Germany's Affimed has inked a deal that makes it the latest in a long string of biotechs to partner up with Merck ($MRK) on a combination study using the PD-1 blockbuster Keytruda. Affimed is underwriting a Phase Ib study that combined its drug AFM13 with Keytruda against Hodgkin lymphoma. AFM13 is a bispecific antibody that is designed to engage NK (natural killer) cells. And Affimed has rights to spring forward into Phase III, if the data look right. Release
@FierceBiotech: Hedge fund's attack on troubled Zafgen draws blood. Story | Follow @FierceBiotech
@JohnCFierce: $ZFGN down 10% on short attack from Kerrisdale. More | Follow @JohnCFierce
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> Some of the top execs in biopharma are warning the U.K. about the potential downside to the country's extensive drug research operations if it leaves the EU. Eli Lilly ($LLY) CEO John Lechleiter, citing a U.K. research center that recruits scientists from across Europe, told the Financial Times that an exit would isolate the country scientifically. Merck's Roger Perlmutter, meanwhile, said an exit would be challenging for its scientists who receive EU grants. Story
> Valeant Pharmaceuticals' ($VRX) brodalumab, a psoriasis treatment abandoned by Amgen ($AMGN) over safety risks, is up for a final FDA decision by Nov. 16. More
> Merck ($MRK) CEO Kenneth Frazier said the recent downswing in value for small and mid-size biotechs creates buying opportunities for companies like his. News
Medical Device News
@FierceMedDev: U.S. regulators nix $3B Philips lighting sale, complicating HealthTech shift. Article | Follow @FierceMedDev
@EmilyWFierce: It's not bedtime yet for J&J in false advertising lawsuit over baby products. FiercePharmaMarketing story | Follow @EmilyWFierce
> Theranos flagged by CMS for serious problems at California lab: WSJ. More
> German radiosurgery player Brainlab invests $7M+ in Jan Medical for portable concussion Dx. Story
> Wound care company ConvaTec laying off 250 in North Carolina after failing to find M&A suitor. Article
Pharma News
@FiercePharma: PetMed marketing overhaul pays off as orders continue to rise in Q3. Article | Follow @FiercePharma
@EricPFierce: EMA suspends Hubei Hongyuan Pharmaceutical after Czech inspectors find dust-covered plant and equipment. ICYMI fron FiercePharmaManufacturing | Follow @EricPFierce
@CarlyHFierce: ICYMI: Amgen's Repatha wins first PCSK9 OK in Japan. Article | Follow @CarlyHFierce
> Novartis adds 100 jobs at Lek site in Slovenia as it muscles up on biosimilars. Report
> Pressure mounts at GSK, with U.S. hedge fund leading calls for exec shakeup. Story
> Indian pharma mulls deal for U.S. injectables maker Sagent Pharma. Article
Animal Health News
> Bird flu losses mount as U.S., Mexico, Canada sign historic pact to control outbreaks. More
> Ceva enters pact with Zoion to develop treatment for dry eye in dogs. Report
> Pharma leaders declare war on antibiotic resistance at Davos. Item
> PetMed marketing overhaul pays off as orders continue to rise in Q3. Story
> Veterinarian turns dog owner's tragedy into cloud-based EHR for pets. Article
Biotech IT News
> BioClinica buys Clinverse to add clinical trial financial management software. More
> GSK scientists accused of data theft in low-tech cybercrime case. Report
> Cedars-Sinai to test Fitbit activity trackers in cancer clinical trial. Item
> Takeda engages Broad for genomic analysis of patient samples from PhIII cancer trial. Story
> Big Pharma consortium rolls out clinical trial investigator platform. Article
Pharma Marketing News
> Synchronized dancers jazz up Reckitt Benckiser's new MegaRed pitch. More
> Fishing for market share, Boehringer Ingelheim casts a new campaign for Pradaxa. Report
> Camera-ready Pfizer and J&J top pharma list of TV ad spenders for 2015. Story
> Oxford Pharmascience scouts marketing partners for new pain meds. Item
> It's not bedtime yet for J&J in false advertising lawsuit over baby products. Article