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Latest Biotechnology, Pharmaceutical and Healthcare News from Speciality Pharma Journal

11:19 EDT 26th April 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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Showing News Articles 1–25 of 396 from Speciality Pharma Journal

Wednesday 25th April 2018

AbbVie Submits Risankizumab BLA to the FDA for Treatment of Moderate to Severe Plaque Psoriasis

NORTH CHICAGO, Ill., April 25, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe plaque psoriasis. ̶...

ADC Therapeutics Terminates its ADCT-502 Program Targeting HER2 Expressing Solid Tumors

LAUSANNE, Switzerland–(BUSINESS WIRE)–ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, today announced that it has terminated the Phase I clinical trial to evaluate its antibody drug conjugate (ADC) ADCT-502 in patients with advanced solid tumors with H...

FDA Grants Fast Track Status to Synlogic’s Investigational Phenylketonuria Therapy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Synlogic (Nasdaq: SYBX), a clinical-stage company applying synthetic biology to probiotic bacteria to develop novel living medicines, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical product candidate, SYNB1618. SYNB1618 is an oral, investigational medicine designed to metabolize phenylalanine...

Shire Announces Further Revised Proposal from Takeda Regarding the Potential $64 Billion Takeover Bid

The Board of Shire (the “Board”) announced earlier today that it had received a further revised proposal from Takeda Pharmaceutical Company Limited (“Takeda”) regarding a possible offer for the Company. The revised proposal comprises 0.839 new Takeda shares and US$30.33 in cash for each Shire ordinary share (the “Revised Proposal”). Based on Takeda’s share price …

FDA Approves Otsuka’s Jynarque as the First Treatment to Slow Kidney Function Decline in Patients at Risk of Rapidly Progressing ADPKD

TOKYO–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a genetic disease with consequences that can lead to dialysis o...

Ionis’ Investigational Huntington’s Disease Drug Demonstrates Lowering of the Disease-Causing Protein and Improvement in Clinical Measures in Phase 1/2 Study

CARLSBAD, Calif., April 24, 2018 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, today presented top-line data from the Phase 1/2 study of IONIS-HTTRx (RG6042) in people with early stage Huntington’s disease (HD) at the 70th American Academy of Neurology (AAN) meeting in Los Angeles, California. Results from exploratory analyses of ̷...

Nektar and Takeda Collaborate to Evaluate Potential Clinical Benefits of Two Novel and Complementary Immuno-Oncology Mechanisms

SAN FRANCISCO, April 24, 2018 /PRNewswire/ — Nektar Therapeutics (NASDAQ: NKTR) announced today that it has entered into a new clinical collaboration with Takeda Pharmaceutical Company Limited to evaluate Nektar’s investigational medicine, NKTR-214, with Takeda’s investigational medicine, TAK-659, as a potential combination treatment regimen in multiple cancer settings.  NKTR-21...

Third Rock Ventures Launches Cedilla Therapeutics to Target Protein Stability Using Small Molecule Therapeutics

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Cedilla Therapeutics, a new biotechnology company broadening the reach of small molecule therapeutics by discovering and exploiting unique insights into protein stability, launched today with $56.2 million in Series A funding from Third Rock Ventures. Cedilla is leveraging a growing understanding of the principles that dictate protein stability and appl...

FDA Committee Recommends Approval of Baricitinib for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

INDIANAPOLIS, April 23, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patien...

Monday 23rd April 2018

FDA Grants Breakthrough Therapy Designation to Pfizer’s Trumenba for Prevention of Invasive Meningococcal B Disease

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that TRUMENBA® (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years. This is the first Breakthrough Therapy desig...

FDA Grants Fast Track Status to MeiraGTx’s AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency

LONDON & NEW YORK–(BUSINESS WIRE)–MeiraGTx Limited, a vertically integrated, clinical stage gene therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AAV-RPGR for the treatment of X-linked retinitis pigmentosa (XLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene. “XLRP is a devastating ...

