Company (location) |
Product |
Description |
Indication |
Status |
Date |
Cancer | |||||
Amgen Inc. (Thousand Oaks, Calif.) |
Xgeva |
Denosumab |
Prevention of skeletal-related events with bone metastases from solid tumors |
The FDA approved the supplemental BLA to expand the currently approved indication to include patients with multiple myeloma |
1/8/18 |
Amgen Inc. (Thousand Oaks, Calif.) |
Kyprolis |
Carfilzomib |
Relapsed or refractory multiple myeloma |
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a label variation to include updated overall survival (OS) data from the head-to-head phase III ENDEAVOR trial |
1/31/18 |
Amgen Inc. (Thousand Oaks, Calif.) and Allergan plc (Dublin) |
Mvasi |
Biosimilar to Avastin |
Multiple types of cancer |
The European Commission granted marketing authorization |
1/22/18 |
Aspyrian Therapeutics Inc. (San Diego) |
RM-1929 |
Conjugate of cetuximab and IRDye 700DX |
Locoregional recurrent head and neck squamous cell carcinoma |
Gained FDA fast track status |
1/18/18 |
Astrazeneca plc (Cambridge, U.K.) and Merck & Co. Inc. (Kenilworth, N.J.) |
Lynparza |
Olaparib; PARP inhibitor |
Deleterious or suspected deleterious germline BRCA-mutated HER2-negative, metastatic breast cancer |
The FDA approved it for use in patients who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting |
1/17/18 |
Astrazeneca plc (Cambridge, U.K.) and Merck & Co. Inc. (Kenilworth, N.J.) |
Lynparza |
Olaparib; PARP inhibitor |
Platinum-sensitive relapsed ovarian cancer |
Japan's Ministry of Health, Labour and Welfare (MHLW) approved it for use as a maintenance therapy for patients, regardless of BRCA mutation status, who responded to their last platinum-based chemotherapy |
1/22/18 |
Berg LLC (Boston) |
BPM-31510 |
Restores the metabolism of cancerous cells |
Pancreatic cancer |
Gained FDA orphan status |
1/23/18 |
Biocon Ltd. (Bangalore, India) and Mylan NV (Canonsburg, Pa.) |
Zedora |
Biosimilar trastuzumab |
Overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer |
It was approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica, of Sao Paulo, Brazil |
1/2/18 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Gilotrif |
Afatinib |
Metastatic non-small-cell lung cancer |
The FDA approved the expanded use of it for the first-line treatment of patients whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations, including three additional EGFR mutations: L861Q, G719X and S768I |
1/18/18 |
Bristol-Myers Squibb Co. (Princeton, N.J.) |
Yervoy |
Ipilimumab |
Advanced melanoma |
The European Commission expanded the indication to include treatment of pediatric patients 12 years of age and older |
1/23/18 |
Cantex Pharmaceuticals Inc. (Weston, Fla.) |
CX-01 |
Polysaccharide |
Acute myeloid leukemia |
The FDA granted orphan designation |
1/4/18 |
Cascadian Therapeutics Inc. (Seattle) |
Tucatinib |
Tyrosine kinase inhibitor |
HER2-positive metastatic breast cancer |
Received a product-specific pediatric waiver from the EMA |
1/3/18 |
Eisai Co. Ltd. (Tokyo) and Merck & Co. (Kenilworth, N.J.) |
Lenvima |
Lenvatinib |
Advanced or metastatic renal cell carcinoma |
Received breakthrough therapy designation from the FDA for it in combination with Keytruda |
1/10/18 |
Eli Lilly Canada Inc. (Toronto) |
Lartruvo |
Olaratumab |
Soft tissue sarcoma |
Health Canada issued a notice of compliance with conditions for the chemotherapy used in combination with doxorubicin for the treatment of adults when treatment with radiation or surgery are not options |
1/25/18 |
Genmab A/S (Copenhagen, Denmark) |
Darzalex |
Daratumumab |
Multiple myeloma |
The FDA granted priority review to the supplemental biologics license application (sBLA) for use in combination with bortezomib, melphalan and prednisone for the treatment of newly diagnosed patients who are ineligible for autologous stem cell transplant; a PDUFA target date of May 21 has been assigned |
1/23/18 |
Hedgepath Pharmaceuticals Inc. (Tampa, Fla.) and Mayne Pharma Ltd. (Melbourne, Australia) |
