Summary of 2014 FDA Approvals
Small Molecules versus Biologics
Below is a summary of the 2014 FDA Approvals with respect to their classification as small molecule or biologic. Data is taken from the FDA website https://www.centerwatch.com/drug-information/fda-approved-drugs/year/2014
In molecular biology and pharmacology, a small molecule is a low molecular weight (<900 daltons) organic compound that may help regulate a biological process, with a size on the order of 10−9 m. Most drugs are small molecules.
From the FDA Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include:
• vaccines
• blood and blood products for transfusion and/or manufacturing into other products
• allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
• human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
• gene therapies
• cellular therapies
• tests to screen potential blood donors for infectious agents such as HIV
CONCLUSIONS:
As shown there were 106 small molecules approved and 59 biologics approved in 2014.
- Sales figures were or their anticipated market size as well as cost/benefit analysis. This was mentioned as a very important requirement in drug development by JNJ. The pharmacy benefit managers, insurers and the pharma companies said they were talked early in the drug development process using cost/benefit analysis as a criteria of go/ no go decision point.
- The insurers are very cost conscious as well as the PBMs. There are some classes that had mainly biologics and this was not oncology. In addition inflammation had lots more small molecule. The breakdown seems to be more meaningful than the totals and there are many reformulations and double indications.
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Cardiology/Vascular Diseases (2 small molecules) |
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Drug Indication |
Pharma |
drug type |
Drug Name |
Approval Date |
For the treatment of severe hypertriglyceridemia |
AstraZeneca |
small molecule |
Epanova (omega-3-carboxylic acids) |
May-14 |
For the reduction of thrombotic cardiovascular events |
Merck |
small molecule |
Zontivity (vorapaxar); |
May-14 |
Dermatology 7 small molecules 2 biologics |
|
For the treatment of acute bacterial skin and skin structure infections |
Durata Therapeutics |
synthetic small molecule |
Dalvance (dalbavancin); |
May-14 |
For the treatment of onychomycosis of the toenails |
Valeant Pharmaceuticals |
synthetic small molecule |
Jublia (efinaconazole) 10% topical gel |
Jun-14 |
For the treatment of onychomycosis of the toenails |
Anacor |
synthetic small molecule |
Kerydin (tavaborole) |
Jul-14 |
For the treatment of unresectable or metastatic melanoma |
Merck |
biologic |
Keytruda (pembrolizumab) |
Sep-14 |
For the treatment of unresectable or metastatic melanoma |
Bristol-Myers Squibb |
biologic |
Opdivo (nivolumab) |
Dec-14 |
For the treatment of acute bacterial skin and skin structure infections |
The Medicines Company |
semisynthetic small molecule |
Orbactiv (oritavancin) |
Aug-14 |
For the treatment of moderate to severe plaque psoriasis |
Celgene |
small molecule |
Otezla (apremilast) |
Sep-14 |
For the treatment of acute bacterial skin and skin structure infections |
Cubist Pharmaceuticals |
small molecule |
Sivextro (tedizolid phosphate) |
Jun-14 |
For the treatment of inflammatory lesions of rosacea |
Galderma Labs |
semisynthetic small molecule |
Soolantra (ivermectin) cream, 1% |
Dec-14 |
Endocrinology 6 small molecules 4 biologics |
|
For the treatment of diabetes mellitus |
Mannkind |
biologic |
Afrezza (insulin human) Inhalation Powder |
Jun-14 |
For the treatment of hypogonadism |
Endo Pharmaceuticals |
small molecule |
Aveed (testosterone undecanoate) injection |
Mar-14 |
For the treatment of type II diabetes |
Bristol-Myers Squibb |
small molecule |
Farxiga (dapagliflozin) |
Jan-14 |
For the treatment of type II diabetes |
Boehringer Ingelheim |
small molecule |
Jardiance (empagliflozin) |
Aug-14 |
For the treatment of deficiency or absence of endogenous testosterone |
Trimel Pharmaceuticals |
small molecule |
