https://www.fiercebiotech.com/biotech/merck-schering-plough-end-respiratory-collaboration
Merck and Schering-Plough have withdrawn their NDA for a pill combining Claritin and Singulair and are breaking up their respiratory collaboration, which has...
schering ploughfierce biotechmerckendrespiratory
https://www.fiercebiotech.com/biotech/bristol-myers-to-buy-medarex-for-2-1b
Anxious to beef up its pipeline, Bristol-Myers Squibb announced late Wednesday that it had struck a deal to buy Medarex for $2.4 billion. But the dealmakers...
bristol myersfierce biotechbuymedarex
https://www.fiercebiotech.com/biotech/fda-under-fire-over-accelerated-approval-data-demands
Researchers have raised concerns about the level of evidence needed to win accelerated approval from the FDA.
accelerated approvalfierce biotechfdafiredata
https://www.fiercebiotech.com/biotech/german-merck-inks-vaccinex-pd-l1-anti-semaphorin-4d-igg4-combo-trial-deal
The word in cancer right now is combination, and Merck KGaA, coming in the same week it opened a new life science R&D collab center in
german mercklung cancerinkantipd
https://www.fiercebiotech.com/r-d/gilead-leaps-to-first-phiii-success-for-all-oral-hepatitis-c-drug-program
Gilead Sciences is sprinting ahead with initial positive results from a Phase III study for what could be a first all-oral combination therapy for certain...
gileadleapsfirstsuccessoral
https://www.fiercebiotech.com/biotech/seneca-biopharma-merges-leading-biosciences-becoming-palisade-bio
Penny stock biotech Seneca Biopharma has found a lifeline in privately owned Leading BioSciences as it merges with the biotech.
senecabiopharmamergesleadingbiosciences
https://www.fiercebiotech.com/biotech/alkermes-clinical-lead-jumps-ship-to-slimmed-down-re-focused-seres
After axing its chief scientific officer last year amid a raft of changes to its C-suite and beyond, Seres Therapeutics has nabbed a new chief medical officer...
alkermesclinicalleadjumpsship
https://www.fiercebiotech.com/biotech/boehringer-backs-out-730m-lung-cancer-pact-hanmi-following-data-review
Boehringer Ingelheim has backed out of the $730 million (
lung cancerboehringerbackspacthanmi
https://www.fiercebiotech.com/biotech/il-2-player-neoleukin-gets-a-leg-up-reverse-merger-aquinox
Last summer, Aquinox Pharmaceuticals dumped its lead asset after the inflammatory pain drug rosiptor failed to beat placebo in phase 3.
ilplayergetslegreverse
https://www.fiercebiotech.com/biotech/chasing-sanofi-pfizer-tees-up-phase-3-trials-for-c-diff-vaccine
Pfizer's preventative vaccine against Clostridium difficile has passed a phase 2 test and will start registration studies in the next few months, in hot...
chasingsanofipfizerteesphase
https://www.fiercebiotech.com/biotech/immunomedics-nabs-j-j-veteran-for-cmo-as-it-presses-adc-redo
For the last year, biopharma veteran Loretta Itri, M.D. has been helping Immunomedics out with its troubled antibody-drug conjugate, sacituzumab govitecan.
immunomedicsnabsjveterancmo
https://www.fiercebiotech.com/research/report-human-genome-project-was-a-worthy-investment
No, the Human Genome Project "wasn't just a money-sucking vanity initiative that only reaped profits for personal genetic testing companies," reports Fast...
human genome projectfierce biotechreportworthyinvestment
https://www.fiercebiotech.com/biotech/tyra-biosciences-banks-106m-adds-to-c-suite-as-it-aims-for-clinic-2022
Tyra Biosciences raised $50 million in early 2020 to get the ball rolling on a pipeline against drug-resistant cancers.
c suitetyrabiosciencesbanksadds
https://www.fiercebiotech.com/regulatory/neos-wins-fda-approval-for-a-melts-your-mouth-take-on-adderall-for-adhd
Neos Therapeutics, at work on extended-release versions of old drugs, won FDA approval for a long-acting ADHD pill that dissolves in patients' mouths.
fda approvalneoswinsmeltsmouth
https://www.fiercebiotech.com/medtech/forsight-raises-10m-seed-round-to-bring-robotics-to-eye-surgery
One of the benefits of surgical robotics is the potential to bring standardized precision to procedures performed almost anywhere and by almost anyone.
seed roundraisesbringroboticseye
https://www.prnewswire.com/news-releases/fiercebiotech-names-arvinas-as-one-of-its-fierce-15-biotech-companies-of-2015-300151256.html
/PRNewswire/ -- Arvinas LLC ("Arvinas") today announced that it has been named by FierceBiotech as one of 2015's Fierce 15 biotechnology companies,...
