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Drug Development

Addressing the Challenges and Opportunities Presented by Advanced Therapies

PAO-M01-19-NI_CL-001

Lyophilization

Flow Sciences, Inc. Partners with Three Companies to Contain Lyophilization Process of New HPAPI

PR-M01-19-NI-052

Robotics

The Global Wearable Robotic Exoskeleton Market is Projected to Reach $5.4 Billion by 2028

PR-M01-19-NI-043

Expression System

Fujifilm Announces the Launch of Its Next Generation Apollo™ X Advanced Mammalian Expression System

PR-M01-19-NI-042

Myopia

SightGlass Vision Multicenter Trial to Study Novel Eyeglasses to Control Nearsightedness for FDA Approval

PR-M01-19-NI-040

Precision Diagnostics

Pillar Biosciences Enters Strategic Partnership with China Biotech Services Holdings to Deliver Precision Diagnostics to Markets in Asia

PR-M01-19-NI-041

Partnership

Abbott and "Malaria No More" Work Together to End Malaria in Odisha, India

PR-M01-19-NI-039

Investment

New Opioid-alternative Raises $3.25 Million for Phase I Trials

PR-M01-19-NI-037

Oncology

The EVA System Colposcope Fulfills Promise of the AVE Algorithm to Change Future of Cervical Cancer Detection

PR-M01-19-NI-038

Announcement

A Path Forward for Increasing Kidney Transplantation

PR-M01-19-NI-036

ALS Research

Collaborative Medicinal Development, LLC Reports that Lead Drug Modifies ALS Progression

PR-M01-19-NI-035

Hematology/Oncology

Blood Cancer Therapeutics: Global Markets to 2023

PR-M01-19-NI-034

Medical Device

Amgen Makes All Repatha® (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price

PR-M01-19-NI-033

RNA Splicing

Biogen and Skyhawk Therapeutics Announce Agreement to Develop Novel Small Molecule RNA Splicing Modifiers for Neurological Disease Targets

PR-M01-19-NI-032

Investment

Sosei Heptares to Receive US$15 Million Milestone Payment From AstraZeneca With First Partnered Program Moving Towards Phase 2

PR-M01-19-NI-030

Immuno-oncology

Regeneron and Sanofi Restructure Immuno-Oncology Collaboration for Discovery and Development Programs

PR-M01-19-NI-031

Leadership

AstraZeneca Announces Organizational Changes

PR-M01-19-NI-029

Approval

Novel Intrasaccular Aneurysm Treatment Device Receives FDA PMA Approval

PR-M01-19-NI-028

Drug Development

Researchers Identify Potential Approach for Treating the Toughest Breast Cancer

PAO-M01-19-NI-013

Immuno-oncology

Sanofi and Regeneron Immuno-oncology Collaboration Ending

PAO-M01-19-NI-012

Investment

Swiss AI Firm Raises Funds for Entry into U.S.

PAO-M01-19-NI-011

R&D

Allergan Establishes R&D Group in Massachusetts

PAO-M01-19-NI-010

Inhalation

FDA Approves First Inhaler with Built-in Sensors

PAO-M01-19-NI-009

Facility

DPS Group Selected to Design Two cGMP Commercial Manufacturing Facilities for Brammer Bio

PR-M01-19-NI-036

Realignment

Theravance Biopharma Announces Alignment of Workforce with Focus on Key Strategic Priorities

PR-M01-19-NI-024

Wearable

CES 2019: Omron Healthcare Launches First Wearable Blood Pressure Monitor, Previews Breakthrough Monitor with EKG and New Digital Health Services

PR-M01-19-NI-027

Immuno-Oncology

PrimeVax Immuno-Oncology Receives IND Permission From FDA

PR-M01-19-NI-026

Digital Health

Statement from FDA Commissioner on the Agency's New Actions under the Pre-Cert Pilot Program to Promote a More Efficient Framework for the Review of Safe and Effective Digital Health Innovations

