Regulatory Intelligence: Meeting the Demands of Today’s Global Regulatory Market     The increase in global...

The Importance of High-Quality Communication in the Healthcare Setting     According to a Commonwealth Fund...

New Resource Sheds Light on FDA CDRH Regulatory Focus     Device developers seeking insight into...

Biden says America’s 'banking system is safe' after regulators back up all SVB deposits March...

GSK's $100M ADC bet in doubt after fatality in first trial of Mersana's cancer therapy...

UK biopharma body praises bank for keeping doors open at life science startups by rescuing...

SVB capital crunch sends biotechs on bank run March 10, 2023 7:44 am https://www.fiercebiotech.com/biotech/biotech-bank-svbs-capital-crunch-sparks-bank-run-companies-huddle-consider-exposure

After slimming down, Applied Molecular Transport no closer to taking UC drug into phase 3...

Vyne swings behind BET inhibitors, seeks partner for failed eczema drug March 10, 2023 4:55...

Olema, prioritizing oral SERD, plans 25% head count cut, pulls back from early-stage work March...

Chutes & Ladders—Biogen names Stelios Papadopoulos' successor March 9, 2023 12:35 pm https://www.fiercebiotech.com/biotech/chutes-ladders-biogen-names-papadopoulos-successor

<!– Medical Innovation Exchange March 9, 2023 7:40 am Smartphone Photos to Detect Anemia

<!– Medical Innovation Exchange March 9, 2023 7:18 am Ultrasound Catheter to Treat Hypertension

Vertex's next off-the-shelf diabetes cell therapy follows in predecessor's footsteps to the clinic March 9,...

FDA placed hold on Fulcrum's sickle cell therapy over hematological malignancy concerns March 9, 2023...

Lilly's 10-year bet on treating Alzheimer's before symptoms start ends in failure March 9, 2023...

Neoleukin, old ending: De novo protein player lays off 70% of staff, searches for strategic...

Inhibikase checks off another clinical hold, readying phase 2 trial for patients with rare brain...

All systems go for Mesoblast’s 2nd attempt to secure allogeneic cell therapy FDA win March...

Fresh Tracks may disappear as biotech mulls sale to continue autoimmune pipeline March 8, 2023...

E-labeling: The Road to Reduced Medical Device Packaging Material     In the consumer world, it’s...

Redx stung by porcupine inhibitor flop in biliary tract cancer, setting biotech back before Jounce...

Chasing Moderna, Merck pays $50M to join race to develop cancer-preventing vaccine March 8, 2023...

Increasing Momentum in Medical Device Security     In 2021, an employee at Ireland’s public health...

BlackHägen Design Announces Death of Founder and Human Factors Engineer Sean Hägen     With deep...

Chiesi offers Affibody breath of fresh air in respiratory disease deal worth up to $637M...

Protagonist's story turns for the better as J&J-partnered psoriasis med clears lesions in midphase trial...

Flagship fledging fetches $50M to fire drugs at specific organs, fix on-target, off-tissue toxicity March...

Third Rock, J&J spinout Rapport arrives with $100M and ambition to transform precision neuroscience March...

Immuneering, saving cash for universal RAS candidate, suspends neuroscience programs March 7, 2023 2:06 am...

Armed with $60M series A and Lilly's backing, Volastra enters clinic via Amgen cancer med...

Rallybio reassembles behind version 2.0 of fetal blood disorder med March 6, 2023 6:57 am...

Aclaris stock halves after phase 2a skin study misses goals March 6, 2023 6:39 am...

To 'keep pace with viral evolution,' Invivyd is also evolving (again) March 6, 2023 6:16...

2 months after depression fail, Atai lays off 30% and reviews pipeline again March 6,...

Merck’s cardiovascular future takes shape as sotatercept overachieves, PCSK9 inhibitor passes phase 2 March 6,...

Adaptimmune absorbs TCR² to extend cash runway and broaden T-cell pipeline March 6, 2023 4:40...

Harbour ships phase 3 data to take lead over argenx, J&J and UCB in Chinese...

Incyte’s LIMBER lumbers to early end as analysis shows Jakafi cancer combo destined to fail...

In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms –...

Novartis ready to head for deep space with Voyager after a year 'kicking the tires'...

