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Collaboration

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

PR-M09-18-NI-071
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
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
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
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
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
Serialization

Transforming with an Equipment Partner: Preparing the Industry for Serialization

PAO-M09-18-CL-001
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
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
Acquisition

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

PR-M09-18-NI-028
Continuous Manufacturing

Kaneka Officially Starts Continuous Manufacturing Under GMP

PR-M09-18-NI-022
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
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
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
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
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
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
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
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
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

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

PR-M08-18-NI-095