What with long summer days, Independence Day celebrations and vacations, it can be tough to keep up with required reading in July. No worries. To catch up with the best-read news--and keep up in conversation with colleagues--check out FiercePharma’s top 10 stories of the month.
FDA savages GSK plant in warning letter. The handwriting was on the wall for a GlaxoSmithKline API operation in the U.K. when the drugmaker recalled more than 425,000 Bactroban antibiotic products last fall after an FDA inspection. Now the extent of the problems at the facility have been laid out in a stern agency warning letter that cited it for penicillin cross-contamination, a problem that can lead to fatal drug reactions, as well as microbial contamination.
Lymphoma trial failure endangers Roche's Gazyva growth plans as Rituxan biosims loom. Roche’s Gazyva fell short in a late-stage lymphoma trial, jeopardizing the company’s expansion plans for the Rituxan follow-up. If Gazyva wants to fill the sales gap after biosims hit, it will need to expand into new groups of patients--and this lymphoma type was meant to be one of them.
Analysts press for M&A as Gilead’s high-flying hep C franchise comes down to earth. Amid intense hep C competition, Gilead Sciences reported plummeting second-quarter sales for the megablockbuster franchise and slashed its full-year revenue forecast. The results are likely to put even more pressure on Gilead to make a game-changing acquisition.
Megamerger-happy investors bid up AZ shares on speculation that Novartis might try a takeover. Would AstraZeneca really find itself contending with another megamerger offer, this time from Novartis? That’s the speculation on the street, and it has investors jazzed enough to bid up the U.K. drugmaker’s shares by 6%, despite the signs pointing away from such a deal.
Suicide of Abbott rep in India raises questions about sales tactics. Reports that a sales representative at Abbott Laboratories in India cited work performance demands in a suicide note have reverberated among colleagues, the Economic Times said, with calls for the drugmaker to take action.
In a warning sign for pharma, ex-J&J execs are convicted in off-label marketing case. Pharma marketers may have felt reprieved after a former Warner Chilcott sales chief was acquitted last month. But now, two former Johnson & Johnson execs have been convicted on off-label marketing charges, raising the specter of more prosecutions in the drug business.
No post-Brexit exit for GSK and AstraZeneca, CEOs will say this week as biopharma rumors swirl. Worried that GlaxoSmithKline or AstraZeneca might pull up their U.K. roots in the wake of Brexit? Rest easy, The Times of London reports. Both companies are set to reassure the world this week that they’re staying put.
Merck's $250M equal-pay lawsuit gains heft as 400 more women claim discrimination. The $250 million gender bias suit against Merck & Co. just picked up more steam. Conditionally certified as a class action in May, the lawsuit has picked up more than 400 plaintiffs to bolster allegations that the company systematically underpaid female sales reps.
Eager for a Pfizer breakup? After new number-crunching, a top analyst sees the split as a no-go. When Pfizer CEO Ian Read raised the idea of a big split, it was a major break from the company’s growth-by-megadeal past--and catnip for investors. But one top pharma analyst now believes Pfizer won't take the plunge.
FDA rejects Sandoz's Neulasta copy, giving Amgen a break from the biosim onslaught. Amgen’s aging superstars have been under assault lately by Novartis’ Sandoz unit and its biosimilars ambitions. But the Big Biotech scored a break at the hands of regulators: The FDA rebuffed Sandoz's biosim version of Amgen's blockbuster Neulasta, Novartis disclosed Tuesday.