Natesto, (testosterone) nasal gel |
May-14 |
For the treatment of acromegaly |
Novartis |
biologic |
Signifor LAR (pasireotide) |
Dec-14 |
For the treatment of type II diabetes mellitus |
GlaxoSmithKline |
biologic |
Tanzeum (albiglutide) |
Apr-14 |
To improve glycemic control in type II diabetics |
Eli Lilly |
biologic |
Trulicity (dulaglutide) |
Sep-14 |
For males with a deficiency or absence of endogenous testosterone |
Upsher-Smith |
synthetic small molecule |
Vogelxo (testosterone) gel |
Jun-14 |
For glycemic control in adults with type II diabetes |
AstraZeneca |
small molecule |
Xigduo XR (dapagliflozin + metformin hydrochloride) |
Oct-14 |
Family Medicine 21 small molecules 11 biologics |
|
For the treatment of diabetes mellitus |
Mannkind |
biologic |
Afrezza (insulin human) Inhalation Powder; |
Jun-14 |
For the treatment of hemophilia B |
Biogen Idec |
biologic |
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] |
Mar-14 |
For the treatment of asthma, |
GlaxoSmithKline |
small molecule |
Arnuity Ellipta (fluticasone furoate inhalation powder) |
Aug-14 |
For the treatment of hypogonadism |
Endo Pharmaceuticals |
small molecule |
Aveed (testosterone undecanoate) injection; |
Mar-14 |
For the treatment of insomnia |
Merck |
small molecule |
Belsomra (suvorexant) |
Aug-14 |
For the maintenance treatment of opioid dependence |
BioDelivery Sciences |
small molecule |
Bunavail (buprenorphine and naloxone) |
Jun-14 |
For chronic weight management |
Takeda Pharmaceuticals U.S.A |
small molecule |
Contrave (naltrexone HCl and bupropion HCl) |
Sep-14 |
For the treatment of acute bacterial skin and skin structure infections |
Durata Therapeutics |
semisynthetic small molecule |
Dalvance (dalbavancin) |
May-14 |
For the management of mild, moderate or severe pain |
Hospira |
small molecule |
Dyloject (diclofenac sodium) Injection |
Dec-14 |
For the treatment of adults with ulcerative colitis and Crohn’s disease |
Millenium Pharmaceuticals |
biologic |
Entyvio (vedolizumab) |
May-14 |
For the treatment of type II diabetes |
Bristol-Myers Squibb |
small molecule |
Farxiga (dapagliflozin) |
Jan-14 |
For the treatment of grass pollen-induced allergic rhinitis |
Merck |
biologic |
Grastek (Timothy Grass Pollen Allergen Extract) |
Apr-14 |
For the treatment of type II diabetes |
Boehringer Ingelheim |
small molecule |
Jardiance (empagliflozin) |
Aug-14 |
For the treatment of onychomycosis of the toenails |
Anacor |
small molecule |
Kerydin (tavaborole) |
Jul-14 |
For the treatment of bacterial vaginosis |
Actavis, Inc |
semisynthetic small molecule |
Metronidazole 1.3% Vaginal Gel |
Apr-14 |
For the treatment of congenital or acquired generalized lipodystrophy |
Bristol-Myers Squibb |
biologic |
Myalept (metreleptin for injection) |
Feb-14 |
For the treatment of deficiency or absence of endogenous testosterone |
Trimel Pharmaceuticals |
semisynthetic small molecule |
Natesto, (testosterone) nasal gel; |
May-14 |
For the treatment of neurogenic orthostatic hypotension |
Chelsea Therapeutics |
synthetic small molecule |
Northera (droxidopa) |
Feb-14 |
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, |
Greer Labs |
biologic |
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) |
Apr-14 |
For the treatment of adults with active psoriatic arthritis |
Celgene |
small molecule |
Otezla (apremilast) |
Mar-14 |
For the treatment of moderate to severe plaque psoriasis |
Celgene |
small molecule |
Otezla (apremilast) |
Sep-14 |
For the treatment of relapsing multiple sclerosis |
Biogen Idec |
biologic |
Plegridy (peginterferon beta-1a) |
Aug-14 |
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome |
Upsher-Smith Laboratories |
small molecule |
Qudexy XR (topiramate) |
Mar-14 |
For the treatment of short ragweed pollen-induced allergic rhinitis |
Merck |
biologic |
Ragwitek (Short Ragweed Pollen Allergen Extract) |
Apr-14 |
For the treatment of acute uncomplicated influenza in adults |
Biocryst |
small molecule |
Rapivab (peramivir injection) |
Dec-14 |
For chronic weight management |
Novo Nordisk |
biologic |
