As 2013 ticked away, Intrexon Corp. extended a string of biotech deals by inking an exclusive channel collaboration (ECC) with Agilis Biotherapeutics LLC, which simultaneously launched with an $8 million financing.

Over the past few years, clinicians have achieved near-miraculous feats in terms of survival of extremely preterm infants. Delivery even at 25 weeks – not too much after the halfway mark of a full-term pregnancy, and a time point at which premature babies were once born only to die – now has a survival rate of 50 percent.

LONDON – With Humira leading the way as the world’s best-selling drug, biologics now account for an increasing proportion of the pharma industry’s turnover and of its pipeline.

In one of its last precedential opinions of 2013, the U.S. Court of Appeals for the Federal Circuit overturned a Patent and Trademark Office (PTO) decision Monday and gave it a reading lesson in obviousness and prior art.

Cardium Therapeutics Inc.’s first data from the first stage of its Phase III trial with its gene therapy Generx (alferminogene tadenovec, Ad5FGF-4) in patients with myocardial ischemia due to arteriosclerosis were favorable enough that the firm is accelerating the study, with interim data in the first half of next year.

Two biotech companies, Argos Therapeutics Inc. and Eleven Biotherapeutics Inc., slid initial public offering (IPO) filings under the wire for 2013 to raise $60 million and $69 million, respectively. The filings cap a spectacular year for IPOs. Thirty-seven biotechs successfully completed IPOs in 2013, raising about $3 billion. Argos and Eleven will join 15 other companies filed and pending for 2014.

Though not a huge surprise, the complete response letter (CRL) from the FDA for Lemtrada (alemtuzumab) sent a rumble through the multiple sclerosis (MS) therapy space, and shook investors in Genzyme Corp., which has been told by the agency that approval of the CD52-targeting antibody requires more trials.

Redhill Biopharma Ltd., of Tel Aviv, Israel, said it entered a definitive agreement with Orbimed Israel Partners Ltd. Partnership, an affiliate of Orbimed Advisors LLC, for the sale of their American Depository Shares and warrants in a $6 million private placement transaction.

Before responding to a World Health Organization (WHO) request, the FDA is seeking comments on the abuse potential and diversion of 26 drug substances, including lisdexamphetamine (Vyvanse, Shire plc), tapentadol (Nucynta, Janssen Pharmaceuticals Inc.) and tramadol (Ultram, Janssen).

The reliability of preclinical research, or lack thereof, has received a lot of attention recently as one of the challenges of the biomedical research enterprise. But clinical-stage research, unfortunately, suffers from rather massive problems of its own.