Company (location) |
Product |
Description |
Indication |
Status |
Date |
Autoimmune | |||||
Biogen Inc. (Cambridge, Mass.) |
Imraldi |
Adalimumab biosimilar referencing Humira; anti-tumor necrosis factor |
Rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis |
Was granted a positive opinion by EMA's CHMP |
6/26/17 |
Fibrocell Science Inc. (Exton, Pa.) |
FCX-013 |
Gene therapy |
Moderate to severe localized scleroderma |
The FDA has granted rare pediatric disease designation |
6/13/17 |
Ipsen SA (Paris) |
Dysport |
AbobotulinumtoxinA for injection |
Spasticity |
The FDA expanded the approved use, based on its supplemental BLA in lower limb spasticity |
6/19/17 |
Merck KGaA (Darmstadt, Germany) |
Mavenclad |
Cladribine tablets |
Relapsing forms of multiple sclerosis |
Received a positive opinion from the EMA's the Committee for Medicinal Products for Human Use |
6/26/17 |
Omeros Corp. (Seattle) |
OMS-721 |
Human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 |
Immunoglobulin A nephropathy |
The FDA granted breakthrough therapy designation |
6/14/17 |
Sandoz (Holzkirchen, Germany; division of Novartis AG) |
Adalimumab |
Biosimilar Humira (Abbvie Inc.) |
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, etc. |
The EMA has accepted for regulatory review the marketing authorization application |
6/1/17 |
Sandoz (Holzkirchen, Germany; division of Novartis AG) |
Infliximab |
Biosimilar Remicade (Johnson & Johnson) |
Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis |
The EMA has accepted for regulatory review the marketing authorization application |
6/1/17 |
Sandoz (Holzkirchen, Germany; generics division of Novartis AG) |
Erelzi |
Biosimilar etanercept |
Rheumatoid arthritis, psoriasis and psoriatic arthritis |
The European Commission approved it for use in Europe |
6/28/17 |
Sanofi SA (Paris) and Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Kevzara |
Sarilumab; interleukin-6 receptor inhibitor |
Moderately to severely active rheumatoid arthritis |
Won European Commission marketing authorization for Kevzara in combination with methotrexate in adult patients who have responded inadequately to, or who are intolerant to, one or more disease modifying antirheumatic drugs |
6/28/17 |
Cancer | |||||
ADC Therapeutics SA (Lausanne, Switzerland) |
ADCT-402 |
Antibody-drug conjugate targeting CD19 |
Diffuse large B-cell lymphoma and mantle cell lymphoma |
The FDA granted orphan status |
6/12/17 |
Amgen Inc. (Thousand Oaks, Calif.) |
Xgeva |
Denosumab; monoclonal antibody that binds to and neutralizes RANK ligand |
Multiple myeloma |
The FDA has accepted its Xgeva supplemental biologics license application that seeks to expand the currently approved indication |
6/20/17 |
Amgen Inc. (Thousand Oaks, Calif.) and Allergan plc (Dublin) |
ABP-215 |
Biosimilar Avastin (bevacizumab, Genentech Inc./Roche Holding AG) |
Various cancers |
Confirmed that the FDA's Oncologic Drugs Advisory Committee will review data supporting the biologics license application at a meeting on July 13 |
6/8/17 |
Astrazeneca plc (London) |
Faslodex |
Fulvestrant |
Hormone receptor-positive, locally advanced or metastatic breast cancer |
The EMA's CHMP has adopted a positive opinion, recommending the marketing authorization of Faslodex in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on anti-estrogen therapy |
6/26/17 |
Aveo Oncology Inc. (Cambridge, Mass.) |
Fotivda |
Tivozanib |
Advanced renal cell carcinoma |
Received a positive opinion from the EMA's Committee for Medicinal Products for Human Use |
6/26/17 |
Breckenridge Pharmaceutical Inc. (Boca Raton, Fla.) |
Azacitidine for injection, 100 mg per vial |
Generic Vidaza (Celgene Corp.); chemotherapy |
Myelodysplastic syndrome |