Saxenda (liraglutide [rDNA origin] injection) |
Dec-14 |
For the treatment of type II diabetes mellitus |
GlaxoSmithKline |
biologic |
Tanzeum (albiglutide) |
Apr-14 |
For the management of severe chronic pain |
Purdue Pharma |
small molecule |
Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets |
Jul-14 |
For the treatment of acute pain |
Iroko Pharmaceuticals |
small molecule |
Tivorbex (indomethacin) |
Feb-14 |
To improve glycemic control in type II diabetics |
Eli Lilly |
biologic |
Trulicity (dulaglutide) |
Sep-14 |
For the management of acute pain |
Mallinckrodt Pharmaceuticals |
small molecule |
Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release |
Mar-14 |
For the treatment of acute otitis externa |
Alcon |
small molecule |
Xtoro (finafloxacin otic suspension) 0.3%; |
Dec-14 |
For the treatment of complicated intra-abdominal and urinary tract infections |
Cubist Pharmaceuticals |
small molecule |
Zerbaxa (ceftolozane + tazobactam) |
Dec-14 |
Gastroenterology 3 small molecules 2 biologics |
|
For the prevention of chemotherapy-induced nausea and vomiting, |
Helsinn |
small molecule |
Akynzeo (netupitant and palonosetron) |
Oct-14 |
For the treatment of gastric cancer |
Eli Lilly |
biologic |
Cyramza (ramucirumab); |
Apr-14 |
For the treatment of adults with ulcerative colitis and Crohn’s disease, |
Millenium Pharmaceuticals |
biologic |
Entyvio (vedolizumab) |
May-14 |
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain |
AstraZeneca |
small molecule |
Movantik (naloxegol) |
Sep-14 |
For the treatment of complicated intra-abdominal and urinary tract infections |
Cubist Pharmaceuticals |
small molecule |
Zerbaxa (ceftolozane + tazobactam) |
Dec-14 |
Genetic Disease 2 small molecule 2 biologic |
|
For the treatment of hemophilia B |
Biogen Idec |
biologic |
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; |
Mar-14 |
For the treatment of certain adult patients with Gaucher disease type 1 |
Genzyme |
small molecule |
Cerdelga (eliglustat) |
Aug-14 |
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome |
Upsher-Smith Laboratories |
small molecule |
Qudexy XR (topiramate) |
Mar-14 |
For the treatment of Mucopolysaccharidosis type IVA |
BioMarin |
biologic |
Vimizim (elosulfase alfa) |
Feb-14 |
Healthy Volunteers 1 biologic |
|
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis |
Greer Labs |
biologic |
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) |
Apr-14 |
Hematology 4 small molecule 6 biologics |
|
For the treatment of hemophilia B |
Biogen Idec |
biologic |
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein]; |
Mar-14 |
For the treatment of relapsed or refractory peripheral T-cell lymphoma |
Spectrum Pharmaceuticals |
small molecule |
Beleodaq (belinostat) |
Jul-14 |
For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia |
Amgen |
biologic |
Blincyto (blinatumomab) |
Dec-14 |
For the treatment of hemophillia A |
Biogen Idec |
biologic |
Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ; |
Jun-14 |
For the treatment of chronic lymphocytic leukemia |
Pharmacyclics |
small molecule |
Imbruvica (ibrutinib) |
Feb-14 |
For the treatment of acquired hemophilia A |
Baxter |
biologic |
Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] |
Oct-14 |
For the treatment of hereditary angioedema |
Pharming Group |
biologic |
Ruconest (C1 esterase inhibitor [recombinant]) |
Jul-14 |
For the treatment of multicentric Castleman’s disease |
Janssen Biotech |
biologic |
Sylvant (siltuximab); |
Apr-14 |
For the reduction of thrombotic cardiovascular events |
Merck |
small molecule |
Zontivity (vorapaxar) |
May-14 |
For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma |
Gilead |
small molecule |
Zydelig (idelalisib) |
Jul-14 |
Immunology 3 small molecules 9 biologics |
|
For the treatment of adults with ulcerative colitis and Crohn’s disease |
Millenium Pharmaceuticals |
biologic |
Entyvio (vedolizumab) |
May-14 |
For the treatment of grass pollen-induced allergic rhinitis |
Merck |
biologic |
Grastek (Timothy Grass Pollen Allergen Extract); |
Apr-14 |
