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EMD Serono Appoints New Senior Vice President, Neurology and Immunology

September 2, 2014 9:09 am | News | Comments

EMD Serono announced today that Drew Young has joined the company as Senior Vice President, Neurology and Immunology. In this capacity, he will be responsible for leading the strategic direction of the U.S. Neurology and Immunology franchise, including future products.

Pfizer and Protalix BioTherapeutics Announce FDA Approval of Pediatric Indication for ELELYSO™

August 28, 2014 1:41 pm | News | Comments

Pfizer and Protalix BioTherapeutics announced that the FDA approved ELELYSO™ for injection for...

Novo Nordisk Buys Production Plant in New Hampshire

August 28, 2014 11:47 am | News | Comments

The facility was established in 1989, expanded in 2003-2006 and acquired by Olympus Biotech in...

Merck Serono Breaks Ground for New Pharmaceutical Manufacturing Facility in China

August 28, 2014 10:48 am | News | Comments

The new facility, which will be the group's second-largest pharmaceutical manufacturing facility...

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US to Begin Safety Testing Ebola Vaccine Next Week

August 28, 2014 9:26 am | by SETH BORENSTEIN, AP Science Writer | News | Comments

The National Institutes of Health announced Thursday that it is launching the safety trial on a vaccine developed by the agency's National Institute of Allergy and Infectious Diseases and GlaxoSmithKline. It will test 20 healthy adult volunteers to see if the virus is safe and triggers an adequate response in their immune systems.

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. difficile -associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.         

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 treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.

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Allergan to Request Court Block Valeant and Pershing Square from Voting Shares Acquired in Violation of Insider Trading Laws

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

Allergan has asked the United States District Court for the Central District of California to set an expedited schedule for discovery and a motion for a preliminary injunction against Valeant Pharmaceuticals, Pershing Square Capital Management, L.P., and its principal, William A. Ackman, for violations of the federal securities laws.

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).

Pfizer And Merck to Collaborate On Study Evaluating Novel Anti-Cancer Combination Regimen

August 26, 2014 8:35 am | News | Comments

Pfizer and Merck announced today that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer.

Donald Johns Joins Biogen Idec to Lead ALS Innovation Hub

August 26, 2014 8:06 am | News | Comments

Biogen Idec announced that Donald R. Johns, M.D., has joined the company as vice president, leading Biogen Idec’s amyotrophic lateral sclerosis (ALS) Innovation Hub (ALS iHub).             

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Cilag GmbH International Acquires Covagen AG

August 25, 2014 8:41 am | News | Comments

Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has acquired Covagen AG, a privately-held, biopharmaceutical company specializing in the development of multispecific protein therapeutics through the FynomAb technology platform.

Roche to Buy InterMune for $8.3B

August 25, 2014 8:10 am | News | Comments

Roche said Sunday it has reached an $8.3 billion deal to buy InterMune Inc., a California-based developer of treatments for lung diseases.                   

Allergan Reviews Meeting Requests in Takeover Bid

August 23, 2014 2:27 pm | by Linda A. Johnson - AP Business Writer - Associated Press | News | Comments

Allergan Inc. is reviewing shareholder requests for a special meeting to consider replacing most of its board, a change fellow drugmaker Valeant Pharmaceuticals International Inc. is seeking as part of the hostile takeover attempt it's been waging since April. Allergan has repeatedly...

FDA Approves Eliquis For DVT And PE

August 21, 2014 3:39 pm | by Pfizer | News | Comments

Bristol-Myers Squibb Company and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. 

Biogen Idec Names Adriana Karaboutis EVP, Technology And Business Solutions

August 21, 2014 3:35 pm | by Biogen Idec | News | Comments

Biogen Idec (NASDAQ: BIIB) announced the appointment of Adriana (Andi) Karaboutis as executive vice president, Technology and Business Solutions, effective September 24, 2014.                  

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Bristol-Myers Squibb & Celgene Collaborate On Immunotherapy & Chemo Combination

August 20, 2014 9:59 am | by Associated Press | News | Comments

Bristol-Myers Squibb Company and Celgene Corporation announced the establishment of a clinical trial collaboration to evaluate a combination regimen of Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, OPDIVO (nivolumab), and Celgene’s chemotherapy ABRAXANE ® (paclitaxel protein-bound particles for injectable suspension), in a Phase I study.

DOJ Closes Probe Into AstraZeneca Trial

August 19, 2014 4:37 pm | by Associated Press | News | Comments

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.                

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.     

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.

Allergan Acquires LiRIS® Program from TARIS Biomedical®

August 14, 2014 8:43 am | News | Comments

Allergan has closed a transaction to acquire worldwide rights to TARIS Biomedical's® lead program, LiRIS®, which is currently in Phase 2 trials for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS).      

AstraZeneca Advances Tralokinumab for Severe Asthma to Phase III

August 14, 2014 8:32 am | News | Comments

AstraZeneca announced the start of the Phase III program for tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by MedImmune, the company’s global biologics research and development arm.  

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.

Eli Lilly to Close Terre Haute Animal Enzyme Plant

August 14, 2014 8:02 am | News | Comments

Eli Lilly and Co. says it will close its Elanco animal enzyme plant in Terre Haute by early 2016 as part of a consolidation push. Lilly spokesman Ed Sagebiel tells the Tribune-Star the Indianapolis-based company is consolidating all of its animal enzyme manufacturing to a site in Great Britain.

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.

AstraZeneca Announces Results of Phase III Gout Treatment Trial

August 13, 2014 8:46 am | News | Comments

AstraZeneca today announced positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy for the treatment of patients with symptomatic gout.

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