Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Abbvie Inc. (North Chicago) |
ABBV-066 |
Risankizumab |
Crohn's disease |
FDA granted orphan drug designation for treatment in pediatric patients |
12/1/16 |
Biogen Inc. (Cambridge, Mass.) and Abbvie Inc. (North Chicago) |
Zinbryta |
Daclizumab beta |
Active relapsing remitting multiple sclerosis |
Health Canada has approved Zinbryta |
12/12/16 |
Celgene Corp. (Summit, N.J.) |
Otezla |
Apremilast; an oral selective inhibitor of phosphodiesterase 4 |
Plaque psoriasis |
Has been granted full marketing authorization by Japan's Ministry of Health, Labor and Welfare for the treatment of adult patients |
12/21/16 |
Celgene Corp. (Summit, N.J.) |
Otezla |
Apremilast; an oral selective inhibitor of phosphodiesterase 4 |
Active psoriatic arthritis |
National Institute for Health and Care Excellence, or NICE, issued a final appraisal determination recommending the use of Otezla for the treatment of adult patients who have had an inadequate response to or have been unable to tolerate disease-modifying antirheumatic drugs |
12/23/16 |
Eli Lilly and Co. (Indianapolis) |
Olumiant |
Baricitinib |
Moderate to severe active rheumatoid arthritis |
EMA's Committee for Medicinal Products for Human Use has issued a positive opinion, recommending approval |
12/19/16 |
Genentech Inc. (South San Francisco) |
Ocrevus |
Ocrelizumab; a humanized antibody designed to selectively target CD-20-positive B cells |
Relapsing forms of multiple sclerosis and primary progressive MS |
The FDA extended the PDUFA date for its review of the BLA for Ocrevus to March 28, 2017, due to additional data submitted by Genentech regarding the commercial manufacturing process |
12/21/16 |
Intercept Pharmaceuticals Inc. (New York) |
Ocaliva |
Obeticholic acid |
Primary biliary cholangitis |
European Commission granted conditional approval for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA |
12/15/16 |
Janssen Biotech Inc. (Horsham, Pa.) |
Stelara |
Ustekinumab |
Moderate to severe plaque psoriasis |
Submitted a supplemental BLA to the FDA seeking approval of Stelara for the treatment of adolescents, 12 to 17 years of age |
12/19/16 |
Janssen Biotech Inc. (Horsham, Pa.) |
Simponi Aria |
Golimumab; fully human antitumor necrosis factor-alpha therapy |
Active psoriatic arthritis and active ankylosing spondylitis |
Submitted two supplemental biologics license applications to the FDA, one seeking approval to market Simponi Aria for the treatment of adults living with active psoriatic arthritis and the other seeking approval for the treatment of adults living with active ankylosing spondylitis |
12/22/16 |
Janssen Inc. (Toronto) |
Stelara |
Ustekinumab |
Moderately to severely active Crohn's disease |
Health Canada has issued a Notice of Compliance for Stelara for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumor necrosis factor-alpha antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids |
12/15/16 |
Medicinova Inc. (La Jolla, Calif.) |
MN-166 |
Ibudilast |
Amyotrophic lateral sclerosis |
EMA granted orphan status |
12/22/16 |
Neovacs SA (Paris) |
Interferon alpha kinoid |
Immunotherapeutic vaccine |
Lupus |
FDA granted fast track status |
12/8/16 |
Neovacs SA (Paris) |
IFNa Kinoid |
N/A |
Moderate to severe lupus |
FDA granted fast track status |
12/9/16 |
Pfizer Inc. (New York) |
Eucrisa |
Topical PDE4 inhibitor crisaborole |
Mild to moderate atopic dermatitis |
FDA granted approval ahead of the Jan. 7, 2017, PDUFA date, for patients 2 and older |
12/15/16 |
Roche Group (Basel, Switzerland) |
Actemra |
Tocilizumab |
Systemic juvenile idiopathic arthritis |
CFDA approved it for the Chinese market |
12/20/16 |
Sanofi SA (Paris) and Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Dupixent |
Dupilumab; inhibits signaling of IL-4 and IL-13 |
Moderate-to-severe atopic dermatitis |
EMA accepted for review the marketing authorization application for Dupixent |
12/9/16 |
