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The Lead

Off-Label Prescribing of Antipsychotic Drug Highlights Lack of Oversight

October 22, 2014 8:38 am | by Adam Miller, The Canadian Press | News | Comments

An increase in the number of prescriptions of a powerful antipsychotic drug for conditions not approved by Health Canada is raising concern about what medical experts call lack of professional and government oversight of doctors' prescribing practices.

Hedge Fund Third Point Urges Amgen to Consider Breakup

October 22, 2014 8:24 am | by The Associated Press | News | Comments

A hedge fund run by a famed investor has taken a large stake in Amgen and now wants the biotech...

J&J to Spend Up to $200M on Ebola Vaccine Program

October 22, 2014 8:09 am | News | Comments

Johnson & Johnson will start safety testing in early January on a vaccine combination that...

Interim Shire Chief Financial Officer to Step Down

October 21, 2014 9:06 am | News | Comments

Shire has announced that James Bowling, Interim Chief Financial Officer, has notified the Board...

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FDA Accepts NDA for Empagliflozin/Metformin Fixed-Dose Combination

October 21, 2014 9:01 am | News | Comments

The FDA has accepted the filing of a New Drug Application for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes.  

Boehringer Ingelheim Starts Global Phase III Study for Colorectal Cancer Treatment

October 21, 2014 8:30 am | News | Comments

Boehringer Ingelheim today announced enrollment of the first patient in a new global Phase III study in patients with metastatic colorectal cancer (mCRC). Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year.

AbbVie to Pay Shire $1.64B Fee Over Canceled Merger

October 21, 2014 8:13 am | News | Comments

AbbVie is walking away from its proposed $55 billion takeover bid of Shire and has agreed to pay the rival drugmaker a $1.64 billion breakup fee. The two companies said the deal was off following the decision last week by AbbVie's board to withdraw support from the proposed acquisition.

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FDA Recommends Approval of Novartis’ AIN457 (secukinumab) for Moderate-to-Severe Plaque Psoriasis

October 20, 2014 3:28 pm | News | Comments

Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the FDA voted 7 to 0 to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

NewLink Genetics Rises on Roche Cancer Partnership

October 20, 2014 2:59 pm | News | Comments

NewLink said it will get $150M upfront from Genentech, and could receive more than $1B in payments based on milestones, as well as royalties if the drug is approved. The drug, now called NLG919, is in early-stage clinical testing.    

Valeant Considering Higher Bid for Allergan after Reporting Strong Q3 Results

October 20, 2014 1:26 pm | by Ross Marowits, The Canadian Press | News | Comments

Valeant Pharmaceuticals said that its strong third-quarter results and a higher growth forecast give it ammunition to win over reluctant takeover target Botox maker Allergan with an increased bid at the appropriate time.     

Anti-Abuse Label Approved for Painkiller Embeda

October 17, 2014 8:36 pm | by The Associated Press | News | Comments

The U.S. Food and Drug Administration says it has approved new labeling for another opioid designed to limit painkiller abuse. The FDA said Friday that Pfizer Inc.'s Embeda can have labeling indicating that it has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted.

Aduro Expands Collaboration with Johnson & Johnson Innovation and Janssen for Lung Cancer Immunotherapies

October 17, 2014 8:40 am | News | Comments

Under the agreement, facilitated by the Johnson & Johnson Innovation center in California, Aduro will receive a $30M up-front payment and is eligible to receive significant development, regulatory and commercialization milestone payments up to a potential total of $817M.

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FDA Panel Votes to Keep Boxed Warning on Chantix

October 16, 2014 4:36 pm | by The Associated Press | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.

Lilly to Realign Puerto Rico Manufacturing Operations

October 16, 2014 3:28 pm | News | Comments

Eli Lilly and Company has announced plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico. The manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015. 

FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

October 16, 2014 8:41 am | News | Comments

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.  

