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Boehringer Ingelheim

FDA advisory committee votes down approval of Boehringer and Lilly's drug for type 1 diabetes

Boehringer Ingelheim and Eli Lilly’s have been dealt a blow from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), after the independent panel voted against the use of the pair’s SGLT2 inhibitor empagliflozin (branded as Jardiance) as an add-on insulin therapy in the treatment of type 1 diabetes.

The drug is already approved, with the FDA passing approval in 2014 for the reduction of blood sugar levels in type 2 diabetes patients.

Boehringer's Ofev scores first-of-its-kind FDA approval in rare lung disease

Boehringer Ingelheim’s Ofev (nintedanib) capsules have now secured marketing authorisation in the US, it has emerged, for the treatment of interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD), a rare lung condition.

The decision, made under the FDA’s Priority Review pathway, was supported by data which demonstrated that the drug reduced lung function decline compared to placebo, and makes Ofev the first and only FDA-approved therapy to slow the rate of decline in this condition,

Boehringer and Lupin team up to battle KRAS-driven cancers in $700m+ deal

Boehringer Ingelheim is set to join forces with Lupin after the pair sealed a partnership agreement to develop, license, and commercialise the latter’s MEK inhibitor compound in combination with Boehringer’s KRAS inhibitor therapies for the treatment of difficult-to-treat KRAS-driven lung and gastrointestinal cancers.

In preclinical studies, this combination therapy, combined from both companies’ products, was shown to increase anti-tumour activity through their “complementary mechanisms of action in keeping KRAS-driven cancers in check”.

Additional data for Boehringer's Giotrif combo shows strong overall survival benefit in lung cancer sub-population

German firm Boehringer Ingelheim has released new interim data from a real-world evidence study investigating the efficacy of Giotrif/Gilotrif (afatinib) followed by AstraZeneca’s Tagrisso (osimertinib) in the treatment of epidermal growth factor receptor mutation-positive (EGFRM+) non-small cell lung cancer (NSCLC) in patients with acquired T790M mutations.

Previously released data from the study detailed overall survival (OS) rates after two years and after 30 months, but the incorporation of electronic health record data from a sub-set of US patients identified the median OS ben

Boehringer buys cancer vaccine company AMAL Therapeutics for €325 million

Boehringer Ingelheim has bought Swiss biotech AMAL Therapeutics, a company focused on cancer immunotherapy and cancer vaccines.

AMAL’s lead candidate, a stage IV colorectal cancer vaccine ATP128, is set to begin its first in-human trials later this month.

AMAL is headquartered on the medical campus of the University of Geneva. The biotech is a spin-out from the Swiss university which was backed by both corporate and institutional investors which include Boehringer Ingelheim Venture Fund and High-Tech Gründerfonds.

Boehringer Ingelheim open new plant in Catalonia

Boehringer Ingelheim has opened a new manufacturing facility in the town of Sant Cugat del Vallès near Barcelona.

The new plant will manufacture Boehringer Ingelheim’s COPD and asthma drug Respimat.

The Catalonia facility has seen Boheringer invest €120 million into the new plant which will see the creation of up to 200 new jobs.

Kymab announces Merck exec Simon Sturge as new CEO

Published on: 08/04/19

UK-based biotech Kymab has identified Merck KGaA executive Simon Sturge as its new Chief Executive Officer, taking over the reins from current CEO and Cambridge Antibody Technology co-founder David Chiswell effective 1 May.

The decision marks a next chapter in an international career spanning more than three decades in pharma and biotechnology; Sturge most recently served at Merck as its Executive Vice President Global Strategy, Business Development & Global Operations.

Boehringer expands manufacturing facility in Shanghai

German firm Boehringer Ingelheim has expanded the capacity of its commercial manufacturing site for biologics in Shanghai, China.

The expansion will see the installation of an additional bioreactor into the company’s OASIS Shanghai facility.

“We are fully committed to our biopharmaceutical contract manufacturing business in China and it is our utmost goal to serve our customers and their patients with high quality medicines in China and in the global market’, said Prof Buecheler, Head of Biopharmaceutical Business Unit at Boehringer Ingelheim.

Boehringer injects €230 million in new Biologicals Development Center

Prominent industry player Boehringer Ingelheim has unveiled plans to invest €230 million into the construction of a new Biologicals Development Center in Germany.

The investment is a bid to expand developmental capacity in order to facilitate growth in the company’s drug pipeline, which will in turn free up resources for contract manufacturing. The new site will focus development in areas of unmet medical need, featuring a combination of biologics analytical and process development, as well as manufacturing capacity for clinical studies.  

Top Ten most popular articles on Pharmafile.com this week

Some of the biggest news this week concerns companies that are looking to move on parts of their business, but as Pfizer has shown, it is sometimes easier said than done. In addition, two former Kite executives have been unable to resist being drawn back into the field, with a big to make their former technology obsolete. 

Check out the week's ten most popular articles on Pharmafile.com now!

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