Genentech alums launch a new biotechnology company; Mallinckrodt sues the FDA over a drug reclassification; Sanofi takes on celiac disease
The government agency said discontinuing Namenda IR before generic competition enters the market could cost Medicare and its beneficiaries billions over the next decade.
Mylan weighs Teva takeover; GSK and UNC launch research center and drug company; FDA approves Roche colorectal cancer drug diagnostic
A court halted the launch of Sandoz's biosimilar; GSK said it is concerned about Advair competition in the US; an FDA panel is expected to vote on a female sexual disorder drug
Spurred by consolidation, the life sciences industry spent more money on acquisitions in the first quarter than it did in all of 2014 combined.
Worldwide spending on cancer medications hit $100 billion last year; Bayer adds an anticoagulant to its pipeline for $100 million; GlaxoSmithKline has a new chairman
The regulator's marketing watchdog said a sales tool makes promises that the drug's label cannot support.
The documents acknowledge biosimilars and branded biologics will differ and set assessment standards.
FDA approves generic Abilify; Mylan raises its offer to buy Perrigo; drugmakers are racing to develop drugs for celiac disease.
More pharma companies hike drug prices post-acquisition; HCV linked to increased risk of cancer; a combined Teva-Mylan would control 25% of the US generic drug market
Walgreen alleges Endo conspired to keep generic Opana ER off the market.
PBM Express Scripts said last year's trends reflect a major shift in how the pharmaceutical industry does business and that generics are not the bargain they once were.
Boston Scientific buys Endo men's health business; Ranbaxy generic Nexium and Valcyte approvals denied by courts; BMS receives priority review for Opdivo lung-cancer indication.
A New Jersey District Court ruled that the Pulmicort Respules patent is invalid, opening the door for Actavis to launch a generic version of the billion-dollar asthma drug.
Bayer exec may be Sanofi's new CEO, GSK gets a new North American Pharma lead, and Pfizer sends painkiller ALO-02 to the FDA.
BMS loses breakthrough therapy status, Gilead's pricing comes under fire in Europe, and pharma fights Italy's off-label Avastin use.
Actavis acquires Auden Mckenzie for $459 million; Sanofi/Regeneron's PCSK9 inhibitor could be first to market; Gilead strikes a deal for Harvoni and Sovaldi with four German health insurers.
The ruling stalls generics until at least September.
Boehringer Ingelheim announced Thursday that it may sell its Roxane Labs generics business, which Bloomberg says may be worth up to $2.3 billion.
FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.
Sandoz received FDA biosimilar nod; new technique yields 25 antibiotics; Novartis sends two COPD drugs for FDA review.
India's Patent Office sets aside Humira patent; Gilead acquires fatty liver disease agent; Bloomberg report says M&A activity likely to persist in 2015.
The drugmaker launched four doses of the blood pressure medication.
A look at the content that grabbed most reader interest over the past year.
Canadian firm presents FDA with its third biosimilar application.
Court clears the way for a Nexavar generic from Natco
Mylan, Teva, and Actavis announced generics of the $3 billion arthritis drug.
Cubist's best-selling product has four of its five patents invalidated; the first biologic of AbbVie's Humira launches in India; Mylan debuts generic Celebrex.
The first low-cost version of the Shire ADHD drug benefits as a first-filer.
AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.
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