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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.

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...

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...

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...

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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).             

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.

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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.                  

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.

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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.

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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.

Dendreon Shares Sink After Company Warns of Debt Woes

August 13, 2014 8:26 am | by The Associated Press | News | Comments

The maker of the prostate cancer treatment Provenge said in a Securities and Exchange Commission filing that there is a "significant risk" it will not be able to repay or refinance $620 million in notes due in 2016.      

Valeant Pharmaceuticals Receives FTC Second Request Under Hart-Scott-Rodino

August 12, 2014 8:39 am | News | Comments

Valeant Pharmaceuticals International  announced that the company has received a request for additional information from the Federal Trade Commission in connection with Valeant's proposed acquisition of Allergan, Inc.      

Health Canada OKs GSK's Plan to Fix Quebec Flu Vaccine Plant Problems

August 12, 2014 8:15 am | by Helen Branswell, The Canadian Press | News | Comments

Health Canada says it has approved a plan by GlaxoSmithKline to fix contamination problems it has been experiencing at its Ste. Foy, Que., flu vaccine production plant. The department says GSK's action plan and the timelines proposed in it are satisfactory.

FDA Approves VELCADE® Retreatment in Patients with Multiple Myeloma

August 11, 2014 8:19 am | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, has announced that the FDA has approved VELCADE® for the retreatment of adult patients with multiple myeloma who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment.

China Jails British-US Investigator Couple

August 8, 2014 1:29 pm | News | Comments

A Briton and an American were sentenced to prison on Friday on charges of illegally trading in the personal details of Chinese citizens after they testified they bought such information to help companies combat fraud.          

Genentech Submits Supplemental Biologics License Application to FDA for Lucentis Indication in Diabetic Retinopathy

August 8, 2014 11:39 am | News | Comments

The submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating the safety and efficacy of Lucentis for this serious eye disease. There are currently no ocular medications approved for the treatment of diabetic retinopathy.

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