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FDA Approves BMS’s Evotaz™ for the Treatment of HIV-1 Infection in Adults

January 30, 2015 8:42 am | News | Comments

Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.   

Dendreon Reaches Agreement for Valeant to Serve as “Stalking Horse Bidder” in Court-Supervised Sales Process

January 30, 2015 8:37 am | News | Comments

Under the terms of the agreement, Valeant would acquire the world-wide rights of PROVENGE® (...

Lilly Beats Wall Street Fourth Quarter Forecasts

January 30, 2015 8:34 am | News | Comments

Eli Lilly has reported fourth-quarter net income of $428.5M. On a per-share basis, the...

Mylan Shareholders Approve Abbott Business Purchase

January 29, 2015 1:13 pm | News | Comments

Mylan announced that its shareholders approved its purchase of an Abbott Laboratories business...

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AstraZeneca, MD Anderson Enter Collaboration to Help Improve Patient Outcomes in Ovarian/ Gynecologic Cancers

January 29, 2015 1:06 pm | News | Comments

AstraZeneca and The University of Texas MD Anderson Cancer Center today announced a multi-year, strategic research collaboration to conduct multiple, parallel clinical and clinically-related studies in ovarian and other gynecologic cancers with the aim of improving patient outcomes.

Abbott Beats Fourth Quarter Profit Forecasts

January 29, 2015 8:29 am | News | Comments

Abbott Laboratories has reported fourth-quarter earnings of $905 million. On a per-share basis, the North Chicago, Illinois-based company said it had profit of 59 cents. Earnings, adjusted for one-time gains and costs, came to 71 cents per share.

Biogen Idec, Fondazione Telethon and Ospedale San Raffaele Announce Global Collaboration to Develop Gene Therapies for Hemophilia

January 29, 2015 8:06 am | News | Comments

The agreement will combine San Raffaele - Telethon Institute for Gene Therapy’s (TIGET) extensive expertise in creating new gene therapy strategies and developing them from the bench to bedside with Biogen Idec’s deep understanding of hematology to potentially treat the underlying causes of hemophilia A and B.

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Photo of the Day: Novartis CEO Joe Jimenez

January 28, 2015 11:16 am | by Mike Auerbach, Editor In Chief | News | Comments

It’s financial reporting season and the pharmaceutical industry is no exception. This week Novartis reported that its fourth quarter net income dropped a whopping 26% or “only” $1.49B compared to $2B from a year ago.      

Amgen Tops Wall Street Fourth Quarter Forecasts

January 28, 2015 8:12 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The world's biggest biotech drugmaker by revenue said it's starting a cycle of several important new product launches — big enough that last year it announced major job reductions and other cost cuts to free up money for the launches.   

Pfizer Net Down on Lower Sales, Higher Research, Legal Costs

January 27, 2015 12:53 pm | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Pfizer's fourth-quarter profit fell by half as worsening generic competition and unfavorable currency rates reduced sales, and higher research spending and legal costs also hurt the bottom line. The world's second-biggest drugmaker by revenue reported lower sales for most of its huge portfolio of prescription medicines, with the biggest hit coming from new generic competition to popular painkiller Celebrex.

Pfizer Beats Wall Street Fourth Quarter Forecasts

January 27, 2015 7:42 am | News | Comments

Pfizer on Tuesday reported fourth-quarter earnings of $1.23B. On a per-share basis, the company said it had net income of 19 cents. Earnings, adjusted for non-recurring costs and costs related to mergers and acquisitions, came to 54 cents per share.

FDA Approves Teva's Generic Nexium® Delayed-Release Capsules

January 27, 2015 7:06 am | News | Comments

Teva Pharmaceutical has announced the Food and Drug Administration (FDA) approval of the first generic equivalent to Nexium (esomeprazole magnesium) Delayed-Release Capsules in the United States.         

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Novartis Posts Fourth Quarter Profit Drop

January 27, 2015 6:53 am | News | Comments

Novartis AG says fourth quarter net income dropped 26 percent but the company still posted a healthy 2014 annual profit. The Basel, Switzerland-based company said Tuesday that fourth quarter net income came in at $1.49 billion, down from $2 billion in the same quarter the year before.

CHMP Issues Positive Opinion for Merck's Investigational Antibiotic SIVEXTRO®

January 26, 2015 11:00 am | News | Comments

Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO® for the treatment of acute bacterial skin and skin structure infections in adults.

