GSK accused of wrongdoing in Poland, Wellbutrin generic revoked

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.

Color keeps GSK generic off the market

GlaxoSmithKline claims that Sandoz needs to change the packaging for its generic Advair.

FDA slammed over generics

Critics say the FDA is not doing enough to ensure generics quality and that communications between industry and the regulator need to improve.

Ranbaxy, Teva settle with New York State

The drugmakers admitted no wrongdoing, but are paying the state $300,000 over an agreement not to challenge generics filings.

Merck latest rival in race to copy Lantus

Merck latest rival in race to copy Lantus


Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.

Biogen CEO cautions on Tecfidera EU launch

Biogen CEO cautions on Tecfidera EU launch


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, Pfizer settle on Viagra generic date

Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.

Osbourne joins Teva for "You Don't Know Jack About MS"

Osbourne joins Teva for "You Don't Know Jack About MS"


Famous from his reality show, "The Osbournes," Jack narrates his life with MS in a web documentary series.

Teva unclear on 2014 future

The company released two financial scenarios. The key is generic Copaxone.

Teva denies rumors of CEO-board friction

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.

Study shows swift move from brand to generic drugs

Study shows swift move from brand to generic drugs


Researchers say it's not just payers supporting the switch, and all ages appear to be brand agnostic.

FDA boots Wellbutrin generic

The agency says the copycat antidepressant failed to meet bioequivalency requirements.

Teva trimming 10% of staff ahead of MS drug expiry

Teva trimming 10% of staff ahead of MS drug expiry


The generics giant said it will lay off about 5,000 employees as it braces for the expiry of one of its specialty brands.

Business briefs: Allergan, Incyte, Medtronic, Aetna

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.

Business briefs: Medtronic, Novo Nordisk, plus OIG's latest probe

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.

AstraZeneca, Sanofi close disappointing quarter


The positive way to frame the companies' quarterly results: "less bad," as generics continued to plague their balance sheets.

BMS to put more sales oomph behind Eliquis, diabetes

BMS to put more sales oomph behind Eliquis, diabetes


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.

Business briefs: Teva, AbbVie, Novartis, Wockhardt

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.

Actavis gets go-ahead to expand generic painkiller portfolio


The drug maker can now add five new doses to its generic Opana ER offerings.

Business briefs: Amgen and Wockhardt

Amgen pays $50 million for a cardio collaboration, and Wockhardt gets locked out of the EU.

Business briefs: Lilly, Novartis, Activartis, plus policy news

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.

EU backs Remicade biosimilars; anti-TNFs at risk


CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.

Not buying it: Medical professionals go generic, study shows


Researchers quantify the rate at which doctors, nurses and pharmacists buy off-label OTC drugs.

Business briefs: Roche, WellPoint, Bayer, Takeda, Allergan

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.

Sandoz readies Enbrel biosimilar for testing


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).

Business briefs: Boehringer Ingelheim, Teva, Medicare

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

Pill-plus value adds beat brand names in the age of ACOs


The effectiveness of new drugs is in decline, says an analysis, and researchers say comparative studies should look beyond efficacy measures.

Business briefs: AbbVie, Teva, HIV, Diabetes, iPhone

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.

Business Briefs: Amgen and Astellas; GSK; Teva; Novo; Livestrong

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

Business briefs: Pfizer, BMS, CMS, Sanofi

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.

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