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Clinic Roundup
Acadia Pharmaceuticals Inc., of San Diego, presented data at the International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia, from its Phase III program testing pimavanserin in Parkinson's disease psychosis (PDP), including data from the pivotal -020 study and related -015 open-label safety extension trial...Adamas Pharmaceuticals Inc., of Emeryville, Calif., reported that the company's Phase II/III EASED (Extended Release Amantadine Safety and Efficacy Study inBioWorld Today | Wednesday, June 19, 2013 -
Financings Roundup
Vertex Pharmaceuticals Inc., of Cambridge, Mass., completed its call for redemption of $400 million in aggregate principal amount of 3.35 percent convertible senior subordinated notes due in 2015BioWorld Today | Wednesday, June 19, 2013 -
Other News To Note
Ablynx NV, of Ghent, Belgium, will make an oral and poster presentation for arthritis candidate, ALX-0061, at the Annual European Congress of Rheumatology in Madrid, Spain, showing a strong efficacy and safety profile for the drug in a Phase II study. Pooled data at 24 weeks of treatment demonstrated that ALX-0061 led to an improvement of 84 percent in ACR20 and 58 percent DAS28 remission. At all doses, the drug was well tolerated with no clinically relevant neutropenia, no clinicallyBioWorld International | Wednesday, June 19, 2013 -
XO1 Cracks Coagulation Conundrum, Raises $11M
A Factor Xa inhibitor, betrixaban, is the star asset in Portola Pharmaceuticals Inc.'s portfolio, which it leveraged to make an initial public offering in May, to raise $122 millionBy Catherine Shaffer | BioWorld International | Wednesday, June 19, 2013 -
Biolinerx Teams with Jiangsu for Hepatitis C Drug in China
Biolinerx is going up against drug-developers such as Vertex Pharmaceuticals Inc., of Cambridge, Mass., which has taken an aggressive two-pronged approach, partnering with industry majors Johnson & Johnson and GlaxoSmithKline plc (GSK) to carry out two different Phase II trials simultaneously on their HCV polymerase inhibitor, VX-135. (See BioWorld Today, Nov. 2, 2012.) For the preclinical development of BL-8030 in China, CTTQ has committed to adhering to FDA and EMA guidelines and givingBy Shannon Ellis | BioWorld International | Wednesday, June 19, 2013 -
Biotech Yields Another in Bumper Crop of IPOs
and Regado Biosciences Inc. – prepared to price IPOs this week, a fourth, Onconova Therapeutics Inc., filed a registration statement with the SEC, seeking to raise up to $75 million. (See BioWorld Today, May 1, 2013, May 17, 2013, and May 20, 2013.) Onconova filed its S-1 Friday evening after the market's close, hours after a similar filing by Conatus Pharmaceuticals Inc. (See BioWorld Today, June 17, 2013.) In its S-1, Onconova said it plans to use the proceeds to fund the clinical developmentBio Perspectives | Tuesday, June 18, 2013 -
Clinic Roundup
Acetylon Pharmaceuticals Inc., of Boston, presented data on lead candidate ACY-1215 for the treatment of relapsed or refractory multiple myeloma at the 18th Congress of the European Hematology Association...NPS Pharmaceuticals Inc., of Bedminster, N.J., presented findings supporting the therapeutic potential of Natpara (rhPTH [1-84]) for adults with hypoparathyroidism in poster sessions at the Endocrine Society's annual meetingBioWorld Today | Tuesday, June 18, 2013 -
SCOTUS Refuses to Sink Pay-for-Delay Settlements
The court's 5-3 opinion, written by Justice Stephen Breyer, holds that the U.S. Court of Appeals for the 11th Circuit was wrong when it affirmed a lower court's dismissal of an FTC challenge to a 2006 settlement between Solvay Pharmaceuticals IncBy Mari Serebrov | BioWorld Today | Tuesday, June 18, 2013 -
Other News To Note
in filing a patent infringement lawsuit against Mylan Pharmaceuticals Inc., of Pittsburgh, which filed an abbreviated new drug application (ANDA) seeking to market a generic version of Azasite (azithromycin 1 percent ophthalmic solution...Psychogenics Inc., of Tarrytown, N.Y., and Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said they expanded the scope of their central nervous system drug discovery partnership and extended the agreement for another two yearsBioWorld Today | Tuesday, June 18, 2013 -
Biotech Yields Another in Bumper Crop of IPOs
and Regado Biosciences Inc. – prepared to price IPOs this week, a fourth, Onconova Therapeutics Inc., filed a registration statement with the SEC, seeking to raise up to $75 million. (See BioWorld Today, May 1, 2013, May 17, 2013, and May 20, 2013.) Onconova filed its S-1 Friday evening after the market's close, hours after a similar filing by Conatus Pharmaceuticals Inc. (See BioWorld Today, June 17, 2013.) In its S-1, Onconova said it plans to use the proceeds to fund the clinicalBy Marie Powers | BioWorld Today | Tuesday, June 18, 2013 -
