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Nature Cell and Biostar Stem Cell Research Institute Begin World’s First Stem Cell-Based Regenerative Treatment for Alzheimer’s Disease in Japan

South Korea’s Biostar Stem Cell Research Institute – jointly operated by Nature Cell and Rbio – announced that Trinity Clinic Fukuoka, a partner hospital in Japan, received approval for the application of regenerative medicine in Alzheimer’s disease and officially began stem cell treatment as of April 12.

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Angela Gillespie Named President of W2O wcg

The W2O network announced that Angela Gillespie has been named President of W2O wcg.

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Veritas Capital to Acquire Revenue-Cycle, Ambulatory Care and Workforce Management Software Unit from GE Healthcare for $1 Billion

Veritas Capital, a leading private equity investment firm, and General Electric announced that an affiliate of Veritas entered into a definitive agreement with GE to acquire the Enterprise Financial Management (Revenue-Cycle, Centricity Business), Ambulatory Care Management (Centricity Practice Solution) and Workforce Management (formerly API Healthcare) assets comprising GE Healthcare’s Value-Based Care Division for $1.05 billion in cash.

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FDA Orphan Drug Designation Granted to TTAC-0001

The U.S. Food and Drug Administration granted orphan drug designation to PharmAbcine Inc.’s leading clinical compound TTAC-0001 for the treatment of glioblastoma multiforme.

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FDA Orphan Drug Designation Granted for MaxiNovel Pharmaceuticals’ MAX-40279 for the Treatment of Acute Myeloid Leukemia

  MaxiNovel Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation for MAX-40279 for the Treatment of Acute Myeloid Leukemia (AML)   GUANGZHOU, China–(BUSINESS WIRE)–MaxiNovel Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (“FDA”) has granted MaxiNovel Orphan Drug Designation for MAX-40279 in the treatment of Acute Myeloid Leukemia (AML). AML is the most […]

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FDA grants Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease

Boehringer Ingelheim announced today that the U.S. Food and Drug Administration granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD).

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FDA Accepts for Filing Supplemental Biologics License Application for Xeomin in Adult Patients with Sialorrhea

Merz North America announced today that the U.S. Food and Drug Administration accepted for filing a supplemental Biologics License Application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients.

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W2O Reports 16th Consecutive Year of Double-Digit Annual Revenue Growth in 2017

W2O, an integrated network of complementary analytics-driven firms, reported another year of double-digit revenue growth with a 17.6 percent increase in revenue to $144.3 million in 2017.

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Eisai, Merck Enter Strategic Oncology Collaboration

Eisai and Merck agreed upon a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor.

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FDA Grants Sunovion’s Latuda Expanded Approval

The FDA approved a supplemental NDA that expands the use of Sunovion’s Latuda to include treating major depressive episode associated with bipolar I disorder in pediatric patients.

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Covance, GSK Ink Strategic Technology Agreement

LabCorp, a leading global life sciences company, announced that its Covance Drug Development business entered into a strategic technology agreement with GlaxoSmithKline plc (GSK).

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Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union.

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Lynparza Receives Positive EU CHMP Opinion in Platinum-Sensitive Relapsed Ovarian Cancer

AstraZeneca and Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending a marketing authorization of Lynparza (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

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Data Shows Long-Term Skin Clearance With Tremfya

New data from the VOYAGE 2 club incalculable trial demonstrated high efficacy response rates were achieved with continuous Tremfya (guselkumab) treatment versus withdrawal.

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Otezla Phase III Data Showed Significant Improvements in Patients with Active Behçet’s Disease with Oral Ulcers

Celgene Corporation announced that data from the phase III RELIEF clinical trial of Oteza (apremilast) in patients with active Behçet’s Disease showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily versus placebo through week 12.

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Biosimilar CT-P13 comparable to reference infliximab and adalimumab in highly anticipated real-world study

PANTS study shows that CT-P13 is an efficacious therapy option when investigating personalised approaches to anti-TNF therapy.

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FDA Grants Marketing Authorization to Banyan Biomarkers for the First Diagnostic Blood Test for Traumatic Brain Injury

The FDA granted the De Novo request for the commercialization of Banyan BTITM (Brain Trauma Indicator), an in vitro diagnostic blood test to aid in the evaluation of patients with suspected TBI, also known as concussion.

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Pfizer Receives FDA Breakthrough Therapy Designation for Atopic Dermatitis Drug Compound

Pfizer Inc.’s once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of patients with moderate-to-severe atopic dermatitis.

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EU Approves Celltrion’s Trastuzumab Biosimilar

The EC approved Herzuma for patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have HER2 overexpression or HER2 gene amplification.

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Phase II Data Support Potential for Novel Anti-VEGF/Anti-Angiopoietin-2 Bispecific Antibody, RG7716, for People With Diabetic Macular Edema

Genentech announced encouraging results from the Phase II BOULEVARD study. In people with vision loss from diabetic macular edema, treatment with intravitreal RG7716 resulted in clinically meaningful and statistically significant improvements in visual acuity gains compared with ranibizumab alone.

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