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Showing 15 posts of 1442 posts found.

valeant_pharma

Actavis and Valeant see FDA approval for IBS drugs

May 28, 2015
Sales and Marketing Actavis, FDA, IBS, Valeant, brett wells

Both Actavis and Valeant have been shown the green light for their respective irritable bowel syndrome (IBS) treatments from the …

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AbbVie’s Humira meets endpoint in eye disease study

May 6, 2015
Research and Development, Sales and Marketing AbbVie, FDA, Humira, Zydus Cadila, adalimumab, uveitis

In a Phase III trial AbbVie’s anti-inflammatory medicine Humira has been shown to significantly lower the risk of uncontrolled uveitis …

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Takeda pays $2.7 billion to settle Actos lawsuits

May 1, 2015
Sales and Marketing Actos, FDA, Takeda, bladder, lilly, pioglitazone, type 2

Takeda has agreed to pay $2.7 billion to finally settle thousands of US lawsuits claiming its diabetes drug Actos can …

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Breo image

GSK sees FDA clearance for asthma drug

May 1, 2015
Sales and Marketing Breo Ellipta, FDA, GSK, Theravance

GlaxoSmithKline and Theravance’s Breo Ellipta inhaler has been approved by the FDA to treat asthma in adults. Whilst the once-daily treatment …

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Apple research apps to require ethics board approval

April 30, 2015
Sales and Marketing Apple, BMJ, FDA, GP, researchkit

New guidelines will require apps developed for Apple’s ResearchKit health platform to be approved by an independent ethics board. The …

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abilify_bms_otsuka

FDA waves through generic BMS antipsychotic

April 30, 2015
Manufacturing and Production, Sales and Marketing Alembic, BMS, FDA, Hetero and Torrent Pharmaceuticals, Teva

The FDA has approved four generic versions of Bristol-Myers Squibb’s top selling Abilify, an atypical antipsychotic drug approved to treat …

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Two oncology successes for Pfizer

April 22, 2015
Research and Development, Sales and Marketing Cancer, FDA, Inotuzumab ozogamicin, NSCLC, Pfizer, Xalkori, oncology

Pfizer has received two boosts in oncology as Xalkori gets a new breakthrough therapy designation from the FDA, and its …

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Daiichi Sankyo to sell Sun Pharma stake

April 21, 2015
Manufacturing and Production, Sales and Marketing Daiichi Sankyo, FDA, India, Ranbaxy, Sun Pharma, generics

Daiichi Sankyo is to sell off all or part of its stake in Sun Pharma and back away from the …

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Merck image

Merck seeks new Keytruda indication in US

April 20, 2015
Sales and Marketing Cancer, FDA, NSCLC, PD-L1, US, keytruda, lung, pembrolizumab

Merck is seeking FDA approval for its successful melanoma drug Keytruda to be used treating lung cancer. The Supplemental Biologics …

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AstraZeneca bags another FDA orphan status in cancer

April 17, 2015
Sales and Marketing AstraZeneca, Cancer, FDA, GlaxoSmithKline, mekinist, melanoma, oncology, selumetinib, trametinib

The FDA has granted AstraZeneca’s cancer medicine selumetinib orphan drug designation for the treatment of uveal melanoma. The company will …

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Copaxone image

FDA approves generic Copaxone for multiple sclerosis

April 17, 2015
Sales and Marketing FDA, Sandoz, Teva, glatiramer acetate injection, glatopa

The FDA has signed-off on the first generic version of Copaxone to treat people with relapsing forms of multiple sclerosis …

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FDA approves Amgen’s heart failure drug

April 16, 2015
Sales and Marketing Amgen, Corlanor, FDA, NICE, Vectibix, heart, ivabradine

Amgen has earned sign-off from the FDA for Corlanor as a treatment for people with worsening heart failure symptoms. Corlanor …

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AbbVie hep C drug gets priority review in Japan

April 16, 2015
Sales and Marketing AbbVie, EC, EU, Europe, Exviera, FDA, Japan, Viekira Pak, Viekirax, hepatitis C, ombitasvir/paritaprevir/ritonavir

AbbVie’s combination hepatitis C treatment looks set to be approved in yet another country after being granted priority review in …

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Pfizer breast cancer trial stopped following promising results

April 15, 2015
Sales and Marketing ASCO, FDA, Pfizer, ibrance, palbociclib

Regulators have stopped a Phase III clinical trial of Pfizer’s Ibrance early after it demonstrated improved survival in women with …

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FDA grants AstraZeneca immune drug orphan status

April 15, 2015
Sales and Marketing AstraZeneca, FDA, Iressa, MEDI4736, MedImmune, NSCLC, US, gefitinib, non-small cell lung cancer, tremelimumab

The US Food and Drug Administration has granted orphan drug designation to AstraZeneca’s anti-CTLA-4 monoclonal antibody tremelimumab for the treatment …

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