PR-M01-19-NI-025

Investment

Antengene Benefits from Second-Round Financing

PAO-M01-19-NI-008

Investment

Biotech Company Stealth BioTherapeutics Files for IPO

PAO-M01-19-NI-007

Clinical Trials

Initial Positive Results Lead to Expanded Cancer Trial

PAO-M01-19-NI-006

Cell and Gene Therapy

New Assays for Detecting Genomic Mutations Launched by Contextual Genomics

PAO-M01-19-NI-005

Investment

Vedanta Increases Investment

PAO-M01-19-NI-004

Drug Pricing

Drug Companies Raise Prices to Start New Year

PAO-M01-19-NI-003

FDA Approval

FDA Approves Parkinson’s Drug

PAO-M01-19-NI-002

M&A

Remembering the Details: Partnering with an Equipment Supplier During a Merger or Acquisition

PAO-M01-19-CL-001

Oncology

Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) as First-line Treatment for Patients with Advanced Esophageal Cancer

PR-M01-19-NI-012

Acquisition

Neogen Acquires Canadian Animal Genomics Laboratory

PR-M01-19-NI-011

Financial Results

Johnson & Johnson Announces Quarterly Dividend for First Quarter 2019

PR-M01-19-NI-010

J.P. Morgan Healthcare Conference

Grace Therapeutics to Present at the 37th Annual J.P. Morgan Healthcare Conference

PR-M01-19-NI-009

Immuno-oncology

GE Healthcare, Vanderbilt University Medical Center Partner for Safer, More Precise Immunotherapy Cancer Treatment

PR-M01-19-NI-023

FDA

PolarityTE Registers OsteoTE™ with U.S. Food and Drug Administration

PR-M01-19-NI-016

Press Releases

Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt®

Press Releases

Life Biosciences LLC Leads Strategic Investment of up to A$44.5 million (US$31.4 million) in Prana

Drug Development

InventisBio and Betta Pharma to Co-Develop Novel Drug for Non-Small Cell Lung Cancer

PR-M01-19-NI-013

Appointment

Biotechpharma UAB is Changing its Management Structure and Appoints Giedrius Žunda as Chief Executive Officer

PR-M01-19-NI-022

Acquisition

Rentschler Biopharma Completes Acquisition of U.S. Manufacturing Site

PR-M01-19-NI-021

Announcement

Baltimore Biotech Earns International Recognition for Advanced Development and Manufacturing Facility

PR-M01-19-NI-020

Appointment

Brammer Bolsters Leadership Team and Announces Chief Quality Officer

PR-M01-19-NI-019

CRISPR

Locus Biosciences Enters a Collaboration and License Agreement with Johnson & Johnson Innovation to develop CRISPR-Cas3 Bacteriophage Therapeutics

PR-M01-19-NI-018

Immuno-oncology

Gilead Invests in Immuno-oncology

PAO-M01-19-NI-001

M&A

Bristol-Myers Squibb to Acquire Celgene to Create a Premier Innovative Biopharma Company

PR-M01-19-NI-017

Drug Development

AOBiome Therapeutics Expands Intellectual Property Estate with Issuance of U.S. Patent for Use of Ammonia Oxidizing Bacteria (AOB) for the Treatment of Eczema

PR-M01-19-NI-008

Announcement

Heron Therapeutics to Present at the 37th Annual J.P. Morgan Healthcare Conference

PR-M01-19-NI-006

Investment

China SXT Pharmaceuticals, Inc. Announces First Closing of Initial Public Offering

PR-M01-19-NI-007

Investment

Connect Biopharmaceuticals Completes $55 Million Series B Financing to Accelerate Clinical Development of Novel Immune Modulators

PR-M01-19-NI-005

Leadership

AbbVie Announces Executive Leadership Changes

PR-M01-19-NI-003

Prescribing Information

Bayer Updates Betaseron (interferon beta-1b) Prescribing Information in Accordance with the U.S. Food and Drug Administration's Pregnancy and Lactation Labeling Rule