Suba-Itraconazole |
Oral formulation of itraconazole |
Basal cell carcinoma nevus syndrome |
The EMA granted orphan designation |
1/12/18 |
Helsinn Group (Lugano, Switzerland) and Mei Pharma Inc. (San Diego) |
Pracinostat |
HDAC inhibitor |
Acute myeloid leukemia |
The EMA granted orphan designation |
1/12/18 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Keytruda |
Pembrolizumab |
Radically unresectable urothelial carcinoma |
The Japanese Ministry of Health, Labor and Welfare approved it |
1/3/18 |
Myriad Genetics Inc. (Salt Lake City) |
BRACAnalysis CDx with Lynparza |
Companion in-vitro diagnostic device with olaparib |
HER2-negative metastatic breast cancer |
The FDA approved it for use as a companion diagnostic |
1/16/18 |
Novartis AG (Basel, Switzerland) |
Kisqali |
Ribociclib |
HR+/HER2- advanced breast cancer |
The FDA granted breakthrough therapy designation to it for initial endocrine-based treatment in premenopausal women |
1/4/18 |
Novartis AG (Basel, Switzerland) |
Kymriah |
Tisagenlecleucel |
Relapsed or refractory diffuse large B-cell lymphoma |
The sBLA for it as a treatment of adult patients who are ineligible for or relapse after autologous stem cell transplant was accepted and assigned a priority review by the FDA |
1/18/18 |
Novartis AG (Basel, Switzerland) |
Lutathera |
Lutetium (177Lu) oxodotreotide |
Gastroentero-pancreatic neuroendocrine tumors |
The FDA approved it |
1/29/18 |
Pharmamar SA (Madrid) |
Aplidin |
Plitidepsin |
Relapsed and refractory multiple myeloma |
Requested the EMA's Committee for Human Medicinal Products (CHMP) re-examine the MAA |
1/4/18 |
Progenics Pharmaceuticals Inc. (New York) |
Azedra |
Iobenguane I 131 |
Malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma |
The FDA accepted the NDA for review; the priority-review action date is April 30, 2018 |
1/2/18 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin |
Advanced classical Hodgkin's lymphoma |
The FDA accepted for filing a supplemental BLA for it in combination with chemotherapy, granted priority review and set the PDUFA target action date for May 1, 2018 |
1/3/18 |
Seattle Genetics Inc. (Bothell, Wash.) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
Adcetris |
Brentuximab vedotin |
CD30-positive cutaneous T-cell lymphoma |
The European Commission extended the current conditional marketing authorization to include the treatment of adult patients after at least one prior systemic therapy |
1/23/18 |
Synthon NV (Nijmegen, the Netherlands) |
SYD-985 |
[Vic-] trastuzumab duocarmazine |
HER2-positive metastatic breast cancer |
Gained FDA fast track status |
1/26/18 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Trisenox |
Arsenic trioxide injection |
Newly diagnosed low-risk acute promyelocytic leukemia (APL) |
The FDA approved the use of it in combination with tretinoin for the treatment of adults whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression |
1/17/18 |
Cardiovascular | |||||
Anges Inc. (Tokyo) |
HGF plasmid |
Gene therapy |
Critical limb ischemia |
Submitted an application for marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan |
1/24/18 |
Cardiome Pharma Corp. (Vancouver, British Columbia) |
Aggrastat |
Tirofiban hydrochloride |
ST-segment elevation myocardial infarction(STEMI) |
The Chinese Center for Drug Evaluation (CDE) approved an expansion of the indications to include patients with STEMI who are intended for primary percutaneous coronary intervention; the CDE also approved a high-dose bolus (HDB) regimen to be used on both indicated patient populations |
1/24/18 |
Upsher-Smith Laboratories LLC (Maple Grove, Minn.) |
Bumetanide |
Diuretic tablets |
Hypertension |
The FDA approved its ANDA |
1/31/18 |
Vifor Fresenius Medical Care Renal Pharma Ltd. (Zurich, Switzerland) and Chemocentryx Inc. (Mountain View, Calif.) |
Avacopan |
Selective inhibitor of the terminal effector complement C5a receptor |