Teva Pharmaceutical Industries Ltd. (Jerusalem) |
Copaxone |
Glatiramer acetate 40 mg/mL injection; 20 mg/mL |
Multiple sclerosis |
Received permission to remove the pregnancy contraindication from the European label for Copaxone |
12/7/16 |
Tigenix NV (Leuven, Belgium) |
Cx601 |
A suspension of allogeneic expanded adipose-derived stem cells locally injected |
Complex perianal fistulas in Crohn's disease |
Submitted its responses to the EMA day 120 list; the company expects a decision from the EMA on Cx601 marketing approval during 2017 |
12/27/16 |
CANCER | |||||
Abbvie Inc. (North Chicago) |
Venclyxto |
Venetoclax monotherapy |
Chronic lymphocytic leukemia (17p deletion or TP53 mutation) |
European Commission has granted conditional marketing authorization |
12/9/16 |
Ability Pharmaceuticals SL (Barcelona) |
ABTL0812 |
Akt/mTOR inhibitor |
Pediatric neuroblastoma |
FDA granted orphan drug designation |
12/15/16 |
Actelion Ltd. (Allschwil, Switzerland) |
Ledaga |
Chlormethine gel 160 mcg/g |
Mycosis fungoides-type cutaneous T-cell lymphoma |
EMA's Committee for Medicinal Products for Human issued a positive opinion |
12/19/16 |
Advanced Accelerator Applications SA (Saint-Genis-Pouilly, France) |
Lutathera |
A Lu-177-labeled somatostatin analogue peptide |
Gastroentero-pancreatic neuroendocrine tumors |
FDA issued a complete response letter (CRL) regarding the NDA; the CRL refers to issues with the format, traceability, uniformity and completeness relating to the NETTER-1 and Erasmus clinical datasets, which are precluding FDA reviewers from performing the required independent analysis of those studies; a safety update on clinical and nonclinical studies, which already is in process, also was requested in the CRL; the letter also noted that any observations made during inspections of manufacturing facilities supporting the NDA need to be resolved prior to approval; no additional studies were requested |
12/22/16 |
Amgen Inc. (Thousand Oaks, Calif.) and Allergan plc (Dublin) |
ABP 215 |
A biosimilar candidate to Avastin (bevacizumab), a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (Genentech Inc./Roche AG) |
Advanced non-squamous non-small-cell lung cancer |
Submitted a marketing authorization application to the EMA for ABP 215 |
12/5/16 |
Armo Biosciences Inc. (Redwood City, Calif.) |
AM0010 |
Pegylated interleukin-10; immuno-oncology drug |
Pancreatic cancer |
European Commission granted it orphan designation |
12/27/16 |
Astrazeneca plc (London) |
Durvalumab |
A PD-L1 human monoclonal antibody |
Locally advanced or metastatic urothelial carcinoma |
FDA has accepted the BLA; PDUFA date is set for the second quarter of 2017 |
12/12/16 |
Biofrontera AG (Leverkusen, Germany) |
Ameluz |
Topical drug; aminolevulinic acid hydrochloride |
Superficial and/or nodular basal cell carcinoma |
EMA's Committee for Medicinal Products for Human Use issued a positive opinion on the firm's submission for label extension for its topical drug Ameluz |
12/21/16 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Nintedanib |
Triple angiokinase inhibitor |
Mesothelioma |
FDA granted orphan designation |
12/15/16 |
CASI Pharmaceuticals Inc. (Rockville, Md.) |
Evomela |
Melphalan for injection |
Multiple myeloma |
China FDA accepted its import drug registration application for Evomela for review |
12/6/16 |
Clinigen Group plc (Staffordshire, U.K.) and Eisai Ltd. (Hatfield, U.K.) |
Halaven |
Eribulin |
Locally advanced or metastatic breast cancer |
Halaven was registered by the Medicines Control Council in South Africa to treat women who have progressed after at least two chemotherapeutic regimens for advanced disease |
12/2/16 |
Clovis Oncology Inc. (Boulder, Colo.) |
Rubraca |
Rucarparib; poly ADP-ribose polymerase inhibitor |
Advanced ovarian cancer |
FDA issued accelerated approval |
12/20/16 |
Daiichi Sankyo Co. Ltd. (Tokyo) |
DS-8201 |
HER2-targeting antibody-drug conjugate |
HER2-positive unresectable and/or metastatic breast cancer |
