Search Results for: Other News to Note
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David Blech Charged with Securities Fraud Charge, Arraigned
He allegedly permitted a trader, dubbed John Doe in the affidavit, to purchase 20,000 shares of an initial public offering of stock for GeneMedicine Inc., of The Woodlands, Texas, in exchange for which John Doe agreed to purchase 5,000 shares of stock issued by two other companies, Hemisphere and Ecogen Inc...Public Information Officer Marvin Smilon, of the U.S. Attorney's Office, told BioWorld Today that a hearing is set for May 14 before Judge Kevin Thomas Duffy, in Manhattan District Court -
Gilead's Much-Awaited Quad Gets Timely FDA Nod in HIV
By Jennifer Boggs Managing Editor Gilead Sciences Inc.'s four-drug, single-tablet HIV drug Quad got its much-anticipated approval Monday, and the drug is expected to shore up the firm's top-selling HIV franchise, which brought in $7.05 billion in revenue in 2011 but faces patent expiries starting in 2018...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 -
Amylin, Lilly Break Up; New Suitor Waiting in the Wings?
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 -
InterMune Bulks Up Balance Sheet for Esbriet EU Launch
Managing Editor Set to make idiopathic pulmonary fibrosis drug Esbriet (pirfenidone) available to patients in Germany Thursday, about six months after receiving European approval, InterMune Inc...Pricing in the other European countries is likely to be lower, but the Germany pricing "is an important step because it's a step that creates some reference pricing," Welch said, "and that's intentional -
Complera Nod Bridges Gilead's HIV Franchise; All Eyes on Quad
Managing Editor Gilead Sciences Inc.'s Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) won FDA approval as expected, but the single-tablet formulation nicknamed "Btripla" likely will prove only a modest addition to the firm's HIV franchise should the highly anticipated Quad regimen yield strong Phase III data later this year...In other news, the firm reported that it resolved all outstanding issues outlined in an FDA warning letter relating to its San Dimas, Calif -
Intercell Looking for 'Renewal' After S. Aureus Vaccine Failure
While Intercell assured investors that all other terms remain the same – Intercell can choose between a co-development and profit-sharing agreement or to opt for milestone payments totaling €120 million, plus double-digit sales royalties – the timing of the news was interesting, coming only a week before Intercell and Merck said they were suspending the V710 study. (See BioWorld International, April 6, 2011.) Meanwhile, Intercell also plans to move forward with a Phase I candidate for -
Optimer Hoping for 'Impactful' Launch with Dificid in CDAD
Assistant Managing Editor After a three-day weekend to digest the news of Optimer Pharmaceuticals Inc.'s approval for macrolide antibiotic Dificid (fidaxomicin), investors jumped on the San Diego-based firm's stock (NASDAQ:OPTR) Tuesday, which, trading at seven times its average volume, gained $1.53, or 11.8 percent, to close at $14.51 -
Stem Cell Tech Firm VistaGen Goes Public via Reverse Merger
Assistant Managing Editor The latest firm to opt for a reverse merger rather than the more traditional initial public offering, VistaGen Therapeutics Inc...Proceeds are expected to support development of TC-5619, in testing for schizophrenia and attention deficit hyperactivity disorder, and other clinical-stage programs, as well as for working capital and other general corporate purposes -
Early Nod for Abiraterone, No Threat to Dendreon's Provenge
Assistant Managing Editor Almost exactly a year after Dendreon Corp...That's the same patient population targeted by Provenge, but analysts are not expecting the two treatments to compete against each other, at least at first -
Alternative Going Mainstream? Biotechs Find Funding Options
Assistant Managing Editor Editor's note: This article originally appeared in BioWorld Insight, which provides cutting-edge analysis of the biotech industry every Monday...Adding to the Financing 'Arsenal' Yet, while having access to the public markets certainly makes accessing cash easier, the toll of discounts and dilution from traditional public offerings and PIPEs can be hard on a company's stock -
