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FDA Removes Partial Clinical Hold on OncoMed Pharmaceuticals' Vantictumab

August 28, 2014 8:40 am | News | Comments

Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer. 

Pfizer’s Vaccine Candidate for Clostridium difficile Receives FDA Fast Track Designation

August 28, 2014 8:10 am | News | Comments

Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C....

FDA Grants Amgen Priority Review Designation for Ivabradine

August 27, 2014 11:53 am | News | Comments

Amgen announced that the FDA has granted priority review designation for ivabradine for the...

Acura Pharmaceuticals Receives NIH Grant to Fund Limitx Novel Abuse Deterrent Technology

August 27, 2014 8:40 am | News | Comments

Acura Pharmaceuticals has been awarded a $300,000 grant by the National Institute On Drug Abuse...

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European Commission Approves Bristol-Myers Squibb’s Daklinza

August 27, 2014 8:20 am | News | Comments

Bristol-Myers Squibb Company today announced that the European Commission has approved Daklinza (daclatasvir) for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Ligand Partner GlaxoSmithKline Receives FDA Approval for Promacta®/Revolade™

August 27, 2014 8:07 am | News | Comments

Ligand Pharmaceuticals Incorporated announced that its partner GlaxoSmithKline has received approval of a supplemental New Drug Application (sNDA) for the once-daily use of Promacta®/Revolade™ (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).

Fresenius Kabi Receives FDA Approval for Kabiven® and Perikabiven®

August 26, 2014 9:19 am | News | Comments

Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration for Kabiven ® and Perikabiven ®, parenteral nutrition (PN) products in a three-chamber bag – the only container of its kind available in the United States.

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PhRMA Launches New Innovation Hub to Highlight Biopharmaceutical Innovation

August 26, 2014 9:08 am | News | Comments

PhRMA launched a new Innovation Hub to showcase the latest data and research on innovation in the biopharmaceutical industry. The new Innovation Hub, accessible via www.Innovation.org, provides easy access to PhRMA resources related to the R&D process, the biopharmaceutical pipeline, and progress fighting diseases.

CDC Director: Ebola Has 'Upper Hand'

August 26, 2014 8:47 am | by JONATHAN PAYE-LAYLEH, Associated Press | News | Comments

The Ebola virus has the "upper hand" in an outbreak that has killed more than 1,400 people in West Africa, a top American health official said, adding that experts have the tools to stop it. Dr. Tom Frieden, the director of the U.S. Centers for Disease Control and Prevention, is visiting Liberia, Sierra Leone and Guinea, the three hardest hit countries, this week.

UN Health Agency: E-Cigarettes Must Be Regulated

August 26, 2014 8:43 am | by JOHN HEILPRIN, Associated Press | News | Comments

The U.N. health agency recommended Tuesday that nations regulate electronic cigarettes and ban them from use indoors until the exhaled vapor is proven not to harm bystanders.In a report to its 194 member nations, the World Health Organization also called for a ban on sales to minors of the popular nicotine-vapor products.

FDA Names Potential Insys Treatment an Orphan Drug

August 26, 2014 8:40 am | by The Associated Press | News | Comments

A potential treatment from Insys Therapeutics Inc. for an aggressive form of brain cancer will have some marketing exclusivity if regulators eventually approve it. The Food and Drug Administration has granted an orphan drug designation to the Chandler, Arizona, drugmaker's pharmaceutical cannabidiol, or CBD.

CDC Director to Visit Ebola Outbreak Countries

August 25, 2014 9:01 am | by MIKE STOBBE, AP Medical Writer | News | Comments

Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, is scheduled to visit Liberia, Sierra Leone and Guine. A CDC spokesman Friday said Frieden wants to meet the African and international health leaders trying to control the outbreak, and to hear what help they need.

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Alkermes Submits New Drug Application to FDA for Aripiprazole Lauroxil for Treatment of Schizophrenia

August 25, 2014 8:44 am | News | Comments

Alkermes today announced that it has submitted a New Drug Application to the FDA for approval of aripiprazole lauroxil, the company’s investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia.

FDA Approves Iroko Pharmaceuticals’ ZORVOLEX for Management of Osteoarthritis Pain

August 25, 2014 8:23 am | News | Comments

Iroko Pharmaceuticals, LLC,  announced today the United States Food and Drug Administration (FDA) has approved ZORVOLEX (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.   

