FDA
Abbvie and Roche report success in Phase II leukaemia trial
August 13, 2015Research and Development AbbVie, Breakthrough Therapy Designation, CLL, EMA, FDA, Roche, chronic lymphocytic leukaemia, leukaemia, venetoclax
AbbVie plans to submit regulatory applications for its leukaemia drug venetoclax to the FDA and the EMA before the end …
Orexigen and Takeda reboot Contrave collaboration
August 12, 2015Research and Development Contrave, FDA, Takeda, orexigen, weight loss drugs
Orexigen has agreed to foot the $200 million bill for a new trial to prove its claims that Contrave, the …
FDA warns drugmaker over Kim Kardashian West promo
August 12, 2015Sales and Marketing Diclegis, Duchesnay, FDA, kim kardashian
Model and media personality Kim Kardashian West’s social media promotion of the morning sickness drug Diclegis has landed its producer …
First 3D-printed drug approved by FDA
August 4, 2015Manufacturing and Production, Research and Development 3d printing, FDA, manufacturing, production
The world of medicine saw a new pharma milestone this week, with the first approval by the FDA of a …
FDA and EMA approve heart drug Praluent
July 27, 2015Sales and Marketing EMA, FDA, PCSK9, Regeneron, Sanofi, high cholesterol, praluent
The FDA and the EMA have both approved Sanofi and Regeneron’s new high cholesterol drug Praluent. Regulators on both sides …
FDA bans drug imports from Indian plant
July 21, 2015Manufacturing and Production Emcure, FDA, GMP, Good Manufacturing Practices, India, compliance, manufacturing, production, safety
The FDA has blocked US imports from the manufacturing plants of a major Indian pharmaceutical firm over safety fears. The …
AstraZeneca receives US approval for Iressa
July 16, 2015Medical Communications, Sales and Marketing AstraZeneca, FDA, Iressa, lung cancer, non-small cell lung cancer
AstraZeneca’s lung cancer therapy Iressa has been approved by the FDA – four years after the company pulled it from the …
FDA approves Lundbeck and Otsuka’s Rexulti for depression
July 14, 2015Sales and Marketing FDA, Lundbeck, Otsuka, Rexulti, US, brexpiprazole, depression, major depressive disorder, schizophrenia
Lundbeck and Otsuka have gained a yes vote from the FDA for their jointly-marketed antidepressant, Rexulti. The US regulator approved …
Actavis contraceptives recalled after packaging errors
July 9, 2015Manufacturing and Production Actavis, FDA, manufacturing, packaging, product recall, production, recalls
Actavis is voluntarily recalling more than half a million boxes of contraceptive pills in the United States due to problems …
Novartis wins US nod for new heart drug
July 8, 2015Research and Development, Sales and Marketing Entestro, FDA, LCZ696, Novartis, ejection fraction, heart failure, reduced ejection fraction, sacubitril
The FDA has given the green light to Novartis’ new heart failure drug, six weeks ahead of the scheduled date …
Vertex’s cystic fibrosis drug gets FDA approval
July 3, 2015Research and Development, Sales and Marketing FDA, Orkambi, Vertex, cystic fibrosis, gene therapy
Vertex Pharmaceuticals cystic-fibrosis drug Orkambi, which could treat as many as 8,500 patients in the US, has been approved by …
FDA sued over failure to disclose Sovaldi data
June 30, 2015Sales and Marketing FDA, Gilead, hepatitis C, sofosbuvir, sovaldi
Two groups that campaign for wider access to medicines have filed a lawsuit against the FDA, in a bid to …
Eisai earns FDA nod for Fycompa
June 22, 2015Sales and Marketing Eisai, FDA, Fycompa
The FDA has expanded the patient groups for whom Eisai’s epilepsy drug Fycompa is available to include people who have …
FDA links with PatientsLikeMe
June 16, 2015Medical Communications, Sales and Marketing FDA, PatientsLikeMe, data
The US Food and Drug Administration has signed a research deal with PatientsLikeMe in a move the online patient network …
Consumer watchdog highlights FDA failures
June 15, 2015Manufacturing and Production, Research and Development, Sales and Marketing FDA, brett wells, hetlioz, public citizen
Consumer watchdog Public Citizen has criticised the FDA for incorrectly expanding the use of Vanda Pharma’s sleep disorder drug Hetlioz …
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Five Facts about cardiovascular disease