The FDA granted final approval |
6/27/17 |
Bristol-Myers Squibb Co. (Princeton, N.J.) |
Opdivo |
Nivolumab |
Locally advanced unresectable or metastatic urothelial carcinoma |
The European Commission has approved Opdivo for adults after failure of prior platinum-containing therapy |
6/6/17 |
Calithera Biosciences Inc. (South San Francisco) |
CB-839 |
Oral inhibitor of glutaminase |
Metastatic renal cell carcinoma |
The FDA granted fast track status for CB-839 in combination with Afinitor (everolimus, Novartis AG) for the treatment of patients who have received two or more prior lines of therapy |
6/8/17 |
Cascadian Therapeutics Inc. (Seattle) |
Tucatinib |
Small-molecule kinase inhibitor that is highly selective for HER2 |
Breast cancer patients with brain metastases |
Was granted orphan drug designation by the FDA |
6/9/17 |
Celltrion Inc. (Incheon, South Korea) and Teva Pharmaceutical Industries Ltd. (Jerusalem) |
CT-P10 |
Biosimilar to Rituxan (rituximab, Roche Holding AG/Biogen Inc.) |
Non-Hodgkin lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis |
The FDA accepted the biologics license application |
6/30/17 |
Coherus Biosciences Inc. (Redwood City, Calif.) |
CHS-1701 |
Biosimilar Neulasta (pegfilgrastim) |
To reduce the chance of infection due to a low white blood cell count in cancer patients |
Received a complete response letter from the FDA requesting a reanalysis of a subset of subject samples using a revised immunogenicity assay that offered greater sensitivity |
6/13/17 |
Eisai Co. Ltd. (Tokyo) |
Lenvima |
Lenvatinib mesylate; multiple-receptor tyrosine kinase inhibitor |
Hepatocellular carcinoma |
Submitted an application for an additional indication in Japan |
6/26/17 |
Epizyme Inc. (Cambridge, Mass.) |
Tazemetostat |
EZH2 inhibitor |
Soft tissue sarcoma |
The FDA granted orphan drug designation |
6/22/17 |
Genentech (unit of Roche Holding AG; Basel, Switzerland) |
Rituxan Hycela |
Rituximab and hyaluronidase human |
Relapsed or refractory follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia |
Received FDA approval for subcutaneous injection for the treatment of adults |
6/23/17 |
Genmab A/S (Copenhagen) |
Darzalex |
Daratumumab; CD38-targeting monoclonal antibody |
Multiple myeloma |
The FDA approved it in combination with Pomalyst (pomalidomide, Celgene Corp.) and dexamethasone for treating patients who have received at least two prior therapies, including Revlimid (lenalidomide, Celgene Corp.) and a proteasome inhibitor |
6/19/17 |
Hutchison China Meditech Ltd. (London) |
Fruquintinib |
Small molecule shown to inhibit vascular endothelial growth factor receptor |
Advanced colorectal cancer |
The CFDA has acknowledged acceptance of the NDA |
6/13/17 |
Idera Pharmaceuticals Inc. (Cambridge, Mass.) |
IMO-2125 |
Agonist of endosomal Toll-like receptor 9 |
Melanoma stages IIb to IV |
The FDA granted orphan drug designation |
6/26/17 |
Intezyne Technologies Inc. (Tampa, Fla.) |
IT-139 |
GRP78 inhibitor |
Pancreatic cancer |
The FDA granted orphan drug designation |
6/21/17 |
Jazz Pharmaceuticals plc (Dublin) |
Vyxeos liposome injection |
Cytarabine and daunorubicin |
Acute myeloid leukemia |
The FDA accepted for filing with priority review its new drug application |
6/2/17 |
Mateon Therapeutics Inc. (South San Francisco) |
OXi-4503 |
Combretastatin A1-diphosphate; dual-mechanism vascular disrupting agent |
Acute myeloid leukemia |
The FDA granted fast track designation |
6/8/17 |
Novartis AG (Basel, Switzerland) |
Tasigna |
Nilotinib |
Philadelphia chromosome-positive (Ph+ CML-CP) chronic myeloid leukemia |
