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FDA Approves Glyxambi Tablets for Adults with Type 2 Diabetes

February 2, 2015 10:59 am | News | Comments

The FDA has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals and Eli Lilly as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments.

Boehringer Ingelheim and Sanofi to Collaborate on Manufacturing Biopharmaceuticals

January 15, 2015 8:34 am | News | Comments

Boehringer Ingelheim and Sanofi announced today that they enter into an alliance to extend...

Chinese Pharma Firm to Establish Operations in Virginia

October 30, 2014 12:56 pm | News | Comments

Virginia's Gov. Terry McAuliffe said Thursday that UniTao Pharmaceuticals LLC has purchased the...

Boehringer Ingelheim and Lilly Revising Operational Structure of Diabetes Alliance

October 29, 2014 8:19 am | News | Comments

In a move that will strengthen their alliance by enhancing efficiencies and enabling greater...

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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.

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.

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FDA Approves Lilly, Boehringer Diabetes Drug

August 1, 2014 1:34 pm | by The Associated Press | News | Comments

Federal regulators have approved a new treatment from U.S. drugmaker Eli Lilly and Co. and its German counterpart, Boehringer Ingelheim, for the most common form of diabetes . The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes.

FDA Accepts NDA Filing for Boehringer Ingelheim's Investigational Nintedanib

July 2, 2014 10:45 am | News | Comments

Boehringer Ingelheim Pharmaceuticals, has announced that the New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the FDA and granted Priority Review designation.       

CHMP Recommends Lilly and Boehringer Ingelheim's New Insulin Glargine Product for Approval in the European Union

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

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes.   

Boehringer Ingelheim's Investigational Antidote for Pradaxa Receives FDA Breakthrough Therapy Designation

June 26, 2014 8:25 am | News | Comments

Boehringer Ingelheim announced that FDA has granted Breakthrough Therapy Designation to idarucizumab, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

Ben Venue Labs to Sell Assets of Bedford Labs to Hikma Pharmaceuticals

May 28, 2014 8:47 am | News | Comments

Hikma will be acquiring Bedford Laboratories' assets, including a large product portfolio, intellectual property rights, contracts for products marketed under license, raw material inventories, a strong research and development and business development pipeline, and a number of employees across key business functions.

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Boehringer Ingelheim Settles U.S.Pradaxa Litigation for $650M

May 28, 2014 8:06 am | News | Comments

Boehringer Ingelheim announced today that it has reached a comprehensive settlement of state and federal cases in the U.S. litigation regarding Pradaxa (dabigatran etexilate mesylate) in the amount of $650 million.      

European Commission Approves Jardiance Tablets for Use in Adults in Europe

May 23, 2014 8:02 am | News | Comments

The European Commission granted marketing authorization for Jardiance (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced.

Facility Concerns Kill Lilly-Boehringer Diabetes Drug

March 5, 2014 11:05 am | News | Comments

Eli Lilly and Boehringer-Ingelheim said  that the Food and Drug Administration didn't approve their diabetes treatment empagliflozin because of concerns about a facility where the drug will be made.        

Boehringer Ingelheim Scores Perfect 100 in Human Rights Campaign’s Corporate Equality Index

December 10, 2013 8:46 am | News | Comments

Boehringer Ingelheim has scored a perfect 100 in the Human Rights Campaign (HRC) Foundation’s Corporate Equality Index. The yearly report from the HRC ranks companies according to their compliance with LGBT practices and policies.   

Life for NJ Chemist Convicted of Poisoning Husband

October 1, 2013 8:18 am | by DAVID PORTER, Associated Press | News | Comments

A Chinese-born chemist who worked for a decade for one of America's biggest pharmaceutical companies was a cold, calculating murderer who poisoned her husband rather than let him divorce her, a judge said Monday as he sentenced her to life in prison.

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Boehringer Ingelheim's Investigational Volasertib Receives FDA Breakthrough Therapy Designation

September 17, 2013 8:07 am | News | Comments

Boehringer Ingelheim Pharmaceuticals today announced the FDA has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), being evaluated for the treatment of patients aged 65 or older with previously untreated acute myeloid leukemia (AML), ineligible for intensive remission induction therapy.

FDA Accepts Boehringer Ingelheim's Supplemental New Drug Application

August 28, 2013 9:30 am | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for Pradaxa@ (dabigatran etexilate mesylate) for its use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE). 

Boehringer Ingelheim Virginia Chemical Plant to Close by End of 2014

August 15, 2013 12:58 pm | News | Comments

Boehringer Ingelheim Chemicals will begin to phase out operations starting in December 2013. The Petersburg facility that has been in operation since the late 1970s manufactures active ingredients for the pharmaceutical industry.   

FDA Approves Boehringer Drug for Lung Cancer

July 14, 2013 6:29 pm | by The Associated Press | News | Comments

The agency said it approved the company's Gilotrif for lung cancer patients who test positive for certain gene mutations in their tumors. The agency approved the drug alongside a diagnostic test from Qiagen NV designed to detect the mutation.

Eli Lilly and and Boehringer Ingelheim Announce Regulatory Submission for New Insulin Glargine Biosimilar Product

July 8, 2013 8:52 am | News | Comments

Eli Lilly and Company and Boehringer Ingelheim today announced that the companies' marketing authorization application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency (EMA).

Hospital to Probe East German Medical Trials

May 13, 2013 3:44 pm | by FRANK JORDANS,Associated Press | News | Comments

Berlin's renowned Charite hospital said Monday it plans to investigate allegations that patients in communist East Germany were used as unwitting guinea pigs in medical trials for Western drug companies. Claims that the dictatorship allowed tests that would have been considered unethical or even illegal in the West were first made shortly after German reunification in 1990, but no wrongdoing was found at the time.

Lilly, Boehringer Submit Diabetes Drug to FDA

March 25, 2013 1:07 pm | by The Associated Press | News | Comments

Eli Lilly and Co. said Monday that it has submitted a new type 2 diabetes treatment it is developing with German drugmaker Boehringer Ingelheim to the Food and Drug Administration. Lilly said the treatment, a once-daily tablet named empagliflozin, belongs to a class of drugs that aim to reduce...

Presidio Pharmaceuticals to Collaborate with Boehringer Ingelheim

March 13, 2013 7:54 am | News | Comments

Presidio Pharmaceuticals, Inc. announced today a non-exclusive collaboration with Boehringer Ingelheim for a Phase IIa clinical trial of an interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with chronic hepatitis C virus (HCV) infection.

Biogen Idec, Forest and Bayer Among Top Sponsors Rated by Investigative Sites in New CenterWatch Survey

March 4, 2013 7:59 am | News | Comments

More than 2,000 global investigative sites rate the best biopharmaceutical companies to work for in a new survey conducted by CenterWatch, a provider of global clinical trials information. The survey results were released today in the March issue of The CenterWatch Monthly newsletter.

FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC

January 15, 2013 3:27 am | News | Comments

Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA).

Boehringer Recalls Manufacturing Lot of Pradaxa

November 8, 2012 3:29 am | News | Comments

NEW YORK (AP) — Boehringer Ingelheim said Wednesday it is recalling a single manufacturing lot of its anticlotting drug Pradaxa because the bottle may be defective.  

Boehringer Ingelheim to Pay $95M in Settlement

October 26, 2012 4:09 am | by PETE YOST,Associated Press | News | Comments

WASHINGTON (AP) — Boehringer Ingelheim Pharmaceuticals Inc. will pay $95 million to settle allegations that the company promoted three drugs for uses that were not medically accepted, the government announced Thursday.  

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