FDA granted fast track designation |
12/2/16 |
Eli Lilly and Co. (Indianapolis) |
Cyrama |
Ramucirumab |
Advanced gastric cancer |
Received approval by the Singapore Health Sciences Authority to treat those with advanced gastric cancer, whose cancer has progressed after prior chemotherapy |
12/14/16 |
Escend Pharmaceuticals Inc. (Menlo Park, Calif.) |
ES-3000 |
Oral, small molecule that targets beta-catenin |
Acute myeloid leukemia |
FDA granted orphan status |
12/29/16 |
Genentech (South San Francisco; unit of Roche Group) |
Avastin |
Bevacizumab |
Platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer |
FDA has approved Avastin either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone |
12/7/16 |
Genmab A/S (Copenhagen) |
Arzerra |
Ofatumumab |
Relapsed chronic lymphocytic leukemia |
European Commission granted a marketing authorization for the use of Arzerra in combination with fludarabine and cyclophosphamide (FC) |
12/13/16 |
Genmab A/S (Copenhagen) and Janssen Pharmaceutical KK (unit of Johnson & Johnson; New Brunswick, N.J.) |
Darzalex |
Daratumumab |
Relapsed or refractory multiple myeloma |
Submitted a new drug application to Japan's Ministry of Health, Labor and Welfare |
12/21/16 |
Genmab A/S (Copenhagen) and Janssen Pharmaceutical KK (unit of Johnson & Johnson; New Brunswick, N.J.) |
Darzalex |
Daratumumab |
Relapsed or refractory multiple myeloma |
Submitted a new drug application to Japan's Ministry of Health, Labor and Welfare, seeking permission to market Darzalex |
12/21/16 |
Juno Therapeutics Inc. (Seattle) and Celgene Corp. (Summit, N.J.) |
JCAR017 |
|
Relapsed or refractory aggressive large B-cell non-Hodgkin lymphoma |
FDA granted breakthrough therapy designation |
12/21/16 |
Kite Pharma Inc. (Santa Monica, Calif.) |
KTE-C19 |
Axicabtagene ciloleucel |
Relapsed/refractory aggressive B-cell non-Hodgkin lymphoma |
Has initiated the rolling submission with the FDA of the biologics license application for KTE-C19 as a treatment for patients who are ineligible for autologous stem cell transplant |
12/6/16 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Keytruda |
Pembrolizumab; anti-PD-1 therapy |
Refractory classical Hodgkin lymphoma |
FDA accepted for review the supplemental biologics license application and granted priority review, setting a PDUFA date of March 15, 2017; Keytruda was granted breakthrough therapy designation earlier |
12/2/16 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Keytruda |
Pembrolizumab; anti-PD-1 therapy |
PD-L1-positive unresectable advanced/recurrent non-small-cell lung cancer |
Has been approved in Japan |
12/20/16 |
Merck & Co. Inc. (Kenilworth, N.J.) |
Keytruda |
Pembrolizumab |
Metastatic non-small-cell lung cancer |
EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda |
12/19/16 |
Novartis AG (Basel, Switzerland) |
Ilaris |
Canakinumab |
TNF-R associated periodic syndrome, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency and familial Mediterranean fever |
EMA's Committee for Medicinal Products for Human Use has recommended approval of Ilaris in Europe to treat three rare and distinct periodic fever syndromes |
12/19/16 |
Pfizer Inc. (New York) |
Ibrance |
Palbociclib; CDK4/6 inhibitor |
Estrogen receptor-positive, HER2-negative advanced breast cancer |
FDA has accepted for review a supplemental new drug application |
12/22/16 |
Sanofi Genzyme (unit of Sanofi SA; Paris) |
Jevtana |
Cabazitaxel |
Metastatic hormone-refractory prostate cancer |
The Scottish Medicines Consortium has accepted Jevtana for routine use in NHS Scotland |
12/13/16 |
Soligenix Inc. (Princeton, N.J.) |
SGX942 |
Dusquetide; innate defense regulator |
Severe oral mucositis in head and neck cancer |
Has been granted promising innovative medicine (PIM) designation in the U.K. |
12/13/16 |
Tesaro Inc. (Waltham, Mass.) |
Niraparib |
A poly ADP ribose polyerase inhibitor |
Recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer |
