• IMBRUVICA,Pharmacyclics,Janssen Biotech,Two Blood Cancers

European Commission (EC) has granted marketing approval for IMBRUVICA? (ibrutinib) throughout the 28 member states of the EU.

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  • Pfizer,Chantix,FDA,black box

FDA staffers aren't as impressed with new safety data on Chantix as Pfizer ($PFE) wants them to be. In briefing documents filed in advance of Thursday's advisory committee meeting, reviewers say the stop-smoking remedy should keep its black-box warning about potential psychiatric side effects.

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  • Pfizer,quit-smoking drug,Chantix

Pfizer Inc failed to convince the U.S. Food and Drug Administration to remove a black box warning on its controversial quit-smoking drug Chantix, with an advisory panel to the agency voting against the removal on Thursday.

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  • Johnson & Johnson,Aduro,cancer

A banner year for Berkeley, CA-based Aduro just got better. The biotech has inked its second licensing pact of the year with Johnson & Johnson ($JNJ), which kicked in a $30 million upfront and boosted its total milestone package to the $1 billion-plus category.

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  • Eisai,lenvatinib,FDA

Eisai Co., Ltd.announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) submitted by its U.S. subsidiary Eisai Inc. for its novel in-house developed anticancer agent lenvatinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refractory differentiated thyroid cancer and granted the NDA Priority Review status.

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  • Eisai,Akynzeo,palonosetron,Netupitant

Eisai's Akynzeo is an oral combination of new drug netupitant and Aloxi (palonosetron) – a drug also marketed by Eisai that is approved to treat US cancer patients during the first 24 hours after the start of chemotherapy treatment, known as the acute phase.

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  • BMS,Opdivo,FDA,Melanoma

FDA accepts for priority review the Biologics License Application for previously treated advanced melanoma, based on data from first Phase 3 randomized trial of a PD-1 immune checkpoint inhibitor; agency grants second breakthrough therapy designation for Opdivo

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  • AstraZeneca,MedImmune,MEDI3902,FDA

MedImmune, has received fast track designation from the US Food and Drug Administration (FDA) for its investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen that causes serious disease in hospitalised patients.

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Recent News

Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted for Review by US FDA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.

First data backs efficacy of BMS' novel HIV drug

A Bristol-Myers Squibb (BMS) drug that causes immature HIV particles to be released from cells early, interrupting their lifecycle, has cleared a proof-of-concept study.

EU Rules Could Restrict Genetic Testing

Genetic testing describes the application of laboratory methods to look at a person’s genes (the inherited DNA instructions). Genetic tests can be used to diagnose a genetic condition; screen for a risk of developing a particular health problems; for the selection of treatments; or to assess responses to treatments.

CHMP adopts positive opinion of Edurant in adolescents with HIV-1

The CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection

FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval

Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.

Pfizer's once-failed cancer drug wins the FDA's 'breakthrough' tag

Pfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.