Japan Ready to Offer Flu Drug for Ebola Treatment

August 25, 2014 8:16 am | by MARI YAMAGUCHI, Associated Press | News | Comments

Japan said Monday it is ready to provide a Japanese-developed anti-influenza drug as a possible treatment for the rapidly expanding Ebola outbreak. Chief Cabinet Secretary Yoshihide Suga said that Japan can offer favipiravir, developed by a subsidiary of Fujifilm Holdings Corp., at any time at the request of the World Health Organization.

Report: CDC Scientist Kept Quiet About Flu Blunder

August 15, 2014 2:56 pm | by MIKE STOBBE, AP Medical Writer | News | Comments

A government scientist kept silent about a potentially dangerous lab blunder and revealed it only after workers in another lab noticed something fishy, according to an internal investigation. The accident happened in January at the headquarters of the Centers for Disease Control and Prevention in Atlanta.

WHO: Use of Untested Drugs for Ebola Should Be Limited to Best Candidates

August 15, 2014 2:49 pm | by Helen Branswell, The Canadian Press | News | Comments

The global health agency says it is only interested in pursuing therapies which have been shown to combat Ebola infection in animal studies as it helps countries prepare to use medical tools that are untested in humans.     

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Turkish Man Pleads Guilty to Importing Illegal Cancer Drugs

August 15, 2014 2:41 pm | News | Comments

Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.          

FDA Accepts CorMedix’ Pivotal Phase 3 Study Protocol

August 15, 2014 8:57 am | News | Comments

CorMedix announced that the FDA has agreed with the design of their pivotal Phase III protocol for Neutrolin in Hemodialysis patients, and the company plans to submit the IND for Neutrolin within the next 30 days.      

FDA Warns Consumers About Fraudulent Ebola Treatment Products

August 15, 2014 8:27 am | News | Comments

The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.

FDA Approves Genentech’s Avastin Plus Chemotherapy for Treatment of Advanced Cervical Cancer

August 15, 2014 8:23 am | News | Comments

Genentech, a member of the Roche Group, announced that the FDA approved Avastin® (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.

FDA Committee Recommends Approval of Tiotropium Respimat for the Maintenance Treatment of COPD

August 15, 2014 8:20 am | News | Comments

Boehringer Ingelheim Pharmaceuticals announced that the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted [10 yes, 3 no] that existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with COPD.

FDA Accepts Pfizer's Biologics License Application For Investigational Meningococcal B Vaccine

August 15, 2014 8:12 am | News | Comments

Pfizer announced that the FDA has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease.     

Scientists Racing to Test Ebola Vaccines in Humans

August 14, 2014 6:30 pm | by Matthew Perrone - Associated Press - Associated Press | News | Comments

Scientists are racing to begin the first human safety tests of two experimental Ebola vaccines, but it won't be easy to prove that the shots and other potential treatments in the pipeline really work. There are no proven drugs or vaccines for Ebola, a disease so rare that it's been hard to...

Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible Particulates

August 14, 2014 9:05 am | News | Comments

Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.

The Path to Optimized Drug Production

August 14, 2014 8:36 am | by Nancy Berg, President and CEO of the International Society for Pharmaceutical Engineering (ISPE) | Blogs | Comments

Scaling up can be a challenge; know the processes and tools for a successful transition.                                              

CDC Recommends Pfizer’s Prevnar 13® Vaccine in Adults Aged 65 Years and Older

August 14, 2014 8:16 am | News | Comments

Pfizer announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein])PCV13) for routine use to help protect adults aged 65 years and older against pneumococcal disease.

Tekmira Not Ready to Use Ebola Drug in Africa

August 14, 2014 8:11 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

A Canadian drugmaker working on an experimental drug for Ebola said Wednesday that it is not ready to make the treatment available in Africa, despite assurances by international health officials that it is ethical to use untested treatments to fight the deadly outbreak.

FDA Approves New Sleeping Drug from Merck

August 13, 2014 4:29 pm | by The Associated Press | News | Comments

Merck & Co. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep. The tablet, Belsomra, works by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night.

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