Anti-neutrophil cytoplasmic antibody associated vasculitis |
Its conditional marketing authorization (CMA) was accepted by the EMA |
1/5/18 |
Dermatologic | |||||
Abbvie Inc. (North Chicago) |
ABT-494 |
Upadacitinib |
Moderate to severe atopic dermatitis |
The FDA granted breakthrough therapy designation |
1/9/18 |
Abeona Therapeutics Inc. (New York and Cleveland) |
EB-101 |
Gene-corrected autologous cell therapy |
Recessive dystrophic epidermolysis bullosa |
The FDA granted regenerative medicine advanced therapy (RMAT) designation, making it eligible for priority review and accelerated approval |
1/30/18 |
Perrigo Co. plc (Dublin) |
Soolantra |
Ivermectin cream, 1% |
Inflammatory lesions of rosacea |
The FDA gave tentative approval |
1/31/18 |
Pharming Group NV (Leiden, the Netherlands) |
Ruconest |
Recombinant C1 esterase inhibitor |
Hereditary angioedema |
The FDA accepted the sBLA for it as a routine prophylaxis to prevent attacks in adult and adolescent patients; the PDUFA date is Sept. 21, 2018 |
1/18/18 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Dupixent |
Dupilumab |
Atopic dermatitis |
The Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing authorization for treatment of adults not adequately controlled with existing therapies |
1/23/18 |
Shire plc (Dublin) |
Cinryze |
C1 esterase inhibitor (human) |
Hereditary angioedema |
Gained FDA approval for the technology transfer of the manufacturing process to its Vienna manufacturing site |
1/25/18 |
Endocrine/Metabolic | |||||
3Sbio Inc. (Shenyang, China) |
Bydureon |
Exenatide microsphere for injection |
Type 2 diabetes |
The CFDA approved it |
1/5/18 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
Patisiran |
RNAi therapeutic targeting transthyretin |
Hereditary ATTR amyloidosis |
The EMA accepted the marketing authorization application and initiated its review; the U.K. Medicines and Healthcare Products Regulatory Agency granted Promising Innovative Medicine status |
1/29/18 |
Amicus Therapeutics Inc. (Cranbury, N.J.) |
Galafold |
Migalastat |
Fabry disease |
The Canadian Drug Expert Committee offered a positive recommendation to list in provincial drug formularies for long-term treatment of adults with confirmed diagnosis and who have an amenable mutation |
1/30/18 |
Chiesi Farmaceutici SpA (Parma, Italy) |
Lamzede |
Velmanase alfa |
Mild to moderate alpha-mannosidosis |
The EMA's Committee for Human Medicinal Products issued a positive recommendation |
1/29/18 |
Clarus Therapeutics Inc. (Northbrook, Ill.) |
Jatenzo |
Oral testosterone undecanoate capsule |
Primary hypogonadism and hypogonadotropic hypogonadism |
The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-10 on it; no votes were mostly based on clinically significant cardiovascular (CV) events associated with patients who took it vs. another testosterone replacement therapy; committee members who voted yes said many patients who are in desperate need of therapy options would be willing to take on the increased CV risk |
1/11/18 |
Dauntless Pharmaceuticals Inc. (San Diego) |
DP-1038 |
Octreotide acetate |
Acromegaly |
The FDA granted orphan drug designation for intranasal administration |
1/31/18 |
Ionis Pharmaceuticals Inc. (Carlsbad, Calif.) |
Inotersen |
Antisense drug |
Hereditary TTR amyloidosis |
The new drug application was accepted for priority review by the FDA |
1/9/18 |
Lipocine Inc. (Salt Lake City) |
Tlando |
Oral testosterone undecanoate capsule |
Primary hypogonadism and hypogonadotropic hypogonadism |
Six members of the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee supported approval of it while 13 panelists said the overall benefit/risk profile was not acceptable and were concerned about the risks for patients who are older, obese, diabetic and prone to cardiovascular issues |
1/12/18 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Segluromet |
Ertugliflozin/metformin |
Type 2 diabetes |
The EMA's Committee for Human Medicinal Products issued a positive recommendation |
