• Celgene,Abraxane,nab-paclitaxel

Celgene's ($CELG) Abraxane can't catch a break in England. Soon after losing coverage for pancreatic cancer on the country's dedicated Cancer Drugs Fund, the treatment got another thumbs-down from its official cost-effectiveness watchdogs.

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  • Roche,MS,crowded space,Severin Schwan

Roche preps for make-or-break MS data with eyes on a crowded space.Roche's in-development treatment for multiple sclerosis met its main efficacy goals in pair of Phase III trials

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  • Pfizer,oncology pipeline,AstraZeneca

Pfizer has agreed to pay iTeos Therapeutics €24 million ($30 million) up front for the exclusive rights to some preclinical candidates, also making an undisclosed equity investment in the company and promising untold milestone payments down the line.

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  • Roche,CLL drug,NHS,Scottish

From today patients in Scotland with chronic lymphocytic leukaemia (CLL) have gained ‘routine’ access to a new treatment option after cost-regulators approved Roche’s Gazyvaro (obinutuzumab) for National Health Service use in the country.

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  • Novartis,Amgen,biotech drug,Neupogen

Novartis said its copycat version of Amgen's Neupogen for patients with low white blood cell counts works as well as the original drug in a late-stage trial. The medicine, made by Novartis' generics arm Sandoz, was being tested in patients with breast cancer undergoing chemotherapy, which often knocks out their white blood cells, giving rise to a condition known as neutropenia.

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  • Epirus,Ranbaxy,biosimilar,India

This is the second knockoff of the global top seller to hit markets outside the U.S.

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  • Amgen,AstraZeneca,Stelara,J&J

Amgen and AstraZeneca have racked up their third straight Phase III win forbrodalumab in plaque psoriasis, beating J&J's Stelara in a head-to-head study. The news comes just two weeks after the pharma partners posted their latest positive results, positioning them for a run at regulators on both sides of the Atlantic.

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  • Bristol-Myers,lung cancer,patients

Bristol-Myers Squibb's closely watched checkpoint inhibitor nivolumab managed to wow analysts this morning with impressive survival results in a Phase II study of patients with advanced squamous cell non-small cell lung cancer.

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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.