FDA granted priority review for the NDA |
12/21/16 |
CARDIOVASCULAR | |||||
Amgen Inc. (Thousand Oaks, Calif.) |
Evolocumab |
PCSK9 inhibitor |
High cholesterol |
Hong Kong Department of Health approved the drug, which is now available |
12/7/16 |
CSL Behring (Marburg, Germany) |
Afstyla |
Antihemophilic factor VIII (recombinant), single chain |
Hemophilia A |
Health Canada approved it |
12/15/16 |
Global Blood Therapeutics Inc. (South San Francisco) |
GBT440 |
An oral, once-daily hemoglobin modifier |
Sickle cell disease |
European Commission designated GBT440 as an orphan product |
12/1/16 |
Portola Pharmaceuticals Inc. (South San Francisco) |
Betrixaban |
An oral, once-daily factor Xa inhibitor anticoagulant |
Venous thromboembolism (VTE) |
FDA accepted its NDA granting priority review; the PDUFA date is June 24, 2017; the EMA validated the marketing authorization application for extended-duration prophylaxis of VTE |
12/28/16 |
Shire plc (Dublin) |
Adynovate |
Antihemophilic factor (recombinant), pegylated, an extended circulating half-life recombinant factor VIII treatment |
Hemophilia A |
FDA approved Adynovate for hemophilia A, in those younger than 12; the FDA also approved Adynovate for use in surgical settings for both adult and pediatric patients |
12/28/16 |
CENTRAL NERVOUS SYSTEM | |||||
Acelrx Pharmaceuticals Inc. (Redwood City, Calif.) |
ARX-04 |
Sufentanil sublingual tablet, 30 mcg |
Moderate to severe acute pain |
Submitted a new drug application (NDA) under section 505(b)(2) |
12/14/16 |
Biohaven Pharmaceutical Holding Co. Ltd. (New Haven, Conn.) |
BHV-0223 |
An orally dissolving tablet |
Amyotrophic lateral sclerosis |
FDA has granted their orphan drug designation request |
12/9/16 |
Egalet Corp. (Malvern, Pa.) |
Oxaydo |
Oxycodone HCl tablets |
Acute and chronic moderate to severe pain |
Submitted a supplemental new drug application (sNDA) for Oxaydo to the FDA to support an abuse-deterrent label claim for the intravenous route of abuse |
12/2/16 |
Eisai Co. Ltd. (Tokyo) |
Zebinix |
Eslicarbazepine acetate |
Partial-onset seizures with or without secondary generalization |
The European Commission granted an extension to the marketing authorization for Zebinix to be used as a daily adjunctive drug to treat children 6 and older |
12/20/16 |
Eisai Inc. (Woodcliff Lake, N.J.) and Arena Pharmaceuticals Inc. (San Diego) |
Belviq |
Lorcaserin HCl |
Chronic weight management |
Received regulatory approval from the Brazilian Health Surveillance Agency for Belviq |
12/20/16 |
Elite Pharmaceuticals Inc. (Northvale, N.J.) |
Generic Norco |
Generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) |
Pain |
Filed an abbreviated new drug application |
12/13/16 |
Grunenthal Group (Aachen, Germany) and Abiogen Pharma SpA (Pisa, Italy) |
Neridronic |
Acid treatment |
Complex regional pain syndrome |
Won FDA breakthrough status |
12/19/16 |
H. Lundbeck A/S (Valby, Denmark) and Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, N.J.) |
Abilify Maintena |
An intramuscular depot formulation of atypical antipsychotic aripiprazole |
Bipolar I disorder |
FDA determined that the supplemental new drug application for the expanded labeling of Abilify Maintena is sufficiently complete to permit a substantive review and is considered filed: the PDUFA date is July 28, 2017 |
12/1/16 |
Ironshore Pharmaceuticals & Development Inc. (Georgetown, Grand Cayman) |
HLD200 |
Delayed-release and extended-release methylphenidate capsules |
Attention deficit hyperactivity disorder |
FDA accepted for review the NDA |
12/16/16 |
Kitov Pharmaceuticals Holdings Ltd. (Tel Aviv, Israel) |
KIT-302 |
Combines celecoxib, the active ingredient in Celebrex (Pfizer Inc.), and amlodipine besylate, the active ingredient in Norvasc (Pfizer Inc.) |
Osteoarthritis pain and hypertension |
A study showed that nine pivotal batches of KIT-302 – three in each dosage form – met six-month stability criteria, enabling the inclusion of registration batches in the company's new drug application submission, planned for the first quarter of 2017 |
