Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Abbvie Inc. (North Chicago) |
Humira |
Adalimumab |
Moderate to severe fingernail psoriasis |
The FDA approved the inclusion of data for that indication in prescribing information for patients with plaque psoriasis |
3/31/17 |
Amgen Inc. (Thousand Oaks, Calif.) |
Amgevita |
Biosimilar of Humira (adalimumab; Abbvie Inc.) |
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, etc. |
Gained European Commission (EC) authorization in all available indications |
3/27/17 |
Biocad (St. Petersburg, Russia) |
Interferon beta-1a |
Biosimilar of Rebif (Merck KGaA) |
Relapsing-remitting multiple sclerosis |
Received marketing authorization from the Ministry of Health of the Russian Federation |
3/7/17 |
Pfizer Inc. (New York) |
Xeljanz |
Tofacitinib citrate; oral JAK inhibitor |
Rheumatoid arthritis (RA) |
Said its China unit received CFDA approval for patients who have had an inadequate response or intolerance to methotrexate; the European Commission approved it in combination with methotrexate |
3/17/17; 3/28/17 |
Regeneron Pharmaceuticals Inc. |
Dupixent |
Dupilumab |
Moderate to severe atopic dermatitis |
FDA approved it as a treatment for adults who are either not helped by topical drugs or for whom those therapies aren't advised |
3/29/17 |
Sanofi SA (Paris) and its Sanofi Genzyme unit |
Dupilumab |
Subcutaneously administered IL-4R alpha-targeting antibody |
Severe atopic dermatitis |
The U.K.'s MHRA granted it a positive scientific opinion through the Early Access to Medicines Scheme, meaning eligible adults can access the drug prior to its marketing authorization in the U.K. |
3/15/17 |
CANCER | |||||
Actelion Ltd. (Allschwil, Switzerland) |
Ledaga |
Chlormethine gel |
Mycosis fungoides-type cutaneous T-cell lymphoma |
European Commission has granted marketing authorization for the use of Ledaga 160 mcg/g |
3/8/17 |
Advaxis Inc. (Princeton, N.J.) |
Axalimogene filolisbac |
Lm Technology immunotherapy |
Metastatic cervical cancer |
The EMA issued an advanced therapy medicinal product certificate for manufacturing quality and non-clinical data confirming that the CMC and non-clinical data comply with the standards that apply for evaluating the marketing authorization application |
3/24/17 |
Amgen Inc. (Thousand Oaks, Calif.) |
Vectibix |
Panitumumab |
RAS wild-type metastatic colorectal cancer |
National Institute for Health and Care Excellence (NICE) issued a Final Appraisal Determination recommending Vectibix as an option for patients in adults in combination with the Folfox or Folfiri chemotherapy regimes |
3/8/17 |
Amgen Inc. (Thousand Oaks, Calif.) |
Blincyto |
Blinatumomab |
Relapsed or refractory acute lymphoblastic leukemia |
The FDA has accepted for priority review the supplemental BLA for Blincyto to include overall survival data from the phase III TOWER study |
3/31/17 |
Apeiron Biologics AG (Vienna) |
Dinutuximab beta |
ch14.18/CHO; APN-311 |
High risk neuroblastoma |
The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval |
3/28/17 |
Array Biopharma Inc. (Boulder, Colo.) |
Binimetinib |
Oral small-molecule MEK inhibitor |
NRAS-mutant melanoma |
Withdrew its new drug application based on discussions and communications with the FDA, including exploration of various paths to approval, and concluded that the clinical benefit demonstrated in the phase III NEMO clinical trial would not be found sufficient to support approval; the ongoing clinical trials will continue |
3/21/17 |
Astrazeneca plc (London) |
Lynparza tablets 300 mg twice daily |
Olaparib; PARP inhibitor |
Platinum-sensitive, relapsed ovarian cancer |