For the treatment of Primary Immunodeficiency |
Baxter |
biologic |
HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] |
Sep-14 |
For the treatment of chronic obstructive pulmonary disease |
GlaxoSmithKline |
small molecule |
Incruse Ellipta (umeclidinium inhalation powder); |
May-14 |
For the treatment of congenital or acquired generalized lipodystrophy |
Bristol-Myers Squibb |
biologic |
Myalept (metreleptin for injection) |
Feb-14 |
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis |
Greer Labs |
biologic |
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) |
Apr-14 |
For the treatment of adults with active psoriatic arthritis |
Celgene |
small molecule |
Otezla (apremilast) |
Mar-14 |
For the treatment of moderate to severe plaque psoriasis |
Celgene |
small molecule |
Otezla (apremilast) |
Sep-14 |
For the treatment of relapsing multiple sclerosis |
Biogen Idec |
biologic |
Plegridy (peginterferon beta-1a) |
Aug-14 |
For the treatment of short ragweed pollen-induced allergic rhinitis |
Merck |
biologic |
Ragwitek (Short Ragweed Pollen Allergen Extract) |
Apr-14 |
For the treatment of multicentric Castleman’s disease |
Janssen Biotech |
biologic |
Sylvant (siltuximab) |
Apr-14 |
For the treatment of HIV-1 |
ViiV HealthCare |
biologic |
Triumeq (abacavir, dolutegravir, and lamivudine); |
Aug-14 |
Infections and Infectious Diseases 13 small molecules 0 biologics |
|
For the treatment of acute bacterial skin and skin structure infections |
Durata Therapeutics |
semisynthetic small molecule |
Dalvance (dalbavancin) |
May-14 |
For the treatment of hepatitis C, |
Gilead |
small molecule |
Harvoni (ledipasvir and sofosbuvir) |
Oct-14 |
For the treatment of visceral, cutaneous and mucosal leishmaniasis |
Knight Therapeutics |
small molecule |
Impavido (miltefosine) |
Mar-14 |
For the treatment of onychomycosis of the toenails |
Valeant Pharmaceuticals |
small molecule |
Jublia (efinaconazole) 10% topical gel |
Jun-14 |
For the treatment of onychomycosis of the toenails |
Anacor |
small molecule |
Kerydin (tavaborole) |
Jul-14 |
For the treatment of bacterial vaginosis |
Actavis, Inc |
small molecule |
Metronidazole 1.3% Vaginal Gel |
Apr-14 |
For the treatment of acute bacterial skin and skin structure infections |
The Medicines Company |
semisynthetic small molecule |
Orbactiv (oritavancin) |
Aug-14 |
For the treatment of acute uncomplicated influenza in adults |
Biocryst |
small molecule |
Rapivab (peramivir injection) |
Dec-14 |
For the treatment of acute bacterial skin and skin structure infections |
Cubist Pharmaceuticals |
small molecule |
Sivextro (tedizolid phosphate) |
Jun-14 |
For the treatment of HIV-1 |
ViiV HealthCare |
small molecule |
Triumeq (abacavir, dolutegravir, and lamivudine) |
Aug-14 |
; For the treatment of genotype 1 chronic hepatitis C virus |
Abbvie |
small molecule |
Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets; |
Dec-14 |
For the treatment of acute otitis externa |
Alcon |
small molecule |
Xtoro (finafloxacin otic suspension) 0.3% |
Dec-14 |
For the treatment of complicated intra-abdominal and urinary tract infections |
Cubist Pharmaceuticals |
small molecule |
Zerbaxa (ceftolozane + tazobactam) |
Dec-14 |
Internal Medicine 1 small molecule |
|
For the treatment of certain adult patients with Gaucher disease type 1, |
Genzyme |
small molecule |
Cerdelga (eliglustat); |
Aug-14 |
Musculoskeletal 2 small molecule 3 biologic |
|
For the treatment of relapsing multiple sclerosis |
Genzyme |
biologic |
Lemtrada (alemtuzumab) |
Nov-14 |
For the treatment of adults with active psoriatic arthritis |
Celgene |
small molecule |
Otezla (apremilast) |
Mar-14 |
For the treatment of relapsing multiple sclerosis |
Biogen Idec |
biologic |
Plegridy (peginterferon beta-1a) |
Aug-14 |
For the management of severe chronic pain |
Purdue Pharma |
small molecule |
Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets |
Jul-14 |
For the treatment of Mucopolysaccharidosis type IVA |
BioMarin |
biologic |
Vimizim (elosulfase alfa) |
Feb-14 |
Nephrology 3 small molecule |
|