12/8/16 |
Lannett Co. Inc. (Philadelphia) |
Morphine sulfate oral solution CII |
Opioid agonist |
Acute and chronic pain |
Received FDA approval |
12/20/16 |
Lupin Pharmaceuticals Inc. (subsidiary of Lupin Ltd.; Mumbai, India) |
Diclofenac capsules |
18 mg and 35 mg, generic version of Zorvolex (Iroko Pharmaceuticals LLC) |
Pain |
FDA tentatively approved an abbreviated new drug application from Lupin |
12/8/16 |
Minoryx Therapeutics SL (Barcelona, Spain) |
MIN-102 |
A selective PPAR gamma agonist |
X-linked adrenoleukodystropy |
Has been granted orphan drug designation |
12/15/16 |
Monosolrx Inc. (Warren, N.J.) |
Diazepam |
Buccal soluble film |
Acute repetitive seizures |
FDA granted orphan designation |
12/1/16 |
Neos Therapeutics Inc. (Dallas) |
Cotempla XR-ODT |
Methylphenidate extended-release orally disintegrating tablet |
Attention deficit hyperactivity disorder |
Completed the resubmission of a new drug application (NDA) to the FDA; last year, the FDA issued a complete response letter requiring the company to conduct a bridging study to demonstrate bioequivalence between the clinical trial material and the to-be-marketed drug product |
12/21/16 |
Neurocrine Biosciences Inc. (San Diego) |
Ingrezza |
Valbenazine; a VMAT2 inhibitor |
Tardive dyskinesia |
FDA's Psychopharmacologic Drugs Advisory Committee will review data included in the NDA of Ingrezza on Feb. 16, 2017; the FDA has granted priority review status, which has a PDUFA date of April 11, 2017 |
12/1/16 |
Pfizer Inc. (New York) |
Chanix |
Varnicline |
Smoking cessation |
FDA approved updates to the label for Chantix that included removal of the boxed warning regarding serious neuropsychiatric events, based on the outcomes of EAGLES, the smoking cessation trial |
12/19/16 |
DIABETES | |||||
Boehringer Ingelheim Pharmaceuticals GmbH (Ingelheim, Germany) and Eli Lilly and Co. (Indianapolis) |
Synjardy XR |
Empagliflozin and metformin hydrochloride extended-release tablets |
Type 2 diabetes |
FDA expanded the label; when used along with diet and exercise, Synjardy XR is indicated to improve blood sugar in adults with type 2 diabetes when both empagliflozin and metformin can be taken |
12/13/16 |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Jardiance |
Empagliflozin |
Type 2 diabetes |
EMA's Committee for Medicinal Products for Human Use adopted a positive opinion to update the Jardiance label, including a change to the indication statement |
12/19/16 |
Eli Lilly and Co. (Indianapolis) and Boehringer Ingelheim GmbH (Ingelheim, Germany) |
Jardiance |
Empagliflozin |
Type 2 diabetes |
FDA approved an expanded label for Jardiance to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease |
12/5/16 |
Evoke Pharma Inc. (Solana Beach, Calif.) |
Gimoti |
Nasal delivery formulation of metoclopramide |
Acute and recurrent diabetic gastroparesis |
Disclosed positive guidance from a recent second pre-NDA meeting to discuss clinical data for inclusion in a 505(b)(2) NDA; the FDA agreed that demonstration of equivalent exposure to the listed drug Reglan (Schwarz Pharma Inc.) in a healthy volunteer pharmacokinetic trial could serve as a portion of an NDA for Gimoti |
12/19/16 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Tresiba |
Insulin degludec injection 100 U/mL, 200 U/mL; a once-daily, long-acting basal insulin |
Diabetes |
FDA approved an expanded indication for Tresiba to improve glycemic control in patients with type 1 and type 2 diabetes from the age of 1 year through adulthood, making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old |
12/20/16 |
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Semaglutide |
A glucagon-like peptide-1 analog administered once-weekly |
Type 2 diabetes |
Submitted a new drug application to the FDA for semaglutide |
12/6/16 |
Theravance Biopharma Inc. (Dublin) |
TD-5108 |
Velusetrag |
Idiopathic and diabetic gastroparesis |