The FDA accepted its NDA patients in the maintenance setting and granted priority review status |
3/29/17 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
BI-836858 |
Anti-CD33 monoclonal antibody |
Myelodysplastic syndromes |
The FDA granted orphan status |
3/10/17 |
Celgene Corp. (Summit, N.J.) and Agios Pharmaceuticals Inc. (Cambridge, Mass.) |
Enasidenib |
AG-221/CC-90007; binds and inhibits the mutant IDH2 enzyme |
Acute myeloid leukemia (AML) |
FDA accepted the NDA for the treatment of patients with relapsed or refractory AML with an isocitrate dehydrogenase 2 (IDH2) mutation; the NDA was granted priority review and has been given a PDUFA date of Aug. 30 |
3/2/17 |
Eagle Pharmaceuticals Inc. (Woodcliff Lake, N.J.) |
Pemetrexed injection |
25 mg/mL |
Locally advanced or metastatic nonsquamous non-small-cell lung cancer and mesothelioma |
The 505(b)(2) NDA for its pemetrexed injection, 25 mg/mL, was accepted for filing with the FDA, with a PDUFA date of Oct. 30 |
3/1/17 |
Effector Therapeutics Inc. (San Diego) |
eFT-508 |
Selective inhibitor of MNK1 and MNK2 |
Diffuse large B-cell lymphoma |
Granted orphan designation by the FDA |
3/10/17 |
EMD Serono Inc. (Rockland, Mass.; biopharmaceutical arm of Merck KGaA) |
Bavencio |
Avelumab; targets PD-1/PD-L1 |
Metastatic Merkel cell carcinoma (MCC) |
The FDA approved it for the treatment of adults and pediatric patients 12 years and older with MCC, including those who have not received prior chemotherapy |
3/24/17 |
Engeneic Ltd. (New York) |
EGFR-targeted, doxorubicin-loaded EDV nanocells |
Bacterially derived EDV nanocells |
Glioblastoma multiforme |
FDA granted orphan drug designation |
3/3/17 |
Exelixis Inc. (South San Francisco, Calif.) |
Cabozantinib |
Tyrosine kinase inhibitor |
Hepatocellular carcinoma |
The FDA has granted orphan drug designation |
3/7/17 |
Gamida Cell Ltd. (Jerusalem) |
Nicord |
Graft from an umbilical cord blood unit that has been enriched with stem and progenitor cells using NAM technology |
Hematopoietic stem cell transplantation (bone marrow transplantation) |
Was granted orphan drug designation by the EMA's Committee for Orphan Medicinal Products |
3/24/17 |
Halozyme Therapeutics Inc. (San Diego) and Genentech (unit of Roche Holding AG; Basel, Switzerland) |
Rituximab/hyaluronidase for subcutaneous injection |
Rituximab coformulated with recombinant human hyaluronidase |
Follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia |
The FDA's Oncologic Drug Advisory Committee voted 11-0 that the benefit/risk was favorable |
3/30/17 |
Lexicon Pharmaceuticals Inc. (The Woodlands, Texas) |
Xermelo |
Telotristat ethyl, previously LX-1032/LX-1606 |
Carcinoid syndrome diarrhea |
FDA approved it in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy |
3/2/17 |
LSK Biopharma (Salt Lake City) |
Apatinib |
Small-molecule angiogenesis inhibitor |
Gastric cancer |
The European Commission granted orphan status |
3/2/17 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Keytruda |
Pembrolizumab; PD-1 inhibitor |
Refractory classical Hodgkin lymphoma |
FDA approved it |
3/16/17 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Keytruda |
Pembrolizumab; PD-1 inhibitor |
Advanced microsatellite instability-high cancer |
The FDA extended the action date for the supplemental BLA in previously treated patients; the new PDUFA date is June 9, 2017 |
3/16/17 |
Merck KGaA (Darmstadt, Germany) |
Erbitux |
Cetuximab |
RAS wild-type metastatic colorectal cancer |