fiercebiotechnamesone
https://www.fiercebiotech.com/r-d/flexion-routed-as-lead-pain-drug-flops-first-pivotal-study
Shares of Flexion Therapeutics cratered Tuesday evening after the Burlington, MA-based biotech said its lead pain treatment flopped in a pivotal Phase IIb...
flexionroutedleadpaindrug
https://www.fiercebiotech.com/medtech/boston-scientific-gives-earnings-forecast-eye-more-acquisitions
Boston Scientific released its full-year earnings forecast that fell below Wall Street expectations as the company reiterated its plans to make several more...
boston scientificgivesearningsforecasteye
https://www.fiercebiotech.com/biotech/car-t-death-drives-lyell-take-2-track-approach-dose-escalation
A death and other adverse events have forced Lyell Immunopharma to take
cardeathdriveslyelltake
https://www.fiercebiotech.com/biotech/moderna-nabs-a-barda-billion-as-its-kickstarts-late-stage-pandemic-vaccine-test
Moderna has been handed an extra $472 million to run its phase 3 COVID-19 vaccine test.
kick startsmodernanabsbardabillion
https://www.fiercebiotech.com/r-d/novo-nordisk-backs-out-of-a-diabetes-deal-zosano
Novo Nordisk has terminated a collaboration deal with Zosano Pharma, walking away from an agreement that would have paired its late-stage diabetes drug with...
novo nordiskbacksdiabetesdeal
https://www.fiercebiotech.com/biotech/j-j-and-google-back-inflammatory-disease-startup-mestag-45m-seed
With a novel fibroblast collaboration already in the works with Johnson & Johnson's Janssen unit, Mestag Therapeutics is further linking arms with the...
inflammatory diseasejgooglebackstartup
https://www.fiercebiotech.com/biotech/crispr-therapeutics-vertex-start-first-company-backed-human-crispr-trial?mkt_tok=eyJpIjoiWXpabE5ESTFOVFl6TjJOaSIsInQiOiJNMjVuY1RNT3czeDhOQmFmdUpjU0h5eFJ1bjhSMEpzU2VvN0ZLKzlIT2VUdTBUSkdHTEU1UGthTlJwdDcxTkRQUlRlcHdmczYwVHRydXBremdFXC9IeWJQVFwveXVcL2UwTkk4YThtK01XM2hrYkFXaU9rM3RPald3QlZVNG1tQTgzViJ9&mrkid=70019526
While research groups in China have already started testing CRISPR in humans, CRISPR Therapeutics and Vertex Pharmaceuticals are the first companies to sponsor...
crispr therapeuticshuman trialvertexstartfirst
https://www.fiercebiotech.com/biotech/cohort-flagship-biotechs-snag-100m-to-make-cystic-fibrosis-treatments
The biotech incubator behind Moderna will pool together its portfolio startups to work on new treatments for cystic fibrosis using up to
fleetflagshipbiotechsget
https://www.fiercebiotech.com/research/cannabinoid-drug-reduces-epileptic-seizures-hard-to-treat-children
In a study involving 162 children and young adults, investigators at UCSF Benioff Children's Hospital San Francisco found that a purified cannabinoid reduced...
epileptic seizurescannabinoiddrugreduceshard
https://www.fiercebiotech.com/medtech/pacira-pours-up-to-25m-into-surgical-reconstruction-player-tela-bio
Pacira Pharmaceuticals has signed on to invest up to
pacirapourssurgicalreconstructionplayer
https://www.fiercebiotech.com/biotech/centrexion-farms-out-pain-med-to-lilly-for-47-5m-and-could-reap-much-more
Eli Lilly is paying $47.5 million upfront to
farmspaindruglilly
https://www.fiercebiotech.com/cro/sygnature-discovery-snaps-up-fellow-british-cro-xenogesis
U.K.-based CRO Sygnature Discovery is buying up fellow native life science services provider XenoGesis in order to boost its preclinical offerings.
fierce biotechsygnaturediscoverysnapsfellow
https://www.fiercebiotech.com/biotech/blockbuster-anti-ngf-pain-drug-fulranumab-j-j-doesn-t-want-it-anymore
Back in early 2015, J&J CEO Alex Gorsky tapped the Phase III anti-NGF pain drug fulranumab as one of the pharma giant's top 10 new drug prospects, a key asset...
blockbusterantingfpaindrug
https://www.fiercebiotech.com/regulatory/fda-oks-lilly-s-blockbuster-hopeful-ramucirumab-for-stomach-cancer
The bull case for Eli Lilly and its long-stunted R&D operation rests largely on a potential string of FDA approvals for the much-hyped ramucirumab, and the...
stomach cancerfdaokslillyblockbuster
https://www.fiercebiotech.com/cro/excellence-global-operations
Crown BioscienceCEO: John GuBased: San Diego, CAFounded: 2006Crown Bioscience, a global CRO with a focus on drug discovery and bioanalytical testing, has 11...
