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The Lead

Regeneron, Sanofi: FDA Accepts BLA for Hyperchoestrolemia Drug

January 26, 2015 10:20 am | by Sanofi | News | Comments

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for PraluentTM (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015. Read more...

FDA Approves Prestalia's Hypertension Treatment

January 26, 2015 10:00 am | by Prestalia | News | Comments

Symplmed Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved...

Meningococcal Vaccine Gets FDA Approval

January 26, 2015 9:44 am | by FDA | News | Comments

The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive...

FDA Clears Roche's MRSA/SA Test

January 26, 2015 9:32 am | by Roche | News | Comments

Roche announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for...

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FDA Approves Novartis' Psoriasis Drug

January 22, 2015 11:44 am | by Novartis | News | Comments

Novartis announced the US Food and Drug Administration (FDA) has approved Cosentyx™ (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.                           

Pharmalink: Open IND Application for IgA Nephropathy

January 21, 2015 9:59 am | by Pharmalink | News | Comments

Pharmalink AB, a specialty pharma company focused on orphan and niche products, announces that its IND for Nefecon is now open with the US Food & Drug Administration (FDA). Read more...                                  

Boehringer Ingelheim: Inhalation Spray Available in U.S.

January 21, 2015 9:53 am | by Boehringer Ingelheim | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced that Spiriva Respimat(tiotropium bromide) Inhalation Spray is now available by prescription through retail pharmacies across the United States. Read more...                                                         

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Bausch + Lomb Introduces New Optical Software

January 21, 2015 9:47 am | by Valeant Pharmaceuticals | News | Comments

Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Bausch + Lomb, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an advanced Swept Source OCT (Optical Coherence Tomography) imaging system and updated software for its VICTUS Femtosecond Laser Platform that will provide surgeons with a new, redesigned interface. Read more...

Aetna Picks Gilead Sciences Hepatitis C Drugs Over Abbvie's

January 20, 2015 12:01 pm | by Associated Press | News | Comments

Insurer Aetna has made new hepatitis C drugs from Gilead Sciences Inc. preferred treatments for customers with the liver-destroying virus. Read more...                                    

Mylan Launches Generic Hepatitis B Treatment

January 16, 2015 11:37 am | by Mylan | News | Comments

Mylan Inc. announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's Epivir-HBV. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Read more...

EGFR Inhibitor Extends OS Compared With Chemo

January 13, 2015 11:51 am | by Boehringer Ingelheim | News | Comments

Boehringer Ingelheim announced overall survival (OS) results were published in The Lancet Oncology from two independent Phase 3 clinical trials (LUX-Lung 3 and LUX-Lung 6) in epidermal growth factor receptor (EGFR) mutation-positive patients with metastatic non-small cell lung cancer (NSCLC). Read more...

Clementia Pharmaceuticals: New Site for FOP Trial

January 12, 2015 11:15 am | News | Comments

Clementia Pharmaceuticals, Inc. announced the opening of a new site in Paris, France for the Phase 2 clinical trial of palovarotene, the company's lead product candidate for the treatment of fibrodysplasia ossificans progressiva (FOP).  Read more...      

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Regeneron, Sanofi: Positive Results in Hypercholesterolemia Trials

January 9, 2015 11:28 am | by Sanofi | News | Comments

Regeneron Pharmaceuticals, Inc. and Sanofi announced that two new ODYSSEY trials, which are the first Phase 3 trials to assess alirocumab administered every four weeks, met their primary efficacy endpoints. Read more...               

FDA Approves Impax Pharmaceutical's Parkinson's Treatment

January 9, 2015 11:21 am | by Impax Pharmaceuticals | News | Comments

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. Read more...

WHO Approves Meningitis A Vaccine for Infants

January 9, 2015 10:43 am | by Meningitis Vaccine Project | News | Comments

The World Health Organization (WHO) has opened the door to routine immunization of infants in sub-Saharan Africa by approving for use an innovative and affordable vaccine that has all but rid the meningitis belt of a major cause of deadly epidemics. Read more...

2 Leading Ebola Vaccines Appear Safe, Further Tests Starting

January 9, 2015 8:51 am | by Maria Cheng - AP Medical Writer | News | Comments

The World Health Organization said the two leading Ebola vaccines appear safe and will soon be tested in healthy volunteers in West Africa. Read more...                  