The U.K. National Institute for Health and Care Excellence (NICE) issued a positive final appraisal determination recommending the routine National Health Service use of Erbitux in combination with either Folfiri (irinotecan/5-fluorouracil/leucovorin) or Folfox (oxaliplatin/5-fluorouracil/leucovorin) |
3/3/17 |
Merck KGaA (Darmstadt, Germany) and Pfizer Inc. (New York) |
Avelumab |
Fully human monoclonal PD-L1 antibody of isotype IgG1 |
Locally advanced or metastatic urothelial carcinoma with disease progression |
The FDA accepted for priority review the BLA for avelumab and set a PDUFA date of Aug. 27 |
3/1/17 |
Moleculin Biotech Inc. (Houston) |
Annamycin |
Liposome formulated anthracycline |
Acute myeloid leukemia |
Gained FDA orphan status |
3/23/17 |
Mundipharma Pte Ltd. (Singapore) |
Mundesine |
Purine-nucleoside phosphorylase inhibitor |
Relapsed/refractory peripheral T-cell lymphoma |
Said the Ministry of Health, Labor and Welfare in Japan approved it |
3/31/17 |
Nantkwest Inc. (Culver City, Calif.) |
Activated natural killer (NK) cell therapy |
NK cell-based platform |
Advanced Merkel cell carcinoma |
The FDA granted orphan drug designation |
3/21/17 |
Novartis AG (Basel, Switzerland) |
Kisqali |
Ribociclib |
Breast cancer |
FDA approved it in combination with an aromatase inhibitor |
3/14/17 |
Novartis AG (Basel, Switzerland) |
CTL-019 |
Tisagenlecleucel-T; chimeric antigen receptor T-cell therapy |
B-cell acute lymphoblastic leukemia |
The FDA accepted the biologics license application filing and granted priority review in relapsed and refractory pediatric and young adult patients |
3/31/17 |
Sapience Therapeutics Inc. (Scarsdale, N.Y.) |
ST-36 |
Designed to inhibit activating transcription factor 5 |
Glioma |
Received FDA orphan designation |
3/30/17 |
Sunesis Pharmaceuticals Inc. (South San Francisco) |
Vosaroxin |
Anti-cancer quinolone derivative |
Relapsed/refractory acute myeloid leukemia |
Submitted its responses to the EMA Day 180 List of Outstanding Issues, issued by the Committee for Medicinal Products for Human Use as part of the centralized review process of the marketing authorization application in patients age 60 and older |
3/23/17 |
Tesaro Inc. (Waltham, Mass.) |
Zejula |
Niraparib; poly(ADP-ribose) polymerase inhibitor |
Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer |
Won FDA approval for the maintenance treatment of women who are in a complete or partial response to platinum-based chemotherapy |
3/28/17 |
CARDIOVASCULAR | |||||
Cardiome Pharma Corp. (Vancouver, British Columbia) |
Brinavess |
Vernakalant hydrochloride, I.V. |
Atrial fibrillation (AF) |
Received a notice of compliance from Health Canada |
3/15/17 |
Catalyst Biosciences Inc. (South San Francisco) |
CB-2679d/ISU-304 |
Next-generation coagulation factor IX variant |
Hemophilia |
The Korean Ministry of Food and Drug Safety approved the IND |
3/29/17 |
Eagle Pharmaceuticals Inc. (Woodcliff Lake, N.J.) |
Ryanodex |
Dantrolene sodium |
Exertional heat stroke |
The 505(b)(2) NDA has been accepted for filing and granted a priority review designation by the FDA |
3/28/17 |
Novo Nordisk A/S (Bagsværd, Denmark) |
Refixia |
Nonacog beta pegol, N9-GP |
Hemophilia B |
Gained a positive opinion from the EMA's Committee for Medicinal Products for Human Use, recommending marketing authorization for the treatment of adolescents and adults |
3/27/17 |
Shire plc (Dublin) |
Cinryze |
C1 inhibitor (human) |
Hereditary angioedema (HAE) |
The European Commission approved a label extension granting three new indications: routine prevention of angioedema attacks in children (ages 6 years and older) with severe and recurrent attacks of HAE who are intolerant to or insufficiently protected by oral preventions treatments, or patients who are inadequately managed with repeated acute treatment |