Gained European Commission approval to include in a summary of product characteristics for Tasigna data showing that the drug has the ability to maintain molecular response after stopping tyrosine kinase inhibitor therapy in Ph+ CML-CP chronic myeloid leukemia patients in chronic phase |
6/7/17 |
Novartis AG (Basel, Switzerland) |
Tafinlar |
Dabrafenib |
Metastatic non-small-cell lung cancer (NSCLC) |
The FDA approved Tafinlar in combination with Mekinist (trametinib) to treat patients with NSCLC whose tumors express the BRAF V600E mutation |
6/26/17 |
Novartis Pharmaceuticals Canada Inc. (Dorval, Quebec; affiliate of Novartis AG) |
Tafinlar + Mekinist combination |
Dabrafenib and trametinib |
Non-small-cell lung cancer |
The combination was approved by Health Canada to treat patients with BRAF V600 mutations whose disease has progressed following systemic therapy |
6/16/17 |
Oncosec Medical Inc. (San Diego) |
pIL-12 |
Tavokinogene telsaplasmid |
Unresectable metastatic melanoma |
Won FDA orphan drug status |
6/12/17 |
Oxonc Development LP (Cayman Islands) |
Xalkori |
Crizotinib 200 mg/250 mg capsules |
ROS1-positive advanced non-small-cell lung cancer |
Said Pfizer Inc., of New York, received regulatory approval in Japan and Taiwan |
6/5/17 |
Pfizer Canada Inc. (Kirkland, Quebec; Canadian operation of Pfizer Inc.) |
Ibrance |
Palbociclib |
Hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer |
Health Canada expanded the indication to include its use in combination with fulvestrant for the treatment of women whose disease progressed after prior endocrine therapy |
6/22/17 |
Pfizer Inc. (New York) |
Sutent |
Sunitinib |
Recurrent renal cell carcinoma |
A supplemental new drug application has been accepted for filing by the FDA to expand the use of Sutent to include it as an adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma following nephrectomy |
6/1/17 |
Roche Holding AG (Basel, Switzerland) |
Ventana ALK (D5F3) CDx Assay |
Companion diagnostic |
To identify ALK-positive non-small-cell lung cancer patients eligible for treatment with Zykadia (ceritinib, Novartis AG) |
The FDA approved it |
6/2/17 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin |
Cutaneous T-cell lymphoma |
Submitted a supplemental BLA to the FDA |
6/21/17 |
Thermo Fisher Scientific Inc. (Carlsbad, Calif.) |
Oncomine Dx Target Test |
Test to screen tumor samples for biomarkers associated with cancer therapies |
Non-small-cell lung cancer |
The FDA approved it |
6/27/17 |
TP Therapeutics Inc. (San Diego) |
TPX-0005 |
Kinase inhibitor against wildtype and mutated ALK, ROS1 and TRK family kinases |
Non-small-cell lung adenocarcinomas harboring ALK, ROS1 or NTRK oncogenic rearrangements |
Gained FDA orphan drug status |
6/28/17 |
Wilson Therapeutics AB (Stockholm, Sweden) |
WTX-101 |
Bis-choline tetrathiomolybdate |
Amyotrophic lateral sclerosis |
The FDA has granted orphan status |
6/12/17 |
Y-Mabs Therapeutics Inc. (New York) |
Burtomab (previously 8H9) |
CD276 antigen inhibitor |
Relapsed or refractory neuroblastoma |
Was granted breakthrough therapy designation by the FDA to treat pediatric patients with central nervous system or leptomeningeal metastasis |
6/9/17 |
Sandoz International GmbH (Holzkirchen, Germany; unit of Novartis AG) |
Rixathon |
Biosimilar rituximab |
Chronic lymphocytic leukemia, rheumatoid arthritis, non-Hodgkin lymphoma |
The European Commission approved it |
6/20/17 |
Cardiovascular | |||||
Amgen Inc. (Thousand Oaks, Calif.) |
Repatha |
Evolocumab; PCSK9 inhibitor |
Major cardiovascular events |
Submitted a supplemental biologics license application to the FDA and a variation to the marketing authorization to the EMA |
6/6/17 |
Anchen Pharmaceuticals Inc. (Irvine, Calif.) |
Generic Tekturna |
Aliskiren hemifumarate tablets, 150 mg and 300 mg |
High blood pressure |
