News feeds from around the industry (Updated Hourly) - Updated on February 12, 2016 Bookmark and Share

FDA News - Business Wire

>Wenzel Spine Announces FDA ClearanceAUSTIN, Texas--(BUSINESS WIRE)--Wenzel Spine, Inc., a pioneer medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, announced today that it received clearance from the U.S. Food and Drug Administration (FDA) to market VariLift®-LX as an interbody fusion device for stand-alone use in the lumbar spine. VariLift®-LX represents the next generation of Wenzel Spine?s innovative product lines of zero-profile, stand-alone, expandable in...

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>CreakyJoints Response to Advertisement ControversyUPPER NYACK, N.Y.--(BUSINESS WIRE)--The majority of Americans who use opioids use them responsibly and legitimately to manage their chronic pain. Today?s statement by the Governor of Vermont incorrectly conflates the issue of opioid addiction with a very common side effect of opioid use, opioid-induced constipation (OIC). People seeking treatment for OIC from one of the three available prescriptions are very unlikely to be addicts seeking opioids for a high. Rather, they would be asking for r...

>Genetic Screening for Women's Cancer Risk May Be Reduced to $200 If Tested with Pap SmearHARTFORD, Conn.--(BUSINESS WIRE)--The cost of genetic screening for cancer risk in women could fall to as low as $200 when performed as part of routine HPV Pap smear testing for the prevention of cervical cancer.

>Navidea Biopharmaceuticals Enrolls First Patient in Cervical Cancer Study of Lymphoseek®DUBLIN, Ohio--(BUSINESS WIRE)--Navidea announced the first patient has been enrolled in a clinical study evaluating Lymphoseek in women with known cervical cancer at The University of Texas MD Anderson Cancer Center.


>FierceBiotech Radio on pharma's day on the Hill, biotech's paucity of M&A, and the gathering storm of biosimilarsFiercePharma's Eric Palmer and FierceBiotech's Damian Garde discuss a bizarre congressional hearing, how biotech's slump affects the buyout climate, and a major development in the world of biosimilars.

>Pursuing new deals to grow the pipeline, Szela axes staffers in Aegerion reorgMary Szela, the new CEO at Cambridge, MA-based Aegerion, has reached for the budget ax to help compensate for the rising tide of competition that has challenged its cholesterol drug Juxtapid. The company announced today that it is chopping about 25% of its staff--roughly 80 workers--as it whittles its roster of employees down to 230.

>4D pharma buys Tucana to add diagnostic capabilities to microbiome R&D toolkit4D pharma has struck a deal to buy Tucana Health. The takeover, which is costing £3.1 million ($4.5 million) upfront with more tied to milestones, is intended to boost 4D pharma's ability to identify patients who may benefit from live biotherapeutics, starting with a treatment for irritable bowel syndrome.

>AveXis and Proteostasis survive the market storm, IPOs raise $145M for R&DThese days there are two kinds of biotech IPOs that make it to the market: The select few solid successes in line with the range and some bargain selections that provide a haircut on the price, where the company ups the number of shares but sells at a significant discount to the range. Another group are just quietly leaving their IPOs on the shelves or pulling out altogether to wait out the storm.

>Intercept books a date with the FDA as buyout rumors simmerAfter an FDA-mandated three-month delay, Intercept Pharmaceuticals is set for a meeting with agency advisers to discuss obeticholic acid, an in-development liver drug tabbed by analysts as a potential blockbuster.

FierceBiotech IT

>DNAnexus connects genomics platform to Sapio Sciences' LIMSDNAnexus has connected its genomics platform to Sapio Sciences' Exemplar laboratory information management system (LIMS). The integration is expected to provide clients with a sample-to-answer tracking system, a resource the collaborators see cutting costs while improving quality control.

>BioClinica rolls out tech-enabled postapproval research serviceThe division, which the company has set up to meet rising demand for postapproval research, will make use of BioClinica's technology capabilities.