1/29/18 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Steglatro |
Ertugliflozin |
Type 2 diabetes |
The EMA's Committee for Human Medicinal Products issued a positive recommendation |
1/29/18 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Steglujan |
Ertugliflozin/sitagliptin |
Type 2 diabetes |
The EMA's Committee for Human Medicinal Products issued a positive recommendation |
1/29/18 |
Mylan NV (Hertfordshire, U.K.) and Biocon Ltd. (Bengaluru, India) |
Semglee |
Insulin glargine |
Diabetes |
The EMA's Committee for Human Medicinal Products issued a positive recommendation |
1/30/18 |
Novo Nordisk (Bagsvaerd, Denmark) |
Ozempic |
Semaglutide injection |
Type 2 diabetes |
Health Canada approved it as an adjunct to diet and exercise to improve glycemic control when metformin is not tolerated or contraindicated |
1/10/18 |
Orphazyme ApS (Copenhagen) |
Arimoclomol |
Small molecule that activates molecular chaperones |
Niemann-Pick disease |
The FDA granted rare pediatric disease designation |
1/22/18 |
Repros Therapeutics Inc. (The Woodlands, Texas) |
Encyzix |
Enclomifene |
Hypogonadotrophic hypogonadism |
The EMA's Committee for Human Medicinal Products issued a negative recommendation |
1/29/18 |
The Medicines Co. (Parsippany, N.J.) |
Inclisiran |
RNAi targeting PCSK9 |
Homozygous familial hypercholesterolemia |
The FDA granted orphan drug designation |
1/26/18 |
Vifor Fresenius Medical Care Renal Pharma Ltd. (Zurich, Switzerland) |
Veltassa |
PatiromerAvacopan |
Hyperkalemia |
Swissmedic approved it |
1/5/18 |
Mallinckrodt plc (Staines-upon-Thames, U.K.) |
Stannsoporfin |
Heme oxygenase inhibitor |
Infantile hyperbilirubinemia |
Completed the rolling submission of a new drug application to the FDA |
1/8/18 |
Spruce Biosciences Inc. (San Francisco) |
SPR-001 |
Small molecule |
Congenital adrenal hyperplasia |
The EMA granted orphan drug designation |
1/8/18 |
Gastrointestinal | |||||
Acacia Pharma Group Ltd. (Cambridge, U.K.) |
Baremsis |
Amisulpride injection |
Postoperative nausea and vomiting |
Its NDA was accepted for filing by the FDA with a PDUFA date of Oct. 5, 2018 |
1/5/18 |
Albireo Pharma Inc. (Boston) |
Elobixibat |
IBAT inhibitor |
Chronic constipation |
Japan's Ministry of Health, Labor and Welfare approved it |
1/22/18 |
Cour Pharmaceuticals Inc. (Chicago) |
TIMP-GLIA |
Nanoparticle-based therapeutic |
Celiac disease |
The FDA granted fast track designation |
1/12/18 |
Lyric Pharmaceuticals Inc. (South San Francisco) |
LP-101 |
Ulimorelin |
Enteral feeding intolerance in critical illness |
The FDA granted fast track designation |
1/18/18 |
Synergy Pharmaceuticals Inc. (New York) |
Trulance |
Plecanatide |
Irritable bowel syndrome with constipation |
The FDA approved a 3-mg tablet for the once-daily treatment in adults |
1/26/18 |
Genitourinary/Sexual Health | |||||
Achaogen Inc. (South San Francisco) |
Plazomicin |
Aminoglycoside |
Complicated urinary tract infections |
The FDA classified the outcome of its fourth quarter 2017 reinspection of Pfizer Inc.'s McPherson facility as voluntary action indicated (VAI); the PDUFA date is June 25 |
1/31/18 |
Endoceutics Inc. (Quebec) |
Intrarosa |
Prasterone |
Vulvar and vaginal atrophy |
The European Commission approved it |
1/17/18 |
Mylan N.V., of Canonsburg, Pa. |
Estradiol |
Vaginal cream 0.01% |
Vulvar and vaginal atrophy |
Received final approval from the FDA for its abbreviated NDA |
1/2/18 |
Omeros Corp. (Seattle) |
OMS-721 |
Human monoclonal antibody |
Primary immunoglobulin A nephropathy |
The EMA's Committee for Orphan Medicinal Products (COMP) issued a positive opinion on its application for orphan drug designation |
1/23/18 |
Therapeuticsmd Inc. (Boca Raton, Fla.) |
TX-001HR |
Estradiol and progesterone in a single, oral softgel |
Moderate-to-severe vasomotor symptoms due to menopause |
Submitted the NDA to the FDA |
1/2/18 |
Hematologic | |||||
Baxter International Inc. (Deerfield, Ill.) |
Bivalirudin |
Thrombin inhibitor |