Submitted an abbreviated new drug application to the FDA seeking authorization to manufacture and market a generic version of Tekturna (Noden Pharma DAC; subsidiary of PDL Biopharma Inc.) |
6/6/17 |
Athera Biotechnologies AB (Stockholm) |
PC-MAb |
Fully human antibody targeting phosphorylcholine |
End-stage renal disease |
The FDA granted orphan drug designation to treat patients who are preparing for or undergo hemodialysis |
6/22/17 |
Catalyst Biosciences Inc. (South San Francisco) |
CB 2679d/ISU304 |
Next-generation coagulation factor IX variant |
Hemophilia B |
The EMA's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan medicinal product designation |
6/1/17 |
Catalyst Biosciences Inc. (South San Francisco) |
CB-2679d/SU304 |
Coagulation factor IX variant |
Hemophilia B |
The European Commission granted orphan designation |
6/29/17 |
CSL Behring (King of Prussia, Pa.) |
Haegarda |
C1 esterase inhibitor subcutaneous (human) |
To prevent hereditary angioedema attacks |
The FDA approved it |
6/26/17 |
Edge Therapeutics Inc. (Berkeley Heights, N.J.) |
EG-1962 |
Uses the Precisa development platform |
Aneurismal subarachnoid hemorrhage |
Received product-specific pediatric waiver from the EMA, which applies to all subsets of the pediatric population and will allow the firm to submit a marketing authorization application without the requirement to conduct pediatric clinical studies |
6/9/17 |
Esperion Therapeutics Inc. (Ann Arbor, Mich.) |
Bempedoic acid 180 mg and ezetimibe 10 mg |
Combination pill |
High cholesterol |
The FDA confirmed the regulatory pathway to approval, and Esperion plans to initiate a pivotal phase III bridging study |
6/27/17 |
Global Blood Therapeutics Inc. (South San Francisco) |
GBT-440 |
Oral, once-daily therapy that works by increasing hemoglobin's affinity for oxygen |
Sickle cell disease |
The EMA determined that it is eligible for its Priority Medicines, or PRIME, program |
6/29/17 |
Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson) |
Xarelto |
Rivaroxaban |
Venous thromboembolism (VTE) |
The FDA accepted for priority review a supplemental NDA for Xarelto to include a 10-mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy |
6/29/17 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Rebinyn |
Nonacog beta pegol; extended half-life factor IX molecule |
Hemophilia B |
The FDA approved the BLA |
6/1/17 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Refixia |
Nonacog beta pegol: N9-GP |
Hemophilia B |
The European Commission granted marketing authorization for Refixia for the treatment of adolescents and adults |
6/7/17 |
Pfizer Inc. (New York) |
Vyndaqel |
Tafamidis |
Transthyretin cardiomyopathy |
The FDA granted fast track status |
6/7/17 |
Pfizer Inc. (New York) |
Epoetin alfa |
Biosimilar Epogen (Amgen Inc.) |
Anemia |
Received a second complete response letter (CRL) from the FDA, which referenced a February warning letter resulting from last year's routine FDA inspection of Pfizer's facility in McPherson, Kan., which was listed as the potential manufacturing site; the issues raised in the warning letter dealt with inadequate investigations and corrective actions for complaints about pieces of cardboard in vials of various injectable drugs that were supposed to be sterile |
6/28/17 |
Portola Pharmaceuticals Inc. (South San Francisco) |
Bevyxxa |
Betrixaban; factor Xa inhibitor |
Prevention of venous thromboembolism |
Won FDA approval |
6/26/17 |
Rigel Pharmaceuticals Inc. (South San Francisco) |
Tavalisse |
Fostamatinib disodium |
Chronic or persistent immune thrombocytopenia |
The FDA filed its NDA |
6/20/17 |
Sangamo Therapeutics Inc. (Richmond, Calif.) and Pfizer Inc. (New York) |
SB-525 |
cDNA gene therapy |
Hemophilia |
The EMA granted orphan designation |
