Poland joins the list of countries in which GlaxoSmithKline is accused of misconduct. Meanwhile, bioequivalence issues have prompted the FDA to revoke its approval of GSK's Wellbutrin generic.
GlaxoSmithKline claims that Sandoz needs to change the packaging for its generic Advair.
Critics say the FDA is not doing enough to ensure generics quality and that communications between industry and the regulator need to improve.
The drugmakers admitted no wrongdoing, but are paying the state $300,000 over an agreement not to challenge generics filings.
Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.
The MS pill saw rapid uptake in the US last year, but its overseas launch won't be as quick, CEO George Scangos conceded this week at an analyst conference.
Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.
Famous from his reality show, "The Osbournes," Jack narrates his life with MS in a web documentary series.
The company released two financial scenarios. The key is generic Copaxone.
Generic giant Teva refuted allegations that the CEO, Jeremy Levin, and the board of directors were at odds over the company's cost-saving maneuvers.
Researchers say it's not just payers supporting the switch, and all ages appear to be brand agnostic.
The agency says the copycat antidepressant failed to meet bioequivalency requirements.
The generics giant said it will lay off about 5,000 employees as it braces for the expiry of one of its specialty brands.
Allergan asks FDA to reconsider Restatis generics requirements, Incyte's Jakafi could be pancreatic cancer nemesis, Medtronic says its strategy is at the heart of where healthcare is going and Aetna's app alliance makes health local and personal.
Medtronic buys up Cardiocom, Novo will file liraglutide to battle obesity, HHS navigates cutback and looks into anti-psychotic prescription rates, Amgen's Neulasta to compete against Teva's Lonquex.
The positive way to frame the companies' quarterly results: "less bad," as generics continued to plague their balance sheets.
Sales slid 9% during the second quarter, with generic Avapro and Plavix inflicting financial pain. The company says it is going to invest more to promote Eliquis among HCPs and plans on deploying a wider diabetes sales force.
FDA grants Teva three years exclusivity to sell Plan B OTC for all ages; FDA gives Humira a thumbs-down for spondyloarthritis; a UK vaccine committee rejects Novartis' meningitis B shot; and Wockhardt gets a warning letter from FDA for its manufacturing practices at an Indian plant.
The drug maker can now add five new doses to its generic Opana ER offerings.
Amgen pays $50 million for a cardio collaboration, and Wockhardt gets locked out of the EU.
Eli Lilly and Boehringer Ingelheim submit a glargine biosimilar to the EMA; Novartis pipeline claims an Enbrel-superior treatment; Activartis med gets orphan drug status; generics makers may have to pay more attention to labels; Administration tweaks healthcare reform implementation over the long weekend.
CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.
Researchers quantify the rate at which doctors, nurses and pharmacists buy off-label OTC drugs.
A JAMA article says prostate cancer patients are getting treatments they don't need; Roche and AstraZeneca will share safety data; WellPoint gives cost sharing a new spin; Bayer seeks to boost its oncology pipeline; Takeda announces organizational changes; and the FDA puts Allergan's Restasis on track for generic competition.
The drug maker says it expects to use the Phase III clinical trial data to back applications in the EU and the US (when it gets a pathway setup).
Good and bad news about Pradaxa; Plan B decision not deemed a big threat to Teva's sales; Study says Medicare patients more likely to receive brand-name medications than VA patients
The effectiveness of new drugs is in decline, says an analysis, and researchers say comparative studies should look beyond efficacy measures.
AbbVie lays off 100 R&D staff; Teva looks to expand Copaxone footprint; researchers crack HIV protein code; monitors may be misleading diabetics and a prototype sensor turns iPhones into virus hunters.
Amgen and Astellas team up to take on Japan; GSK acquires Swiss vaccine developer's innovative platform; Ireland makes generic switches easier; Novo backs wet AMD therapy; Nike ditches Livestrong
Pfizer cuts 136 workers loose in Ireland, BMS is investing in heart failure treatments, CMS has an official new leader, and Sanofi's iBGStar may have a competitor.