Tag Archives: FDA

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

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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.

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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

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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

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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

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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

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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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Top Pharma News and Developments that Made Headlines in April

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 Brineura for a specific form of Batten disease

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The U.S. Food and Drug Administration approved Brineura as a treatment for a specific form of Batten disease. Being an enzyme replacement therapy, Brineura’s active ingredient (cerliponase alfa) is a recombinant form of human TPP1, the enzyme deficient in patients with CLN2 disease.

Brineura is set to slow loss of walking ability in pediatric patients aged 3 and older suffering from late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.

The FDA granted approval of Brineura to BioMarin Pharmaceutical Inc.

 

Novartis entered clinical trial agreement with Allergan

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Novartis entered into a clinical trial agreement with Allergan to use its FXR agonist and Allergan’s cenicriviroc (CVC) for the treatment of non-alcoholic steatohepatitis (NASH) as part of a Phase IIb study.

NASH is known to be one of the biggest triggers of liver diseases leading to liver transplants worldwide. At the moment, there aren’t any approved treatments for NASH.

As part of the agreement, Novartis and Allergan will conduct a Phase IIb clinical trial to assess the safety, efficacy and tolerability of their combines therapies for NASH.

 

Bristol-Myers Squibb enters into separate agreements with Biogen & Roche

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Bristol-Myers Squibb entered into two separate agreements with Biogen and Roche to License anti-eTau and anti-myostatin compounds.

Under the agreements, Bristol- Myers Squibb plans to license BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy (PSP), to Biogen, and BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy, to Roche.

 

Roche’s Tecentriq won FDA OK

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Genentech, a unit of Swiss drugmaker Roche Holding AG, got approval from the FDA for its already approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer. The FDA granted Tecentriq an accelerated approval as an initial treatment for patients with advanced bladder cancer who are not eligible for standard cisplatin chemotherapy.

Tecentriq belongs to PD-1 inhibitors drug class. The latter helps the immune system fight cancer by blocking a mechanism used by tumors to escape attack.

 

GlaxoSmithKline’s malaria vaccine Mosquirix to undergo pilot studies in Ghana, Kenya and Malawi

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GlaxoSmithKline’s Mosquirix is set to undergo real-world pilot studies in Ghana, Kenya and Malawi, 3 African countries selected by the World Health Organization, starting next year.

The pilots will enroll babies aged between 5 to 17 months. Besides testing the vaccine’s efficacy, the study will also focus upon whether it’s possible or not to deliver 4 doses in the sub-Saharan areas.

World Health Organization selected the three African countries because of their high malaria rates despite broad use of insecticidal bed nets and well-functioning immunization programs.

 

Takeda partners Harrington Discovery Institute for rare disease therapeutics development

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Pharma company Takeda has partnered with Harrington Discovery Institute at University Hospitals in Cleveland, Ohio, to advance breakthrough therapeutic discoveries in rare diseases.

Under the agreement, Takeda will leverage Harrington Discovery Institute’s established operating model to set up a new programme to advance the development of medicines for rare diseases.

The Harrington programme will assist US MD and PhD researchers to carry out disruptive and transformative research, that may lead to the development of new treatments.
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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: