According to a report from Tufts Center for the Study of Drug Development (CSDD), clinical trials using adaptive designs, which currently account for about 20 percent of trials, are on the rise. Simple designs, such as sample size re-estimations as well as early terminations due to futility, are the most popular. "Companies are receptive to them, and they're beginning to use them increasingly," Kenneth Getz, director of sponsored programs at Tufts CSDD, told BioWorld Insight. Adoption of more

Fiscal 2015 could shape up to be an even tighter budget year for federal agencies like the FDA and National Institutes of Health. Even though Congress has yet to pass a fiscal 2014 budget, the agencies are beginning work on their 2015 budget proposals. In a memo, the White House Office of Management and Budget told agency heads to include a 5 percent reduction below the net discretionary total provided for their agencies in the president's 2014 budget, which was released last month. Recognizing

Scripps Research Institute (TSRI) scientists have developed a powerful new technique for rapidly discovering antibodies that have a desired biological effect. "The time from selection of the target through discovery of the antibody and completion of initial animal tests totaled only about five months," noted Hongkai Zhang, a research associate in the lab of Richard A. Lerner, the Lita Annenberg Hazen Professor of Immunochemistry at TSRI. Zhang of the Department of Molecular Biology is first

It's been a long time since we've witnessed 11 biotechs successfully completing their initial public offierings (IPOs) on the U.S. market during the first five months of the year. That number only usually accrues in the space of a year. In fact you have to go back to 2007 when 13 biotech IPOs were completed in the same period. The IPO market has certainly taken off big time this year and biotechs are rushing to take advantage of the favorable environment. So far, according to BioWorld Snapshots

Financings Elan Corp. priced an offering of $850 million aggregate principal amount of 6.25 percent senior notes due 2021. Evoke Pharma Inc. filed an S-1 seeking to raise $23 million in its IPO. Mast Therapeutics Inc. plans to raise $30 million through a public offering. NPS Pharmaceuticals Inc. closed a public offering of 6.9 million shares at $14.53 per share. Ophthotech Corp. raised $175 million to support a Phase III program for Fovista, an anti-PDGF agent. Prosensa Therapeutics BV filed for

"The world can't wait for the pharmaceutical industry to be disrupted. Disruption is a good thing when it happens to others, but we fear it when it happens to us." – Bernard Munos, InnoThink Center for Research in Biomedical Innovation, Indianapolis "H9N2 is spread across all of Eurasia in the primary host of flu virus, namely, chickens. It causes no apparent disease, but shares a lot of genetic material with H7N9, suggesting that it, too, could turn lethal. We've been watching it evolve in

"Nature is the main bioterrorist." – Influenza researcher Albert Osterhaus on the bioterrorism risk from studying pandemic influenza virus strains "Our belief is that you can take some of the moving parts away and de-risk them by at least having a homogenous molecule. That's where we think the future will be." – Trevor Hallam, chief scientific officer of San Francisco-based antibody-drug conjugate developer Sutro Biopharma Inc., discussing the Phase III failure of Pfizer Inc.'s ADC inotuzumab

Drugs continue to fail. Most candidates that enter into the development process do not come out the other end as approved therapies. But the reasons for those failures have shifted. Compared to a decade ago, Steven Paul told BioWorld Insight, attrition due to either safety or a lack of drug-like properties of a lead compound has been "fundamentally reduced." Such attrition has not been eliminated. But nowadays, drugs fail more often because "they just don't work for the disease they were

Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Evotec AG (Hamburg, Germany) Genentech Inc. (South San Francisco; unit of Roche Group) ND Extended drug discovery alliance for three additional years The collaboration, initiated in May 2010, involves Evotec's technology platform and drug discovery expertise 4/23/13 MAY Galapagos NV (Mechelen, Belgium) AbbVie Inc. (Chicago) $50 Extended clinical development collaboration on the oral JAK1 inhibitor

Financings Acadia Pharmaceuticals Inc. completed a public offering for gross proceeds of $115 million. Cyclacel Pharmaceuticals Inc. closed a public offering for gross proceeds of $20.5 million. Effector Therapeutics Inc. closed a $45 million Series A round. Epizyme Inc. set terms for its proposed IPO, aiming to sell 4.3 million shares at a price range of $13 to $15. Ironwood Pharmaceuticals Inc. priced a public offering for gross proceeds of $136.5 million. Jennerex Biotherapeutics Inc

Karyopharm Therapeutics Inc. announced last week that it raised $48.2 million in a Series B financing, a rather large round these days, especially for a Series B. In fact, according to BioWorld Snapshots, it's the second largest raise this year by a private U.S. biotech, behind the $150 million Series F round raised by Intrexon Corp., of Germantown, Md., earlier this month. "We are fortunate that our previous investors kept their interest in the company and contributed to this round of financing

Total Value in 2013: $7,174M* Number of Deals in 2013: 119 Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Advaxis Inc. (Princeton, N.J.) FusionVax Inc. (Taiwan) ND Memorandum of understanding under which Advaxis will, subject to a definitive agreement, exclusively license ADXS-HPV to FusionVax for development in Asia Advaxis will license rights for the Asia territory, exclusive of India, for all indications; FusionVax will make an up-front payment

Company Company Deal Value Biogen Idec Inc. Elan Corp. plc $3.25B MacroGenics Inc. Gilead Sciences Inc. $1B Xencor Inc. Celgene Corp. $300M Bluebird Bio Celgene Corp. $225M The Medicines Co. Alnylam Pharmaceuticals Inc. $205M AmorChem Celgene Corp. $200M Afraxis Inc. Genentech Inc. $187.5M BIND Biosciences Inc. Amgen Inc. $180.5M Concert Pharmaceuticals Inc. Jazz Pharmaceuticals plc $120M Genentech Inc. RQx Pharmaceuticals Inc. $111M

While partnering strategies can provide access to essential products and technology, mergers and acquisitions can achieve the same goals and also provide greater leverage and control of the acquired assets. With a wide variety of biotech companies that have promising candidate products in late-stage clinical trials, and pharma companies still needing to tweak their product portfolios, the expectation is that the next big pharma acquisition of a biotech company is only just around the corner

The backlog of new applications at the Patent and Trademark Office has grown to more than 600,000 thanks in part to sequestration. And patent experts expect it to continue growing because of the mandatory cuts in fee revenue. Bills giving the FDA oversight of compounding manufacturers and setting up a track-and-trace mechanism for the drug supply chain are headed to the Senate floor. The Senate Health, Education, Labor and Pensions Committee passed the Pharmaceutical Compounding Quality and