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Latest Biotechnology, Pharmaceutical and Healthcare News from Speciality Pharma Journal

07:45 EST 17th November 2018 | BioPortfolio

Here are the most relevant search results for "Speciality Pharma Journal" found in our extensive news archives from over 250 global news sources.

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In addition to our news stories we have dozens of PubMed Articles about Speciality Pharma Journal for you to read. Along with our medical data and news we also list Speciality Pharma Journal Clinical Trials, which are updated daily. BioPortfolio also has a large database of Speciality Pharma Journal Companies for you to search.

Showing News Articles 1–25 of 556 from Speciality Pharma Journal

Friday 16th November 2018

MorphoSys and I-Mab Sign Strategic Partnering Agreement for MorphoSys’s Novel Immuno-Oncology Agent MOR210

MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab Biopharma (“I-Mab”), a biotech company focusing exclusively on innovative biologics in immuno-oncology and autoimmune diseases, jointly announced today that they have entered into an exclusive strategic collaboration and regional licensing agreement for MOR210. MOR210 is MorphoSys’s propriet...

Agios Presents Updated Data from Phase 1 Study of AG-881 in Patients with IDH Mutant Positive Advanced Glioma

NEW ORLEANS, Nov. 16, 2018 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today presented updated data from the ongoing Phase 1 study evaluating single agent AG-881 in advanced glioma. The data were featured in an oral presentation at the Society …

AstraZeneca Provides Update on the Phase 3 Trial of Imfinzi and tremelimumab in Stage IV Non-Small Cell Lung Cancer

AstraZeneca and MedImmune, its global biologics research and development arm, today announced final overall survival (OS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy and the combination of Imfinzi and tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-...

Immunicum Collaborates with Merck KGaA and Pfizer to Evaluate Ilixadencel in Combination with Avelumab in Multi-Indication Phase Ib/II Study

Immunicum AB (publ; IMMU.ST) announced today that it has entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to evaluate its lead product, ilixadencel, an off-the-shelf cell-based cancer immune primer, in combination with avelumab*, a human anti-PD-L1 monoclonal antibody, in a planned multi-indication Phase Ib/II clinical trial. Immunicum will initiate a study &#...

Thursday 15th November 2018

uniQure Announces Initial Topline Data from Dose-Confirmation Study of AMT-061 in Patients with Hemophilia B

LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Nov. 15, 2018 (GLOBE NEWSWIRE) — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe unmet medical needs, today announced initial clinical data in patients treated in the Company’s Phase IIb dose-confirmation study of AMT-061, an investigational AAV5-based gene therapy c...

FDA Grants Breakthrough Therapy Designation to Seattle Genetics’ Adcetris for Frontline Peripheral T-Cell Lymphomas

BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and ...

Arena Pharmaceuticals and United Therapeutics Announce Global License Agreement for Arena’s Investigational PAH Drug Ralinepag

SAN DIEGO and RESEARCH TRIANGLE PARK, N.C., Nov. 15, 2018 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and United Therapeutics Corporation (Nasdaq: UTHR) today announced that the companies have entered into a global license agreement for Arena’s Phase 3 investigational drug candidate, ralinepag, a next-generation, oral, selective and potent prostacyclin receptor ag...

Blueprint Medicines’ Avapritinib Demonstrates Positive Results in Clinical Trial in Patients with Advanced Gastrointestinal Stromal Tumors

CAMBRIDGE, Mass., Nov. 15, 2018 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, today announced updated data for the registration-enabling NAVIGATOR clinical trial of avapritinib, a potent and highly selective KIT and PDGFRA inhibitor in development for patients ...

Boehringer Ingelheim and Epizyme Partner for Development of Novel Epigenetic Oncology Therapies

CAMBRIDGE, Mass. and INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim and Epizyme, Inc. (Nasdaq: EPZM) today announced a new global collaboration focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer. Specifically, these targets are ...

Lilly Submits New Drug Application for Lasmiditan to the FDA for Acute Treatment of Migraine

INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally a...

Dragonfly and Celgene Expand Collaboration in Immunotherapies for Patients with Solid and Hematological Cancers

WALTHAM, Mass., Nov. 14, 2018 /PRNewswire/ — Dragonfly Therapeutics, Inc. (“Dragonfly” or the “Company”), today announced it entered into a new agreement with Celgene Corporation and its affiliates (“Celgene”) to discover, develop and commercialize innovative immunotherapies for patients with solid and hematological cancers. The new agreement builds upon C...

