Top Pharma News and Developments that Made Headlines in May

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


Merck’s Keytruda got FDA approval to treat genetically ID’d tumors


Merck’s Keytruda was approved by the FDA to treat patients whose cancers have a specific genetic feature, making that the first time the FDA approved a cancer treatment based on a common genetic feature and not on the location where the tumor originated.

Keytruda is used for the treatment of solid tumors that have a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).


The FDA approved first generic Strattera for the treatment of ADHD

The first generic versions of Strattera  have been approved by the FDA to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.


Strattera will be marketed by Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited.


Bristol-Myers Squibb entered strategic collaboration with Array BioPharma


Bristol-Myers Squibb has entered a clinical research collaboration with Array BioPharma to test the latter’s investigational MEK inhibitor, binimetinib in combination with its Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen. This could be a treatment for metastatic colorectal cancer in patients with microsatellite stable tumors.

Bristol-Myers Squibb’s Opdivo has recently been accepted for priority review in liver cancer.


Sanofi and Regeneron Got FDA Approval for Kevzara


Sanofi and Regeneron announced FDA approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patientswho have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).

Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA.

In the US, Kevzara will be marketed by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.


Novartis receives FDA approval for expanded use of Zykadia


The US Food and Drug Administration approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.

Zykadia first received accelerated approval in 2014 for patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib.

In January 2017, the FDA granted Zykadia Breakthrough Therapy designation for the first-line treatment of patients with ALK-positive metastatic NSCLC with metastases to the brain, and Priority Review for first-line ALK-positive metastatic NSCLC.


AstraZeneca’s Imfinzi was shown to reduce the risk of disease worsening or death in the Phase III PACIFIC trial


AstraZeneca and MedImmune, its global biologics research and development arm, revealed positive results for the Phase III PACIFIC trial of Imfinzi (durvalumab) as sequential treatment in patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy combined with radiation therapy.

AstraZeneca also received accelerated approval from the US FDA for Imfinzi in previously treated patients with advanced bladder cancer.


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  • EASL 2018 – 210 rooms in seven 4-star hotels
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  • EHA 2018 – 1200 rooms in thirty 4-star hotels
  • ERS 2018 – 615 rooms in twenty 4-star hotels
  • EURETINA 2018 – 460 rooms in twelve 4-star hotels
  • EASD 2018 – 765 rooms in sixteen 4-star hotels
  • ECTRIMS 2018 – 620 rooms in ten hotels
  • ESMO 2018 – 1092 rooms in twenty-one 4-star hotels.

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