PR-M01-19-NI-004

Biosimilar

Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration

PR-M01-19-NI-002

Launch

Launch of Generic Lialda® Delayed-Release Tablets Expands Mylan's Gastroenterology Product Offering

PR-M01-19-NI-001

Study Results

Lilly Announces Publication of Analyses Showing Benefit of the Addition of Verzenio®(abemaciclib) in Multiple Subgroups of Patients with Advanced Breast Cancer

PR-M12-18-NI-085

Oncology

Rakuten Aspyrian Enrolling Phase 3 Trial of ASP-1929 for Head and Neck Cancer

PR-M12-18-NI-086

Investment

Biohaven Announces Closing Of $144M Public Offering Of Common Shares, Including Full Exercise Of Underwriters' Option To Purchase Additional Shares

PR-M12-18-NI-084

Market Prediction

Pneumatic Nebulizers Market Will Surge at 5.3% CAGR to Hit $875 Mn by 2024: Global Market Insights, Inc.

PR-M12-18-NI-083

Financing

Entrada Therapeutics Raises $59 Million Series A to Advance Intracellular Biologics Platform

PR-M12-18-NI-081

New Facility

Pall Opens Center of Excellence in Shanghai

PR-M12-18-NI-080

Advisory Board

Kymera Therapeutics Announces Expansion of Scientific Advisory Board to Advance Pre-Clinical Molecules Toward the Clinic

PR-M12-18-NI-079

Acquisition

Bruker Completes the Acquisition of Alicona Imaging GmbH

PR-M12-18-NI-082

Press Releases

Erasca Launches with $42 Million Series A Financing to Support Bold Mission of Erasing Cancer

EMA Approval

Eiger Announces PRIME Designation Granted by European Medicines Agency for Lonafarnib for Treatment of Hepatitis Delta Virus Infection

PR-M12-18-NI-078

Drug Development

Aristea Therapeutics Launches with Phase 2 Drug Candidate and $15M in Series A Funding from Novo Holdings A/S

PR-M12-18-NI-076

Artificial Intelligence

Biocept and Prognos Enter Into Partnership to Apply Artificial Intelligence to Optimize Commercialization of Biomarker-Targeted Therapies in Oncology

PR-M12-18-NI-075

Inflammation

IFM Therapeutics Announces Newly Discovered Mechanism of Inflammatory Processes in the Body

PR-M12-18-NI-072

Appointment

AOBiome Therapeutics Announces Appointment of Dr. Judith Ng Cashin as Chief Medical Officer

PR-M12-18-NI-074

Biomanufacturing Facility

LakePharma Announces its cGMP MicroBiomanufacturing Center is Now Operational

PR-M12-18-NI-073

Alzheimer's Disease

Public Supports NIH Grants for Alzheimer's Microbes, Reports Alzheimer's Germ Quest, Inc.

PR-M12-18-NI-071

FDA

FDA Report on Declining Sales/Distribution of Antimicrobial Drugs for Food Animals, a Reflection of Improved Antimicrobial Stewardship

PR-M12-18-NI-068

Vaccine

Genetic Immunity Grants Exclusive License of Therapeutic HIV Vaccine Technology to JSC Pharmadis for Russia and Commonwealth of Independent States

PR-M12-18-NI-070

Strategic Alliance

Ajinomoto and XL-protein Forge Strategic Alliance to Develop PASylated Therapeutics Applying the Corynex® Platform

PR-M12-18-NI-069

FDA

Statement from FDA Commissioner on New Steps to Promote Innovations in Medical Devices that Help Advance Patient Safety

PR-M12-18-NI-067

Opioid Dependency

Could the Opioid Epidemic Be Relieved by a Vaccine?