Percutaneous coronary intervention |
Won FDA approval for a frozen, premixed, ready-to-use formulation (0.9 % sodium chloride injection) for use as an anticoagulant |
1/23/18 |
CTI Biopharma Corp. (Seattle) |
Pacritinib |
Oral tyrosine kinase inhibitor |
Myelofibrosis |
The EMA's Committee for Medicinal Products for Human Use granted the three-month extension the company sought for submitting response to a day 120 list of questions regarding its marketing authorization application |
1/29/18 |
Global Blood Therapeutics Inc. (South San Francisco) |
Voxelotor |
Hemoglobin modifier |
Sickle cell disease |
Received breakthrough therapy designation from the FDA |
1/10/18 |
Novartis AG (Basel, Switzerland) |
Promacta |
Eltrombopag |
Severe aplastic anemia |
The FDA designated it a breakthrough therapy when combined with standard immunosuppressive therapy |
1/5/18 |
Roche Holding AG (Basel, Switzerland) and Chugai Pharmaceutical Co. Ltd. (Tokyo) |
Hemlibra |
Emicizumab |
Hemophilia A factor with VIII inhibitors |
The EMA's Committee for Human Medicinal Products issued a positive recommendation |
1/29/18 |
Shire plc (Dublin) |
Adynovi |
Extended half-life recombinant factor VIII treatment |
Hemophilia A |
The European Commission granted marketing authorization for on-demand and prophylactic use in patients 12 and older |
1/17/18 |
Immune | |||||
Eli Lilly and Co. (Indianapolis) |
Taltz |
Ixekizumab |
Active psoriatic arthritis |
The European Commission granted marketing authorization for it, alone or in combination with methotrexate, for the treatment in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drug therapies |
1/26/18 |
Momenta Pharmaceuticals Inc. (Cambridge, Mass.) |
Glatopa |
Glatiramer acetate injection |
Relapsing forms of multiple sclerosis |
The FDA classified the outcome of its fourth quarter 2017 re-inspection of Pfizer Inc.'s McPherson facility as "voluntary action indicated" (VAI); the abbreviated NDA remains under regulatory review |
1/31/18 |
Nohla Therapeutics Inc. (Seattle) |
NLA-101 |
Hematopoietic stem and progenitor stem cell therapy |
Hematopoietic stem cell transplantation |
The European Commission granted orphan drug designation |
1/24/18 |
Infection | |||||
60 Degrees Pharmaceuticals LLC (Washington) |
Tafenoquine |
8-aminoquinoline |
Malaria |
Received FDA fast track designation |
1/5/18 |
Achaogen Inc. (South San Francisco) |
Plazomicin |
Aminoglycoside |
Complicated urinary tract infections |
The FDA accepted for review its new drug application with a PDUFA date of June 25 |
1/3/18 |
Armis Biopharma Inc. (Fort Collins, Colo.) |
Ximycin |
Localized antimicrobial agent |
Surgical site infections |
The FDA designated it as a qualified infectious disease product, or QIDP, for prophylactic treatment in high-risk patients undergoing nonemergent colorectal surgery |
1/30/18 |
Cutispharma Inc. (Wilmington, Mass.) |
Firvanq |
Vancomycin hydrochloride oral solution |
Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus |
The FDA approved it |
1/30/18 |
Glaxosmithkline plc (London) |
Fluarix Quadrivalent |
Vaccine |
Influenza |
The FDA granted an expanded approval to include children ages 6 months to 3 years of age |
1/16/18 |
Glaxosmithkline plc (London) |
Shingrix |
Recombinant, adjuvanted Herpes zoster vaccine |
Herpes zoster and post-herpetic neuralgia |
The EMA's Committee for Human Medicinal Products issued a positive recommendation |
1/29/18 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Doravirine |
Non-nucleoside reverse transcriptase inhibitor |
HIV-1 infection |
The FDA accepted for review two new drug applications and set the PDUFA date for Oct. 23, 2018 |
1/9/18 |
Paratek Pharmaceuticals Inc. (Boston) |
Omadacycline |
Antibiotic |
Acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia |
Started the rolling submission of an NDA to the FDA |
1/4/18 |
Sato Pharmaceutical Co. Ltd. (Tokyo) |
Nailin |
Oral antifungal agent |
Onychomycosis |
Obtained marketing and manufacturing approval for it |
