spending by Pharma is Growing Slowly

PAO-M07-18-NI-008

FDA Approval

New Treatment for Excessive Sweating Gets FDA Approval

PAO-M07-18-NI-008

Investment

Women’s Health Company to Expand

PAO-M07-18-NI-007

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

Diabetes

Diabetes Research Institute Launches New Clinical Trial to Explore Effects of Omega-3 Fatty Acids and Vitamin D in Type 1 Diabetes

PR-M07-18-NI-043

Clinical Trials

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

PR-M07-18-NI-042

Clinical Research

Eating Well Might Improve Cancer Treatments

PAO-M07-18-NI-006

Investment

Organ-on-a-Chip Company Raises $36 Million

PAO-M07-18-NI-005

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

FDA Clearance

RedDress Receives FDA 510(k) Clearance for RD1 System

PR-M07-18-NI-032

Collaboration

Applied BioMath, LLC Announces Collaboration with Revitope for Mechanistic PK/PD Modeling in Solid Tumors

PR-M07-18-NI-034

Acquisition

EnsembleIQ Acquires Media Brands from Lebhar-Friedman

PR-M07-18-NI-031

Clinical Study

BioArctic Receives Regulatory Approval in Finland for a Clinical Study in Patients With Complete Spinal Cord Injury

PR-M07-18-NI-033

Announcement

Bosch Packaging Business Up for Sale

PAO-M07-18-NI-004

Opioids

Gottlieb Discusses Results of Online Opioid Summit

PAO-M07-18-NI-003

Announcement

Alcon Set Out On its Own

PAO-M07-18-NI-002

Approvals

Japan Approves Two New AstraZeneca Cancer Meds

PAO-M07-18-NI-001

Acquisition

BD Acquires TVA Medical to Advance Leadership in Solutions for Chronic Kidney Disease

PR-M07-18-NI-030

FDA Filing Acceptance

Bausch + Lomb Announces U.S. FDA Filing Acceptance For Loteprednol Etabonate Ophthalmic Gel, 0.38%

PR-M07-18-NI-029

Drug Development

Mylan Adds to Central Nervous System Portfolio With Launch of Generic Exelon® Patch

PR-M07-18-NI-028

FDA Approval

Camargo Congratulates US WorldMeds on Obtaining FDA Approval for the First Non-Opioid Medicine for the Management of Opioid Withdrawal Symptoms

PR-M07-18-NI-027

FDA Clearance

Companion Medical Announces FDA Clearance for the InPen System for Android

PR-M07-18-NI-026

Announcement

Governor Murphy Announces Teva Pharmaceuticals to Locate US Headquarters in New Jersey

PR-M07-18-NI-025

Packaging

Bosch Plans to Sell its Packaging Business

PR-M07-18-NI-024

Investment

Evonetix Awarded Innovate UK Funding for £1.3 Million Gene Synthesis Project

PR-M07-18-NI-023

Serialization

Recipharm Announces Global Serialisation Collaboration

PR-M07-18-NI-022

Oncology

Phase III IMpassion130 study showed Roche’s Tecentriq plus Abraxane significantly reduced the risk of disease worsening for metastatic triple negative breast cancer

PR-M07-18-NI-021

Market Expansion

Sanofi to further accelerate its scientific presence with the opening of a Global R&D Operations Hub in Chengdu, China

PR-M07-18-NI-017

Investment

Biogen Exercises Option to Increase Ownership in Samsung Bioepis

PR-M07-18-NI-018

Bioconjugation

Abzena and Telix sign strategic manufacturing and bioconjugation agreement

PR-M07-18-NI-016

Cannabis

The Wave of Cannabis Legalization is Impending Abroad

PR-M07-18-NI-019

Life Sciences

Google, Amazon, Facebook and Apple Propel the Life Sciences Industry with Strategic Partnerships

PR-M07-18-NI-020

Acquisition

Catalent Signs Agreement to Acquire Juniper Pharmaceuticals, Inc.