FDA granted fast track designation |
12/7/16 |
INFECTION | |||||
Abbvie Inc. (North Chicago) |
G/P |
Pan-genotypic regimen of glecaprevir/pibrentasvir |
Chronic hepatitis C virus |
Submitted a new drug application |
12/20/16 |
Arsanis Inc. (Waltham, Mass.) |
ASN100 |
A combination of two fully human monoclonal antibodies that collectively neutralize six important S. aureus cytotoxins |
To prevent Staphylococcus aureus pneumonia |
FDA granted fast track designation |
12/2/16 |
Bionet-Asia Co. Ltd. (Bangkok, Thailand) |
Vaccine |
Recombinant acellular pertussis booster vaccine containing a genetically detoxified pertussis toxin |
Pertussis |
Received marketing authorization approval from the Thai FDA |
12/27/16 |
Emergent Biosolutions Inc. (Gaithersburg, Md.) |
BAT |
Botulism antitoxin hepatavalent |
Symptomatic botulism |
Health Canada has approved the company's new drug submission |
12/13/16 |
Gilead Sciences Inc. (Foster City, Calif.) |
Vemlidy |
Tenofovir alafenamide |
Chronic hepatitis B virus |
Was approved by the Japanese Ministry of Health, Labour and Welfare |
12/20/16 |
Gilead Sciences Inc. (Foster City, Calif.) |
SOF/VEL/VOX |
Once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg |
Chronic hepatitis C virus |
Submitted an NDA to the FDA |
12/9/16 |
Pfizer Inc. (New York) |
Nimenrix |
Meningococcal group A, C, W-135, and Y conjugate vaccine |
Invasive meningococcal disease caused by Neisseria meningitidis serogroup B |
EC approved an expanded indication in infants as young as 6 weeks of age |
12/20/16 |
Profounda Inc. (Orlando, Fla.) |
Impavido |
Mitefosine |
Primary amebic meningoencephalitis |
FDA granted orphan drug designation |
12/19/16 |
Vernalish plc (Winnersh, U.K.) |
CCP-08 |
Third product from Tris' extended-release cough/cold pipeline |
Cough/cold |
FDA accepted the CCP-08 NDA for full review |
12/22/16 |
INFLAMMATORY | |||||
Flexion Therapeutics Inc. (Burlington, Mass.) |
Zilretta |
FX006 |
Osteoarthritis of the knee |
Submitted an NDA |
12/13/16 |
Vericel Corp. (formerly Aastrom Biosciences Inc.; Cambridge, Mass.) |
MACI |
Autologous cultured chondrocytes on porcine collagen membrane |
Symptomatic single or multiple full-thickness cartilage defects of the knee |
FDA approved MACI to repair cartilage defects, with or without bone involvement, in adults |
12/15/16 |
MISCELLANEOUS | |||||
AB2 Bio Ltd. (Lausanne, Switzerland) |
IL-18BP |
Tadekinig alfa |
Hemophago-cytic lymphohistiocytosis |
EMA has granted orphan drug designation |
12/12/16 |
Aerie Pharmaceuticals Inc. (Irvine, Calif.) |
Rhopressa |
Netarsudil ophthalmic solution 0.02% |
Glaucoma or ocular hypertension |
Its third-party manufacturing vendor will not be ready for pre-approval inspection by the FDA until the end of February 2017; Aerie withdrew its NDA in October due to the manufacturer not being prepared |
12/27/16 |
Agilis Biotherapeutics LLC (Cambridge, Mass.) |
AGIL-AADC |
Gene therapy candidate |
Aromatic L-amino acid decarboxylase deficiency |
European Commission granted orphan medicinal product designation in the EU |
12/2/16 |
Amgen Inc. (Thousand Oaks, Calif. (Thousand Oaks, Calif.) and UCB SA (Brussels) |
Romosozumab |
Monoclonal antibody that works by binding and inhibiting the activity of the protein sclerostin |
Osteoporosis |
Submitted for review to Japan's PMDA an application seeking marketing approval of romosozumab for the treatment of osteoporosis for those at high risk of fracture |
12/21/16 |
Antares Pharma Inc. (Ewing, N.J.) |
Quickshot Testosterone |
A drug-device combination product for the delivery of testosterone enanthate |
Hypogonadism |
Submitted an NDA to the FDA for Quickshot Testosterone |
12/22/16 |
Apellis Pharmaceuticals Inc. (Louisville, Ky.) |
APL-2 |
A complement C3 inhibitor |
Paroxysmal nocturnal hemoglobinuria |
FDA has granted fast track designation |
12/21/16 |
Biogen Inc. (Cambridge, Mass.) and Ionis Pharmaceuticals Inc. (Carlsbad, Calif.) |
Spinraza |
Nusinersen |