Veru’s EUA ambitions crash after FDA declines to authorize its COVID treatment March 3, 2023...

Big Pharma regained ‘mojo’ last year, but biotech valuations remain ‘precarious’: report March 3, 2023...

Praxis share price halved after essential tremor fail, but biotech still plans phase 3 March...

Aeglea's latest layoffs, pipeline cull curb spending, but cash crunch still on the cards March...

Chutes & Ladders—Billy Dunn departs FDA neuroscience team after 18 years March 2, 2023 10:54...

Managing Legacy Technology Security     To help address the cybersecurity risks of legacy devices used...

<!– Medical Innovation Exchange March 2, 2023 6:50 am Alpha TAU Killing Tumors With Highly...

A duo of deals sees Avenue secure rare disease med while Allist lands cancer drug...

Novo Nordisk recruits new staff, lays off others as US R&D consolidated in Boston March...

MorphoSys, once a discovery powerhouse, exits preclinical R&D, lays off staff to focus cash on...

Inovio’s endpoint switcheroo backfires as phase 3 misses on new measure, hits on old March...

Flamingo folds Dynacure into its flamboyance to wade through biotech markets together March 1, 2023...

FDA advisors support efficacy and safety of GSK's RSV vaccine with more confidence than Pfizer...

Confo hands baton to Lilly for non-opioids pain med development in $40M upfront deal March...

<!– Medical Innovation Exchange March 1, 2023 7:55 am Bacteria Create Protein Nanowires for Biosensing

<!– Medical Innovation Exchange March 1, 2023 6:54 am Patient-Specific Soft Robotic Heart Replicas for...

New Ambrx CEO spies path for ousted breast cancer med as partner posts encouraging phase...

Developing an Effective and Sustainable Regulatory Strategy for Today’s Global Market     Global regulatory demands...

Regulating Point of Care Printed Devices     The use of 3D printing for medical devices...

G1 sheds staff, while Sorrento WARNs of cuts amid torrential downpour of industry layoffs March...

PMW sidelines two programs as lead tumor suppressor candidate picks up pace in clinic March...

Vertex pays ImmunoGen $15M to use antibody-drug conjugates to improve CRISPR therapy March 1, 2023...

Atea dumps dengue drug as ‘unevaluable’ endpoint causes timelines, forecast costs to spiral March 1,...

Chroma bags another nine-digit financing, taking $135M series B to bolster epigenetic-focused platform February 28,...

Sarepta’s DMD gene therapy inches closer to market as FDA declines to hold advisory meeting...

Pfizer's RSV vaccine wins support of FDA panel despite lingering safety and efficacy questions February...

Flex Medical Molding Achieves MedAccred Plastics Injection Molding Accreditation     Flex Medical Molding (Shenzhen) Co.,...

<!– Medical Innovation Exchange February 28, 2023 10:17 am Neuroimmune Modulation for Inflammatory Disease: Interview...

Alzheimer's meds are here. But for the Down syndrome community, it's still the 1980s February...

Protecting Innovation in FemTech     As opportunities for innovation and investment in women’s healthcare accelerate,...

<!– Medical Innovation Exchange February 28, 2023 8:21 am Ovarian Organoids to Study Reproductive Health

FDA flags Guillain-Barré risks for GSK, Pfizer RSV shots, but just one will need safety...

Junshi’s lipid lowering drug hits phase 3 goals, teeing up challenge to Amgen, Sanofi in...

Latest biotech-on-biotech merger sees aimless Adamis snapped up by DMK February 28, 2023 1:55 am...

Aptinyx, reeling from series of setbacks, dumps dementia drug, stops PTSD trial after phase 2...

Theravance takes another blow, but vows to fight on with slimmed headcount and new trial...

AstraZeneca grows Canadian snowshoe print with 500 new jobs and rare disease hub February 27,...

Dunn with the FDA: head of agency's neuroscience unit to depart February 27, 2023 7:53...

<!– Medical Innovation Exchange February 27, 2023 7:27 am Wearable Device Senses When Vocal Fatigue...

<!– Medical Innovation Exchange February 27, 2023 6:59 am HIV Vaccine Candidate Stops Virus As...