PR-M07-18-NI-011

Acquisition

Amazon to Acquire PillPack

PR-M07-18-NI-014

Announcement

Adamis Pharmaceuticals Announces Distribution and Commercialization Agreement for Symjepi

PR-M07-18-NI-011

Precision Medicine

BC Platforms and Tieto Partner to Integrate Genomic and Clinical Data to Advance Precision Medicine

PR-M07-18-NI-012

FDA Approval

Dermira Receives FDA Approval for Qbrexza™ (glycopyrronium) Cloth to Treat Primary Axillary Hyperhidrosis

PR-M07-18-NI-013

Biosimulation

The global biosimulation market size is expected to reach USD 3.77 billion by 2024

PR-M07-18-NI-010

Clinical Data

Mallinckrodt Rheumatoid Arthritis Phase 4 Clinical Study for H.P. Acthar® Gel (Repository Corticotropin Injection) Achieves its Enrollment Target

PR-M07-18-NI-009

Announcement

Novartis announces intention to seek shareholder approval for 100% spinoff of Alcon eye care devices business; initiates share buyback of up to USD 5 bn

PR-M07-18-NI-006

Investment

I-Mab Successfully Raised USD 220 Million in Series C Funding

PR-M07-18-NI-008

FDA

FDA approves novel device for treating breathing difficulty from severe emphysema

PR-M07-18-NI-008

Partnership

Broad and Bayer Expand Partnership, Launching New Research Effort to Develop Therapies for Heart Failure

PR-M07-18-NI-005

Cannabis

Cannabics Pharmaceuticals Enters a Memorandum of Understanding With Clinical-Stage Biopharmaceutical Company Focused on the Treatment of Ophthalmic Disorders

PR-M07-18-NI-004

Announcement

ChinaRx Author, Rosemary Gibson, to Speak at Rx-360 Conference

PR-M07-18-NI-003

Market Intelligence

Microbiology Testing Market to Grow at 6.4% CAGR to 2023

PR-M07-18-NI-002

Acquisition

Bain Capital Private Equity Acquires DSM Sinochem Pharmaceuticals

PR-M07-18-NI-001

Announcement

Science Exchange Adds Allergan EVP & Chief R&D Officer David Nicholson to Its Board of Directors

PR-M06-18-NI-099

Investment

Ligand Receives $47 Million from WuXi Biologics for Expansion of Worldwide OmniAb® Platform License Agreement

PR-M06-18-NI-098

Clinical Data

Novartis and Amgen Highlight Findings from a Large Global Patient Survey on Migranes

PR-M06-18-NI-101

Biosimilars

Amgen Announces Top-Line Results From Phase 3 Study Of ABP 710, Biosimilar Candidate To Infliximab

PR-M06-18-NI-100

Orphan Drug

Arrowhead Receives Positive EMA Opinion on Orphan Designation for ARO-AAT for Treatment of Congenital Alpha-1 Antitrypsin Deficiency

PR-M06-18-NI-097

Innovation

Distek, Inc. Releases the PrepEngine Mini Sample Prep Station

PR-M06-18-NI-096

Announcement

GE Healthcare to Become Standalone Company

PR-M06-18-NI-095

FDA Approval

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

PR-M06-18-NI-095

Celgene Corporation

Skyhawk Therapeutics Announces Strategic Collaboration with Celgene to Discover and Develop Novel mRNA Splicing Modifiers using Skyhawk's STAR* Technology Platform

Genome

Precision BioSciences Raises $110M to Advance ARCUS Genome Editing Programs

PR-M06-18-NI-093

Strategic Collaboration

AbbVie and Calico Announce Extension of Groundbreaking Collaboration

PR-M06-18-NI-092

Bioprinting

3D Bioprinting Market Size Worth $2.6 Billion by 2024 | CAGR 18.4%: Grand View Research, Inc.

PR-M06-18-NI-090

Clinical Trials

Javara Launches Next Generation Integrated Clinical Trials Platform

PR-M06-18-NI-088

Clinical Trials

Rigel Initiates Phase 1 Clinical Trial of R835, an IRAK1/4 Inhibitor for Autoimmune and Inflammatory Diseases

PR-M06-18-NI-091

Clinical Trials

Arcus Biosciences and Infinity Pharmaceuticals Announce Clinical Collaboration to Evaluate Lead Programs in Triple-Combination Studies

Serialization

Italian Pharmaceutical Manufacturer and CMO, IBI Lorenzini, Selects TraceLink to Comply with Global Serialization Regulations

PR-M06-18-NI-087

Drug Delivery

Automated Insulin Delivery System Approved for Use by More Pediatric Patients

PAO-M06-18-NI-023

Immunotherapy

India Gets First Immunotherapy for Lung Cancer

PAO-M06-18-NI-022

Microbiome

Kaleido Raises More Money for Development of Microbiome-Based Therapeutics

PAO-M06-18-NI-021

FDA

Trump Administration Proposes HHS Restructuring, Including Major Changes at FDA

PAO-M06-18-NI-020

Phase 3

Lilly to Present Phase 3 Data at AHS 2018 Highlighting Innovative Potential Treatments for Migraine and Cluster Headache