Merck’s Keytruda Significantly Improved Overall Survival Compared to Chemotherapy in Certain Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Phase 3 KEYNOTE-181 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma has met a primary endpoint of overall survival (OS) in patients...

Wednesday 14th November 2018

AbbVie’s Mavyret Shows High Virologic Cure Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis

NORTH CHICAGO, Ill., Nov. 13, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRET™ (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. Results from the Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET, ...

Ferring Enters Exclusive Agreement with INVO Bioscience to Commercialize the Novel INVOcell System for Use in Treatment of Infertility

PARSIPPANY, N.J.–(BUSINESS WIRE)–Ferring Pharmaceuticals announced today that it has signed an agreement to acquire from INVO Bioscience Inc. (OTCQB:IVOB) the exclusive U.S. commercialization rights for the INVOcell intravaginal culture (IVC) system, which comprises the INVOcell IVC device, retention device, and holding block. The INVOcell IVC device uses a woman’s own body as a nat...

Catabasis andthe University of Texas Southwestern Partner to Explore the Potential Benefits of Edasalonexent on Cardiac Function in Duchenne and Becker Muscular Dystrophies

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced a collaboration with Pradeep Mammen, MD, FACC, FAHA, founder and Medical Director of the Neuromuscular Cardiomyopathy Clinic at the University of Texas Southwestern (UT Southwestern) Medical Center as well as Co-Director of the National Institute ...

FDA Accepts Shire’s Supplemental New Drug Application for Gattex for Children with Short Bowel Syndrome

Cambridge, Mass. – November 13, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) the global leader in rare diseases, announced today the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental new drug application to extend the indication of GATTEX® (teduglutide [rDNA origin]) for Injection to pediatric patients (aged 1-17 years old) with Short Bowel Syndrome …

FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Abraxane for PD-L1-Positive Metastatic TNBC

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) ...

Amgen Presents Results Highlighting the Long-Term Safety and Efficacy of Repatha in the Longest Duration Study of a PCSK9 Inhibitor to Date

THOUSAND OAKS, Calif., Nov. 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the final report of the Open-Label Study of Long-TERm Evaluation Against LDL-C (OSLER-1), demonstrating long-term treatment with Repatha® (evolocumab) was associated with robust and consistent reductions in low-density lipoprotein cholesterol (LDL-C), with no increase in overall rates of adverse ...

Monday 12th November 2018

Ophthotech Announces Results from Phase 2a Safety Trial of Zimura in Combination with Lucentis in Wet Age-Related Macular Degeneration

NEW YORK–(BUSINESS WIRE)–Ophthotech Corporation (NASDAQ:OPHT) today announced the results from its Phase 2a safety trial of Zimura® (avacincaptad pegol), the Company’s complement factor C5 inhibitor, in patients with wet age-related macular degeneration (AMD). This trial was designed to evaluate the safety of different dosage regimens of Zimura combination therapy in wet AMD and w...

FDA Grants Priority Review to Lynparza sNDA as Maintenance Therapy for Newly-Diagnosed, BRCAm Advanced Ovarian Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted priority review for the approval of LYNPARZA (olaparib) (two 150 mg tablets twice daily) as a …

FDA Grants Priority Review to Lymparza sNDA as Maintenance Therapy for Newly-Diagnosed, BRCAm Advanced Ovarian Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted priority review for the approval of LYNPARZA (olaparib) (two 150 mg tablets twice daily) as a …

Friday 9th November 2018

FDA Provides Accelerated Approval to Merck’s Keytruda for Treatment of Patients with Hepatocellular Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval...

FDA Approves Yupelri for Maintenance Treatment of Adult Patients with COPD

DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for YUPELRITM (revefenacin) inhalation solution for the maintenance...

Obsidian Presents Preclinical Data Demonstrating Precise Regulation of Cytokines and CAR in T cells with Destabilizing Domain Technology using FDA-Approved Drugs

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Obsidian Therapeutics, Inc., a biotechnology company developing cell therapies with pharmacologic operating systems, today announced the presentation of preclinical data demonstrating fine-tuned regulation of cytokine production and CAR-T function using Destabilizing Domains (DDs) paired with FDA-approved small molecule drugs. Obsidian will reveal a sui...

SELLAS Life Sciences Announces Additional Data Showing Consistent Clinical Effect Across HLA Allele Subgroups in Triple Negative Breast Cancer Patients Treated with Nelipepimut-S Plus Trastuzumab

NEW YORK, Nov. 09, 2018 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced data from a preplanned secondary efficacy analysis across human leukocyte antigen (HLA) allele subgroups from...


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