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Showing 15 posts of 1442 posts found.

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FDA bans clinical trial co-ordinator who faked patient samples and stole funds

March 22, 2016
Manufacturing and Production, Medical Communications FDA, HIV, clinical trials, faked, forgery, mcquerry, prison

The US Food and Drug Administration has permanently banned a clinical trial co-ordinator who was found to have falsified patient …

News
disease

FDA approves new anthrax treatment

March 22, 2016
Manufacturing and Production, Research and Development Antibacterial, FDA, US, anthim, anthrax, defense, inhalational

The US Food and Drug Administration (FDA) has approved Anthim (obiltoxaximab) to treat inhalational anthrax in combination with appropriate antibacterial …

News
breckenridge_pharma

FDA approves Breckenridge’s generic of Pfizer’s anti-epilepsy drug

March 18, 2016
Research and Development, Sales and Marketing FDA, Neurontin, Pfizer, anti-epilepsy, approval, breckenridge, gabapentin, tris pharma

Breckenridge Pharmaceutical Inc. has announced that their generic of Pfizer’s anti-epilepsy drug Neurontin (gabapentin) has been approved by the US …

News
bayercross3

FDA approves Bayer haemophilia A drug Kovaltry

March 17, 2016
Research and Development, Sales and Marketing Bayer, FDA, approval, drug, drug approval, haemophilia, haemophilia a, kovaltry, viii compound

Bayer (ETR:BAYN) has received approval from the US Food and Drug Administration (FDA) for Kovaltry (octocog alfa), an unmodified, full-length …

News

Genentech cancer immunotherapy gets Priority FDA Review in bladder cancer

March 15, 2016
Manufacturing and Production, Research and Development FDA, Genentech, Roche, atezolizumab, bladder cancer, priority review

The US FDA has granted Roche subsidiary Genentech a Priority Review for atezolizumab in treating advanced bladder cancer, whose disease …

News
vascepa

COMMENT: What does Amarin’s off-patent victory over the FDA mean for the industry?

March 14, 2016
Medical Communications, Sales and Marketing Amarin, FDA, off label, off-label, vascepa

Last week, Pharmafile.com reported that small biopharma Amarin had settled litigation with US drugs regulator the FDA that will allow …

Feature
arzerra_novartis

Novartis seeks expanded Arzerra use in US

March 11, 2016
Research and Development Arzerra, CLL, FDA, Genmab, Novartis

Novartis has submitted a supplemental Biologics License Application (sBLA) to the US FDA for the use of Arzerra (ofatumumab) in …

News

FDA grants approval for first generic version of Viagra

March 10, 2016
Manufacturing and Production, Research and Development, Sales and Marketing FDA, Pfizer, Teva, erectile dysfunction, generic, viagra

The US Food and Drug Administration (FDA) has granted approval to the first generic version of Pfizer’s blockbuster erectile dysfunction …

News
amarin_logo

Amarin wins case against FDA to promote Vascepa for off-label uses

March 10, 2016
Medical Communications, Research and Development, Sales and Marketing Amarin, FDA, first amendment, off label, vascepa

Amarin has announced a settlement with the US Food and Drug Administration (FDA) that resolves the dispute over the Irish-based …

News
lupin_pharma_logo

Lupin completes acquisition of US-based Gavis Pharmaceuticals

March 10, 2016
Research and Development, Sales and Marketing FDA, Gavis, Lupin, acquisition, generics

Indian drug manufacturer Lupin has announced the completion of its acquisition of New Jersey-based pharmaceutical firm, Gavis, in a deal …

News
teva_copy

Teva suffers EpiPen generic setback after FDA rejection

March 4, 2016
Medical Communications, Research and Development FDA, Teva, analphylaxis, approval, auto injector, auto-injector, rejection

The release of Teva Pharmaceuticals generic for the anaphylaxis treatment, EpiPen (epinephrine), is now expected to be severely delayed after …

News
dr_robert_califf_fda

Senate confirms Dr Robert Califf to lead FDA

February 25, 2016
Medical Communications Drug pricing, FDA, Robert Califf

The US Senate has confirmed Dr Robert Califf as Commissioner of the Food and Drugs Administration, in an overwhelming 89-4 …

Appointment
novartis_pic

Novartis drug PKC412 gets Breakthrough designation for AML

February 19, 2016
Medical Communications, Research and Development FDA, Novartis, acute myeloid leukaemia

Novartis’ PKC412 (midostaurin)  has become the latest in a sequence of FDA Breakthrough Therapy designations awarded this week- bagging the …

News
az_logo_on_building

AZ’s durvalumab awarded breakthrough status in bladder cancer

February 18, 2016
Research and Development AstraZeneca, FDA, bladder cancer

AstraZeneca, and its biologics/R&D arm MedImmune, have won FDA Breakthrough Therapy status for their bladder cancer drug durvalumab (MEDI4736), which …

News
fda

Biosimilars: Can the US catch up in 2016?

February 12, 2016
Medical Communications, Sales and Marketing Eli Lilly, Enbrel, FDA, Neulasta, Novartis, Pfizer, Sandoz, Zarxio, biosimilars

What are biosimilars? Biosimilars are essentially the biological equivalent of generic drugs to their branded small-molecule counterparts (what Ibuprofen is …

Feature
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