PR-M06-18-NI-085

Insulin

Boehringer Ingelheim and Lilly announce positive top-line Phase III data results for empagliflozin as adjunct to insulin in type 1 diabetes

PR-M06-18-NI-084

Clinical Data

Array BioPharma Announces a 62% Observed Overall Survival at One Year from the Phase 3 BEACON CRC Safety Lead-In

PR-M06-18-NI-086

Clinical Trials

Oramed Enrolls First Patient in Its Glucose Clamp Study for Oral Insulin

PR-M06-18-NI-083

Research

BNBuilders Completes Construction on Vertex Pharmaceuticals Research Center in San Diego

PR-M06-18-NI-082

Parenterals

A Risk Analysis Approach to Producing Environmentally Sensitive Parenterals

PA0-M06-18-CL-007

R&D

Global Transfer Membrane Market 2018-2023 - Increasing R&D Spending By Pharmaceutical and Biotechnology Companies

PR-M06-18-NI-081

Scientific Advisory Council

Mallinckrodt Launches Scientific Advisory Council

PR-M06-18-NI-081

Drug Candidate

Prometic Presents New Data on NASH Drug Candidate PBI-4547

PR-M06-18-NI-080

Orphan Drug

Processa Pharmaceuticals Receives Orphan Designation Status For PCS499 In Necrobiosis Lipoidica From The Food And Drug Administration (FDA)

PR-M06-18-NI-079

Acquisition

Lilly Completes Acquisition of ARMO BioSciences

PR-M06-18-NI-078

Announcement

West Appoints Bernard Birkett to Chief Financial Officer

PR-M06-18-NI-077

Acquisition

Sanofi completes its acquisition of Ablynx following the expiration of the Squeeze-out Procedure

PR-M06-18-NI-074

Capsules

Oramed Initiates Food Effect Study for Its Oral Insulin Capsule ORMD-0801

PR-M06-18-NI-076

Genome

Johnson & Johnson Innovation Opens JLABS @ NYC in Collaboration with New York State and the New York Genome Center

PR-M06-18-NI-075

M&A

Roche and Foundation Medicine reach definitive merger agreement to accelerate broad availability of comprehensive genomic profiling in oncology

PR-M06-18-NI-073

Capsules

Building Healthcare Brands through Recognizable Capsules

PAO-06-18-CL-004

Antiviral

Progress on New Antiviral Drugs at Chimerix

PAO-M06-18-NI-019

Investment

Successful IPO for Verrica Pharmaceuticals

PAO-M06-18-NI-018

CAR-T Therapy

Cellectic CAR-T Therapy Contains Safety Switch and More

PAO-M06-18-NI-017

CRISPR

New Diagnostic Tool for Heart Disease Based on CRISPR Technology

PAO-M06-18-NI-016

Announcement

NuMedii Expands Board of Directors and Scientific Advisory Board with the Addition of Two Oncology Experts

PR-M06-18-NI-071

FDA

FDA Grants QIDP Designation to Acurx's Lead Antibiotic Product Candidate, ACX-362E for Clostridium Difficile Infection

PR-M06-18-NI-068

Clinical Trials

Aminex Therapeutics Initiates First Clinical Trial of Novel Immunotherapy AMXT 1501 + DFMO in Cancer Patients

PR-M06-18-NI-072

Serialization

Vantage Solutions guides Reed-Lane through smooth serialization projects

PR-M06-18-NI-070

Robotics

Pharmaceutical Robots Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018 - 2026

PR-M06-18-NI-069

Product Launch

Distek, Inc. Releases Small Volume Conversion Kit for symphony 7100 Bathless Dissolution Tester

PR-M06-18-NI-067

Regulatory

Reducing Time to Market with Targeted Regulatory Affairs Support

PAO-06-18-CL-003

Research

A Key to the Cage: Opening the Living Membrane Gate

PR-M06-18-NI-066

Preclinical Data

Artemis Therapeutics Announces Two Recent Publications Highlighting Artemisone's Activity Against Human Cytomegalovirus And Malaria

PR-M06-18-NI-063

Clinical Trials

Array BioPharma to Present Overall Survival Results from the Phase 3 LUNGevity Takes Step Forward in Clinical Trial Eligibility Reform for Lung Cancer Patients

PR-M06-18-NI-062

FDA Approval

Grifols Expands its NAT Solutions Portfolio with New FDA Approvals for Two Assays

PR-M06-18-NI-064

Drug Discovery

Could a Bispecific Antibody Be A Functional Cure for AIDS?

PAO-M06-18-NI-015