CSL, seeking to stall Takeda drug, links antibody to rare disease benefits and plans global...

Months after going public, Apexigen lays of 55% of staff and considers exit routes February...

Keytruda killer: Chipscreen bags Chinese rights to Biocytogen's bispecific antibody February 27, 2023 4:33 am...

After spending $6.5B for Momenta, J&J readies 'pipeline in a product' for pivotal year February...

What can bats, naked mole rats and Jaws tell us about human biology? Paratus is...

Destiny seals C. diff therapy's phase 3 fate with Sebela February 24, 2023 5:35 am...

Fulcrum's clinical hold caps off tough week for sickle cell drug development February 24, 2023...

ObsEva demolishes US C-suite in latest cost-cutting measures as Nasdaq delisting looms February 24, 2023...

Nektar’s bitter pill: Phase 2 fail ends Lilly-partnered lupus program and prompts eczema rethink February...

Novartis punts Pliant-partnered NASH prospect amid pipeline prioritization pivot February 24, 2023 1:08 am https://www.fiercebiotech.com/biotech/novartis-punts-pliant-partnered-nash-prospect-amid-pipeline-prioritization-pivot

Chutes & Ladders—Roivant founder ditches board for White House bid February 23, 2023 4:22 pm...

<!– Medical Innovation Exchange February 23, 2023 12:55 pm Electrostatic Face Mask Self-Charges with Breathing

<!– Medical Innovation Exchange February 23, 2023 12:25 pm NextGen COVID-19 Antibodies Destroy Spike Protein

Sangamo shelves sickle cell therapy, joining rivals forced to rethink development plans February 23, 2023...

FDA Seeks Industry Collaboration on Medical Device Active Surveillance System     The FDA is seeking...

Graphite pencils out sickle cell therapy after adverse event, cutting half of workforce loose February...

Infinity pools resources with MEI Pharma in oncology-focused merger February 23, 2023 7:17 am https://www.fiercebiotech.com/biotech/infinity-pools-resources-mei-pharma-oncology-focused-merger

Prilenia searches for positive signs as oral ALS drug fails to improve disease severity in...

After a tough year, VBL merges with Notable Labs February 23, 2023 6:26 am https://www.fiercebiotech.com/biotech/vbl-merges-notable-labs-latter-reels-103m

Moderna, on its back foot, reassures investors on flu vaccine after mixed phase 3 data...

As Novartis pulls back from legacy sickle cell program, Intellia CEO calls the market 'wide...

Layoffs not letting up: Impel, Cybin, EQRx all trim head counts with eyes on saving...

Jounce pounces on exit opportunity, laying off 57% of staff alongside reverse merger with Redx...

AstraZeneca doubles down on hot cancer target, paying $63M for ADC months after bispecific deal...

Graphite pencils out sickle cell therapy after patient death, cutting half of workforce loose February...

Capsida reels in another Big Pharma deal, this time diving into eye disease with AbbVie...

Fallout from Quantum Genomics' phase 3 fail claims top executives as biotech searches for a...

BioCryst hits another hurdle, delays trial for its 1 remaining clinical candidate February 22, 2023...

'We beg you': Biotechs plead for help and funds to find long COVID treatments February...

After last-ditch effort, cellular medicine biotech Rubius moves to dissolve February 22, 2023 5:14 am...

Ailing Aileron enters endgame as breast cancer data trigger layoffs and search for a buyer...

Kinnate buys OrbiMed and Foresite's stakes in cancer venture, paying $24M to go solo in...

From Roivant to the White House on anti-woke agenda: Ramaswamy unveils presidential bid February 22,...

Moderna's latest genomics move sees it team up with Life Edit to develop new gene...

MedTech Developers Can Improve Surgical Workflows Through Thoughtful Innovation     A surgeon’s workflow inside of...

Akebia says FDA staffing constraints are throwing a roadblock into appeal process February 21, 2023...

Pfizer's maternal RSV vaccine filing gets priority review, setting up showdown with AstraZeneca, Sanofi February...

Bridge holds firm despite placebo beating drug in midphase ulcerative colitis trial February 21, 2023...

With $135M in fresh funds, Hemab aims to leapfrog drug development for neglected blood disorders...

