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FDA Approval

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

PR-M09-18-NI-072

Collaboration

Tolero Pharmaceuticals Announces Clinical Research Collaboration with AbbVie for Acute Myeloid Leukemia Trial

PR-M09-18-NI-071

FDA Approval

Eisai And Merck Announce FDA Approval Of LENVIMA® (lenvatinib) Capsules For First-line Treatment Of Unresectable Hepatocellular Carcinoma (HCC)

PR-M09-18-NI-070

Acquisition

Ziylo Acquired by Novo Nordisk in Deal That Could Exceed US$800m

PR-M09-18-NI-069

Generics

FDA approves first generic version of EpiPen

PR-M09-18-NI-068

Genetics

New Genetic Understanding Could Lead to Brain Cancer Treatments

PAO-M09-18-NI-017

Drug Development

Patients with Rare Leukemia Disease Will Have New Treatment Option

PAO-M09-18-NI-016

License Agreement

Elysium Health™ Announces Exclusive License for Use of Nicotinamide Riboside for the Slowing of Aging and Prevention of Age-Related Diseases from Mayo Clinic and Harvard

PR-M09-18-NI-067

FDA Approval

U.S. Food and Drug Administration Approves Opdivo®(nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer

PR-M09-18-NI-065

FDA Approval

Veristat Congratulates Agios Pharmaceuticals on the FDA Approval of TIBSOVO®

PR-M09-18-NI-064

Duchenne Muscular Dystrophy

Fight Against Duchenne Muscular Dystrophy Gets Major Funding Boost

PR-M09-18-NI-063

Clinical Trial

Xeris Pharmaceuticals and OHSU Conducting Artificial Pancreas Clinical Trial Using Xeris’ Novel Ready-to-Use Liquid Glucagon

PR-M09-18-NI-066

FDA Approval

Sirnaomics Oncology IND Receives Green Light from US FDA to Initiate Study for Treatment of Cholangiocarcinoma

PR-M09-18-NI-062

Clinical Trial

Trovagene Announces Completion of Second Dosing Cohort of Patients Treated with Onvansertib (PCM-075) in Ongoing Phase 1b/2 AML Trial

PR-M09-18-NI-061

Clinical Results

Biohaven Reports Positive Results From Double-Blind, Placebo-Controlled, Investigator Initiated, Proof Of Concept Trial Of BHV-0223 For Anxiety

PR-M09-18-NI-060

Drug Development

Neurocrine Biosciences to Present Data on INGREZZA® (valbenazine) and Opicapone at the 2018 World Congress on Parkinson's Disease and Related Disorders

PR-M09-18-NI-058

Study Results

Regeneron and Teva Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip

PR-M09-18-NI-059

Acquisition

Allergan Makes Neurotoxin Buy with Acquisition of Bonti Inc.

PAO-M09-18-NI-015

Investment

J&J Anticipates Growth

PAO-M09-18-NI-014

NDA

Ortho Dermatologics Resubmits U.S. New Drug Application For DUOBRII™ (halobetasol propionate and tazarotene) Lotion

PR-M09-18-NI-057

Acquisition

Stratford Pharmaceuticals, LLC Acquired by Eli Global

PR-M09-18-NI-055

Phase II

Peptide Logic Awarded A $ 2.9 Million SBIR Phase II Grant To Develop Peripherally-Restricted And Long-Acting Kappa-Opioid Receptor (LA-KOR) Agonists For Moderate-To-Severe Pain

PR-M09-18-NI-056

Artificial Intelligence

WuXi AppTec Research Service Division and Cyclica Collaborate to Drive Polypharmacology in Drug Discovery Through AI-Augmented Technologies

PR-M09-18-NI-054

FDA Approval

FDA Approves KALYDECO® (ivacaftor) as First and Only Medicine to Treat the Underlying Cause of CF in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene

PR-M09-18-NI-050

CDMO

Preparing for Hurricane Florence in Pharma

PAO-M09-18-NI-013

FDA Approval

Latest Apple Watch Gets FDA Approval as a Class II Device

PAO-M09-18-NI-012

Collaboration

BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza

PR-M09-18-NI-052

FDA Approval

Sun Pharma Announces U.S. FDA Approval of CEQUA™ to Treat Dry Eye Disease

PR-M09-18-NI-053

Study Results

Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip

PR-M09-18-NI-051

Collaboration

RXi Pharmaceuticals and Karolinska Institutet Enter into Collaboration to Develop sd-rxRNA Compounds to Improve Functionality and Persistence of T Cells and NK Cells