>CosmosID raises $6M to advance microbiome bioinformatics offeringCosmosID has raised $6 million to advance its microbiome software business. The Series B round is intended to enable CosmosID to build out and enhance multiple aspects of its operation, with the expansion of engineering capabilities and improvement of genotype-phenotype linkage abilities high on its agenda.

>Illumina signs biobank deals to fuse genome data, EMRsIllumina has signed deals to genotype the sample collections at four biobanks. Each of the projects is aiming to build a repository of linked genotypic and phenotypic data, with the sequencing results generated by Illumina being paired to electronic medical records (EMRs) possessed by the owners of the biobanks.

>Stallergenes resumes work after IT-related shutdown, hires head of tech opsStallergenes Greer has resumed production at its plant that was blighted by IT problems. The restart of manufacturing comes nearly two months after regulators found the IT system introduced at the site in August was causing operational disruptions and erroneous product deliveries.

FierceBiotech Research

>Investigators at The Hutch draw up a new battle plan for metastasisResearch coming from the Fred Hutchinson Cancer Research Center and Johns Hopkins Medical Institute concludes that the deadly spreading of cancer occurs in clusters rather than single cancer cells.

>U.K. scientists get a green light to modify human embryosFertilization experts in the U.K. have been given a green light to start modifying human embryos, an experiment which they expect will give them unique insights into the way in which an embryo transforms into a healthy baby.

>Gene therapy pioneer James Wilson uses CRISPR/Cas9 to target liver disease One of the pioneers in the whole gene therapy movement of the past 35 years has combined his knowledge of viral vectors with the hot new CRISPR/Cas9 tech to tackle a rare genetic liver disease. And his work with rodents highlighted both the promise of this new technology as well as an unexpected hurdle.

>Researchers discover fusion protein that promotes cancer via three distinct ways in pediatric brain tumorsScientists at The Children's Hospital of Philadelphia (CHOP) and the Dana Farber Cancer Institute have uncovered an important cancer-driving fusion protein that promotes a pediatric brain tumor via three distinct mechanisms.

>Oxford team fingers an inflammatory protein as a trigger for cancerResearchers from Oxford University working on a protein named PAD4 have made new tracks in identifying its role in cancer, spotlighting a new therapeutic strategy for cancer drug hunters.


>Pfizer builds on early Ibrance lead as Novartis, Lilly rivals inch closerPfizer's Ibrance has already been prescribed to more than 20,000 patients, and the company says it has a "very heavy" clinical trial program testing it in multiple types of breast cancer and beyond.

>Some top GSK investors aren't sold on a breakup--and they're backing CEO Witty, tooSome of GlaxoSmithKline's prominent investors may be pushing for a four-way breakup of the company. But others are just fine preserving the status quo--and keeping CEO Andrew Witty at the helm to do it.

>After a big 2015, Regeneron predicts slowing 2016 sales for launch superstar EyleaLast month, Regeneron announced 2015 Eylea sales that had investors excited. But that didn't soften the blow on Tuesday, when it warned that the med's growth in the U.S. would slow down.

>Top Senate Democrat grills HHS about opioid panel's alleged ties to industryAbout a third of panelists at a Department of Health and Human Services (HHS) meeting on painkiller prescribing had financial ties to companies that make the drugs, a recent report showed. A top Senate Democrat is not pleased with those findings, and he's grilling the HHS about the members' relationships with the industry.

>Sanofi's outlook less than sunny as key diabetes franchise continues to sagSanofi delivered a good-news, bad-news set of fourth-quarter results: Earnings better than expected and solid growth in emerging markets, but shortfalls in overall revenue and operating profits. Its follow-up to big-selling Lantus, Toujeo, beat projections, but its long-anticipated cholesterol fighter, Praluent, brought in just a few million euros.

FiercePharma Manufacturing

>FDA quality focus will definitely mean winners and losers, report saysThe FDA intends to change the way it handles plant inspections, using metrics to suggest which plants may be having issues and making more frequent trips to those that appear at risk. While those companies committed to quality may be rewarded for their efforts, a new report warns that those that are already struggling with quality can expect to be more under the thumb of regulators.