Roche Posts Flat Nine-Month Sales

October 16, 2014 8:14 am | by JOHN HEILPRIN, Associated Press | News | Comments

Roche Holding AG posted flat sales for the first nine months of 2014, but said Thursday the results show strong demand for its cancer drugs and emerging new products.              

AbbVie Wants Out of $55B Shire Deal

October 16, 2014 8:11 am | by The Associated Press | News | Comments

AbbVie's board is telling shareholders to vote against its own $55 billion takeover bid for the Irish drugmaker Shire after the U.S. made reincorporating overseas a less lucrative tax maneuver.          

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Mylan Recalls Some Lots of Nitroglycerin Spray Used to Treat Angina

October 15, 2014 2:14 pm | by The Canadian Press | News | Comments

Some lots of the product, called Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose, are potentially missing the dip tube, a part of the pump component. A missing dip tube could pose a problem with delivery of nitroglycerin to the patient.  

Supreme Court Weighs Generic Drug Dispute

October 15, 2014 1:28 pm | by SAM HANANEL, Associated Press | News | Comments

The Supreme Court seems divided as it considers a high-stakes patent dispute between rival pharmaceutical companies over the world's best-selling multiple sclerosis treatment.             

Merck Ex-Financial Analyst Facing Insider Trading Charge

October 15, 2014 8:14 am | News | Comments

A former senior finance analyst at Merck & Co. is facing an insider trading charge after authorities said Tuesday that he passed secrets to a friend he met at college that earned $722,000 in illegal profits.       

Shire: AbbVie Should Proceed with $55B Acquisition

October 15, 2014 8:06 am | by The Associated Press | News | Comments

Shire wants AbbVie to stick with its roughly $55 billion acquisition bid, and it is reminding its U.S. counterpart of the hefty breakup fee it will receive if things don't work out.            

FDA: Little Evidence to Drop Chantix Boxed Warning

October 14, 2014 11:50 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal regulators say Pfizer has provided low-quality evidence to support its request to remove a bold-letter warning from its anti-smoking drug Chantix about suicidal behavior. The twice-a-day tablet has carried the FDA's strongest warning label, known as a black box, since 2009 following reports of suicidality, hostility and depression among some patients.

Sucampo Announces Extension of AMITIZA License and Collaboration Agreement With Takeda

October 14, 2014 9:08 am | News | Comments

Sucampo Pharmaceuticals has announced that it signed an amendment to the existing collaboration and license agreement covering the United States and Canada for AMITIZA with Takeda Pharmaceutical Company.        

FDA Accepts Pfizer's Palbociclib New Drug Application for Priority Review

October 14, 2014 8:52 am | News | Comments

This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.

Bristol-Myers Squibb, Pharmacyclics and Janssen Announce Clinical Collaboration to Evaluate OPDIVO® and IMBRUVICA® in Non-Hodgkin Lymphoma

October 14, 2014 8:48 am | News | Comments

The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL).

J&J Beats Wall Street Third Quarter Forecasts

October 14, 2014 8:06 am | News | Comments

Johnson & Johnson has reported third-quarter earnings of $4.75 billion. The results topped Wall Street expectations. The average estimate of analysts surveyed by Zacks Investment Research was for earnings of $1.42 per share.    

Endo Buys Struggling Auxilium for $2.6B to Augment Urology Franchise

October 10, 2014 9:36 am | News | Comments

Endo International’s $2.6 billion purchase of Auxilium Pharmaceuticals complements Endo’s urology and male health portfolio, and the company intends to leverage its resources to optimize and drive increased adoption of three key Auxilium drugs, according to an analyst with research and consulting firm GlobalData.

Allergan Boosts Outlook

October 9, 2014 1:54 pm | News | Comments

Allergan, which has been fending off buyout offers from Valeant Pharmaceuticals, boosted its earnings outlook for the year and current quarter.                  

FDA Approves VELCADE® for Injection for Previously Untreated Patients with Mantle Cell Lymphoma

October 9, 2014 1:48 pm | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, today announced that the FDA has approved VELCADE® for injection for use in previously untreated patients with mantle cell lymphoma. VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL.

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