For the treatment of hyperphosphatemia in patients with chronic kidney disease |
Keryx Biopharma |
small molecule |
Auryxia (Ferric citrate) |
Sep-14 |
For the treatment of hepatitis C |
Gilead |
small molecule |
Harvoni (ledipasvir and sofosbuvir) |
Oct-14 |
For the treatment of genotype 1 chronic hepatitis C virus |
Abbvie |
small molecule |
Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets |
Dec-14 |
Neurology 10 small molecules 2 biologics |
|
For the treatment of insomnia |
Merck |
small molecule |
Belsomra (suvorexant) |
Aug-14 |
For the management of mild, moderate or severe pain |
Hospira |
small molecule |
Dyloject (diclofenac sodium) Injection |
Dec-14 |
For the treatment of non-24-hour sleep-wake disorder in the totally blind |
Vanda Pharmaceuticals |
small molecule |
Hetlioz (tasimelteon) |
Jan-14 |
For the treatment of relapsing multiple sclerosis |
Genzyme |
biologic |
Lemtrada (alemtuzumab) |
Nov-14 |
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain |
AstraZeneca |
small molecule |
Movantik (naloxegol) |
Sep-14 |
For the treatment of moderate to severe dementia of the Alzheimer’s type |
Forest Laboratories |
small molecule |
Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride) |
Dec-14 |
For the treatment of neurogenic orthostatic hypotension |
Chelsea Therapeutics |
small molecule |
Northera (droxidopa) |
Feb-14 |
For the treatment of relapsing multiple sclerosis |
Biogen IDEC |
biologic |
Plegridy (peginterferon beta-1a) |
Aug-14 |
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome |
Upsher-Smith Laboratories |
small molecule |
Qudexy XR (topiramate) |
Mar-14 |
For the management of severe chronic pain |
Purdue Pharma |
small molecule |
Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets |
Jul-14 |
For the treatment of acute pain |
Iroko Pharmaceuticals |
small molecule |
Tivorbex (indomethacin) |
Feb-14 |
For the management of acute pain |
Mallinckrodt Pharmaceuticals |
small molecule |
Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release |
Mar-14 |
Nutrition and Weight Loss 2 small molecule 3 biologics |
|
For chronic weight management |
Takeda Pharmaceuticals U.S.A |
small molecule |
Contrave (naltrexone HCl and bupropion HCl) |
Sep-14 |
For the treatment of type II diabetes |
Boehringer Ingelheim |
small molecule |
Jardiance (empagliflozin) |
Aug-14 |
For chronic weight management |
Novo Nordisk |
biologic |
Saxenda (liraglutide [rDNA origin] injection) |
Dec-14 |
For the treatment of type II diabetes mellitus |
GlaxoSmithKline |
biologic |
Tanzeum (albiglutide) |
Apr-14 |
To improve glycemic control in type II diabetics |
Eli Lilly |
biologic |
Trulicity (dulaglutide) |
Sep-14 |
Obstetrics/Gynecology (Women’s Health) 2 small molecule |
|
For the treatment of previously treated BRCA mutated advanced ovarian cancer, |
AstraZeneca |
small molecule |
Lynparza (olaparib) |
Dec-14 |
For the treatment of bacterial vaginosis |
Actavis, Inc |
small molecule |
Metronidazole 1.3% Vaginal Gel |
Apr-14 |
Oncology 6 small molecules 4 biologics |
|
For the prevention of chemotherapy-induced nausea and vomiting |
Helsinn |
small molecule |
Akynzeo (netupitant and palonosetron) |
Oct-14 |
For the treatment of relapsed or refractory peripheral T-cell lymphoma |
Spectrum Pharmaceuticals |
small molecule |
Beleodaq (belinostat) |
Jul-14 |
For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia |
Amgen |
biologic |
Blincyto (blinatumomab) |
Dec-14 |
For the treatment of gastric cancer |
Eli Lilly |
biologic |
Cyramza (ramucirumab) |
Apr-14 |
For the treatment of chronic lymphocytic leukemia |
Pharmacyclics |
small molecule |
Imbruvica (ibrutinib) |
Feb-14 |
For the treatment of unresectable or metastatic melanoma |
Merck |
biologic |
Keytruda (pembrolizumab) |
Sep-14 |
For the treatment of previously treated BRCA mutated advanced ovarian cancer |
AstraZeneca |
small molecule |
Lynparza (olaparib) |
Dec-14 |
For the treatment of unresectable or metastatic melanoma |
Bristol-Myers Squibb |
biologic |
Opdivo (nivolumab) |
Dec-15 |
For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma |
Gilead |
small molecule |
