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 today announced enrollment of the first patient in a new global Phase III...
Boehringer Ingelheim Pharmaceuticals announced that the FDA Pulmonary-Allergy Drugs Advisory...
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 UnionJune 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 DesignationJune 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).
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.
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.
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.
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 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.
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.
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.
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 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.
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 ProductJuly 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).
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.
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, 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 SurveyMarch 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 NSCLCJanuary 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).
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.
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.
SPIRIVA®* celebrates 10 years of ongoing commitment to patients and advancing clinical innovation in COPDSeptember 2, 2012 10:23 pm | by Boehringer Ingelheim | News | Comments
Ingelheim am Rhein, Germany / New York, N.Y., USA (3 September 2012) - Coinciding with the annual European Respiratory Society Congress, ERS 2012, SPIRIVA® (tiotropium), the first once-daily long-acting inhaled anticholinergic maintenance treatment for patients with Chronic...
Large scale registry shows atrial fibrillation management is suboptimal and unequal around the worldAugust 31, 2012 2:23 pm | by Boehringer Ingelheim | News | Comments
Munich, Germany, August 29, 2012 – New one-year follow-up results from the global RE-LY AF registry, a multinational primary care registry, have been announced for the first time during the European Society of Cardiology (ESC) Congress 2012. The findings show that 11.7% of patients...
Ingelheim, Germany, 30 August 2012 – Boehringer Ingelheim has announced the European approval for its latest innovation in Animal Health: the MycoFLEX® Headspace bottle, a simple and practical way to mix the two pig vaccines Ingelvac CircoFLEX® and Ingelvac MycoFLEX® for...
Munich, Germany, August 27, 2012 – Boehringer Ingelheim has announced today that the combined treatment experience with Pradaxa® has crossed one million patient-years1 in the prevention of thromboembolic events in patients after surgery and in patients with non-valvular atrial...
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