>FDA warning to Ipca Labs shines light on rampant data falsificationFDA inspectors have cited data manipulation and falsification at any number of manufacturing facilities in India, but a new warning letter for three Ipca Laboratories plants shows that it was rampant at that company, enforced by senior managers in the quality-control unit to keep product supply flowing.

>Report says CMOs without U.S. facilities risk being left out of 'hot' market A new report from CPhI of the U.S. market says that international API and drug manufacturers need to consider investing in U.S. manufacturing sites as drugmakers look to source products in the U.S. because of concerns over quality in some other countries.

>Dr. Reddy's grows U.S. sales even in face of FDA actionThree of Dr. Reddy's Laboratories' key plants were singled out in a warning letter after FDA inspectors tallied up a host of data manipulation and contamination violations. But India's third-largest drugmaker was still able to grow sales in the U.S. last quarter even with production at the three facilities interrupted by remediation efforts.

>Regulator suspends Spanish drugmaker over 'critical quality defects' Regulators in Spain are punishing a Barcelona-based drugmaker for a series of manufacturing shortfalls, recalling all batches produced by the company, Farma Mediterrania, from 2014 to present. The crackdown is the second in as many months by Spanish authorities on local producers.


>Merck, J&J, Pfizer consider joining Zika vaccine raceWhile the early entrants to the race for a Zika vaccine have been on the smaller side--think Hawaii Biotech, NewLink Genetics and Inovio Pharmaceuticals--the big guns are now joining in. Just one day after Sanofi announced a firm plan to develop a vaccine for the mosquito-borne disease, a parade of Big Pharmas has joined GlaxoSmithKline in "evaluating their technologies" for the potential of developing a Zika vaccine.

>Pfizer's vaccine sales leap in 2015 thanks to Prevnar 13Riding Prevnar 13 uptake, Pfizer's vaccines unit capped off a big growth year on Tuesday, reporting Q4 sales increases of 45% and full-year 2015 growth of 44%.

>Affinivax nets another $2.5M from Gates Foundation to advance Prevnar competitorCambridge, MA-based Affinivax launched in November 2014 with a $4 million Gates Foundation investment and plans to develop a pneumococcal vaccine that it believes could go beyond Prevnar, the best-selling vaccine in the world. Now, the biotech is announcing $2.5 million in follow-on funding from the Gates Foundation, which it will use to advance its lead candidate, CEO Steve Brugger told FierceVaccines.

>UT Southwestern team creates new drug that could aid in vaccine developmentResearchers at UT Southwestern Medical Center have discovered a new drug that could help in vaccine development. It activates the innate immune system in a novel way.

>NCI's Cancer Centers join in HPV vaccination pushAll 69 of the United States' National Cancer Institute-designated centers have joined together to issue a statement urging an increase in HPV vaccinations, declaring the vaccines "tragically underused" and calling low uptake a "public health threat."

Pharma News - Business Wire

>CiteAb reconoce a Cell Signaling Technology como la ?Empresa de Anticuerpos del Año? y la ?Elegida de los Investigadores?DANVERS, Massachusetts (EE.UU.)--(BUSINESS WIRE)--Cell Signaling Technology (CST), un proveedor líder de anticuerpos, kits y servicios, recibió el Premio 2016 de CiteAb como la ?Elegida de los Investigadores? y por segundo año consecutivo el reconocimiento de la ?Empresa de Anticuerpos del Año?. Ya en su segundo año, los Premios a los Anticuerpos de CiteAb buscan honrar a los mejores proveedores, reactivos e individuos del sector de anticuerpos en investigación, y reconocer los esfuerzos real...

