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The Lead

New Data on Boehringer Ingelheim's COPD Treatment

May 21, 2015 1:30 pm | News | Comments

Boehringer Ingelheim announced new data analyses from the pivotal Phase III TONADO 1&2 studies (NCT01431274/NCT01431287), which explored the efficacy and safety of investigational tiotropium/olodaterol delivered via the Respimat inhaler for chronic obstructive pulmonary disease (COPD) compared to the individual components (tiotropium and olodaterol delivered by the RESPIMAT inhaler) alone. Read more...

Novartis Announces COPD Phase 3 Results

May 21, 2015 1:23 pm | News | Comments

Today, Novartis announced for the first time detailed results from its phase III EXPEDITION...

Lakewood-Amedex: Novel Class Of Antimicrobials Kills Multidrug Resistant-Tuberculosis

May 20, 2015 12:51 pm | News | Comments

Lakewood-Amedex Inc., a leading developer of novel anti-infective pharmaceuticals, announced...

FDA Approves First and Only Four-Times-A-Year Schizophrenia Treatment

May 20, 2015 12:44 pm | News | Comments

There's a new treatment option for schizophrenia – Invega Trinza (three-month paliperidone ...

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Johnson & Johnson Expects Lucrative Return on Drug Pipeline

May 20, 2015 12:35 pm | by Associated Press | News | Comments

Johnson & Johnson expects a lucrative return from its pharmaceutical business, with plans to seek approval by 2019 for more than 10 new products, each with the potential to top $1 billion in annual sales. Read more...

HedgePath Pharmaceuticals To Receive $2.5 Million in Funding From Mayne Pharma

May 19, 2015 12:36 pm | News | Comments

HedgePath Pharmaceuticals, Inc., a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today that it has entered into a definitive agreement with an affiliate of Mayne Pharma Group Limited under which Mayne Pharma will invest $2.5 million in HPPI in a private common stock and warrant financing.  Read more...

Eleven Biotherapeutics: Phase 3 Study Results of EBI-005 in Dry Eye Disease

May 18, 2015 11:38 am | News | Comments

Study did not achieve primary endpoints; no statistical difference between EBI-005 and vehicle control. Read more....

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Specialty Drugs Spotlight: The Week’s Top Pharma News

May 15, 2015 2:25 pm | by Stephanie Guzowski, Editor | News | Comments

From pharma collaborations on therapies to fallouts over failed clinical trials, here are your headlines this week. Read more...

Trial Explores Rivaroxaban in Catheter Ablation

May 15, 2015 1:01 pm | News | Comments

Janssen Pharmaceuticals, Inc. and its development partner, Bayer HealthCare, today announced results from the VENTURE-AF trial. The study explored the potential of once-daily Xarelto (rivaroxaban) as an alternative to vitamin K antagonists (VKA), used to reduce the risk of blood clots, in people with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation. Read more...

Tonix Pharmaceuticals Launches Phase 3 Study in Fibromyalgia

May 15, 2015 12:53 pm | News | Comments

Tonix Pharmaceuticals Holding Corp. announced that it has begun a Phase 3 clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablet, 2.8 mg) in fibromyalgia, having recently randomized the first patient. The study is expected to enroll approximately 500 patients with fibromyalgia at approximately 35 clinical centers in the U.S. Read more...

Early Data Release Ends Obesity Drug Study

May 13, 2015 12:50 pm | by Stephanie Guzowski, Editor | News | Comments

A safety study of obesity drug Contrave has been terminated after Orexigen Therapeutics released early, misleading trial data, say researchers. Takeda Pharmaceutical is seeking to end its collaboration with Orexigen. Read more...

Orexigen: Statement on Termination of Study, Updates on Contrave Collaboration with Takeda

May 13, 2015 12:39 pm | News | Comments

Orexigen Therapeutics, Inc. Tuesday issued the following statement regarding the termination of the Light Study a cardiovascular (CV) outcomes trial that compared the obesity drug Contrave. Read more...

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FDA Panel Backs Vertex Combination Pill for Cystic Fibrosis

May 13, 2015 10:11 am | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

Federal health advisers on Tuesday recommended approval for an experimental combination drug to treat cystic fibrosis, despite unresolved questions about the benefit of one of the pill's two ingredients. Read more...

AbbVie Receives Breakthrough Designation for Cancer Drug

May 7, 2015 11:40 am | by Stephanie Guzowski, Editor | News | Comments

The U.S. Food and Drug Administration has granted breakthrough therapy designation for its leukemia drug, venetoclax, to speed up the regulatory review process. Read more...

Kymab Raises $90M to Support Monoclonal Antibody Pipeline

May 7, 2015 8:26 am | by Ryan Bushey, Associate Editor | Articles | Comments

The Bill and Melinda Gates Foundation was one of the primary investors this round. Read more...