Zydelig (idelalisib) |
Jul-14 |
For the treatment of ALK+ metastatic non-small cell lung cancer |
Novartis |
small molecule |
Zykadia (ceritinib) |
Apr-14 |
Ophthalmology 2 small molecule 1 biologic |
|
For the treatment of non-24-hour sleep-wake disorder in the totally blind |
Vanda Pharmaceuticals |
small molecule |
Hetlioz (tasimelteon) |
Jan-14 |
For use during eye surgery to prevent intraoperative miosis and reduce post-operative pain |
Omeros |
small molecule |
Omidria (phenylephrine and ketorolac injection) |
Jun-14 |
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis |
Greer Labs |
biologic |
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) |
Apr-14 |
Orthopedics/Orthopedic Surgery 1 small molecule |
|
For the treatment of adults with active psoriatic arthritis |
Celgene |
small molecule |
Otezla (apremilast) |
Mar-14 |
Otolaryngology (Ear, Nose, Throat) 1 small molecule 3 biologic |
|
For the treatment of grass pollen-induced allergic rhinitis |
Merck |
biologic |
Grastek (Timothy Grass Pollen Allergen Extract) |
Apr-14 |
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis |
Greer Labs |
biologic |
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) |
14-Apr |
For the treatment of short ragweed pollen-induced allergic rhinitis |
Merck |
biologic |
Ragwitek (Short Ragweed Pollen Allergen Extract) |
Apr-14 |
For the treatment of acute otitis externa |
Alcon |
small molecule |
Xtoro (finafloxacin otic suspension) 0.3% |
Dec-14 |
Pediatrics/Neonatology 2 small molecule 2 biologics |
|
; For the treatment of hemophilia B |
Biogen Idec |
biologic |
Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] |
Mar-14 |
For the treatment of asthma |
GlaxoSmithKline |
small molecule |
Arnuity Ellipta (fluticasone furoate inhalation powder) |
Aug-14 |
For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome |
Upsher-Smith Laboratories |
small molecule |
Qudexy XR (topiramate) |
Mar-14 |
For the treatment of Mucopolysaccharidosis type IVA |
BioMarin |
biologic |
Vimizim (elosulfase alfa) |
Feb-14 |
Pharmacology/Toxicology 3 small molecule 1 biologic |
|
For the prevention of chemotherapy-induced nausea and vomiting |
Helsinn |
small molecule |
Akynzeo (netupitant and palonosetron) |
Oct-14 |
For the maintenance treatment of opioid dependence |
BioDelivery Sciences |
small molecule |
Bunavail (buprenorphine and naloxone) |
Jun-14 |
For the treatment of opiod-induced constipation in adults with chronic non-cancer pain |
AstraZeneca |
small molecule |
Movantik (naloxegol) |
Sep-14 |
For the treatment of congenital or acquired generalized lipodystrophy |
Bristol-Myers Squibb |
biologic |
Myalept (metreleptin for injection) |
Feb-14 |
Psychiatry/Psychology 1 small molecule |
|
For the maintenance treatment of opioid dependence |
BioDelivery Sciences |
small molecule |
Bunavail (buprenorphine and naloxone) |
Jun-14 |
Pulmonary/Respiratory Diseases 6 small molecule 3 biologic |
|
For the treatment of asthma |
GlaxoSmithKline |
small molecule |
Arnuity Ellipta (fluticasone furoate inhalation powder) |
Aug-14 |
For the treatment of idiopathic pulmonary fibrosis |
InterMune |
small molecule |
Esbriet (pirfenidone) |
Oct-14 |
For the treatment of grass pollen-induced allergic rhinitis |
Merck |
biologic |
Grastek (Timothy Grass Pollen Allergen Extract) |
Apr-14 |
For the treatment of chronic obstructive pulmonary disease |
GlaxoSmithKline |
small molecule |
Incruse Ellipta (umeclidinium inhalation powder) |
May-14 |
For the treatment of idiopathic pulmonary fibrosis |
Boehringer Ingelheim |
small molecule |
Ofev (nintedanib) |
Oct-14 |
For the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis |
Greer Labs |
biologic |
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) |
Apr-14 |
For the treatment of short ragweed pollen-induced allergic rhinitis |
Merck |
biologic |
Ragwitek (Short Ragweed Pollen Allergen Extract) |
Apr-14 |
For the treatment of chronic obstructive pulmonary disease |
Boehringer Ingelheim |
small molecule |
Striverdi Respimat (olodaterol) |
Jul-14 |
For the treatment of ALK+ metastatic non-small cell lung cancer |