>CiteAb zeichnet Cell Signaling Technology mit den Preisen ?Antikörper-Unternehmen des Jahres? und ?Wahl der Forscher? ausDANVERS, Massachusetts--(BUSINESS WIRE)--Cell Signaling Technology (CST), ein führender Anbieter von Antikörpern, Test-Kits und Dienstleistungen, ist mit dem 2016 CiteAb Award für ?Researchers? Choice? (Wahl der Forscher) und im zweiten Jahr in Folge mit der Auszeichnung ?Antibody Company of the Year? (Antikörper-Unternehmen des Jahres) gewürdigt worden. Mit den in diesem Jahr zum zweiten Mal vergebenen CiteAb Antibody Awards sollen die besten Anbieter, Reagenzien und Persönlichkeiten im Bere...

>Protagen supports novel route to serum based Prostate Cancer DiagnosticsDORTMUND, Germany--(BUSINESS WIRE)--Protagen AG, announced today the identification of novel protein biomarkers in prostate cancer, which are potential drug targets supporting novel strategies in precision medicine.

>Waters and BioCity Debut New Open Access Analytical Laboratory in the BioHub at Alderley Park, UKMILFORD, Mass.--(BUSINESS WIRE)--Waters Corporation (NYSE:WAT) and BioCity, the UK's largest bioscience incubator company, celebrated the opening of a new open access analytical laboratory. Located in the BioHub at Alderley Park, the laboratory offers Waters? state-of-the-art liquid chromatography (LC), mass spectrometry (MS) and informatics technologies, within a suite of analytical modules for scientists working in the pharmaceutical and life science industries. Chancellor of the Exchequer,...

>Results of New Survey Show Nearly Two Thirds of Surveyed Adults with Major Depressive Disorder (MDD) Who Report Taking Their Medication as Prescribed Still Experience Symptoms at Least WeeklyPRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Results from a recent survey6 of adults with major depressive disorder (MDD), psychiatrists and primary care providers show that nearly two thirds of surveyed adults with MDD who self-report that they take their medication as prescribed say they still deal with MDD symptoms at least weekly (61 percent)4, implying that there may be a need for alternative treatment options that better address the symptoms of MDD. The Living with MDD survey was...

Xconomy Life Sciences

>Blood Simple? Grail's Cancer Screening Quest Faces Tough Questions[Corrected, 2/4/16, 2:05pm. See below.] Three weeks ago the world’s biggest genomic sequencing company, Illumina (NASDAQ: ILMN), unveiled a spinout called Grail to make blood tests that could spot all kinds of cancer in seemingly healthy people, perhaps as soon as 2019. If you know anything about the history of screening healthy people for cancer, […]

>East Coast Bio Roundup: CRISPR, Tessier-Lavigne, Pricing, Spero & MoreThere was biotech news up and down the East Coast this week. In Boston, all eyes were on the first biotech IPO of the year—and the sector let out a collective sigh when things went well. New York, meanwhile, suffered a tough blow to its life sciences scene, as one of its strongest advocates announced […]

>Rockefeller's Tessier-Lavigne Heads Back to the Bay to Run Stanford[Updated, 2/5/16, 7:06 am ET] Marc Tessier-Lavigne spent much of his professional life on the West Coast before becoming president of Rockefeller University in 2011. From that perch, the neuroscientist was a ringleader in New York’s emerging life sciences community. After five years, however, he?s heading back to the San Francisco Bay Area to run […]

>Improving Odds for Women in Tech? Take Notes from BiotechAt our entrepreneurial support organization, the Council for Entrepreneurial Development (CED), we often joke about adhering to the proper dress and catering code for our networking events: jeans and beer for tech; suits, wine and cocktails for life sciences. But there is more to these superficial differences between the two networks serving 1,200 entrepreneurial companies […]

>Syngenta, NC Biotech, PSEG Solar, & More NC Innovation NewsPanthers country is licking its wounds from Sunday night?s big game, but there?s plenty going on in the business community to take minds off of the stinging Super Bowl defeat. Here?s a recap of some of the top headlines in North Carolina biotech, tech, and cleantech news. —Switzerland-based agribusiness giant Syngenta (NYSE: SYT), which maintains […]