Prime Therapeutics Finds Poor Adherence to High-Cost Multiple Sclerosis Therapy

PAUL, Minn., April 23, 2018 /PRNewswire/ — Two new studies by pharmacy benefit manager Prime Therapeutics LLC (Prime), using real-world integrated medical and pharmacy data, show members with multiple sclerosis (MS) had 8.3 times higher annual total health care expense than members without MS. More than 80 percent of the excess cost was due to …

FDA Requests Additional Information for Pfizer’s Application for its Proposed Trastuzumab Biosimilar

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, the FDA highlighted the need for additional technical information. The additional requested informatio...

Ocrevus Significantly Reduces Disease Activity and Disability Progression in Relapsing Multiple Sclerosis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new OCREVUS® (ocrelizumab) data were presented at the 70th American Academy of Neurology (AAN) Annual Meeting from April 21-27 in Los Angeles, California. The data showcase the efficacy of OCREVUS in relapsing multiple sclerosis (RMS) through several ...

Friday 20th April 2018

Biogen Pays $1 Billion to Expand Partnership with Ionis to Develop Drugs for Various Neurological Diseases

CAMBRIDGE, Mass. & CARLSBAD, Calif.–(BUSINESS WIRE)–Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals (Nasdaq: IONS) announced today they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases. This collaboration capitalizes on Biogen’s expertise in neuroscienc...

Argos Discontinues Late-Stage Trial of Investigational Vaccine for Patients with Metastatic Renal Cell Carcinoma

DURHAM, N.C., April 19, 2018 (GLOBE NEWSWIRE) — Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapulde...

Theravance Biopharma’s Trelegy Ellipta Significantly Benefits COPD Patients in Landmark IMPACT Study

DUBLIN, April 19, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today highlighted the publication in the New England Journal of Medicine (NEJM) of the landmark IMPACT study of Trelegy Ellipta in patients with chronic obstructive pulmonary disease (COPD). The IMPACT study is one of the largest trials ever conducted in COPD patients …

Thursday 19th April 2018

GW Pharma Wins Unanimous Recommendation from FDA Committee for Approval of its Cannabis-Based Drug

London, UK, Carlsbad, CA, April 19, 2018 – GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, today announced that the Peripheral and Central Nervous Sy...

Personal Genome Diagnostics’ TMB Analysis Shows Promising Checkpoint Inhibitor Efficacy in Early-Stage Lung Cancer Study

BALTIMORE, April 19, 2018 /PRNewswire/ — Personal Genome Diagnostics Inc. (PGDx) today reported that its whole exome analysis platform contributed to an important new study published in the New England Journal of Medicine (NEJM) showing promising efficacy for a leading checkpoint inhibitor in early stage lung cancer.1 The study also showed that patients who had …

FDA Grants Priority Review to the sBLA for Opdivo in Previously Treated Patients with Small Cell Lung Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application for Opdivo (nivolumab) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. The FDA action date...

FDA Approves AstraZeneca’s Tagrisso as First-Line Therapy for EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. The approval is based on results …

FDA Approves Rigel’s Tavalisse for Chronic Immune Thrombocytopenia in Adult Patients

SOUTH SAN FRANCISCO, Calif., April 17, 2018 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) approved TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. TA...

Wednesday 18th April 2018

FDA Approves Crysvita, The First Therapy for X-Linked Hypophosphatemia, A Rare Inherited Form of Rickets

NOVATO, Calif. and TOKYO and LONDON, April 17, 2018 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, Kyowa Hakko Kirin Co. Ltd(Kyowa Hakko Kirin), and Kyowa Kirin International PLC (Kyowa Kirin International) today announced that the U.S. Food and Drug Administ...

Tuesday 17th April 2018

FDA Grants Breakthrough Therapy Designation to Genentech’s Hemlibra for Patients with Hemophilia A Without Inhibitors

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to HEMLIBRA®(emicizumab-kxwh) for people with hemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the developmen...

Monday 16th April 2018

FDA Approves Opdivo + Yervoy Combination as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell ...


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