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
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
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
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
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
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
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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