6/8/17 |
Shire plc (Dublin) |
Veyvondi |
Von Willebrand factor (recombinant) |
Bleeding in von Willebrand disease |
The EMA validated its MAA to prevent and treat bleeding episodes and perioperative bleeding in adults (ages 18 and older) diagnosed with von Willebrand disease |
6/23/17 |
Swedish Orphan Biovitrum AB (Stockholm) |
Alprolix |
Eftrenonacog alfa |
Bleeding in patients with hemophilia B |
Received EMA approval to update the dosing information to include information indicating that patients on long-term prophylaxis to protect against bleeding and who are well-controlled on a 100 IU/kg once every 10 days regimen might be treated on an interval of 14 days or longer |
6/28/17 |
Central nervous system | |||||
Abeona Therapeutics Inc. (New York) |
ABO-201 (AAV-CLN3) |
AAV-based single intravenous gene therapy program |
Juvenile Batten disease |
The FDA granted orphan designation |
6/30/17 |
Alkermes plc (Dublin) |
Aristada extended-release injectable suspension |
Aripiprazole lauroxil |
Schizophrenia |
The FDA has approved two-month Aristada |
6/7/17 |
Axovant Sciences GmbH (Basel, Switzerland) |
Nelotanserin |
Selective inverse agonist of the 5HT2A receptor |
Visual hallucinations disorder in dementia with Lewy bodies |
The FDA designated it a fast track drug |
6/20/17 |
Biodelivery Sciences International Inc. (Raleigh, N.C.) |
Belbuca |
Buprenorphine hydrochloride buccal film |
Severe pain |
Health Canada issued a notice of compliance approving Belbuca for the management of pain severe enough to require daily, continuous, long-term treatment and is opioid responsive and for which alternative options are inadequate |
6/26/17 |
Braeburn Pharmaceuticals Inc. (Princeton, N.J.) and Knight Therapeutics Inc. (Montreal) |
Probuphine |
Buprenorphine subdermal implant |
Opioid drug dependence |
The new drug submission has been accepted for review by Health Canada |
6/14/17 |
Egalet Corp. (Wayne, Pa.) |
Oxaydo |
Immediate-release oral formulation of oxycodone HCl |
Acute and chronic, moderate to severe pain |
Received an FDA complete response letter regarding the prior approval supplement; the agency wants more information regarding the effect of food on 15 mg and the intranasal abuse-deterrent properties of the 10-mg and 15-mg dosages |
6/21/17 |
Endo International plc (Dublin) |
Opana ER |
Oxymorphone hydrochloride extended release |
Pain severe enough to require daily, around-the-clock, long-term opioid treatment |
The FDA requested it voluntarily remove it from the market, following a meeting to review pre- and post-marketing data about the abuse of Opana ER, the product's overall risk-benefit profile and the abuse of generic oxymorphone ER and oxymorphone immediate-release products |
6/12/17 |
H. Lundbeck A/S (Valby, Denmark) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Trintellix |
Vortioxetine |
Cognitive dysfunction in major depressive disorder |
The FDA issued a complete response letter (CRL) regarding the supplemental NDA to include new data in the clinical trials section of the U.S. prescribing information |
6/26/17 |
Lannett Co. Inc. (Philadelphia) |
Generic hydrocodone bitartrate and acetaminophen tablets |
Therapeutic equivalent of Norco (Allergan plc) |
Pain |
Received FDA approval at three different doses |
6/27/17 |
Neos Therapeutics Inc. (Dallas) |
Cotempla XR-ODT |
Methylphenidate |
Attention-deficit hyperactivity disorder |
The FDA approved it for the treatment of in patients 6 to 17 years old |
6/21/17 |
Novartis AG (Basel, Switzerland) |
AMG 334 |
Erenumab; anti-CGRP monoclonal antibody |
Prevention of migraines |
The EMA accepted its MAA |
6/22/17 |
Pfizer Inc. (New York) and Eli Lilly and Co. (Indianapolis) |
Tanezumab |