global operationsfierce biotechexcellence
https://www.fiercebiotech.com/medical-devices/j-j-mulls-selling-off-its-diabetes-businesses
Johnson & Johnson is pondering what to do next with its diabetes device subsidiaries Animas, LifeScan and Calibra Medical.
jsellingdiabetesdevicebusinesses
https://www.fiercebiotech.com/biotech/mirati-once-again-subject-takeover-talks-bloomberg
With Thanksgiving around the corner, Big Pharmas are reportedly considering adding an extra main course to the M&A menu.
big pharmamiratisubjecttakeover
https://www.fiercebiotech.com/biotech/introgen-files-voluntary-chapter-11-petition-to-facilitate-restructuring
Introgen Files Voluntary Chapter 11 Petition to Facilitate Restructuring Company to Focus on Expanding Contract Manufacturing Operations AUSTIN,...
introgenfilesvoluntarychapterpetition
https://www.fiercebiotech.com/biotech/aimmune-aces-peanut-allergy-phase-3-teeing-up-fda-filing
Aimmune has presented strong data from a phase 3 trial of its pea
peanut allergyacesphaseteeingfda
https://www.fiercebiotech.com/cro/parexel-to-go-private-5b-pamplona-capital-buyout-deal
After growing rumors this week, Parexel has become the latest CRO to be bought up as the industry continues its M&A bonanza.
go privateparexelpamplonacapitalbuyout
https://www.fiercebiotech.com/partnering/kite-pharma-doubles-down-on-crucial-nci-partnership-expands-work-on-car-t-tcrs
Today, Kite expanded its research and development deal--or CRADA--with some key researchers at the National Cancer Institute to cover additional programs and...
kite pharmadoublescrucialncipartnership
https://www.fiercebiotech.com/biotech/intra-cellular-tanks-phiii-schizophrenia-failure
Intra-Cellular Therapies ($ITCI) shed about $1.2 billion in market cap on the top-line data on a Phase III trial for its ITI-007 to treat schizophrenia that...
fierce biotechintracellulartanksschizophrenia
https://www.fiercebiotech.com/regulatory/shire-heads-to-fda-its-dry-eye-drug-despite-a-so-so-phiii
Shire is gearing up to file an FDA application for lifitegrast, a dry eye treatment it picked up for $160 million, despite some mixed results in a late-stage...
dry eyeshireheadsfdadrug
https://www.fiercebiotech.com/biotech/barda-loses-leader-middle-race-to-create-covid-19-vaccine
The U.S. agency leading efforts to develop a vaccine against COVID-19 has lost its leader.
bardalosesleadermiddlerace
https://www.fiercebiotech.com/r-d/danish-trial-results-show-stem-cells-improve-failing-hearts
Results from a clinical trial of 59 patients with chronic ischemic heart disease and severe heart failure found that a new stem cell treatment improved heart...
trial resultsstem cellsdanishshowimprove
https://www.fiercebiotech.com/medtech/abiomed-acquires-precardia-and-its-catheter-based-system-to-treat-heart-failure
After scoring two FDA clearances last year for medical devices to treat heart and respiratory failure, Abiomed is banking on the old adage that good things...
abiomedacquirescatheterbasedsystem
https://www.fiercebiotech.com/medtech/ride-health-gives-patients-a-lift-to-covid-19-treatment-vaccine-trials
Access to private transportation, or lack thereof, has long been a barrier to participation in clinical trials.
ridehealthgivespatientslift
https://www.fiercebiotech.com/cro/worldwide-clinical-trials-nabs-new-chief-financial-officer-as-it-moves-hq
Worldwide Clinical Trials has poached former PPD executive Brian Tuttle to serve as its new chief financial officer as it also moves its headquarters to...
chief financial officerclinical trialsworldwidenabsnew
https://www.fiercebiotech.com/biotech/novavax-targets-may-approval-for-covid-19-vaccine-u-s
Novavax is targeting a second-quarter FDA filing for emergency us
novavaxtargetsmayapprovalcovid
https://www.fiercebiotech.com
Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on Fierce Biotech as their must-read source for the latest news,...
fierce biotechnews reports
https://www.fiercebiotech.com/medtech/pfizer-to-open-global-network-digital-hubs-starting-greece
Pfizer is planning to establish a multinational network of digital research hubs with a focus on artificial intelligence and big data analytics.
global networkdigital hubspfizeropenincluding
https://www.fiercebiotech.com/biotech/um-blueprints-sprawling-new-biotech-complex
The University of Miami medical school says that a new, 1.4 million square foot laboratory complex will help propel development of a new biotech cluster in the...
umblueprintssprawlingnewbiotech
https://www.fiercebiotech.com/biotech/4dmt-will-regain-full-rights-to-blinding-disease-therapy-from-roche-to-initiative-new
Roche has told 4D Molecular Therapeutics that it's time to wind down a sponsored trial for an eye disease gene therapy and send the rights for the therapy back...
gene therapyrochewalksawayeye