Spinal muscular atrophy |
FDA approved it for every type of SMA and every age; the rolling NDA was submitted in September and the drug had priority review |
12/28/16 |
Galderma Pharma SA (Lausanne, Switzerland) |
Restylane Refyne and Restylane Defyne |
N+E1111ext-generation hyaluronic acid dermal fillers |
Moderate to severe deep facial wrinkles and folds |
Received FDA approval of Restylane Refyne to treat moderate to severe facial wrinkles and folds and Restylane Defyne to treat moderate to severe deep facial wrinkles and folds |
12/13/16 |
Kadmon Holdings Inc. (New York) |
KD034 |
Generic trientine hydrochloride product |
Wilson's disease |
Submitted an abbreviated new drug application |
12/7/16 |
Novartis AG (Basel, Switzerland) |
Lucentis |
Ranibizumab |
Visual impairment due to choroidal neovascularization |
European Commission granted an additional indication for Lucentis |
12/8/16 |
Prometic Life Sciences Inc. (Laval, Quebec) |
Plasminogen |
A naturally occurring protein that is synthesized by the liver and circulates in the blood |
Plasminogen congenital deficiency |
Initiated the rolling submission to the FDA of its BLA |
12/20/16 |
Repros Therapeutics Inc. (The Woodlands, Texas) |
Androxal |
Enclomiphene |
Obesity-related hypogonadism |
FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 16 to 5 that the achievement of testosterone improvement while maintaining evidence of spermatogenesis was not sufficient to provide evidence of clinical benefit; some panel members suggested that an additional endpoint related to symptoms should be assessed |
12/8/16 |
Santhera Pharmaceuticals Holding AG (Liestal, Switzerland) |
Raxone |
Idebenone |
Duchenne muscular dystrophy |
U.K.'s Medicines and Healthcare Products Regulatory Agency designated it as a Promising Innovative Medicine, or PIM, and as a suitable candidate for entry into Step II of the Early Access to Medicines process |
12/27/16 |
Sarepta Therapeutics Inc. (Cambridge, Mass.) |
Exondys 51 |
Eteplirsen |
Duchenne muscular dystrophy |
EMA validated the previously submitted marketing authorization application for eteplirsen to treat Duchenne muscular dystrophy amenable to exon 51 skipping |
12/21/16 |
Viking Therapeutics Inc. (San Diego) |
VK0214 |
Orally available thyroid receptor beta agonist |
X-linked adrenoleukodystrophy |
FDA granted orphan drug designation |
12/8/16 |
RESPIRATORY | |||||
Adamis Pharmaceuticals Corp. (San Diego) |
Epinephrine |
Injection USP 1:1000 0.3 mg pre-filled single-dose syringe |
Anaphylaxis |
Resubmitted an FDA new drug application to address the issues raised by the FDA in the agency's June 2016 complete response letter (CRL) regarding the volume of dosage that the syringe delivers, what is claimed in the label and what is required by the FDA |
12/19/16 |
Astellas Pharma Inc. (Tokyo) and Immunomic Therapeutics Inc. (Rockville, Md.) |
ASP0892 |
DNA vaccine |
Peanut allergies |
FDA has granted fast track designation for the drug candidate ASP0892 for the mitigation of severe hypersensitivity reactions due to peanut allergy |
12/21/16 |
Cempra Inc. |
Solithromycin |
Ketolide antibiotic |
Community-acquired bacterial pneumonia |
Received a complete response letter from the FDA relating to its new drug applications for oral and intravenous solithromycin in adults |
12/30/16 |
Glaxosmithkline plc (London) and Innoviva Inc. (South San Francisco) |
FF/UMEC/VI |
Once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol |
Chronic obstructive pulmonary disease |
Disclosed the filing of a regulatory submission with the EMA |
12/5/16 |
Theravance Biopharma Inc. (Dublin), Glaxosmithkline plc (London and Innoviva Inc. (South San Francisco) |
Closed Triple |
Combination of fluticasone furoate, umeclidinium and vilanterol in a single Ellipta inhaler |
Chronic obstructive pulmonary disease |
Filed a marketing authorization application in the EU |
12/6/16 |
|
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. | |||||
