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- Read more about CHMP issued negative opinion for Genmab’s Arzerra for treatment of patients with relapsed CLL
Genmab announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the use of Arzerra® (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL). The Marketing Authorization Application (MAA) was submitted by Novartis in July 2015 under the ofatumumab collaboration between Novartis and Genmab.

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- Read more about Supernus receives US patent covering Oxtellar XR
Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company, announced the issuance on June 21, 2016 of a seventh patent (number 9,370,525) by the United States Patent and Trademark Office (USPTO) covering Oxtellar XR, its novel once-daily extended-release oxcarbazepine product. The patent provides protection for the product with expiration that is no earlier than 2027.
- Read more about Angiochem End-of-Phase 2 Meeting with FDA for ANG1005
Angiochem, a biotechnology company developing proprietary peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for ANG1005. As a result, the company is in final preparation stages to commence its Phase 3 trial to support a New Drug Application (NDA) for ANG1005 in patients with leptomeningeal carcinomatosis (LC) from breast cancer.
- Read more about Incyte’s Ruxolitinib in GVHD receive Breakthrough Therapy Designation by FDA
Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD.
- Read more about Collegium launch Xtampza ER capsules in US
Collegium Pharmaceutical, Inc. announced the commercial launch of Xtampza ER (oxycodone) extended-release (ER) capsules in the United States. Xtampza ER was approved by the US Food and Drug Administration (FDA) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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- Read more about FDA Cleared Perrigo’s Non-GMO* Infant Formulas For The U.S. Store Brand Market
Perrigo Company plc announced it has received final U.S. Food and Drug Administration clearance for three milk-based, store brand non-GMO infant formulas. Shipments to retail customers have already commenced.
- Read more about FDA give Orphan Drug Designation to WAVE Life Sciences Receives WVE-120101
WAVE Life Sciences Ltd. announced that its lead candidate WVE-120101, which is being investigated for the treatment of Huntington’s disease (HD), has received Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). WVE-120101 targets rs362307, a Single Nucleotide Polymorphism (SNP) that is associated with the disease-causing mutation in the huntingtin (HTT) gene. WAVE’s approach enables selective silencing of the disease-causing HTT allele, while leaving the healthy HTT allele to produce normally functioning protein.
- Read more about USFDA grant Fast Track Designation to Fate Therapeutic’s ProTmune™
Fate Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ProTmune™ for the reduction of incidence and severity of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). In addition, the Company announced that its multi-center, randomized, controlled Phase 1/2 clinical trial of ProTmune in adult subjects with hematologic malignancies is open for patient enrollment.
- Read more about Poxel’s First Stage of the Ongoing PXL770 Phase 1 Trial show Positive Results
Poxel SA announced positive results from the single ascending dose stage, which is the first stage of the ongoing PXL770 Phase 1 clinical trial. PXL770 is a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, a key enzyme in energy metabolism acting as an energy sensor regulating glucose and lipid levels. AMPK activation is considered to mimic the effects of long-term exercise and plays an important role in diabetes management, especially for patients with cardiovascular risk factors.
- Read more about Hologic's Aptima® Zika Virus Assay receive Emergency Use Authorization by FDA
Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the company's new, diagnostic assay for Zika virus infection. The Aptima® Zika Virus assay is a molecular diagnostic tool for the qualitative detection of RNA from Zika virus in human serum and plasma specimens. The Aptima Zika Virus assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.