PR-M09-18-NI-049

Approval

Trovagene Receives USAN Approval for "Onvansertib" as Nonproprietary Name for First-in-Class, 3rd Generation PLK1 Inhibitor Drug Candidate, PCM-075

PR-M09-18-NI-048

Serialization

Transforming with an Equipment Partner: Preparing the Industry for Serialization

PAO-M09-18-CL-001

Oncology

GeneNews and LifeX™ Partner to Deliver Proprietary "Liquid Biopsy" Molecular Diagnostics to Health Systems to Detect Cancer at Earliest Stages

PR-M09-18-NI-047

CRISPR

MilliporeSigma Awarded Australian CRISPR Nickase Patent for Foundational Genome-Editing Technology

PR-M09-18-NI-046

Clinical Data

Actinium to Provide Update on Pivotal Phase 3 SIERRA Trial Following Positive Data Monitoring Committee Meeting

PR-M09-18-NI-043

Study Results

Janssen Reports Positive Topline Results for ATLAS Phase III Study of a Novel, Long Acting Injectable Two-Drug Regimen for the Treatment of HIV-1

PR-M09-18-NI-045

Drug Discovery

Perlara announces Glycogen Storage Diseases PerlQuest with the University of Notre Dame

PR-M09-18-NI-044

Annoucement

Novartis Unloads Sandoz US Components

PAO-M09-18-NI-011

IPO

Ophthalmic Drug Developer Kodiak BioSciences Files for IPO

PAO-M09-18-NI-010

Oncology

EU Gives Nod to KEYTRUDA and Chemotherapy Combination Treatment

PAO-M09-18-NI-009

Acquisition

Portage to Acquire SalvaRx Limited

PR-M09-18-NI-042

Phase 2

Oragenics, Inc. Resumes Phase 2 Clinical Trial of AG013 in Oral Mucositis Following Positive Routine Safety Review

PR-M09-18-NI-041

Research

Novocure and US Oncology Research Announce Collaboration on PANOVA-3 Trial for Patients with Advanced Pancreatic Cancer

PR-M09-18-NI-040

Collaboration

Leadiant Biosciences to Collaborate with National Institutes of Health on Therapy in Late-Stage Development for GNE Myopathy

PR-M09-18-NI-039

Oncology

CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study

PR-M09-18-NI-038

Breakthrough Therapy

Breakthrough Therapy Designation for New Asthma Drug

PAO-M09-18-NI-008

Drug Development

Sanofi-Aventis Collaborates with Dyadic International on Cl Gene Expression

PAO-M09-18-NI-007

Investment

AxiaMed Announces $12.4 Million Capital Investment Led By Health Enterprise Partners

PR-M09-18-NI-036

Strategic Collaboration

Crescendo Biologics Reaches Technical Milestone for a Second Target in Strategic Collaboration with Takeda

PR-M09-18-NI-035

Clinical Study

Electromed, Inc. Announces Results of an Independent Clinical Study: Bronchiectasis Exacerbations Reduced, Lung Function Stabilized with SmartVest®

PR-M09-18-NI-037

Drug Designation

Martin Pharmaceuticals’ LIVANTRA™ Receives FDA Orphan Drug Designation in Second Indication

PR-M09-18-NI-033

Clinical Data

Aerie Pharmaceuticals Reports Topline Result from Rhopressa® Mechanism of Action Study

PR-M09-18-NI-034

FDA Clearance

Inova Diagnostics Receives FDA Clearance for Test to Detect Antibodies to HMGCR

PR-M09-18-NI-031

Orphan Drug Designation

FDA Grants Orphan Drug Designation to Onspira Therapeutics' Investigational Interleukin-1 Receptor Antagonist for the Treatment of Bronchiolitis Obliterans

PR-M09-18-NI-032

Drug Development

The Buck Institute, Insilico Medicine, and Juvenescence Found Napa Therapeutics to Develop Drugs to Impede Age-Related Disease

PR-M09-18-NI-030

New Drug Application

AVEO Announces Acceptance of CANbridge Investigational New Drug Application for CAN017 (AV-203) Trial in Esophageal Squamous Cell Cancer (ESCC) in China

PR-M09-18-NI-029

Acquisition

Catalent Completes Tender Offer for All Outstanding Shares of Juniper Pharmaceuticals, Inc.