$650M Aragon Buyout Brings J&J's Replacement for Zytiga
Johnson & Johnson's (J&J) planned takeover of Aragon Pharmaceuticals Inc...Other recent newsmakers in the CRPC space include Cambridge, Mas.-based Tokai Pharmaceuticals Inc., with the triple-acting prostate cancer drug galeterone, for which the firm raised $35.5 million in a Series E round last monthBy Randy Osborne | BioWorld Today | Tuesday, June 18, 2013 -
Pharma: Other News To Note
In conjunction with the workshop, Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, and Eli Lilly and Co., of Indianapolis, issued a statement supporting the American Diabetes Association's call for an independent review of the safety data of incretin-based therapiesBioWorld Today | Monday, June 17, 2013 -
Clinic Roundup
Astex Pharmaceuticals Inc., of Dublin, Calif., updated Phase I trial results for SGI-110 in a poster session at the 18th Congress of the European Hematology Association, June 13-16 in Stockholm, SwedenBioWorld Today | Monday, June 17, 2013 -
Mast Flags Offering's $22.9M for Sickle Cell Phase III Trial
Mast – then known as Adventrx Pharmaceuticals Inc. – in 2011 brought MST-188 aboard with the buyout of Synthrx Inc., of Houston, which had licensed MST-188 from Los Angeles-based Cytrx Corp. (See BioWorld Today, Feb. 15, 2011.) Brand-named Flocor by Cytrx, the drug fizzled in a 255-patient Phase III trial...Earlier this month, Hemaquest Pharmaceuticals Inc., of San Diego, completed enrollment in a randomized, double-blind, placebo-controlled Phase IIb study of HQK-1001 , a small-chain fatty acidBy Randy Osborne | BioWorld Today | Monday, June 17, 2013 -
Biolinerx Teams with Jiangsu for Hepatitis C Drug in China
Biolinerx is going up against drug-developers such as Vertex Pharmaceuticals Inc., of Cambridge, Mass., which has taken an aggressive two-pronged approach, partnering with industry majors Johnson & Johnson and GlaxoSmithKline plc (GSK) to carry out two different Phase II trials simultaneously on their HCV polymerase inhibitor, VX-135. (See BioWorld Today, Nov. 2, 2012.) For the preclinical development of BL-8030 in China, CTTQ has committed to adhering to FDA and EMA guidelines and givingBy Shannon Ellis | BioWorld Today | Monday, June 17, 2013 -
Conatus Pharma Seeks $69M for Liver Drug Emricasan
Conatus Pharmaceuticals Inc., which has quietly labored on liver drug emricasan (IDN-6556) since gaining global rights to the asset in its 2010 acquisition of Pfizer Inc...spin-out Idun Pharmaceuticals Inc., became the latest biotech to register with the SEC for an initial public offering (IPOBy Marie Powers | BioWorld Today | Monday, June 17, 2013 -
XO1 Cracks Coagulation Conundrum, Raises $11M
A Factor Xa inhibitor, betrixaban, is the star asset in Portola Pharmaceuticals Inc.'s portfolio, which it leveraged to make an initial public offering in May, to raise $122 millionBy Catherine Shaffer | BioWorld Today | Monday, June 17, 2013 -
Pharma: Clinic Roundup
Astex Pharmaceuticals Inc., of Dublin, Calif., presented updated clinical results of its hypomethylating agent, SGI-110, in a poster session at the 18th Congress of the European Hematology Association in Stockholm, SwedenBioWorld Today | Monday, June 17, 2013 -
Other News To Note
Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said a preclinical study of its influenza DNA vaccine against the newly emergent virulent H7N9 flu virus showed that the vaccine achieved immune response levels exceeding what are considered protective levels in other common influenza subtypes...Omthera Pharmaceuticals Inc., of Princeton, N.J., established a date for a special meeting of stockholders to vote on a proposed merger agreement between Omthera, Zeneca Inc., a subsidiary of London-basedBioWorld Today | Monday, June 17, 2013 -
Pharma Clinical & FDA Action Update: May 2013
Pharmaceuticals Inc. (Berkeley, Calif.) and Onyx Pharmaceuticals Inc. (South San Francisco) Stivarga Regorafenib Metastatic gastrointestinal stromal tumor FDA approved it 5/16/13 Boehringer Ingelheim GmbH (Ingelheim, Germany) Tiotropium Delivered by the Respimat Softmist inhaler Asthma Phase III data showed it increased time to first severe exacerbation and first episode of asthma worsening 5/22/13 Bristol-Myers Squibb Co. (New York) Nivolumab An anti-PD-1 Inoperable Stage III and Stage IVBioWorld Insight | Monday, June 17, 2013
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