3/17/17 |
Shire plc (Dublin) |
SHP-655 (formerly BAX-930) |
Recombinant ADAMTS13 |
Acute episodes of hereditary thrombotic thrombocytopenic purpura |
Gained FDA fast track designation in patients with a constitutional deficiency of the von Willebrand factor-cleaving protease ADAMTS13 |
3/23/17 |
Spark Therapeutics Inc. (Philadelphia) and Pfizer Inc. (New York) |
SPK-9001 |
Gene therapy |
Hemophilia B |
It was granted support through the EMA's PRIority MEdicines (PRIME) program |
3/3/17 |
Swedish Orphan Biovitrum AB (Stockholm) |
Elocta |
Efmoroctocog alfa; factor VIII Fc fusion protein |
Hemophilia A |
Received EMA approval for a type II 15 K variation tied to "providing a consistent and reliable supply" of Elocta; the variation involves several changes, including the approval of Elocta drug substance manufacturing in 15,000-liter scale bioreactors |
3/3/17 |
CENTRAL NERVOUS SYSTEM | |||||
Acelrx Pharmaceuticals Inc. (Redwood City, Calif.) |
ARX-04 |
Sufentanil sublingual tablet, 30 mcg |
Moderate to severe acute pain |
The EMA notified the firm that the marketing authorization application passed validation and the scientific review of the application is underway |
3/29/17 |
Allergan plc (Dublin) |
Vraylar |
Cariprazine |
Schizophrenia |
The FDA accepted for filing its supplemental NDA, seeking the addition of new clinical data evaluating the drug for the maintenance of efficacy in adults with schizophrenia to the current product label |
3/9/17 |
Apicore Inc. (subsidiary of Medicure Inc.; Winnipeg, Manitoba) |
Tetrabenazine tablets, 12.5-mg and 25-mg |
Generic Xenazine (Valeant Pharmaceuticals International Inc.) |
Involuntary movements (chorea) of Huntington's disease |
Received final approval from the FDA for the company's abbreviated NDA |
3/24/17 |
Bial Portela & CA (Porto, Portugal) and Eisai Inc. (Woodcliff Lake, N.J.) |
Zebinix |
Eslicarbazepine acetate |
Newly diagnosed focal onset epilepsy |
Received a positive opinion for use as a once-daily monotherapy to treat adults from the EMA's Committee for Medicinal Products for Human Use |
3/29/17 |
Bioq Pharma Inc. (San Francisco) |
Ropivacaine Readyfusor |
Single-use infusion product pre-filled with 0.2% ropivacaine |
Post-surgical pain |
The Australian Therapeutic Goods Administration has approved it in pain in adults via continuous peripheral nerve block and continuous wound infiltration |
3/15/17 |
Eisai Inc. (Woodcliff Lake, N.J.) |
Fycompa |
Perampanel |
Partial-onset seizures in epilepsy |
Was approved in South Africa for adjunctive treatment |
3/13/17 |
Endo International plc (Dublin) |
Opana ER |
Oxymorphone hydrochloride extended release |
Severe pain |
Responded to the recommendation by the FDA's Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees (adcom), which voted 18-8, with one abstention, that the risks outweighed the benefits of continued use; Endo expressed confidence in the body of evidence supporting a favorable risk-benefit profile |
3/16/17 |
GW Pharmaceuticals plc (London) |
Epidiolex |
Cannabidiol or CBD |
Lennox-Gastaut Syndrome |
The EMA has designated it an orphan drug |
3/30/17 |
H. Lundbeck A/S (Valby, Denmark) and Otsuka Pharmaceutical Co. |
Brexpiprazole |
Second-generation (atypical) oral antipsychotic |
Schizophrenia |
The EMA has accepted for review a marketing authorization application |
3/24/17 |
Innocoll Holdings plc (Athlone, Ireland) |
Xaracoll |
Bupivacaine HCl collagen-matrix implant |
Post-surgical |