GSK Expands Its Asthma and COPD Portfolio in the US

January 26, 2015 10:36 am | News | Comments

GlaxoSmithKline has announced the simultaneous availability of two of its recently approved products for the treatment of asthma and COPD to retail pharmacies in the US. Over the past 15 months, GSK has launched four inhaled respiratory therapies in the US, all delivered in its Ellipta inhaler.

Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent

January 26, 2015 8:30 am | News | Comments

Gilead Sciences has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C.

Array BioPharm to Acquire Novartis’ Encorafenib

January 23, 2015 8:23 am | News | Comments

Array BioPharma today announced that it has reached a definitive agreement with Novartis Pharma AG to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in Phase 3 development.        

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FDA Panel Recommends Approval of Astellas’ CRESEMBA for Treatment of Invasive Aspergillosis and Mucormycosis

January 22, 2015 3:45 pm | News | Comments

The FDA Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral broad-spectrum CRESEMBA for the treatment of invasive aspergillosis, and 8 to 2 with one abstention to recommend approval for the treatment of invasive mucormycosis.

Photo of the Day - HIV Drug Protests in Peru

January 22, 2015 3:14 pm | by Mike Auerbach, Editor In Chief | News | Comments

In Peru, BMS' atazanavir is available as a second-line HIV drug, but its high price is out of reach of many Peruvians with HIV/AIDS.                     

Fitch: SCOTUS Extends Patent Benefit for Teva; Generics Lose for Now

January 22, 2015 8:20 am | News | Comments

The Supreme Court (SCOTUS) decision that a federals appeals court wrongly overturned Teva Pharmaceutical's (Teva) Copaxone patent is a positive credit development for the drug maker, according to Fitch Ratings.       

FDA Approves Novartis’ Cosentyx for Moderate-to-Severe Plaque Psoriasis

January 21, 2015 2:12 pm | News | Comments

Novartis announced that the FDA has approved Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.         

FDA Approves Baxter's PHOXILLUM Solution for Electrolyte Management During Continuous Renal Replacement Therapy

January 21, 2015 8:15 am | News | Comments

Baxter International has announced the FDA has approved PHOXILLUM Renal Replacement Solutions as replacement solutions in continuous renal replacement therapy to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances.

Supreme Court Sides with Teva in Drug Dispute

January 21, 2015 8:11 am | by SAM HANANEL, Associated Press | News | Comments

The U.S. Supreme Court on Tuesday sided with Teva Pharmaceutical in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug. The justices ruled 7-2 that a federal appeals court wrongly overturned five of Teva's patents for the drug Copaxone.

Johnson & Johnson Tops Fourth Quarter Earnings Expectations

January 21, 2015 8:05 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The strong dollar and stiff competition for some products squeezed J&J in the fourth quarter and it missed Wall Street expectations for revenue, triggering a rare sell-off of its shares. The world's biggest maker of health care products did edge past profit forecasts and there were other bright spots, including a 10% jump in prescription drug sales and increasing use of medical care in the U.S.

Bristol-Myers Names Caforio as CEO

January 21, 2015 8:01 am | News | Comments

Bristol-Myers Squibb has named its chief operation officer, Giovanni Caforio, as its new CEO. He will take over after the company's annual shareholders' meeting on May 5, replacing current CEO, Lamberto Andreotti.      

UCB Announces US and EU Regulatory Filings for the Investigational Antiepileptic Drug Brivaracetam

January 21, 2015 7:58 am | News | Comments

In the US, the FDA has accepted for review the New Drug Application (NDA) for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for brivaracetam in the same proposed indication.

Aetna Picks Gilead Sciences Hepatitis C Drugs Over AbbVie's

January 19, 2015 9:43 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Aetna has reached a deal with Gilead bringing discounts for Sovaldi and Harvoni, which have list prices of about $84,000 and $94,000, respectively, for a course of treatment. The amount of the discount wasn't disclosed.      

Johnson & Johnson Ebola Groups Get $117M in Funding

January 19, 2015 9:37 am | News | Comments

Johnson & Johnson is working with a slew of organizations to speed up development of an Ebola vaccine, and the company said Friday that a European health organization awarded them $117 million.         

Evotec Achieves Milestones in TargetAD Collaboration With Janssen

January 15, 2015 2:31 pm | News | Comments

Evotec AG has announced the achievement of several small, but very important milestones in its TargetAD collaboration with Janssen Pharmaceuticals, Inc. for the identification and selection of novel targets from Evotec's TargetAD database and for the transition of targets into the drug discovery process.

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