GSK won't patent drugs sold in low-income countries; experimental dermatitis therapy met Phase III endpoints; the FDA issues biosimilar labeling guidance
The FDA approves another generic version of Abilify; drug price increases driving profit growth; Spark plans to submit eye-drug to the FDA in 2016
Roche CEO sounds off on UK health system cost controls; Concordia Healthcare buys rare-disease drugmaker; Cipla acquires two generic drugmakers
Copaxone sales rise despite generic competition; Valeant to defend tax strategy; Bristol-Myers Squibb to test Opdivo with mogamulizumab in the US
The drugmaker told investors that the actual-use trial failed to meet the primary objectives.
The FDA approves AstraZeneca's Iressa as a first-line lung-cancer therapy; Mylan and Dr. Reddy's launch generic versions of dementia treatment Namenda; health insurer consolidation may lead to pressure on drug prices
Novartis CEO says pharma must regulate itself; Shire reportedly is in talks to buy biotech Actelion; Lilly insulin outperforms Lantus although safety concerns remain
The FBI is investigating Johnson & Johnson's morcellator; Sanofi purchased another priority review voucher; generic drug prices are falling at a slow rate
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.
Click here to learn about the Agency Issue.
- When it comes to professional ads, print makes its comeback
- Amgen takes issue with yet-to-be published multiple-myeloma drug report
- Following positive outcomes data, a new diabetes class is on the rise
- How Watson for Oncology is advancing cancer care
- Creative partners should push pharma clients to tell better stories