Pfizer's New Cancer Drug May Get Early Approval

January 8, 2015 1:27 pm | by Linda A. Johnson - AP Business Writer | News | Comments

Analysts believe Pfizer's new cancer drug appears poised for approval within a few months and could be a new blockbuster. Read more...                    

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Pharming and Salix: HAE Trial's First Patient Treated

January 8, 2015 10:26 am | by Ruconest | News | Comments

Pharming Group NV and Salix Pharmaceuticals, Ltd. announced that the first patient was treated in their Phase 2 clinical study of Ruconest, (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg, for prophylaxis in patients with hereditary angioedema (HAE).  Read more...

Eisai Responds: Decision to Remove Halaven Therapy from CDF

January 8, 2015 10:03 am | by Eisai | News | Comments

Eisai announced its extreme disappointment that the National Cancer Drugs Fund (NCDF) panel has apparently made the decision to remove Halaven(eribulin) from the Cancer Drugs Fund (CDF), following a process of arbitrary evaluation. Read more...

ContraVir Pharmaceuticals: FDA Meeting About Antiviral Drug Trial

January 7, 2015 10:51 am | News | Comments

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced that it has been granted a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss its proposal for the design of a Phase 3 trial of ContraVir's lead antiviral candidate, FV-100.  

Gilead Climbs After CVS Health Favors Its Hep C Drugs

January 5, 2015 2:56 pm | by Associated Press | News | Comments

Shares of Gilead Sciences climbed on a rough day for the overall market after CVS Health said Gilead's pricey hepatitis C treatments will become a preferred treatment on several of its pharmacy benefits management plans. Read more...

Aethlon Medical Announces Approval of Ebola Treatment Protocol

January 2, 2015 10:16 am | News | Comments

Aethlon Medical, Inc. (AEMD), the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, today announced that the United States Food and Drug Administration (FDA) has approved a clinical protocol to treat Ebola-infected individuals in the U.S. with the Aethlon Hemopurifier. 

FDA Approves sBLA for CLL Treatment

December 26, 2014 9:54 am | by Associated Press | News | Comments

Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for Gazyva in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL). read more...

Spectrum Pharmaceuticals: Submission of NDA for Multiple Myeloma

December 26, 2014 9:47 am | by Associated Press | News | Comments

Ligand Pharmaceuticals Incorporated announces that its partner Spectrum Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Captisol-enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. Read more...

Researchers Take 'First Baby Step' Toward Anti-Aging Drug

December 26, 2014 9:11 am | by Science Translation Medicine | News | Comments

Researchers could be closing in on a "fountain of youth" drug that can delay the effects of aging and improve the health of older adults, a new study suggests. Seniors received a significant boost to their immune systems when given a drug that targets a genetic signaling pathway linked to aging and immune function, researchers with the drug maker Novartis report. Read more...

FDA Approves Myriad's PARP Inhibitor for Ovarian Cancer

December 19, 2014 2:08 pm | News | Comments

Myriad Genetics, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza (olaparib). Read more...

Combo Drug Therapy Doubles Positive Effect for Women with Breast Cancer

December 19, 2014 1:20 pm | News | Comments

In a groundbreaking study that offers new hope for women with advanced breast cancer, UCLA researchers published final clinical trial results that showed the amount of time women with advanced breast cancer were on treatment without their cancer worsening was effectively doubled when they took the experimental drug palbociclib. Read more...

10 Up-and-Coming Healthcare Medical Innovations

December 18, 2014 12:10 pm | by Christina Jakubowski, Managing Editor, Bioscience Technology | Articles | Comments

The Cleveland Clinic recently unveiled their annual Top 10 Medical Innovations for 2015– a list that casts an optimistic light on up-and-coming healthcare advances that may reach consumers next year. Their number one? Read more...                         

Inovio Initiates DNA Immunotherapy Trial for Cancers

December 18, 2014 10:48 am | News | Comments

Inovio Pharmaceuticals, Inc. announced it has initiated a phase 1 trial of its hTERT DNA immunotherapy (INO-1400) alone or in combination with Inovio's 1L-12 immune activator (INO-9012) in adults with breast, lung, or pancreatic cancer at high risk of relapse after surgery and other cancer treatments. Read more...

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