Received formal meeting minutes from the FDA regarding its NDA, and said the FDA has provided steps to follow to address issues the agency was concerned about, including a number of brief studies that should be conducted |
3/30/17 |
Newron Pharmaceuticals SpA (Bresso, Italy) |
Xadago |
Safinamide |
Parkinson's disease (PD) |
The FDA approved it for patients who are currently taking levodopa/carbidopa and experiencing "off" episodes, or periods in which their medications are not working well, causing an increase in PD symptoms |
3/22/17 |
Opko Health Inc. (Miami) |
CUR-1916 |
Oligonucleotide-based Antagonat |
Dravet syndrome |
The European Commission designated it an orphan product |
3/9/17 |
Opko Health Inc. (Miami) |
Antagonat (CUR-1916) |
Antagonat technology |
Dravet syndrome |
Gained FDA orphan status |
3/23/17 |
Sunovion Pharmaceuticals Inc. (Marlborough, Mass.) |
Aptiom |
Eslicarbazepine acetate |
Partial-onset seizures |
Submitted a supplemental new drug application (sNDA) to the FDA seeking to expand the indication to include use as monotherapy or adjunctive therapy to treat children 4 and older |
3/14/17 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
SD-809 |
Deutetrabenazine |
Tardive dyskinesia |
FDA accepted the NDA and granted priority review, assigning a PDUFA date of Aug. 30 |
3/1/17 |
Upsher-Smith Laboratories Inc., of Maple Grove, Minn. |
Qudexy XR capsules |
Topiramate |
Migraine headache |
Received FDA approval of two supplemental NDAs for use as prophylaxis of migraine headache in adults and adolescents, 12 and older |
3/31/17 |
Zogenix Inc. (Emeryville, Calif.) |
ZX-008 |
Fenfluramine |
Lennox-Gastaut syndrome |
The European Commission has designated it an orphan medicinal product |
3/2/17 |
DIABETES | |||||
Astrazeneca plc (London) |
Qtern |
10 mg dapagliflozin and 5 mg saxagliptin |
Type 2 diabetes |
Gained FDA approval for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who have inadequate control with the SGLT-2 inhibitor dapagliflozin (10 mg) or who are already treated with dapagliflozin and saxagliptin, a DPP-4 inhibitor |
3/1/17 |
Izun Pharmaceuticals Corp. (New York) |
Curasite wound care hydrogel |
Topical combination of three botanical extracts in a hydrogel base |
Diabetic foot and leg ulcers and first and second degree partial thickness burns |
The FDA has approved its 510(k) application |
3/7/17 |
Merck & Co. Inc. (Kenilworth, N.J.) and Pfizer Inc. (New York) |
Ertugliflozin |
SGLT2 inhibitor |
To help improve glycemic control in adults with type 2 diabetes |
The FDA has accepted for review three new drug applications (NDAs): monotherapy, fixed-dose combination of ertugliflozin and Januvia (sitagliptin), and fixed-dose combination of ertugliflozin and metformin |
3/7/17 |
Novo Nordisk A/S (Bagsværd, Denmark) |
Semaglutide |
A glucagon-like peptide-1 analogue |
Type 2 diabetes |
Submitted a new drug application to the Japanese Ministry of Health, Labour and Welfare for semaglutide |
3/1/17 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Fiasp |
Insulin aspart |
Diabetes |
Its Canada unit reported approval in that country |
3/28/17 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Fast-acting insulin aspart |
Insulin aspart (Novolog/Novorapid) in a new formulation |
Diabetes |
Resubmitted the NDA to the FDA |
3/30/17 |
GASTROINTESTINAL | |||||
Shionogi & Co. Ltd. (Osaka, Japan) and Purdue Pharma LP (Stamford, Conn.) |
Symproic 0.2 mg tablets C-II |
Naldemedine |
Opioid-induced constipation in adults with chronic noncancer pain |
Gained FDA approval |
3/27/17 |
Synergy Pharmaceuticals Inc. (New York) |
Trulance |
Plecanatide; guanylate cyclase-C agonist |
