Bad news for AstraZeneca: FDA lays out roadmap for would-be Symbicort copycats

Courtesy of AstraZeneca The FDA has issued AstraZeneca's ($AZN) least favorite form of draft guidance--the kind that helps other drugmakers develop copies of a blockbuster seller. Regulato

Bayer, J&J aim to protect Xarelto's market lead with focus on clinical data

Bayerand Johnson & Johnson ($JNJ) know that right now, there's an impression out there that rival drugEliquis--from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY)--is superior to their next-gen clo

CFDA officially joins the Interim Management Committee of ICMRA

Upon the approval of the State Council, China Food and Drug Administration (CFDA) officially joined the Interim Management Committee of the International Coalition of Medicines Regulatory Authorities

2015 Minister-level Seminar on Pharmaceutical Supervision and Management for Developing Countries held in Beijing

On June 24, 2015, the 2015 Minister-level Seminar on Pharmaceutical Supervision and Management for Developing Countries undertaken by China Food and Drug Administration (CFDA) was held in Beijing. Min

Allergan to close plant in Iceland, lay off 300

Allergan ($AGN) ChairmanPaul Bisarohas been quick to cut what he sees as redundant operations and people to help pay for his aggressive buying. Now, he has set his sights on the company's ancestry, wi

Pharma to EU officials: We need 'contingency' supply plans in case of 'Grexit'

Drugmakers are raising an alarm about shortages in Greece as the possibility of a "Grexit" looms. That "worst-case scenario" could put supplies in peril, the European Federation of Pharmaceutical Indu

Danny Glover signs up with Avanir to spotlight pseudobulbar affect

Actors cry and laugh on command, but people who have pseudobulbar affect (PBA) can't control their crying jags or laughing fits. That's the central idea of Nuedexta-makerAvanir's new PBA awareness eff

Bigger pharma may be scraping for good deals, but Horizon has plenty of options, analysts say

Horizon Pharma ($HZNP) isn't exactly the only specialty pharma company hunting for deals. Allergan ($AGN), Mallinckrodt ($MNK), Endo ($ENDP) and the ever-acquisitive Valeant ($VRX) have all been on sh

U.S. drug payers have been able to beat back high prices for some COPD and diabetes drugs, much to the chagrin of GlaxoSmithKline ($GSK) and Sanofi ($SNY). But several new categories promise to break out in a big way, and we are not talking just about hepatitis C drugs. Experts suggest new classes of oncology drugs as well and cholesterol fighters will be widely used and highly priced. While a worry for payers, that is a positive for investors in companies like Merck ($MRK), Sanofi ($SNY) and Bristol-Myers Squibb ($BMY).

Rare-disease specialist Alexion Pharmaceuticals ($ALXN) won a double header from the EMA today when the agency recommended approval of two of its drugs, including Kanuma, the enzyme replacement med it

UPDATED: Merck cancer drugs and Sanofi, Amgen cardio meds have formularies on high alert

U.S. drug payers have been able to beat back high prices for some COPD and diabetes drugs, much to the chagrin of GlaxoSmithKline ($GSK) and Sanofi ($SNY). But several new categories promise to break