Humanized monoclonal antibody that selectively targets, binds to and inhibits nerve growth factor |
Chronic pain in patients with osteoarthritis and chronic low back pain |
Gained FDA fast track status |
6/14/17 |
Profounda Inc. (Orlando, Fla.) |
Miltefosine |
Alkyl-lysophospholipid analogue |
Granulomatous amebic encephalitis |
The FDA granted orphan designation |
6/29/17 |
Resq Pharma Inc. (Chicago) |
Lipidrescue therapy |
Lipid emulsion |
Local anesthetic systemic toxicity |
The FDA granted orphan drug designation |
6/19/17 |
Shire plc (Dublin) |
Mydayis |
Mixed salts of a single-entity amphetamine product |
Attention deficit hyperactivity disorder |
Gained FDA approval |
6/22/17 |
Zogenix Inc. (Emeryville, Calif.) |
ZX-008 |
Low-dose fenfluramine |
Lennox Gastaut syndrome |
The FDA granted orphan drug designation |
6/23/17 |
Diabetes | |||||
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Victoza |
Liraglutide |
Cardiovascular risk in patients with type 2 diabetes |
Received a positive 17-2 vote from an FDA advisory committee that there's substantial evidence it reduces cardiovascular risk in patients with type 2 diabetes |
6/22/17 |
Gastrointestinal | |||||
Synergy Pharmaceuticals Inc. (New York) |
Trulance |
Plecanatide |
Irritable bowel syndrome with constipation |
The FDA accepted for filing its supplemental NDA |
6/8/17 |
Takeda Pharma AG (Pfaffikon, Switzerland; subsidiary of Takeda Pharmaceutical Co. Ltd.) and Tigenix NV (Leuven, Belgium) |
Cx-601 |
Suspension of allogeneic expanded adipose-derived stem cells |
Complex perianal fistulas in patients with Crohn's disease |
The Swiss Agency for Therapeutic Products accepted the marketing application |
6/21/17 |
Infection | |||||
Abbvie Inc. (North Chicago) |
Maviret |
Glecaprevir/pibrentasvir |
Chronic hepatitis C virus infection |
The EMA's CHMP issued a positive opinion recommending marketing authorization |
6/26/17 |
Biocryst Pharmaceuticals Inc. (Research Triangle Park, N.C.) |
Rapivab |
Peramivir injection; intravenous viral neuraminidase inhibitor |
Acute uncomplicated influenza |
The FDA has accepted for review the supplemental new drug application for a pediatric indication; the application has been classified as a priority review and has a PDUFA goal date of the end of September |
6/6/17 |
Gilead Sciences Canada Inc. (Mississauga, Ontario; part of Gilead Sciences Inc.) |
Vemlidy |
Tenofovir alafenamide (TAF) 25 mg tablets |
Chronic hepatitis B virus infection with compensated liver disease |
Health Canada has granted a notice of compliance for Vemlidy |
6/20/17 |
Gilead Sciences Inc. (Foster City, Calif.) |
Single tablet regimen containing bictegravir (50 mg) and emtricitabine/tenofovir alafenamide (200/25 mg) |
Integrase strand transfer inhibitor and FTC/TAF |
HIV-1 infection |
Submitted a NDA to the FDA |
6/13/17 |
Gilead Sciences Inc. (Foster City, Calif.) |
Vosevi |
Single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg |
Chronic hepatitis C virus |
The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the marketing authorization application |
6/26/17 |
Janssen Sciences Ireland UC (Cork, Ireland; a Janssen Pharmaceutical company of Johnson & Johnson) |
Tivicay and Edurant regimen |
Dolutegravir and rilpivirine |
HIV-1 infection |
Said that Viiv Healthcare Ltd., of London, has made regulatory submissions to the EMA and FDA for the single-tablet, two-drug regimen |
6/5/17 |
Melinta Therapeutics Inc. (New Haven, Conn.) |
Baxdela |
Delafloxacin |
Acute bacterial skin and skin structure infection caused by susceptible bacteria |
The FDA approved it |
6/20/17 |
Teva Pharmaceutical Industries Ltd. |
Generic Truvada (Gilead Sciences Inc.) |
Emtricitabine/tenofovir disoproxil fumarate |
HIV-1 |