Irritable bowel syndrome with constipation |
Submitted a supplemental NDA |
3/28/17 |
INFECTION | |||||
Abbvie Inc. (North Chicago) |
Glecaprevir/pibrentasvir (G/P) |
Pan-genotypic, ribavirin-free regimen of G/P |
Chronic hepatitis C virus |
The Japanese Ministry of Health granted priority review |
3/15/17 |
Cempra Inc. (Chapel Hill, N.C.) |
Solithromycin |
A first-in-class fluoroketolide antibiotic candidate |
Community-acquired pneumonia |
Withdrew its marketing authorization application in Europe seeking approval of oral capsule and intravenous formulations |
3/29/17 |
CSRA Inc. (Falls Church, Va.) |
Recombinant rF1V |
Plague vaccine |
Infection with Yersinia pestis |
Said a vaccine being developed by its subsidiary, Dynport Vaccine Co. LLC (DVC), was granted FDA orphan drug designation |
3/9/17 |
Dynavax Technologies Corp. (Berkeley, Calif.) |
Heplisav-B |
Vaccine |
Hepatitis B infection |
The FDA accepted for review its responses to a complete response letter issued in November regarding its biologics license application |
3/2/17 |
Glaxosmithkline plc (London) |
Fluarix |
Quadrivalent influenza vaccine |
Influenza A subtype viruses and type B viruses |
Submitted a supplemental BLA to the FDA, seeking an expanded indication for children 6 months through 35 months of age |
3/16/17 |
Mylan NV (Hertfordshire, U.K.) |
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets |
Antiretroviral fixed-dose combination |
HIV/AIDS |
Received tentative FDA approval under the U.S. President's Emergency Plan for AIDS Relief |
3/21/17 |
Pfizer Inc. (New York) |
Trumenba |
Meningococcal group B vaccine |
Invasive meningococcal disease caused by meningitidis serogroup B |
Said the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending it be granted marketing authorization in the European Union for active immunization of individuals 10 years and older |
3/27/17 |
Polypid Ltd. (Petah Tikva, Israel) |
D-Plex |
Doxycycline/polymer-lipid encapsulation matrix |
Local antibacterial prevention and treatment during surgical procedures |
Was designated a qualified infectious disease product by the FDA |
3/9/17 |
Scynexis Inc. (Jersey City, N.J.) |
SCY-078 I.V. formulation |
Antifungal |
Vulvovaginal candidiasis and invasive candidiasis |
FDA informed it to hold the initiation of any new clinical studies with the intravenous (I.V.) formulation of SCY-078 until the FDA completes a review of all available preclinical and clinical data of the I.V. formulation of SCY-078; ongoing and future trials using the oral formulation of SCY-078 are unaffected by this regulatory action |
3/6/17 |
Symbiomix Therapeutics LLC (Newark, N.J.) |
Solosec |
Secnidazole oral granules |
Bacterial vaginosis |
The FDA accepted for filing the company's NDA |
3/24/17 |
MISCELLANEOUS | |||||
Astrazeneca plc (London) and Medimmune (its R&D company) |
Inebilizumab (formerly MEDI-551) |
Anti-CD19 monoclonal antibody |
Neuromyelitis optica spectrum disorder |
The EMA has designated it an orphan drug |
3/30/17 |
Abeona Therapeutics Inc. (New York) |
EB-101 |
Gene therapy |
Recessive dystrophic epidermolysis bullosa |
The EMA granted orphan designation |
3/9/17 |
Acerus Pharmaceuticals Corp. (Toronto) |
Gynoflor |
Ultra-low-dose estrogen (estriol) and probiotic (Lactobacillus acidophilus) combination vaginal tablet |
Vaginal atrophy and certain vaginal infections |
Filed a new drug submission with Health Canada |
3/2/17 |
Aerie Pharmaceuticals Inc. (Irvine, Calif.) |
Rhopressa |
Netarsudil ophthalmic solution |
Glaucoma or ocular hypertension |
Resubmitted its NDA; the NDA was withdrawn in October due to the contract manufacturer not yet being prepared for pre-approval inspection |