PR-M09-18-NI-028

Clinical Data

ArQule Announces Publication of Preclinical Data for ARQ 531, a Reversible Inhibitor of Both Wild Type and Mutant BTK

PR-M09-18-NI-027

Preclinical Data

Synlogic Publishes Preclinical Data Supporting Development of SYNB1618, a Synthetic Biotic™ Medicine as a Potential Treatment for Phenylketonuria

PR-M09-18-NI-026

Regulatory

MolecuLight® Inc.'s first-of-its-kind handheld fluorescence imaging device receives FDA De Novo clearance for US wound care market

PR-M09-18-NI-025

Continuous Manufacturing

Kaneka Officially Starts Continuous Manufacturing Under GMP

PR-M09-18-NI-022

Clinical Trials

Entasis Therapeutics Announces Positive Topline Results from Phase 2 Trial of ETX2514SUL in Patients with Complicated Urinary Tract Infections including Acute Pyelonephritis

PR-M09-18-NI-024

Injectables

Kaléo Confirms U.S. Availability of AUVI-Q® (epinephrine injection, USP) Auto-injector for Back-to-School Season

PR-M09-18-NI-023

Generics

Mylan Launches First Generic for Adcirca® Tablets

PR-M09-18-NI-021

FDA Approval

Medicure Announces FDA Approval of Acute Care Cardiovascular Drug Sodium Nitroprusside Injection

PR-M09-18-NI-020

Collaboration

Cellect and Cell2in Launch Collaboration to Significantly Improve Stem Cell Selection and Expansion

PR-M09-18-NI-017

Distribution Agreement

Orsini Healthcare Specialty Pharmacy Selected by Alnylam Pharmaceuticals to Distribute ONPATTRO™ (patisiran)

PR-M09-18-NI-019

Oncology

New Analysis Identifies Patient Populations With Cancer-associated VTE Who Could Benefit From Treatment With Oral, Once-daily LIXIANA®▼ (edoxaban)

PR-M09-18-NI-018

Regulatory

Regeneron Provides Regulatory Update on EYLEA® (aflibercept) Injection sBLA in Wet Age-Related Macular Degeneration

PR-M09-18-NI-016

Drug Development

Bayer Gets FDA Approval for Hemophilia A Drug

PAO-M09-18-NI-006

Pediatric

Incorrect Dosing Cup Leads to Recall of Children’s Advil Suspension

PAO-M09-18-NI-005

Drug Development

Funding Raised for Development of Drug to Treat Symptoms of Menopause

PAO-M09-18-NI-004

FDA Approval

Merck’s HIV-1 Drugs Delstrigo and Pifeltro Get FDA Approval

PAO-M09-18-NI-003

Appointment

New Lilly Oncology President Selected

PAO-M09-18-NI-002

Workforce

Grant Will Fund Workforce Development Program for Biopharma Industry

PAO-M09-18-NI-001

Consumer App

FDA Allows Marketing of First Direct-to-Consumer App for Contraceptive Use to Prevent Pregnancy

PR-M09-18-NI-015

Biosimilar

JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Bevacizumab Biosimilar to Treat Lung Cancer

PR-M09-18-NI-013

Clinical Trial

First Patient Dosed in Phase 1/2 Study Evaluating SOBI003 for Treatment of Mucopolysaccharidosis Type IIIA (MPS IIIA)

PR-M09-18-NI-012

FDA Approval

FDA approves new treatment for a rare genetic disorder, Fabry disease

PR-M09-18-NI-014

Acquisition

Nuvo Pharmaceuticals™ Announces Letter of Intent to Acquire Commercial Products and Infrastructure from Aralez Pharmaceuticals

PR-M09-18-NI-011

Acquistion

Olon Acquires Manufacturing Facility in India

PR-M09-18-NI-075

Logistics

LATAM Cargo Opens Pharma Hub in Denmark

PR-M09-18-NI-073

Biotherapeutics

Gyros Protein Technologies Introduces Gyrolab CHO-HCP E3G Kit for Impurity Testing of Biotherapeutics

PR-M09-18-NI-010

Clinical Use

Conavi Medical Announces Clinical Use of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities

PR-M09-18-NI-009

Licensing Agreement

Cancer Prevention Pharmaceuticals Completes North American Licensing Deal with Mallinckrodt

PR-M09-18-NI-008

Phase I

Samsung Bioepis to Initiate Phase 1 Clinical Trial of SB26 Ulinastatin-Fc Fusion Protein

