Regulatory

Almac Group announces further expansion in support of clinical and commercial drug supplies at its European Campus in Dundalk, Ireland following successful HPRA Inspections

January 18, 2018

Craigavon, N.I., 18 January 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organisation, today confirmed the successful completion of Health Products Regulatory Authority (HPRA) inspections of Almac Clinical Services Ireland and Almac Pharma Services Ireland at its European campus in Dundalk, Ireland. Almac previously confirmed that it secured new premises in Dundalk, […]

Pharming Announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks

January 17, 2018

LEIDEN, Netherlands, January 17, 2018 /PRNewswire/ —   Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Pharming’s supplemental Biologics License Application (sBLA) for RUCONEST® [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult […]

Novartis granted US FDA Priority Review for Kymriah™ (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL

January 17, 2018

EAST HANOVER, N.J., Jan. 17, 2018 /PRNewswire/ — Novartis today announced that its supplemental Biologics License Application (sBLA) for Kymriah™ (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) […]

Outpost Medicine Announces Acceptance of Two Investigational New Drug Applications for OP-687 by U.S. FDA

January 17, 2018

INDIANAPOLIS and LONDON, Jan. 17, 2018 /PRNewswire/ — Outpost Medicine, a biopharmaceutical company focused on the development of new treatments of urologic and gastrointestinal disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted two Investigational New Drug (IND) applications for its lead product candidate, OP-687. The FDA Division of Bone, Reproductive […]

Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL

January 17, 2018

Basel, January 17, 2018 – Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted […]

Centrexion Therapeutics Announces Fast Track Designation Granted by FDA to CNTX-4975 for Treatment of Knee Osteoarthritis Pain

January 16, 2018

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975 for the treatment of pain associated with knee osteoarthritis. CNTX-4975, Centrexion’s Phase 3 ready lead therapy, is a synthetic, ultra-pure […]

Midatech and UCSF receive IND approval for DIPG treatment MTX110

January 16, 2018

Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the international specialty pharmaceutical company focused on developing and commercialising products in oncology, today announces approval of the investigational new drug (IND) application from the US Food and Drug Administration (FDA) to conduct a study of MTX110, an investigational nano-inclusion product, for the treatment of the fatal childhood brain […]

Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA

January 16, 2018

Holzkirchen, January 16, 2018 – Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*. “When patients are dealing with a chronic […]

Meditraq launches to simplify serialisation data challenge

January 15, 2018

A new serialisation implementation partner has formed to assist the increasing number of companies needing to meet the data requirements of looming global regulation changes. With the pharmaceutical industry struggling to meet serialisation requirements in over 55 countries, Meditraq supports its customers with the deployment of serialisation software solutions. Part of the Tjoa Group, together […]

Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-121 Acne Treatment In Lotion Form

January 12, 2018

LAVAL, Quebec, Jan. 12, 2018 /PRNewswire/ — Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) (“Valeant”) , today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion (ALTRENO™1) with a PDUFA action date of Aug. 27, 2018. If […]

FDA Grants Fast Track Designation to Concert Pharmaceuticals’ CTP-543 for the Treatment of Alopecia Areata

January 12, 2018

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543, a novel, oral Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair […]

Aradigm Reports Results of FDA Advisory Committee Meeting on Linhaliq

January 12, 2018

HAYWARD, Calif., Jan. 11, 2018 (GLOBE NEWSWIRE) — Aradigm Corporation (NASDAQ:ARDM) (the “Company”) today announces that the Antimicrobial Drugs Advisory Committee (ADAC) of the US Food and Drug Administration (FDA) did not recommend approval for Linhaliq™ as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung Pseudomonas aeruginosa infections. The Advisory Committee voted […]

Helsinn Group and MEI Pharma Announce that Pracinostat has Received Orphan Drug Designation from the European Medicines Agency for the Treatment of Acute Myeloid Leukemia (AML)

January 11, 2018

LUGANO, Switzerland and SAN DIEGO, Jan. 11, 2018 /PRNewswire/ — Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to […]

Morphotek Announces FDA Acceptance Of Investigational New Drug Application For Next-Generation Farletuzumab Antibody-Drug Conjugate MORAb-202

January 10, 2018

EXTON, Pa., Jan. 10, 2018 /PRNewswire/ — Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) Application for MORAb-202, an antibody-drug conjugate (ADC), to treat solid tumors that express folate receptor alpha (FRA). A Phase 1 dose-escalation study will be conducted […]

Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for FT 218 for the Treatment of Narcolepsy

January 10, 2018

DUBLIN, Ireland, Jan. 10, 2018 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (NASDAQ:AVDL), “Avadel” or “the Company,” today announced that FT 218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. FT 218, a once-nightly formulation of sodium oxybate using Avadel’s proprietary Micropump® technology, is currently […]

AbbVie’s Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis

January 9, 2018

NORTH CHICAGO, Ill., Jan. 8, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. […]

MEI Pharma Announces FDA Clearance of Investigational New Drug Application for CDK Inhibitor Voruciclib

January 9, 2018

SAN DIEGO, Jan. 8, 2018 /PRNewswire/ — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for voruciclib, an orally available Cyclin Dependent Kinase 9 (CDK9) inhibitor, […]

GBT Receives FDA Breakthrough Therapy Designation for Voxelotor for Treatment of Sickle Cell Disease (SCD)

January 9, 2018

SOUTH SAN FRANCISCO, Calif., Jan. 09, 2018 (GLOBE NEWSWIRE) — Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to voxelotor (previously called GBT440) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD […]

Eisai and Merck Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib mesylate) and KEYTRUDA® (pembrolizumab) as Combination Therapy for Advanced and/or Metastatic Renal Cell Carcinoma

January 9, 2018

TOKYO and KENILWORTH, N.J., Jan. 9, 2018 /PRNewswire/ — Eisai Co., Ltd. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) in combination with Merck’s anti-PD-1 therapy […]

Midatech receives confirmation that its Q-Octreotide (MTD201) first in-human EU study is approved

January 9, 2018

Midatech (AIM: MTPH, Nasdaq: MTP), the international specialty pharmaceutical company focused on developing and commercialising products in oncology, today announces it has received oral confirmation from Polish regulators that its first in-human study of its sustained release product octreotide MTD201 is approved. Formal written confirmation of the approval is expected within the next two weeks. […]

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