FDA approved it in combination with other antiretroviral agents, and for pre-exposure prophylaxis |
6/12/17 |
Inflammatory | |||||
Icon Bioscience Inc. (Newark, Calif.) |
Dexycu |
Sustained-release, biodegradable formulation of the anti-inflammatory agent dexamethasone designed using Icon's Verisome technology |
Inflammation associated with cataract surgery |
The FDA accepted its NDA |
6/27/17 |
Miscellaneous | |||||
Agile Therapeutics Inc. (Princeton, N.J.) |
Twirla |
Low-dose combined hormonal contraceptive patch |
Birth control |
Resubmitted the NDA to the FDA, in response to a February 2013 complete response letter from the agency, which recommended that Agile conduct a new clinical trial and provide additional information on the manufacturing process |
6/28/17 |
Alexion Pharmaceuticals Inc. (New Haven, Conn.) |
Soliris |
Eculizumab |
Refractory generalized myasthenia gravis |
Won a positive opinion from the EMA's CHMP supporting its application to extend the current therapeutic indication for Soliris to include the treatment in patients who are anti-acetylcholine receptor antibody-positive |
6/26/17 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
Givosiran (ALN-AS1) |
RNAi therapy targeting aminolevulinic acid synthase 1 |
Prophylaxis of attacks in patients with acute hepatic porphyria |
Won FDA breakthrough status |
6/1/17 |
Amag Pharmaceuticals Inc. (Waltham, Mass.) |
Makena subcutaneous auto-injector |
Drug-device combination product |
To reduce the risk of preterm birth |
The FDA accepted the supplemental new drug application |
6/27/17 |
Amgen Inc. (Thousand Oaks, Calif.) |
Mimpara |
Cinacalcet |
Secondary hyperparathyroidism (HPT) |
The EMA adopted a positive opinion for the marketing authorization for HPT in children 3 years and older who have end-stage renal disease on maintenance dialysis therapy where secondary HPT is not adequately controlled with standard-of-care treatment |
6/27/17 |
Amicus Therapeutics Inc. (Cranbury, N.J.) |
Migalastat |
Chaperone therapy |
Fabry disease |
Submitted an NDA to Japan's PMDA |
6/29/17 |
Ammonett Pharma LLC (Midlothian, Va.) |
Oratrope |
MK-0677; ibutamoren mesylate |
Growth hormone deficiency |
The FDA granted orphan drug designation |
6/20/17 |
Bene-Arzneimittel GmbH (Munich) |
Elmiron |
Pentosan polysulfate sodium |
Bladder pain syndrome characterized by either glomerulations or Hunner's lesions |
The EC granted approval in adults with moderate to severe pain, urgency and frequency of micturition |
6/13/17 |
Biomarin Pharmaceutical Inc. (San Rafael, Calif.) |
Brineura |
Cerliponase alfa; enzyme replacement therapy |
Neuronal ceroid lipofuscinosis type 2 |
The European Commission (EC) granted marketing authorization |
6/2/17 |
Cara Therapeutics Inc. (Stamford, Conn.) |
Intravenous CR-845 |
Peripherally acting kappa opioid receptor agonist |
Moderate-to-severe uremic pruritus |
The FDA granted breakthrough therapy designation in chronic kidney disease patients undergoing hemodialysis |
6/26/17 |
Clarus Therapeutics Inc. (Northbrook, Ill.) |
Jatenzo (formerly Rextoro) |
Testosterone replacement product |
Low testosterone in hypogonadal men |
Resubmitted its NDA to the FDA |
6/28/17 |
Conatus Pharmaceuticals Inc. (San Diego) |
IDN-7314 |
Oral pan-caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death |
Primary sclerosing cholangitis |
The FDA granted orphan drug designation |
6/27/17 |
Ionis Pharmaceuticals Inc. (Carlsbad, Calif.) |
Spinraza |
Nusinersen |
5q spinal muscular atrophy |
The European Commission granted marketing authorization under the EMA's accelerated assessment program |
6/2/17 |
Kamada Ltd. (Rehovot, Israel) |
Inhaled AAT |
Inhaled alpha-1 antitrypsin (AAT) therapy |
Alpha-1 antitrypsin deficiency |