Blockchain Can Solve Pharma’s Costly Data Integrity Problem     In the pharmaceutical industry, quality data...

CRO Avania Acquires MAXIS     Avania, a global medical technology contract research organization (CRO), has acquired MAXIS,...

<!– Medical Innovation Exchange February 20, 2023 7:57 am Raman-Based Urine Sensor Detects Cancer Metabolites

Astellas has menopause accelerated approval ambition thwarted by FDA at last minute February 20, 2023...

Assignor Estoppel: Protecting Your Patent Rights     The centuries-old common law doctrine of assignor estoppel...

<!– Medical Innovation Exchange February 17, 2023 7:12 am Exclusive Look at HandX Robotic-Assisted Surgical...

<!– Medical Innovation Exchange February 17, 2023 6:41 am Personalized CAR-T Cell Therapy

Pfizer pulls 50% of people from phase 3 Lyme disease study for GCP violations at...

Moderna checks a few boxes in phase 3 mRNA flu shot trial, but misses on...

Chutes & Ladders—John Reed jumps Sanofi ship, boards J&J team February 16, 2023 10:19 am...

<!– Medical Innovation Exchange February 16, 2023 8:31 am Ingestible Sensor Reveals Gastric Motility

<!– Medical Innovation Exchange February 16, 2023 7:56 am Automated Mass Spec Technique to Detect...

Months after kidney transplant trial resumes, Talaris discontinues program and cuts third of workforce February...

'It's the right call': GSK expresses no regrets on abandoning cell therapy as oligo strategy...

Theratechnologies assembles science team to retool solid tumor trial after clinical hold February 16, 2023...

By merging with struggling Erytech, Pherecydes spies opportunity to boost AMR strategy February 16, 2023...

Newron's shares accelerate as one-year schizophrenia data boosts chances of historic approval February 16, 2023...

Merck KGaA, spying a major market, pays Aqilion €10M to tackle tough autoimmune target February...

On hunt for better gene med delivery, Aera exits stealth with $193M and Alnylam vet...

GSK vaccine R&D head touts consistency of RSV data but is mum on restarting maternal...

Arrowhead’s $3.7B J&J deal is done, CEO says, after ‘out of the blue’ NASH decision...

<!– Medical Innovation Exchange February 15, 2023 7:42 am Acoustic Stimulation for Insomnia

After several flops, Merck exec stands by aggressive Keytruda prostate cancer program February 15, 2023...

<!– Medical Innovation Exchange February 15, 2023 6:56 am Self-Assembling Peptides as a Bioink

Biogen's brand-new CEO shuns 'desperation factor' but signals major business development ahead February 15, 2023...

J&J returns NASH med back to Arrowhead's quiver with Hep B still in limbo February...

AlloVir's cell therapy tackles infection in midphase kidney transplant trial February 15, 2023 5:17 am...

Concert persuades FDA to keep breakthrough tag for alopecia therapy despite Lilly's arrival February 15,...

Biogen bails on BTK race just 19 months after placing $125M bet February 15, 2023...

<!– Medical Innovation Exchange February 14, 2023 8:20 am Automated Feeding Platform to Study Mosquito...

<!– Medical Innovation Exchange February 14, 2023 7:01 am Electrochemical Sensor for Detailed SARS-CoV-2 Immunity...

New biotech VC takes off with $520M and a flight deck stacked with big-name investors...

Sesen sweetens Carisma deal to win over rogue investors in time for Valentine's Day February...

<!– Medical Innovation Exchange February 14, 2023 6:37 am Nanowire Assay Detects Brain Tumors from...

Medical Device Computational Modeling and Simulation Reports Highlights Best Uses and Barriers to Adoption    ...

Pharnext ditches Alzheimer’s plans, saying more development would be too costly February 14, 2023 5:59...

Soligenix's stock sinks 38% after FDA refuses to consider lymphoma therapy application February 14, 2023...

Replay rolls again, creating TCR-NK cell therapy startup with MD Anderson to close in on...

GSK nixes next-gen COVID-19 antibody collaboration, leaving Vir to fly solo, seek new partners February...

Cullinan sets sail toward U.S. with novel bispecific from Harbour BioMed for $25M in cash...

Integrating Games into Medical Devices To Improve Patient Outcomes      Digital games are a part...