3/2/17 |
Aeterna Zentaris Inc. (Charleston, S.C.) |
Macrilen |
Macimorelin |
Adult growth hormone deficiency |
The EMA's pediatric committee agreed to the company's proposal to defer execution of its pediatric investigation plan (PIP) for Macrilen until after it files a marketing authorization application seeking approval to market it for the evaluation of adult growth hormone deficiency in Europe |
3/8/17 |
Alexion Pharmaceuticals Inc. (New Haven, Conn.) |
Soliris |
Eculizumab; terminal complement inhibitor |
Refractory generalized myasthenia gravis |
The FDA accepted for review the supplemental BLA to extend the indication as a potential treatment for patients who are anti-acetylcholine receptor antibody-positive |
3/9/17 |
Alexion Pharmaceuticals Inc. (New Haven, Conn.) |
Soliris |
Eculizumab |
Refractory generalized myasthenia gravis |
Submitted an application to Japan's Ministry of Labour and Welfare (MHLW) to extend the indication for patients who are anti-acetylcholine receptor (AChR) antibody-positive |
3/24/17 |
Allergan plc (Dublin) |
Juvederm Vollure XC |
Formulated with Vycross technology |
Moderate to severe facial wrinkles and folds |
Received FDA approval to market it; in the U.S. pivotal clinical trial, 59% of subjects saw improvement in moderate to severe nasolabial folds for up to 18 months |
3/21/17 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
Givosiran (ALN-AS1) |
RNAi therapeutic targeting aminolevulinic acid synthase 1 |
Acute hepatic porphyrias |
The EMA has granted access to its priority medicines scheme |
3/2/17 |
Atyr Pharma Inc. (San Diego) |
Resolaris (previously ATYR-1940) |
Derived from a naturally occurring protein released by human skeletal muscle cells |
Limb girdle muscular dystrophy |
Resolaris was granted orphan drug designation |
3/1/17 |
Atyr Pharma Inc. (San Diego) |
Resolaris |
Intravenous protein therapeutic |
Limb girdle muscular dystrophy |
The EMA granted orphan drug designation |
3/6/17 |
Bausch + Lomb (subsidiary of Valeant Pharmaceuticals International Inc.; Laval, Quebec) and Nicox SA, of Sophia Antipolis, France |
Latanoprostene bunod ophthalmic solution, 0.024% |
Intraocular pressure lowering single-agent eye drop |
Open angle glaucoma or ocular hypertension |
The FDA set a PDUFA date of Aug. 24 for its decision on the NDA |
3/22/17 |
Chemocentryx Inc. (Mountain View, Calif.) |
Avacopan |
Targets the complement C5a receptor |
C3 glomerulopathy |
Was designated an orphan drug by the FDA |
3/23/17 |
Ipsen Biopharma-ceuticals Canada Inc. (Mississauga, Ontario; Canadian affiliate of Ipsen SA) |
Dysport |
AbobotulinumtoxinA |
Cervical dystonia and adult upper limb spasticity |
Health Canada has approved it |
3/15/17 |
Janssen-Cilag International NV (Beerse, Belgium) |
Eprex |
Epoetin alfa |
Symptomatic anemia |
Said the French health authority Agence Nationale de Sécurité du Médicament et des Produits de Santé approved it in adults with low- or intermediate-1-risk primary myelodysplastic syndromes who have low serum erythropoietin |
3/27/17 |
Keryx Biopharma-ceuticals Inc. (Boston) |
Auryxia |
Ferric citrate tablets |
Iron deficiency anemia |
The FDA accepted for review the supplemental NDA for patients with non-dialysis dependent chronic kidney disease |
3/9/17 |
Kiadis Pharma NV (Amsterdam) |
ATIR-101 |
Allodepleted T-cell immunotherapeutics |
Hematopoietic stem cell transplantation for a malignant disease |
