Other, sub-Saharan countries are at the very beginning...They wouldn't have to do this in a mature market, or in some of the other emerging markets, whether it's about education, or a secure distribution, or even pharmacovigilance, which they will have to build their own systems for

In addition to its Quad application, Gilead also is seeking approval of elvitegravir as a drug in its own right...In addition to promising data from its all-oral, interferon-free regimen, Gilead has benefited from disappointing news from competing programs at BMS and Idenix Pharmaceuticals Inc

The decision to halt it now is at least based on solid evidence...ThromboGenics and BioInvent continue to believe the drug has potential in oncology and in other areas, including ophthalmology and liver disease

rose 13 percent Monday on news that macitentan, its dual endothelin receptor antagonist (ERA), hit the primary endpoint in a pivotal Phase III trial in pulmonary arterial hypertension (PAH), raising the prospect that the company will be able to revitalize its aging PAH franchise with a safer, more potent drug...In a research note, Peter Welford, analyst at Jefferies International, wrote that he was retaining a peak sales forecast of CHF800 million for now, although "a 45 percent reduced risk of

Bradbury and other company execs, however, pointed to the financial terms, which call for Amylin to make a one-time up-front cash payment of $250 million – that hefty chunk will reduce the company's cash position to about $210 million – plus future revenue-sharing payments equal to 15 percent of global net sales of exenatide products capped at $1.2 billion plus accrued interest

BioWorld Perspectives Contributing Writers Editor's note: Paul M. Rivard is a shareholder at Banner & Witcoff and can be reached at Part 1, and here to read Part 2...To be patent-eligible, the invention needs to have "markedly different" characteristics and uses compared to the product of nature

Btripla, the follow-on to HIV blockbuster Atripla – Gilead Sciences Inc...ISI Group analyst Mark Schoenebaum wrote in a research note that while a 5 percent to 6 percent delta "may have resulted in superiority," Quad came in at 4 percent...Based on our prior discussions with physicians and payers, we do not believe Quad needed to demonstrate superiority over Atripla to be commercially successful," wrote Brian Abrahams of Wells Fargo Securities in a research note

BioWorld Perspectives Contributing Writers Editor's note: Timothy D. Johnston is a partner in the Boston law firm of Nutter McClennen & Fish LLP, where he specializes on intellectual property, and other complex commercial, litigation...This is very good news for biotechnology companies, for which patents are often a critical asset, and for the patent system, which has been increasingly bogged down by what were often baseless attempts to challenge the enforceability of patents. (See BioWorld

With other options off the table, that pretty much leaves drug and device costs...The guidance is good news for companies like Endocyte Inc., of West Lafayette, Ind., which is developing EC20 as a companion imaging diagnostic to its EC145 cancer candidate...Editor's note: Mark McCarty, Washington editor for Medical Device Daily (www.medicaldevicedaily.com), contributed to this article

Other soldiers get left at base camps to recover, which can take three days...To be fair, the company is developing human neural stem cells as a platform to treat other, less rare (though still qualifying as rare) diseases...Prize An astute reader forwarded the news that Johnson & Johnson admitted to bribing doctors in Greece, Poland and Romania and paying kickbacks in Iraq under the infamous UN "oil for food" program

In an earlier research note, Tenthoff had considered a takeout price for Clinical Data to be in the $47-per-share to $75-per-share range, assuming peak sales of Viibryd reached those heights...Other law firms joined the mix throughout the day

On a more troubling note, the FDA placed a clinical hold on the HIV/AIDS non-nucleoside reverse transcriptase inhibitor GSK2248761 ('761, formerly IDX899), which Idenix licensed two years ago this week to GlaxoSmithKline plc...The remaining 'partial clinical hold' does not appear to significantly restrict the near-term development program and primarily requires the completion of IDX184 dosing in the Phase IIb before combination studies with other HCV direct antiviral agents can be started," Liang

analyst Bret Holley pointing out the increasing licensing value of ADC technology in a recent note wrote, "Additional collaborations such as this highlight the value of SGEN's ADC technology and should continue to grow the company's revenue base...In other dealmaking news...Immutep SA, of Orsay, France, announced a license agreement granting GlaxoSmithKline (GSK) exclusive worldwide rights to ImmuTuneIMP731 and any other antibodies that deplete LAG-3 positive cells

BioWorld International Correspondent Shares in Intercell AG plummeted 40 percent Monday on news that its patch-based vaccine for traveler's diarrhea failed to demonstrate efficacy in two studies, a Phase III trial in Central America and a Phase II pilot study in India...Its alliance with GSK involves up to 11 indications, but all other programs are at a much earlier stage of development...But that market reaction was exaggerated, according to a research note from Peter Welford and colleagues at

Assistant Managing Editor Basilea Pharmaceutica AG's antibiotic ceftobiprole failed for the third time to clear FDA review due to data integrity issues, news that sent shares falling 15 percent but could give the Swiss company more ammunition in its ongoing arbitration process claiming damages against partner Johnson & Johnson...In addition to the two complete response letters pointing to data integrity issues, the FDA also smacked J&J with a warning letter in August, for failing to ensure proper

BioSpooky News Blurbs of the Year By Michael Harris BioWorld Executive Editor Editor's note: Last week's BioWorld Perspectives featured a special Halloween article, "Honoring Biotech's Best Costumes...The FDA virtually gave GlaxoSmithKline plc's Avandia (rosiglitazone) a heart attack of its own when it essentially limited the drug's access to existing patients and only those new patients who could attest they had tried every other diabetes drug without success...There are almost daily news reports of

Nevertheless, the news alone should make the current tender offer, which values the firm at about $18.5 billion, less tempting to Genzyme shareholders...And, to date, no other prospective buyers have emerged...We expect Genzyme to pursue strategic alternatives, including a White Knight, which could command an acquisition price more in line with our sum of the parts analysis of $85 per share," he wrote in a research note

But most analysts had expected the sale of all three businesses to total about $1 billion, with the genetics unit going for around $650 million, so terms of the LabCorp deal offered a nice surprise, particularly given that other firms have had trouble selling off noncore units. (See BioWorld Today, July 22, 2010.) Most recently, Abbott, of Abbott Park, Ill., opted against selling a vaccine division – picked up in last year's acquisition of Solvay Pharmaceuticals Inc. – after failing to receive

News of the serious adverse events (SAEs) arising from the post-combinations study of IDX184 and IDX320 caused shares in Idenix (NASDAQ:IDIX) to tumble $2.81, closing at $3.18...But due to the hold, no other studies of those HCV candidates can proceed