Withdrew its marketing authorization application (MAA) with the EMA after concluding that the agency does not view the data submitted to date as sufficient for approval of the MAA, and that the supplementary data needed for approval requires an additional clinical trial |
6/23/17 |
Mithra Pharmaceuticals SA (Liège, Belgium) |
E-4 |
Estetrol |
Neonatal encephalopathy |
Received orphan drug designation from the EMA |
6/12/17 |
Nicox SA (Sophia Antipolis, France) |
Zerviate |
Cetirizine ophthalmic solution 0.24% |
Ocular itching associated with allergic conjunctivitis |
Received FDA approval |
6/1/17 |
Proqr Therapeutics NV (Leiden, the Netherlands) |
QR-110 |
RNA oligonucleotide targeting LCA 10 due to the p.Cys998X mutation |
Leber's congenital amaurosis type 10 |
Received FDA fast track designation |
6/1/17 |
Protalix Biotherapeutics Inc. (Carmiel, Israel) |
PRX-102 |
Pegunigalsidase alfa |
Fabry disease |
The FDA approved its supplemental new drug application (sNDA), which allows the company to convert its manufacturing facility from a single dedicated product facility to a multiproduct facility |
6/2/17 |
Psivida Corp. (Watertown, Mass.) |
Durasert |
Micro-insert |
Posterior segment uveitis |
Submitted a marketing authorization application to the EMA |
6/23/17 |
Rasrx LLC (Newport Beach, Calif.) |
RASRx-1902 |
Oral therapy |
Duchenne muscular dystrophy |
The FDA granted orphan drug designation |
6/16/17 |
Reata Pharmaceuticals Inc. (Irving, Texas) |
Omaveloxolone |
Synthetic triterpenoid compound |
Friedreich's ataxia |
The FDA granted orphan designation |
6/23/17 |
Santhera Pharmaceuticals AG (Liestal, Switzerland) |
Raxone |
Idebenone |
Duchenne muscular dystrophy (DMD) |
The U.K.'s Medicines and Healthcare products Regulatory Agency granted Raxone a positive scientific opinion through the Early Access to Medicines Scheme for DMD patients with respiratory function decline not taking glucocorticoids |
6/23/17 |
Synlogic Inc. (Cambridge, Mass.) |
SYNB-1020 |
Oral probiotic microbes developed using Snylogic's Synthetic Biotic platform |
Hyperammonemia in a group of rare genetic diseases called urea cycle disorders |
The FDA granted fast track designation |
6/27/17 |
Tarix Orphan LLC (Cambridge, Mass.) |
TXA127 |
Pharmaceutical grade formulation of the naturally occurring peptide Angiotensin |
Epidermolysis bullosa |
The EMA has designated it orphan status |
6/13/17 |
Therachon AG (Basel, Switzerland) |
TA-46 |
Directly modulates the function of the fibroblast growth factor receptor 3 |
Achondroplasia, the most common form of short-limbed dwarfism |
The EMA and FDA both granted orphan drug designation |
6/21/17 |
Respiratory | |||||
Adamis Pharmaceuticals Corp. (San Diego) |
Symjepi |
Epinephrine (adrenaline) injection (0.3 mg pre-filled single dose syringe) |
Type I allergic reactions, including anaphylaxis |
The FDA approved it for emergency treatment |
6/16/17 |
Aeolus Pharmaceuticals Inc. (Mission Viejo, Calif.) |
AEOL-10150 |
Metalloporphyrin designed to neutralize reactive oxygen and nitrogen species |
Prevention of fatal respiratory failure |
Gained FDA fast track status in patients at risk for radiation pneumonitis following a radiological or nuclear incident sufficient to cause acute radiation syndrome |
6/9/17 |
Sandoz (unit of Novartis AG; Basel, Switzerland) |
Fluticasone propionate/salmeterol |
Generic version of Advair Diskus (Glaxosmithkline plc) |
Asthma, and maintenance treatment for chronic obstructive pulmonary disease |
The FDA accepted its abbreviated new drug application |
6/16/17 |
|
Notes The date indicated refers to the BioWorld issue in which the news item can be found. For more information about individual companies and/or products, see Cortellis. | |||||