1/22/18 |
Shire plc (Dublin) |
SHP-620 |
Maribavir |
Cytomegalovirus (CMV) infection and disease |
The FDA granted breakthrough therapy designation for it in transplant patients resistant or refractory to prior therapy |
1/5/18 |
Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) |
TAK-426 |
Inactivated, alum-adjuvanted, whole Zika virus vaccine |
Zika virus |
The FDA granted fast track designation |
1/30/18 |
Tetraphase Pharmaceuticals Inc. (Watertown, Mass.) |
Eravacycline |
IV antibiotic |
Complicated intra-abdominal infections |
Submitted an NDA to the FDA |
1/4/18 |
Venatorx Pharmaceuticals Inc. (Malvern, Pa.) |
VNRX-5133 |
Beta-lactamase inhibitor |
Complicated urinary tract infections and complicated intra-abdominal infections |
The FDA granted qualified infectious disease product and fast track designations |
1/4/18 |
Inflammatory | |||||
Centrexion Therapeutics Corp. (Boston) |
CNTX-497 |
Injection of trans-capsaicin |
Pain associated with knee osteoarthritis |
The FDA granted fast track designation |
1/17/18 |
Sandoz (Basel, Switzerland, unit of Novartis AG) |
Adalimumab |
Biosimilar to Humira |
Inflammatory diseases |
The FDA accepted its BLA, submitted under the 351(k) pathway |
1/17/18 |
Sonoma Pharmaceuticals Inc. (Petaluma, Calif.) |
Sinudox |
Antimicrobial nasal irrigation |
Chronic sinusitis |
The United Arab Emirates Ministry of Health & Prevention approved it |
1/10/18 |
Musculoskeletal | |||||
Amgen Inc. (Thousand Oaks, Calif.) and UCB SA (Brussels) |
Evenity |
Romosozumab |
Osteoporosis |
The EMA accepted the marketing authorization application |
1/9/18 |
Benitec Biopharma Ltd. (Sydney) |
BB-301 |
Gene therapy |
Oculopharyngeal muscular dystrophy |
The FDA granted orphan designation |
1/17/18 |
Ipsen Biopharmaceuticals Canada Inc. (Mississauga, Ontario) |
Dysport Therapeutic |
AbobotulinumtoxinA |
Lower limb spasticity |
Health Canada approved it for pediatric patients 2 years of age and older |
1/10/18 |
Santhera Pharmaceuticals Holding AG (Liestal, Switzerland) |
Raxone |
Idebenone |
Duchenne muscular dystrophy |
The EMA's Committee for Human Medicinal Products issued a second negative recommendation |
1/29/18 |
Neurology/Psychiatric | |||||
Aquestive Therapeutics Inc. (Warren, N.J.) |
Clobazam |
Oral soluble film |
Seizures associated with Lennox-Gastaut syndrome |
The FDA accepted for review its new drug applications for adjunctive treatment in patients 2 or older |
1/19/18 |
Avadel Pharmaceuticals plc (Dublin) |
FT 218 |
Formulation of sodium oxybate |
Narcolepsy |
The FDA granted orphan drug designation |
1/11/18 |
Ensysce Biosciences Inc., of San Diego |
PF-614 |
Extended-release oxycodone prodrug |
Moderate to severe chronic pain |
The FDA granted fast track designation for pain management when a continuous, around-the-clock analgesic is needed for an extended period of time |
1/30/18 |
GW Pharmaceuticals plc (London) |
Epidiolex |
Cannabidiol |
Seizures associated with Lennox-Gastaut syndrome and Dravet syndrome |
Submitted its marketing authorization application to the EMA as adjunctive treatment |
1/2/18 |
Janssen Pharmaceuticals, Inc. (Titusville, N.J.; unit of Johnson & Johnson) |
Invega Sustenna |
Paliperidone palmitate |
Schizophrenia |
The FDA approved data from the PRIDE study to be included on the label, showing it demonstrated superior effectiveness in delaying time to relapse vs. a group of seven oral antipsychotics in adults with schizophrenia in real-world circumstances |
1/4/18 |
Trevena Inc. (Chesterbrook, Pa.) |
Olinvo |
Oliceridine |
Poderate to severe acute pain |
The FDA accepted its NDA |
1/4/18 |
Vistagen Therapeutics Inc. (South San Francisco) |
AV-101 |
L-4-chlorokyurenine |
Major depressive disorder |
The FDA granted fast track designation |
1/4/18 |
Ocular | |||||
Alimera Sciences Inc. (Atlanta) |
Iluvien |
Fluocinolone acetonide intravitreal implant |
Recurrent and persistent non-infectious uveitis affecting the posterior segmen |