PAO-M12-18-NI-019

CRISPR

Gene Amplification Controls Obesity in Mice

PAO-M12-18-NI-018

New Facility

Sanofi to Consolidate Massachusetts Activities

PAO-M12-18-NI-017

Drug Development

AbbVie Exercises Option to License Parkinson’s Tech from BioArctic

PAO-M12-18-NI-015

Dementia

Single Gene Identified as Culprit in Early-Onset Dementia

PAO-M12-18-NI-016

Drug Approval

AstraZeneca and FibroGen Receive First Approval for Anemia Drug in China

PAO-M12-18-NI-014

Marketing

Partnership Initiates Fight to Regulate Lawsuit Ads Targeting “Bad Drugs”

PAO-M12-18-NI-013

Biologics

Rentschler Expands Capabilities in Biologics Contract Manufacturing

PAO-M12-18-NI-012

Quality

Continuous Quality is Essential in Parenteral Manufacturing

PAO-M12-18-CL-003

Biologics Manufacturing

AGC Triples U.S. Biopharmaceutical Production Capacity

PR-M12-18-NI-066

Market Prediction

Emerging Medical Device Market Expected to Exceed $400 Billion by 2023

PR-M12-18-NI-065

Patient Adherence

Sempre Health and UPMC Health Plan Expand Program that Improves Affordability and Adherence for Critical Medications

PR-M12-18-NI-064

Collaboration

Marken and TrakCel Collaborate to Serve Cell and Gene Trials

PR-M12-18-NI-087

Cell and Gene Therapy

DeltaRex-G Generates Significant Interest in a Commentary Published in Molecular Therapy Family of Journals, the Official Organ of the American Society of Gene and Cell Therapy (ASGCT)

PR-M12-18-NI-063

Medical Device

Statement from Jeff Shuren, Director of the CDRH, on Updated Safety Communication About Rates of Duodenoscope Contamination from Preliminary Postmarket Data

PR-M12-18-NI-062

Surgical Robots

The global Surgical Robots Market is Projected to Reach 6.5 billion by 2023 from USD 3.9 billion in 2018 at a CAGR of 10.4%

PR-M12-18-NI-061

Public Offering

Biohaven Announces Proposed Public Offering of Common Shares

PR-M12-18-NI-060

Clinical Trial Patient Populations

Amgen And Lazarex Cancer Foundation Team Up To Allow More Diversity In Clinical Trials

PR-M12-18-NI-059

Cell Expansion

Cell Expansion Market to Reach US $26 Billion by 2024, Says TMR

PR-M12-18-NI-058

Launch

Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

PR-M12-18-NI-057

Investment

GenEdit Closes $8.5 million Series Seed Financing

PR-M12-18-NI-056

Approval

World-first Approval For Multiple Myeloma Drug APLIDIN(R)

PR-M12-18-NI-055

Drug Development

Alligator Bioscience Starts Clinical Phase I Study With ATOR-1015

PR-M12-18-NI-054

Strategic Collaborations

Oxford BioTherapeutics Expands Strategic Collaboration with WuXi Biologics and Licenses WuXiBody™ Platform for Five Bispecific Antibody Programs for up to $450 Million

PR-M12-18-NI-053

Acquisition

Therapix Biosciences Provides Update Regarding FSD Acquisition

PR-M12-18-NI-052

Presentation

Abbott to Present at J.P. Morgan Healthcare Conference

PR-M12-18-NI-051

FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on New Actions Advancing the Agency's Biosimilars Policy Framework

PR-M12-18-NI-049

Appointment

BiomX Appoints Sailaja Puttagunta as Chief Medical Officer

PR-M12-18-NI-048

Companion Diagnostics

Roche to Develop Companion Diagnostic Test to Help Identify Patients Eligible for Anti-PD-1 Therapy Based on Biomarker Expression, Not Location, of Solid Tumors

PR-M12-18-NI-050

Innovation

Brii Biosciences Builds Innovative Pipeline, Forges Public-Private Partnerships to Bring Novel Medicines to Chinese Patients

