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Novavax Enters Co-Exclusive Licensing Agreement with Sanofi
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Five Prime Therapeutics Submits IND Application
For Novel B7-H4 Antibody FPA150
01.04.18
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Biocon and Mylan Receive ANVISA Approval
For the first biosimilar Trastuzumab to be approved in Brazil
01.02.18
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Clover Receives CTA Approval For Enbrel Biosimilar
The CFDA's approval is for SCB-808, for the treatment of rheumatoid arthritis
12.29.17
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FDA Grants Progenics' NDA Priority Review
For AZEDRA, a treatment for patients with rare neuroendocrine tumors
12.29.17
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Motif Bio Phase 3 Study Results Published
The REVIVE-1 study results were published in the Clinical Infectious Diseases journal
12.21.17
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Basilea's Ceftobiprole Receives QIDP Designation
The drug aims to treat bacterial bloodstream infections caused by Staphylococcus aureus
12.21.17
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FDA Approves Roche's Perjeta
For the treatment of HER2-positive early breast cancer at high risk of recurrence
12.21.17
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FDA Accepts Allergan and Paratek's Joint NDA
For Seysara (sarecycline) for the treatment of moderate to severe acne
12.21.17
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Valeant Completes Sale of Sprout Pharmaceuticals Subsidiary
The divestiture was to former shareholders
12.21.17
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FDA Grants Priority Review to Janssen Biotech
The NDA is for apalutamide, a treatment for prostate cancer
12.21.17
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Shire Top-Line Results Miss Endpoints
The study evaluated treatment of pediatric patients with Hunter syndrome
12.19.17
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Sandoz Phase I Biosimilar Achieves Positive Results
Proposed biosimilar to Neulasta demonstrates PK, PD, safety and efficacy
12.08.17
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FDA Grants Idera Pharmaceuticals Fast Track Designation
IMO-2125 focuses on the treatment of PD-1 refractory metastatic melanoma
11.30.17
Drug Development
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FDA Grants Dova Pharmaceuticals' NDA Priority Review
Their decision on the NDA is expected by Spring of 2018
11.28.17
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Catalyst Achieves Positive Results from Second Phase 3 Trial
The positive results support the planned NDA submission in the first quarter of 2018
11.27.17
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The European Commission Approves Treatment for Recurrent Ovarian Cancer
ZEJULA is the first PARP inhibitor approved in Europe for women suffering with the specific types of cancer
11.20.17
Industry News
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FDA Awards Fast Track Designation to Intra-Cellular Therapies' Schizophrenia Drug
Lumateperone has potential to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases
11.20.17
Industry News
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Jazz Pharmaceuticals’ Vyxeos Granted Accelerated Assessment
Phase III results demonstrate a statistically significant improvement in overall survival for versus standard of care
11.06.17
Trials & Filings
EU Approves Merck KGaA and Pfizer's BAVENCIO
Monotherapy to treat metastatic Merkel cell carcinoma, a rare and aggressive skin cancer
09.21.17
Drug Development
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FDA Approves First CAR-T Immunotherapy
Uses Thermo Fisher’s CTS Dynabeads Technology
08.31.17
Breaking News
Novavax Enters Co-Exclusive Licensing Agreement with Sanofi
MAbxience Names New Chief Executive Officer
Ribobay Pharma Integrates Cytvia’s FlexFactory Platform for Oligonucleotides
WestGene’s mRNA Therapeutic Cancer Vaccine Approved by FDA
5 Prime Sciences, Lilly Partner to Advance Cardio-Metabolic Disease Drug Development
View Breaking News >
CURRENT ISSUE
April 2024
Anti-Counterfeiting Technology
Navigating Global CDMO Trends
Weight-loss Drug Packaging
Clinical Supply CDMOs
Industry Experts Weigh in on Oral Solid Dosage
Newsmakers Q&A: Almac Group
Economical Mobile Workstations for Lower-Grade Cleanrooms
Pharmaceutical Manufacturing Equipment & Trends
Insight Into Obesity-Related Clinical Research
Inflation Reduction Act and the Impact on Biosimilars
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