Codeine-Based Cough Suppressant Will be Another Choice for Next Cold-Flu Season

May 6, 2015 8:50 am | by Seth Augenstein, Digital Reporter | News | Comments

A new, codeine-based cough suppressant produced by a British pharmaceutical company was approved by the U.S. Food and Drug Administration. Read more...

Kowa Pharmaceuticals: Pitavastatin Safe Compared with Placebo, Other Statins

May 5, 2015 11:39 am | News | Comments

Kowa Pharmaceuticals America, Inc., announced that the results of a meta-analysis of 15 randomized, controlled clinical trials, to assess the effects of Livalo (pitavastatin) on glycemic parameters and new-onset diabetes (NOD) in non-diabetic individuals were presented as a late-breaking abstract at the 83rd European Atherosclerosis Society (EAS) Congress held in Glasgow, UK. Read more..

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Hepatitis C Therapy Clears Virus in 93% of Patients in BMS-Funded Trial

May 5, 2015 11:11 am | by Stephanie Guzowski, Editor | Articles | Comments

Bristol-Myers Squibb is trying its hand at its own combination of drugs — daclatasvir, asunaprevir, and beclabuvir. A 12-week dose of the investigational three-drug hepatitis C combination cleared the virus in 93 percent with liver cirrhosis who hadn’t previously been treated, finds a study, published today in The Journal of the American Medical Association (JAMA). Read more...

Gilead's Hepatitis C Drugs Made About $4.45B in Sales in Q1

May 4, 2015 3:06 pm | by Ryan Bushey, Associate Editor | Articles | Comments

This news greatly surpassed analyst expectations. Read more...

Multiple Types of Resistance to New Lung Cancer Drug Identified

May 4, 2015 12:09 pm | by Dana-Farber Cancer Institute | News | Comments

After identifying three different types of resistance to a promising investigational lung cancer drug in a phase 1 trial, a team of researchers led by Dana-Farber Cancer Institute scientists say new targeted inhibitors and combinations are urgently needed to stay ahead of tumors' constant and varied molecular shape-shifting. Read more...

Braeburn Expands Pipeline to Include Two Schizophrenia Treatments

May 1, 2015 11:47 am | News | Comments

Braeburn Pharmaceuticals announced today that it has expanded its current therapeutic focus beyond addiction and pain to include schizophrenia and other serious psychiatric disorders. Read more..

AIT's Cystic Fibrosis Treatment Granted European Orphan Drug Designation

May 1, 2015 9:20 am | News | Comments

Advanced Inhalation Therapies Ltd (AIT), a leading anti-microbial therapeutic company, announced that the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, granted orphan medicinal product designation to AIT-CF, the Company's proprietary high dose formulation of nitric oxide (NO), for the treatment of cystic fibrosis. Read more...

AOP Orphan Launches Lojuxta to the Austrian Market

April 30, 2015 4:45 pm | News | Comments

The Austrian pharmaceutical company AOP Orphan, a European pioneer in the field of rare diseases, is launching Lojuxta into the Austrian market. Lojuxta was authorized by the EMA (European Medical Agency) in July 2013. Read more...

FDA Approves Injection for Melting Away Double-Chin Fat

April 30, 2015 1:50 pm | by Associated Press | News | Comments

The Food and Drug Administration said Wednesday it approved an injection designed to melt away double-chin fat. Read more...

The Prospect of Drugs to Treat Gluten Sensitivity

April 30, 2015 1:31 pm | by Stephanie Guzowski, Editor | News | Comments

Pharmaceutical companies are working to develop treatments as a first line of defense against gluten-sensitive symptoms — including abdominal pain, bloating, diarrhea, headaches and fatigue. Read more...

FDA Accepts Otonomy's NDA for Middle Ear Effusion

April 29, 2015 12:27 pm | News | Comments

​Otonomy, Inc. a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that its New Drug Application (NDA) for the approval of AuriProTM. Read more...

FDA Accepts BLA For Biogen, AbbVie MS Treatment

April 29, 2015 12:14 pm | News | Comments

Today Biogen and AbbVie announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ Biologics License Application (BLA) requesting marketing approval of ZINBRYTA (daclizumab high-yield process) for relapsing forms of multiple sclerosis (MS). Read more...

FDA to Review Amgen's High Cholesterol Drug

April 29, 2015 11:58 am | News | Comments

Amgen announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) will review data supporting the Company's Biologics License Application (BLA) for RepathaTM (evolocumab) for the treatment of high cholesterol at a meeting on June 10, 2015. Read more...

Lilly's Cyramza Receives Fourth FDA Approval

April 27, 2015 12:07 pm | News | Comments

Eli Lilly and Company has received its fourth U.S. Food and Drug Administration (FDA) approval for Cyramza (ramucirumab). Read more...

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