The EMA's Pediatric Committee accepted the firm's pediatric investigation plan (PIP) for ATIR101 for adjunctive treatment, and the committee agreed the company may defer conducting the studies defined in the PIP until after it files a marketing authorization application in Europe for the use of ATIR101 for the treatment of blood cancers |
3/29/17 |
Ligand Pharmaceuticals Inc. (San Diego) |
Antibody |
Uses Ligand's OmniAb technology |
Undisclosed |
Said CNA Development LLC, an affiliate of Janssen Pharmaceuticals Inc., filed an IND |
3/29/17 |
Mesoblast Ltd. (Melbourne, Australia) |
MSC-100-I.V. |
A tier 1, intravenously delivered product candidate comprising 100M mesenchymal stem cells per unit dose; cell therapy |
Steroid-refractory acute graft-vs.-host disease |
FDA granted fast track status |
3/8/17 |
Prometic Life Sciences Inc. (Laval, Quebec) |
PBI-4050 |
Orally active, antifibrotic |
Alström syndrome |
FDA granted orphan drug designation |
3/6/17 |
PTC Therapeutics Inc. (South Plainfield, N.J.) |
Translarna |
Ataluren |
Nonsense mutation Duchenne muscular dystrophy |
The FDA has acknowledged the filing over protest of the company's new drug application; the FDA has assigned a Prescription Drug User Fee Act date of Oct. 24 |
3/7/17 |
Radius Health Inc. (Waltham, Mass.) |
Abaloparatide-SC |
Synthetic peptide that engages the parathyroid hormone receptor |
Postmenopausal osteoporosis |
Said the FDA will require additional time to complete its review of the NDA, and the PDUFA goal date has been extended by three months |
3/13/17 |
Roche Holding AG (Basel, Switzerland) |
Rituxan |
Rituximab |
Pemphigus vulgaris |
Said Genentech disclosed that the FDA granted breakthrough therapy designation |
3/27/17 |
Sangamo Therapeutics Inc. (Richmond, Calif.) |
SB-913 |
Genome editing product candidate |
Mucopoly-saccharidosis type II |
The FDA granted orphan drug designation |
3/2/17 |
Serenity Pharmaceuticals LLC (Milford, Penn.) |
Noctiva nasal spray |
Desmopressin acetate; synthetic analogue of vasopressin |
Nocturnal polyuria |
The FDA approved it in adults who awaken at least two times per night to urinate |
3/6/17 |
Swedish Orphan Biovitrum AB (Stockholm) |
Orfadin |
Nitisinone |
Hereditary tyrosinemia type-1 |
The FDA approved a supplemental new drug application, which allows an extension of shelf life for the 20-mg capsules from 24 months to 36 months when refrigerated (2-8 degrees C), and also allows in-use storage at room temperature (25 degrees C or lower) |
3/7/17 |
Toray Industries Inc. (Tokyo) |
Remitch OD |
2.5 mcg tablets |
Pruritus in hemodialysis and chronic liver disease patients |
Received approval for an additional orally disintegrating tablet formulation |
3/31/17 |
RESPIRATORY | |||||
Alk-Abello A/S (Horsholm, Denmark) |
Sublingual allergy immunotherapy tablet |
Allergen extract immunotherapy |
House dust mite-induced allergic rhinitis |
FDA approved the BLA |
3/3/17 |
Alk-Abello A/S (Horsholm, Denmark) |
Miticure |
House dust mite sublingual allergy immunotherapy tablet |
Pediatric allergic rhinitis |
Said partner Torii Pharmaceutical Co. Ltd., of Tokyo, submitted an application to the Japanese Ministry of Health, Labour and Welfare, seeking to expand its use |
3/27/17 |
Nicox SA (Sophia Antipolis, France) |
AC-170 |
Cetirizine eye drop formulation |
Ocular itching associated with allergic conjunctivitis |
Resubmitted an NDA, after receiving confirmation that the cGMP concerns surrounding the production site of the active pharmaceutical ingredient were resolved |
3/10/17 |
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Notes Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. For more information about individual companies and/or products, see Thomson Reuters Cortellis. | |||||