PR-M09-18-NI-007

Clinical Trials

GI Dynamics Announces FDA Approval for EndoBarrier Pivotal Trial

PR-M09-18-NI-006

Neuroprotective Therapies

Accelerator Life Science Partners Launches Magnolia Neurosciences Corporation with $31 Million Series A to Develop Targeted Neuroprotective Therapies

PR-M09-18-NI-004

FDA Approval

FDA Grants Breakthrough Therapy Designation for Xolair(Omalizumab) for Food Allergies

PR-M09-18-NI-005

FDA Approval

TherapeuticsMD Announces FDA Approval of ANNOVERA™ (Segesterone Acetate/Ethinyl Estradiol Vaginal System) for Birth Control

PR-M09-18-NI-002

FDA Approval

Alnylam Announces First-Ever FDA Approval of an RNAi Therapeutic, ONPATTRO™(patisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

PR-M09-18-NI-003

Retinal Cell Replacement Therapy

ProtoKinetix Enters into 3rd Phase of Retinal Cell Replacement Therapy Testing at UBC

PR-M09-18-NI-001

Clinical Trial

Enrollment Passes Halfway Milestone in Clinical Trial Evaluating the Effect of an Exclusive Human Milk Diet

PR-M08-18-NI-122

FDA Approval

US Food and Drug Administration Approves ARAKODA™ (tafenoquine) Tablets for Oral Use; First Preventative Antimalarial Approved in Almost Two Decades

PR-M08-18-NI-121

Treatment

Castle Creek Pharmaceuticals Receives FDA Fast Track Designation for Diacerein 1% Ointment for Treatment of Epidermolysis Bullosa Simplex

PR-M08-18-NI-120

Study Results

VolitionRx Limited Announces Completion of Sample Collection in Endometriosis Study

PR-M08-18-NI-119

Patent Application

Relmada Therapeutics Allowed Patent Application in China Covering NMDA Receptor Antagonist d-Methadone for Treatment of Psychiatric Symptoms

PR-M08-18-NI-118

Clinical Trial

BeiGene Initiates New Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab Combined with Chemotherapy as First-line Treatment for Patients with Advanced Squamous Non-Small Cell Lung Cancer in China

PR-M08-18-NI-115

Acquisition

Emergent BioSolutions to Acquire PaxVax from Cerberus Capital Management

PR-M08-18-NI-114

Growth Strategy

Perrigo Expands OTC Growth Strategy With Rx-To-OTC Switch Licensing For Nasonex®

PR-M08-18-NI-117

Clinical Trial

I-Mab's Announces China Clinical Trial Approval of Long-acting hGLP-1 to Treat Type 2 Diabetes

PR-M08-18-NI-116

Appointment

UPM Pharmaceuticals Appoints Dr. Chi-Chang Wung as Director of Analytical Development

PR-M08-18-NI-125

CRISPR

CRISPR is Helping Dogs with Muscular Dystrophy and Young Boys Could be Next

PAO-M08-18-NI-030

FDA Guidance

FDA Published Draft Guidance on Use of Placebo Control Groups

PAO-M08-18-NI-029

Clinical Data

Novartis Reports Promising Results for its New Alpha Specific PI3K Inhibitor BYL719

PAO-M08-18-NI-028

FDA Approval

AbbVie Receives FDA Approval for IMBRUVICA® Plus Rituximab as a Blood Cancer Treatment

PAO-M08-18-NI-027

Clinical Trial

Sangamo Announces Positive Preliminary Data from the Phase 1/2 Alta Study Evaluating SB-525 Gene Therapy for Hemophilia A

PR-M08-18-NI-113

Small Molecule

SwRI to host 2018 small molecule drug development workshop

PR-M08-18-NI-112

FDA Approval

FDA Approves Treatment for Two Rare Types of Non-Hodgkin Lymphoma

PR-M08-18-NI-111

Vaccines

GSK Ships 2018-19 Seasonal Influenza Vaccines for US Market

PR-M08-18-NI-110

FDA Approval

Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

PR-M08-18-NI-109

Drug Pricing

New Senate Bill Includes Amendment on Drug Pricing in Ads for Prescription Meds

PAO-M08-18-NI-026

Research

Researchers Make Discovery about Leptin Resistance

PAO-M08-18-NI-025

Generics

FDA Approves First Generic Drug Under New Pathway Aimed at Enhancing Market Competition for Sole Source Drugs