Novartis |
small molecule |
Zykadia (ceritinib) |
Apr-14 |
Rheumatology 1 small molecule |
|
For the treatment of adults with active psoriatic arthritis |
Celgene |
small molecule |
Otezla (apremilast) |
Mar-14 |
Sleep 1 small molecule |
|
For the treatment of non-24-hour sleep-wake disorder in the totally blind |
Vanda Pharmaceuticals |
small molecule |
Hetlioz (tasimelteon) |
Jan-14 |
Urology 1 small molecule |
|
For the treatment of complicated intra-abdominal and urinary tract infections |
Cubist Pharmaceuticals |
small molecule |
Zerbaxa (ceftolozane + tazobactam) |
Dec-14 |
It is almost impossible to set up a conspiracy against big pharma’s abusive practices.Every avenue their high priced lawyers can think of to stop budding conspiracies has been blocked by law where possible. One possible road might be to do research and development in other countries outside US legal juristiction, however most drugs without FDA approval can and are stopped at the border and confiscated even if as in Canada the same drug produced in the US is being manufactured in Canada.Almost certainly Cisplatin is under patent in the US and the patent holder has the right to refuse the use of the drug for any reason they want, including being used in this cluster bomb drug. The manufacturer is almost certainly making huge profits from selling Cisplatin and I doubt they want to see a cheap drug cure many cancers. I guess the only way to go is to try and turn to a country like India.A number of cancer drugs were being sold by US patent holders at wholesale prices that were to high for most Indians. The government of India refused to allow these companies to patent their medicines in India and forced them to license the drugs and much cheaper prices.Most US patents are not operative in India, they can produce US style insulin pumps at a fraction of our cost as they can in China and Vietnam or Mexico. It would be difficult to send these pumps to buyers in the US from India but by shipping them from another country, say Canada or Mexico most would make it past customs. As for Cancer treatment, India and china have some very fine trained biochemist and doctors, who could easily apply many of the immunological treatments against cancer. All arms of the immune system have been used to produce miracle treatments that have cured some patients that were on their death beds.The treatments can be tested carefully in these countries, and improved by any methods including some I have suggested.By advertising in the US to cancer patients that they can inexpensively have these working treatments cheaply as a medical tourist, it is only a matter of time before they will cure the disease wholesale and break the medical industrial complex down. As far as generics that are not being produced here, by setting up a non profit corporation that produces any and all drugs that come off patent as a goal, at the cheapest price less a reasonable markup for cost of manufacture etc. one by one they will end the abuse of not producing or overpricing generics.
………
Significance
Successively overcoming a series of biological barriers that cancer nanotherapeutics would encounter upon intravenous administration is required for achieving positive treatment outcomes. A hurdle to this goal is the inherently unfavorable tumor penetration of nanoparticles due to their relatively large sizes. We developed a stimuli-responsive clustered nanoparticle (iCluster) and justified that its adaptive alterations of physicochemical properties (e.g. size, zeta potential, and drug release rate) in accordance with the endogenous stimuli of the tumor microenvironment made possible the ultimate overcoming of these barriers, especially the bottleneck of tumor penetration. Results in varying intractable tumor models demonstrated significantly improved antitumor efficacy of iCluster than its control groups, demonstrating that overcoming these delivery barriers can be achieved by innovative nanoparticle design.
http://www.pnas.org/content/early/2016/03/23/1522080113.full