FDA
Amgen and Novartis tussle over biosimilar injunction
June 4, 2015Sales and Marketing Amgen, FDA, Neupogen, Novartis
Novartis has begun its court battle with Amgen over its biosimilar of cancer drug Neupogen, which Amgen is trying to …
FDA to assess female libido drug
June 4, 2015Sales and Marketing FDA, Sprout Pharmaceutical, flibanserin, libido
The FDA is inching closer to a historic approval of a drug in the US commonly dubbed ‘Viagra for women’. …
Pfizer gets first approval for rare lung disease
May 29, 2015Sales and Marketing FDA, Pfizer, Rapamune, lung disease
Pfizer’s Rapamune will become the first drug available to treat the very rare lung disease lymphangioleiomyomatosis (LAM) after receiving approval …
Actavis and Valeant see FDA approval for IBS drugs
May 28, 2015Sales 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 …
AbbVie’s Humira meets endpoint in eye disease study
May 6, 2015Research 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 …
Takeda pays $2.7 billion to settle Actos lawsuits
May 1, 2015Sales 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 …
GSK sees FDA clearance for asthma drug
May 1, 2015Sales 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 …
Apple research apps to require ethics board approval
April 30, 2015Sales 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 …
FDA waves through generic BMS antipsychotic
April 30, 2015Manufacturing 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 …
Two oncology successes for Pfizer
April 22, 2015Research 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 …
Daiichi Sankyo to sell Sun Pharma stake
April 21, 2015Manufacturing 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 …
Merck seeks new Keytruda indication in US
April 20, 2015Sales 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 …
AstraZeneca bags another FDA orphan status in cancer
April 17, 2015Sales 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 …
FDA approves generic Copaxone for multiple sclerosis
April 17, 2015Sales 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 …
FDA approves Amgen’s heart failure drug
April 16, 2015Sales 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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Five Facts about cardiovascular disease