PR-M12-18-NI-042

FDA

XOSPATA® (gilteritinib) Available at Biologics by McKesson

PR-M12-18-NI-045

Pricing

Tenax Therapeutics Announces Pricing of $10 Million Underwritten Offering

Expansion

NYCEDC Grants $1M To Quentis Therapeutics For Expansion of LifeSci Space in West Harlem

PR-M12-18-NI-043

Appointment

Kaleido Biosciences Announces Appointment of Katharine Knobil, M.D., as Chief Medical Officer and Head of Research & Development

PR-M12-18-NI-041

FDA Approval

FDA Approves Roche's Tecentriq in Combination with Avastin and Chemotherapy for the Initial Treatment of People with a Specific Type of Metastatic Lung Cancer

PR-M12-18-NI-041

Financing

Impel NeuroPharma Closes $67.5 Million Series D Financing

PR-M12-18-NI-040

Immuno-Oncology

Immuno-oncology Development Trends and Opportunities

PR-M12-18-NI-038

Alzheimer's Disease

First Drug Candidate From Eisai-UCL Research Collaboration To Enter Alzheimer's Disease Clinical Trials

PR-M12-18-NI-037

Financial Results

Amgen Announces 10 Percent Increase In 2019 First Quarter Dividend

PR-M12-18-NI-036

Approval

Genentech Receives Additional Approval for Tecentriq

PAO-M12-18-NI-011

Appointment

Roche Exec Moves to Gilead

PAO-M12-18-NI-010

FDA

FDA Issues Draft Guidance for Companion Diagnostics

PAO-M12-18-NI-009

Spin-off Business

Mallinckrodt Spins off its Generics Business

PAO-M12-18-NI-005-11

Growth

WuXi AppTec Plans for Growth

PAO-M12-18-NI-005-10

Expansion

Investor Group Purchases 110-Acre Pharmaceutical Campus in Huntsville, Alabama

PR-M12-18-NI-047

M&A

Histo-Scientific Research Laboratories and Vet Path Services Merge

PR-M12-18-NI-046

Gene and Cell Therapy

PPD Expands GMP Lab Testing Capabilities for Biologics

PR-M12-18-NI-035

FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA's New Effort for Developing and Class Labeling of In Vitro Companion Diagnostics for Classes of Oncology Therapeutic Products

PR-M12-18-NI-034

Stem Cells

USRM announces U.S. Stem Cell Clinic Expansion of Products and Services

PR-M12-18-NI-033

Market Prediction

Worldwide Opportunity Outlook on the Anti-obesity Drugs Market to 2022 - Key Players are Eisai, Novo Nordisk and Vivus - ResearchAndMarkets.com

PR-M12-18-NI-032

FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's New Strategic Framework to Advance Use of Real-World Evidence to Support Development of Drugs and Biologics

PR-M12-18-NI-031

FDA Acceptance

FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis

PR-M12-18-NI-030

FDA Approval

Olympus Spiration® Valve System Is FDA Approved for the Endobronchial Treatment of Emphysema

PR-M12-18-NI-029

Clinical Trial

Prometic to Initiate PBI-4050 Pivotal Phase 3 Clinical Trial in Alström Syndrome

PR-M12-18-NI-028

Appointment

Sartorius Supervisory Board Appoints Two New Executive Board Members

PR-M12-18-NI-027

License Agreement

Ablexis Announces Licensing Agreement with Allogene Therapeutics

PR-M12-18-NI-026

Leukemia

Astellas Presents Updated Results from Phase 1 Study of Gilteritinib Plus Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

PR-M12-18-NI-025

Obesity

The Anti-Obesity Drugs Market Will Register a CAGR of Almost 8% by 2023

PR-M12-18-NI-024

Chronic Migraine

Migraine Drugs Market Size Worth $7.8 Billion by 2025 | CAGR: 18.0%: Grand View Research, Inc.

PR-M12-18-NI-023

Microbiome

ISOThrive Study Reveals Novel Bacterial microFood May Relieve Acid Reflux by Restoring the Distal Esophageal Microbiome

PR-M12-18-NI-021