Addressing the next wave of COVID-19 through a new approach to vaccines February 13, 2023...

Facilitating Increased Digital Monitoring     Some years ago, a visit to a doctor’s office or...

<!– Medical Innovation Exchange February 13, 2023 8:29 am 3D Bioengineered Skin Grafts Fit Complex...

3 years after rejecting $1B buyout, Sorrento files for bankruptcy amid legal battles February 13,...

Frequency falters after phase 2 ear infection fail, axing 2 assets and 55% of staff...

Ena slices data to claim flu success in phase 2 and nasal spray's wide-ranging potential...

On the turnaround trail, tiny Corbus pays $7.5M for rival to Seagen's oncology ADC Padcev...

Reed relinquishes R&D reins at Sanofi to pursue new opportunity, sparking race to find successor...

Broadening the Commercialization Partnership February 10, 2023 10:44 am https://www.fiercebiotech.com/sponsored/broadening-commercialization-partnership

Blueprint told to stop sketching as FDA slaps partial hold on phase 1/2 trial February...

Faced with safety issues over inflammation drug, AstraZeneca spinout Aristea closes shop February 10, 2023...

Mineralys, amid signs of thawing IPO market, upsizes offering to raise $192M for race with...

Eliem drops depression drug, ending pursuit of Biogen-Sage and laying off 55% of team February...

Chutes & Ladders—Former Roche pharma chief tapped to be new Bayer CEO February 9, 2023...

<!– Medical Innovation Exchange February 9, 2023 8:34 am Antibacterial Smart Sutures Visible in CT...

'Expect us to act' on M&A, AbbVie CEO says as company plots post-Humira plans February...

<!– Medical Innovation Exchange February 9, 2023 8:03 am Voice-Activated Sample Prep for Safer Handling

<!– Medical Innovation Exchange February 9, 2023 7:46 am Terahertz Spectroscopy to Assess Severity of...

Despite rapidly emptying pipeline, AstraZeneca stays loyal to vaccine, immune therapy business February 9, 2023...

Magenta's C-suite heads out the door with 85% of staff as closing process gets underway...

AstraZeneca deals another blow to IL-12, dumping therapy to follow BMS, Merck KGaA out of...

Aligos' hep B functional cure dream fizzles out as cash crunch and layoffs force focus...

Talent, Training and Scientific Infrastructure. All in NC. February 8, 2023 2:42 pm https://www.fiercebiotech.com/sponsored/talent-training-and-scientific-infrastructure-all-nc

The Power of Visuals     According to the Ebbinghaus Forgetting Curve, humans forget approximately 50%...

<!– Medical Innovation Exchange February 8, 2023 7:14 am Focused Ultrasound Releases Brain Biomarkers

<!– Medical Innovation Exchange February 8, 2023 7:03 am Hydrogel Cell Carrier for Fistula Healing

<!– Medical Innovation Exchange February 8, 2023 6:50 am Bottlebrush Particle for Synergistic Drug Combinations

Harnessing the Potential of LinkedIn for MedTech Professionals     At some point since the start...

After pandemic breather, Big Pharma sees drug development costs rise and returns sink: report February...

Preparing for next pandemic, Korea's SK pumps $261M into vaccine R&D site February 8, 2023...

Regor gets permission to glimpse Pfizer's FBI communique in GLP-1 trade secrets dispute February 8,...

Vistagen, jittery after seeing rivals fail, pauses plan to restart phase 3 anxiety trial pending...

BIO: Big Pharma offers menu of partnering options, but biotechs want licensing entrée February 7,...

As J&J quietly overhauls R&D, Arrowhead waits for news on RNAi hepatitis B therapy February...

PRI Establishes Working Group to Improve Medical Device Quality and Supply Chain Resiliency     The...

Chin Named Chief Financial Officer of Akido     Eric Chin is the new Chief Financial...

FDA’s Oncology Center of Excellence slowed launch of new projects in 2022 to focus on...

<!– Medical Innovation Exchange February 7, 2023 6:40 am Neural Chip Detects, Suppresses Neurological Symptoms

<!– Medical Innovation Exchange February 7, 2023 6:22 am Antibacterial Peptide Spray Safe for Use...