Tag Archives: Boehringer Ingelheim

Top Pharma News & Developments that Made Headlines in March

These are last month’s pharma news and developments brought to you by Congress Bookers, a reliable accommodation partner for lead pharma companies worldwide.

 

FDA approved Roche’s OCREVUS

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The US Food and Drug Administration (FDA) approved Roche’s OCREVUS (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis (MS).

OCREVUS reduced relapses per year by half during the two RMS Phase III studies. Furthermore, in a separate PPMS Phase III study, OCREVUS was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain compared with placebo with a median follow-up of three years.

The European Medicines Agency (EMA) has validated OCREVUS’ Marketing Authorisation Application (MAA) which is currently under review.

 

AstraZeneca Partnered with Circassia

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AstraZeneca entered a strategic collaboration with respiratory biopharmaceutical company Circassia Pharmaceuticals plc. The agreement was signed for the development and commercialisation of inhaled respiratory medicines Tudorza and Duaklir in the US.

Tudorza and Duaklir are used for the treatment of chronic obstructive pulmonary disease (COPD). While Tudorza was launched in the US in 2012, Duaklir will be submitted for US regulatory review in 2018.

Under the agreement, AstraZeneca will receive a minority equity stake in Circassia while the latter will lead the promotion of Tudorza and was granted the rights to Duaklir in the US. AstraZeneca will complete ongoing development activities and continue to manufacture and supply both medicines.

 

MedImmune Formed Alliance with Sanofi Pasteur for MEDI8897

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MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, have formed an alliance to develop and commercialise potential next-generation respiratory syncytial virus antibody MEDI8897.

The two companies will jointly develop and commercialise MEDI8897, a monoclonal antibody (mAb) for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV).

MedImmune and Sanofi Pasteur will equally share all costs and profits.

 

Mylan in Global Settlement & License Agreements with Genentech and Roche on Herceptin

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In March, Mylan has agreed to the terms of a global settlement with Genentech and Roche in what concerns patents for Herceptin (trastuzumab). This enables Mylan to have global licenses for its trastuzumab product.

Under the agreement, Mylan will be able to commercialize its trastuzumab product in markets worldwide. The licenses pertain to all countries except Japan, Brazil and Mexico.

As part of the settlement, Mylan agreed to withdraw its pending Inter Partes Review (IPR) challenges against two US Genentech patents (patent numbers 6,407,213 and 6,331,415).

 

Boehringer Ingelheim Expanded Its Collaboration with Vanderbilt University

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Boehringer Ingelheim has entered a collaboration with Vanderbilt University. This adds to an already existing collaboration by focusing on the research and development of small molecule compounds targeting the protein SOS. This molecule activates KRAS and triggers a molecular switch that plays a key role when tackling some of the deadliest types of cancer.

This collaboration has led to discoveries that might set the scene for the development of novel cancer treatment options based on molecules that are able to block this critical cancer driver.

 

Merck’s Keytruda Got FDA Nod for Treating Blood Cancer

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Merck got a first approval from the U.S. Food and Drug Administration (FDA) under the accelerated approval program for its immunotherapy drug Keytruda as a treatment for a type of blood cancer. Keytruda is already approved for treating lung, head and neck cancers.

FDA’s accelerated approval program allows for quicker approval of drugs that fill an unmet medical need.

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February’s Top Pharma News & Developments

These are last month’s pharma news and developments brought to you by Congress Bookers, a reliable accommodation partner for lead pharma companies worldwide.

 

AstraZeneca entered agreement with TerSera Therapeutics for Zoladex

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AstraZeneca entered an agreement with TerSera Therapeutics LLC for the commercial rights to Zoladex in the US and Canada. Zoladex is used to treat prostate cancer, breast cancer and several benign gynaecological disorders.

Under the agreement, TerSera is set to pay AstraZeneca USD 250 million upfront, plus USD 70 million in sales-related milestones and a quarterly share of sales in the “mid-teen percentage” range. AstraZeneca will also develop and supply Zoladex to TerSera.

 

Novo Nordisk filed for regulatory approval of semaglutide for the treatment of type 2 diabetes in Japan

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Novo Nordisk has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for semaglutide, a new glucagon-like peptide-1 analogue for the treatment of adults with type 2 diabetes.

This move follows the recent once-weekly semaglutide regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and SwissMedic.

 

Allergan Launched See America

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Allergan launched a new initiative dubbed See America, through which it aims to make vision health a priority for all US residents. Increasing awareness of the diseases that can cause blindness and enhancing access to vision care for those who need it most are the initiative’s main focus.

The launch followed the release of a report published by the National Academies of Sciences, Engineering, and Medicine (NASEM), which stressed upon the overwhelming number of Americans affected by blindness from preventable causes.

 

Amgen’s Parsabiv got FDA approval

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The US Food and Drug Administration (FDA) approved Amgen’s Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.

Parsabiv is the first therapy approved for this condition in 12 years. It is also the only calcimimetic that can be administered intravenously three times a week after the hemodialysis session.

 

Roche to start second late-stage study of Alzheimer’s disease drug

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Roche’s partner AC Immune revealed that Roche is set to launch a second Phase III study of the experimental Alzheimer’s disease therapy crenezumab. The latter was discovered by AC Immune and out-licensed to Roche’s Genentech unit in 2006. The CREAD2 trial will enrol 750 patients with prodromal or mild Alzheimer’s disease.

 

Boehringer Ingelheim’s Giotrif got approved for lung cancer in China

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Global pharmaceutical company Boehringer Ingelheim announced that their afatinib (Giotrif), an irreversible second-generation ErbB family blocker, was approved for lung cancer in China.

Afatinib has received Imported Drugs License (IDL) status by the China Food and Drug Administration (CFDA) for locally advanced or metastatic EGFR mutation-positive lung cancer patients who have not received any prior therapy with tyrosine kinase inhibitors, as well as for patients with locally advanced or metastatic squamous cell carcinoma of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy.

Afatinib is the first and only second-generation ErbB family blocker approved in China.

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Congress Bookers provides a whole range of services needed to organize a group for a medical congress. On our website, you will find a full list of hotel allotments for the most important medical congresses in 2017, regardless of their location. The biggest congresses next year are:

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  • ESMO 2017 – 440 rooms in ten 4-star hotels
  • ESC 2017 – 150 rooms in five 4-star hotels
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  • EASD 2017 – 423 rooms in thirteen 4-star hotels
  • EAACI 2017 – 688 rooms in fourteen 4-star hotels