Received validation of a type II variation submitted with the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K.; the submission seeks to add the indication to the label in Europe |
1/5/18 |
Kala Pharmaceuticals Inc. (Waltham, Mass.) |
KPI-121 |
1%, a twice-per-day corticosteroid |
Inflammation and pain following ocular surgery |
The NDA was accepted for review by the FDA with a PDUFA date of Aug. 24, 2018 |
1/8/18 |
Psivida Corp. (Watertown, Mass.) |
Durasert |
Three-year microinsert |
Posterior segment uveitis |
Submitted its NDA to the FDA |
1/9/18 |
Shire plc (Dublin) |
Xiidra |
Lifitegrast |
Dry eye disease |
Approved in Canada for the treatment of the signs and symptoms in adults |
1/4/18 |
Sonoma Pharmaceuticals Inc. (Petaluma, Calif.) |
Acuicyn |
Antimicrobial solution |
Blepharitis on the eyelid and eyelash |
The United Arab Emirates Ministry of Health & Prevention approved it |
1/10/18 |
Other/Miscellaneous | |||||
Sinclair Pharma plc (London) |
Ellanse |
Bioresorbable collagen stimulator |
Facial wrinkles and folds |
Received regulatory approval by ANVISA in Brazil |
1/17/18 |
Sonoma Pharmaceuticals Inc. (Petaluma, Calif.) |
Microsafe |
Antiseptic mouth and throat rinse |
Pain and inflammation caused by mucositis |
The United Arab Emirates Ministry of Health & Prevention approved it |
1/10/18 |
Respiratory | |||||
Aradigm Corp. (Hayward, Calif.) |
Linhaliq |
Liposomally encapsulated ciprofloxacin |
Non-cystic fibrosis bronchiectasis chronic lung infections with Pseudomonas aeruginosa |
FDA Antimicrobial Drugs Advisory Committee (ADAC) voted 12-4 against approval; received a CRL recommending a third-party verification of its phase III results and an additional phase III trial, plus a human factors study |
1/30/18 |
Astrazeneca plc (Cambridge, U.K.) |
Daliresp |
Roflumilast |
Severe COPD associated with chronic bronchitis and history of exacerbations |
The FDA approved 250 mcg as a starting dose once daily for the first four weeks of treatment followed by 500 mcg thereafter to help reduce the rate of treatment discontinuation in some patients |
1/26/18 |
Astrazeneca plc (Cambridge, U.K.) and Merck & Co. Inc. (Kenilworth, N.J.) |
Fasenra |
Benralizumab |
Bronchial asthma |
Japan's Ministry of Health, Labour and Welfare (MHLW) approved it as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite other asthma treatments, including high-dose inhaled corticosteroid |
1/22/18 |
Astrazeneca plc (London) |
Fasenra |
Benralizumab |
Severe eosinophilic asthma |
The European Commission approved it as an add-on maintenance treatment in adult patients |
1/11/18 |
Faron Pharmaceuticals Ltd. (Turku, Finland) |
Traumakine |
Recombinant human interferon beta-1 |
Acute respiratory distress syndrome |
The FDA granted fast track status |
1/30/18 |
Theravance Biopharma Inc. (Dublin) and Mylan NV (Hertfordshire, U.K.) |
TD-4208 |
Revefenacin |
Chronic obstructive pulmonary disease |
The FDA accepted their NDAand indicated that it doesn't plan to convene an advisory committee meeting to discuss it; the PDUFA goal date is Nov. 13, 2018 |
1/30/18 |
Vertex Pharmaceuticals Inc. (Boston) |
Orkambi |
Lumacaftor/ivacaftor |
Cystic fibrosis |
The European Commission granted an extension of its marketing authorization to include children ages 6 through 11 with two copies of the F508del mutation |
1/11/18 |
Toxicity/Intoxication | |||||
Braeburn Pharmaceuticals Inc. (Princeton, N.J.) |
CAM-2038 |
Buprenorphine weekly and monthly depot injection |
Opioid use disorder |
Received a complete response letter (CRL) from the FDA regarding the new drug application (NDA); the agency requested additional information in order to progress the application forward; it has not asked for additional clinical studies to be conducted |
1/23/18 |
Enzychem Lifesciences Corp. (Fort Lee, N.J.) |
EC-18 |
Oral, small-molecule candidate |
Acute radiation syndrome |
The FDA granted orphan designation |
1/22/18 |
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. |