BG-12 Positive in First Phase III; Biogen Poised for Oral MS Entry
Assistant Managing Editor Biogen Idec Inc.'s immune modulator BG-12 (dimethyl fumarate) yielded better-than-expected top-line data in its first Phase III trial, news that bodes well for the Cambridge, Mass.-based firm's foray into the oral multiple sclerosis (MS) drug market and may help stave off competitive threats to its lucrative MS franchise...The news sent shares of Biogen (NASDAQ:BIIB) up $5.26, to close Monday at $78.55 -
Vivus, Orexigen Jump on CV Data, but No Obesity Win Yet
In a research note, the analysts pointed to other data included in the firm's poster presentation at ACC, particularly data showing that LDL-cholesterol was statistically significantly higher in the Qnexa arms compared to placebo -
Telaprevir vs. Boceprevir? HCV War More About Nonresponders
Assistant Managing Editor Less than a month away from FDA advisory panels on hepatitis C virus (HCV) candidates telaprevir and boceprevir, the two protease inhibitors met up again at the European Association for the Study of the Liver meeting in Berlin, as analysts continued trying to figure out which one will have an edge over the other in the marketplace...Those analyses "continued to demonstrate telaprevir's advantages," Wells Fargo analyst Brian Abrahams wrote in a research note -
Alternative Going Mainstream? Biotechs Find Funding Options
Assistant Managing Editor Editor's note: This is a special reprint from the March 7, 2011, issue of BioWorld Insight, the weekly analytical companion to BioWorld Today -
Esbriet Wins EMEA Approval, InterMune Plans Fall Launch
Assistant Managing Editor InterMune Inc.'s idiopathic pulmonary fibrosis (IPF) drug pirfenidone still faces some regulatory hurdles in the U.S., but the Brisbane, Calif.-based company is set to roll out its commercialization force in Europe this fall following official marketing authorization of pirfenidone, branded Esbriet, in mild to moderate IPF...There currently are no drugs available, and other late-stage products, including endothelin receptor antagonists from Gilead Sciences Inc. (Letairis -
Clinical Data Lands Buyout as Forest Makes $1.2B Viibryd Bet
Assistant Managing Editor Buyout speculation fueled by the late January approval of depression drug Viibryd (vilazodone) – not to mention last week's chatter after President and CEO Drew Fromkin cancelled his presentation at BIO CEO – ended Tuesday with a resounding thud, as Clinical Data Inc...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 -
Clinical Data Lands Buyout as Forest Makes $1.2B Viibryd Bet
BioWorld Today Assistant Managing Editor Buyout speculation fueled by the late January approval of depression drug Viibryd (vilazodone) – not to mention last week's chatter after President and CEO Drew Fromkin cancelled his presentation at BIO CEO – ended Tuesday with a resounding thud, as Clinical Data Inc...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 -
Celgene Dips on Disappointing Earnings, Lung Cancer Data
Analysis from all patients showed a 33 percent ORR in the Abraxane group vs. 23 percent in the control group, for a 31 percent improvement. (See BioWorld Today, March 18, 2010.) Prior to the PFS news, analysts had put Abraxane's market potential in NSCLC at anywhere from $100 million to $500 million peak sales...last year, the big biotech's goal was to re-energize sales of the drug in breast cancer, with plans to reach $1 billion by 2015, and expand it into other oncology areas. (See BioWorld -
Late-Stage Cancer Vaccine Firm NewLink Files for $86M IPO
According to BioWorld Snapshots, a total of 18 firms have priced offerings this year, though most raised less than hoped for...In addition to the Phase III trial in pancreatic cancer, funds from the proposed IPO also are expected to support other pipeline programs...In other financings news -
Bolstering Cash Position, YM Raises $40M in Public Offering
Those anemia results in particular were "potentially game changing," wrote analyst Joseph Pantginis, of Roth Capital Partners, in a Dec. 7 research note, especially since the effects on anemia, "a key contributor to morbidity, are not seen with the other JAK inhibitors...In other financings news
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