Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., reported that fourth quarter 2015 U.S. net sales of Eylea (aflibercept) injection increased 44 percent to $746 million vs. fourth quarter 2014 and the full year net sales increased 54 percent to $2.68 billion over 2014 net sales. Read More

Ziopharm Oncology Inc., of Boston, said the first patient has been enrolled in a phase I study of its second generation non-viral CD19-specific chimeric antigen receptor modified T-cell therapy in patients with advance lymphoid malignancies. The CD19-specific T cells were modified using the Sleeping Beauty system to stably express the CAR in T cells. Ziopharm described the Sleeping Beauty transposon-transposase as a unique non-viral system for introducing genes encoding CARs and T-cell receptors into lymphocytes and is exclusively licensed by Intrexon Corp., of Germantown, Md., through the University of Texas MD Anderson Cancer Center and accessed as part of Ziopharm's collaboration. (See BioWorld Today, Jan. 15, 2015.) Read More

Otsuka Pharmaceutical Co. Ltd., of Tokyo, inked an agreement granting Medimetriks Pharmaceuticals Inc., of Fairfield, N.J. exclusive development and commercialization rights for OPA-15406 in the U.S. and Puerto Rico, along with manufacturing rights. Otsuka is set to receive an up-front payment of $22 million and milestone payments through approval of the new drug application, as well as sales royalties. Medimetriks assumed responsibility to fund and manage phase III studies in the U.S. for OPA-15406, a topical, non-steroidal phosphodiesterase IV, or PDE-4, inhibitor that represents a new treatment class for atopic dermatitis. Read More

Beigene Ltd., of Beijing, said it closed its IPO of 7.59 million American depositary shares (ADS), each representing 13 of its ordinary shares, at $24 per ADS. That includes the full exercise of the underwriters' option to purchase additional ADSs. Read More

NEW YORK – By the time the 18th annual BIO CEO & Investor Conference got under way on its second and last day, the issue of drug pricing vs. treatment value had already reared its head in nearly every panel. And, during a session convened Tuesday morning to tackle the topic head-on, industry experts said the debate is unlikely to fade away as it has in years past. Read More

NEW YORK – Last year's big win by Biogen Inc. with Alzheimer's disease candidate aducanumab, the first potentially disease-modifying drug to hit its prespecified endpoint in a proof-of-concept study, restored optimism to a space that had been riddled with failure and reaffirmed faith in the amyloid beta (abeta) hypothesis – at least for some. Read More

The Senate committee on Health, Education, Labor and Pensions (HELP) voted the FDA Device Accountability Act of 2015 (S. 1622), along with six other health care-related bills, out of committee at a Feb. 9 executive session. Bipartisan comity was on display for most of the hearing, although one piece of legislation seems destined to stir up yet more controversy on Capitol Hill. Read More

CEO Jonathan Peacock told BioWorld Today that the phase III program with drug-device combo Inopulse in pulmonary arterial hypertension (PAH) will start "hopefully in the next few weeks," now that Bellerophon Therapeutics Inc. has in hand a positive analysis of final phase II data with the inhaled nitric-oxide product. Read More

President Barack Obama's $4.1 trillion final 2017 budget proposal arrived on the Hill Tuesday, requesting an 8 percent rise in FDA funding to $5.1 billion, a $2 billion boost for the National Institutes of Health's (NIH) budget to $33.1 billion and a supplemental request for $1.8 billion in emergency funds to fight the Zika virus. Read More

After grappling with the limited clinical data the FDA uses to determine biosimilarity and what that might mean in the real world, at the end of the day Tuesday the agency's Arthritis Advisory Committee (AAC) got it. Read More