PR-M08-18-NI-108

Acquisition

Ligand Makes Offer to Acquire Vernalis, a Leader in Structure-Based Drug Discovery, For Approximately $43 Million in Cash

PR-M08-18-NI-107

Melanoma

Newly Published Independent Study on a Prospective Cohort Highlights DecisionDx-Melanoma Prognostic Test’s Ability to Accurately Identify High-Risk Melanoma Patients

PR-M08-18-NI-106

Agreement

NuCryo Vascular Announces Commercialization Agreement with Lokai Medical for Innovative Treatment for Peripheral Arterial Disease

PR-M08-18-NI-105

Collaboration

Trans-Hit Bio Signs an Exclusive Commercial Agreement with the Biobank of the Maricopa Integrated Health System (MIHS) to Support Industry R&D

PR-M08-18-NI-104

Health App

Garmin® Health and Cardiogram announce integration of Cardiogram Heart Health app and Garmin Wearables

PR-M08-18-NI-103

FDA Approval

Sesen Bio Announces Vicinium Granted Fast Track Designation by FDA for Treatment of Non-Muscle Invasive Bladder Cancer

PR-M08-18-NI-099

Collaboration

OvaScience and Millendo Therapeutics Announce Merger to Create Leading Rare Endocrine Disease Company

PR-M08-18-NI-102

FDA Approval

Ironshore Pharmaceuticals Announces FDA Approval of JORNAY PMTM(Methylphenidate) Extended-Release Capsules CII for the Treatment of ADHD

PR-M08-18-NI-101

Drug Development

Synspira’s PAAG Therapy Demonstrates Persistence Against Pseudomonas aeruginosa Persister Cells

PR-M08-18-NI-100

Drug Design

Cook Medical Introduces a New Length of Zilver® PTX®

PR-M08-18-NI-087

Clinical Trial

Clovis Oncology Announces First Patient Enrolled in the Phase 3 ATHENA Trial

PR-M08-18-NI-085

Drug Discovery

BioAxone BioSciences Receives Notice of Allowance on Patent for Treatment of Cerebral Cavernous Malformations and Cerebral Aneurysms with Rho Kinase Inhibitors

PR-M08-18-NI-089

Regulatory Approval

CERENOVUS Receives European Regulatory Approval For BRAVO Flow Diverter to Treat Intracranial Aneurysms

PR-M08-18-NI-088

Collaboration

Context Therapeutics Signs Strategic Research Collaborations for Apristor® (onapristone extended release) With Key Academic Leaders in the Progesterone Receptor (PR) and Breast Cancer Fields

PR-M08-18-NI-086

Regenerative Medicine Therapies

Affordable Regenerative Stem Cell Therapy is Now Offered Through Zen Care Physical Medicine in Irvine at an Extraordinary Value

PR-M08-18-NI-094

Acquisition

Boston Scientific Announces Agreement to Acquire VENITI, Inc.

PR-M08-18-NI-092

Antibody Treatment

BioArctic Obtains Exclusive Rights to Develop Antibody Treatments for Alzheimer's Disease from a Research Project Jointly Owned with Eisai

PR-M08-18-NI-090

Regulatory

Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX® (daratumumab) Split Dosing Regimen

PR-M08-18-NI-093

Authorization Management

Quadax Introduces Prior Authorization Management Service to Streamline the Authorization Process for Labs

PR-M08-18-NI-091

Generics

First Generic Version of Epipen Receives FDA Approval

PAO-M08-18-NI-024

Drug Approval

Fast Approval for Roche Drug Alecensa in China

PAO-M08-18-NI-023

Influenza

Brexit Issues Could Impact Flu Shot Deliveries to the UK

PAO-M08-18-NI-022

Drug Development

SPR Therapeutics’ Single- and Dual-Lead Peripheral Nerve Stimulation Devices Pass FDA

PAO-M08-18-NI-021

Fill-Finish

Meeting the Changing Demands for Sterile-Fill Finish Operations

PAO-08-18-CL-002

Clinical Trial

Milestone Pharmaceuticals Announces First Patient Randomized in the Phase 3 NODE-301 Clinical Trial Evaluating Etripamil for Termination of Paroxysmal Supraventricular Tachycardia (PSVT) Episodes

PR-M08-18-NI-098

Clinical Trial

First Participant Enrolled in BiondVax's Universal Flu Vaccine Pivotal Phase 3 Clinical Trial

PR-M08-18-NI-095