New pediatric data shoot Rocket's gene therapy toward phase 2, leaving behind FDA concerns September...

Zealand rival to Takeda bowel disease drug hits goal in phase 3 September 30, 2022...

Kinarus stops midphase study in hospitalized COVID-19 patients early, adding to long list of failed...

Aligos demands jury trial to settle Janssen theft allegations, files fraud counterclaims September 29, 2022...

Biohaven's Nurtec-less pipeline takes another gut punch, fails ALS trial September 29, 2022 6:05 am...

Troubled CytoDyn ditches COVID-19 indication, enters tricky NASH landscape with new leader at helm September...

Novo enters NLRP3 arena, paying Ventus $70M for NASH hopeful September 29, 2022 4:45 am...

Galecto links blood cancer prospect to reduced fibrosis in early data drop September 29, 2022...

With cash dwindling, Axcella shares look at blinded NASH data September 29, 2022 2:40 am...

Good Idera: Pharma buys rare-disease-focused Aceragen in all-stock deal to keep money flowing September 29,...

<!– Medical Innovation Exchange September 28, 2022 1:12 pm Nanorattles for Rapid Detection of Multiple...

<!– Medical Innovation Exchange September 28, 2022 12:58 pm Algae-Based Microrobots Deliver Antibiotics within Lungs

Eisai and Biogen’s phase 3 Alzheimer’s win puts amyloid back in the driver’s seat, for...

AHRQ Announces Real World Data Competition for HCOs     On September 27, the Agency for...

Out of Context: CEO says now not the time to build a 'big independent biotech'...

Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance     The FDA...

TCR2's cell therapy racks up 22% response rate in heavily pretreated solid tumor patients September...

It’s a hit: Eisai springs ‘major surprise’ with phase 3 win for Biogen-partnered Alzheimer’s drug...

Pheon nabs $68M to ready clinical launch based on ADC-featured pipeline September 27, 2022 11:16...

A Single Source of Truth Helps Regulatory Teams     Regulatory teams participate in every step...

Nykode hits early-stage goals for pan-variant COVID shot, but future plans murky September 27, 2022...

Months after an executive exodus, Exicure tells 66% of staff to exit as it suspends...

Genentech pays $70M to access Arsenal's armory of T-cell tools in quest for solid tumor...

FDA slaps partial hold on Avidity's lead program, docking dystrophy study over serious adverse event...

Sanofi pays Scribe $25M to access CRISPR tools, writing new chapter in its NK cell...

FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some...

<!– Medical Innovation Exchange September 26, 2022 8:45 am Microfluidic Device Mimics Embryonic Heartbeat to...

Lava looks hot to Seagen as pharma pays $50M for preclinical T-cell engager for cancer...

Activist investor snaps Mereo's olive branch as proxy feud looms September 26, 2022 4:35 am...

Anebulo lifts lid on midphase cannabis intoxication therapy data, teeing up further development September 26,...

Black, Hispanic patients are neglected by 'one size fits all' MS trials. Genentech aims to...

Aeon looks to phase 3 after botox-like treatment hits mid-stage trial goals for rare muscle...

Ferring's C. difficile drug overcomes skepticism to secure FDA committee nod September 23, 2022 4:24...

Months after exiting clinical hold, Pfizer readies to resume dosing in phase 3 gene therapy...

AstraZeneca dumps Ionis drug despite hit in phase 2 cholesterol trial September 23, 2022 1:24...

Chutes & Ladders—Maxwell Biosciences taps CMO, 2 other leaders as it aims to shed preclinical...

FDA advisory committee votes down Spectrum’s lung cancer hopeful in wake of efficacy concerns September...

Enhancing Patient Engagement with THREAD’s eCOA Solution September 22, 2022 11:46 am https://www.fiercebiotech.com/sponsored/enhancing-patient-engagement-threads-ecoa-solution

<!– Medical Innovation Exchange September 22, 2022 10:58 am Face Mask Detects Respiratory Viruses, Alerts...

Rivus raises $132M series B as obesity, NASH prospects for metabolic drug heat up September...

Servier severs CAR-T collab with Allogene, handing back rights outside the US to 3 candidates...

FDA slaps hold on DBV peanut allergy trial in call for protocol changes September 22,...

GSK plays the white knight, paying $66M to rescue Spero’s oral antibiotic after FDA rejection...

<!– Medical Innovation Exchange September 21, 2022 8:48 am Smartphone Camera Measures Blood Oxygen

FDA Announces Funding Opportunities for Medical Device Development Tools     The FDA Center for Devices...

Raising the Bar on Quality for MedTech Production     Quality is a cornerstone in the...

Cash-depleted Acerus undergoes strategic review to stay afloat September 21, 2022 6:20 am https://www.fiercebiotech.com/biotech/cash-depleted-acerus-undergoes-strategic-review-spark-corporate-magic

Adamis’ shares nosedive as sole clinical-stage asset flunks COVID-19 trial September 21, 2022 5:44 am...

Bay State biotechs Sesen and Carisma blend together in bid to transform cancer treatment September...

Puma pounces on failed Takeda drug, snapping up cancer prospect for knockdown price September 21,...

Rise of the machines: Novo Nordisk pledges $200M to create first quantum computer for life...

AbCellera doubles down on Vancouver, kicking off 2nd expansion phase to build integrated antibody R&D...

Veranex Acquires Medidee     Veranex, a global, tech-enabled service provider dedicated to the medical technology...

M&As: Maximizing the Partnership Process on Both Sides     At the MedExecWomen meeting on June...

Celgene, Acceleron alum Backstrom tapped to be the top purveyor at Scholar Rock September 20,...

Johnson & Johnson opens 400-person R&D facility to strengthen Bay Area presence September 20, 2022...

Merck finally gets FDA nod to relaunch HIV trials, but drops preventive therapy plans September...

Rocket inks Renovacor buyout to propel its heart disease gene therapy ambitions September 20, 2022...

Thought COVID was bad? DOD taps Evotec to bolster its defenses against bubonic plague September...

Alzheon’s Alzheimer’s asset axes brain injury biomarker in phase 2 trial September 20, 2022 2:57...

Clover touts phase 3 omicron data as wait for COVID-19 vaccine approvals drags on September...

Celsion rebrands to Imunon to reflect immunotherapy, COVID-19 vaccine ambitions September 20, 2022 1:38 am...

<!– Medical Innovation Exchange September 19, 2022 11:31 am 3D Printed Light Sensor for Light-Sensitive...

Agilex Biolabs expands GLP Toxicology capacity with the commissioning of its new purpose designed testing...

Fierce Biotech Summit: As the biotech market teases turning a corner, stakeholders say we're in...

<!– Medical Innovation Exchange September 19, 2022 6:56 am Soft Robot Biodegrades Inside Body

Everest appoints Gilead, COVID therapy vet CEO to bring therapies to market in China September...

After scoring hit in US study, Pfizer racks up EU infant win for 20-valent pneumococcal...

Fortress falls: Virios flunks fibromyalgia study but claims drug may work in the omicron era...

Genfit revs up liver failure strategy with $41M biotech buyout, bagging phase 2-ready candidate September...

Intellia's gene editing therapies both post early successes as evidence grows for CRISPR potential September...

AstraZeneca's Alexion bet continues to pay off as danicopan improves hemoglobin levels in phase 3...

With 70% staff gone, Nordic Nanovector board members jump ship amid 'strategic review' September 16,...

Chutes & Ladders—Biden lands on leader for new agency that will oversee 'cancer moonshot' initiatives...

With cash evaporating quickly, Palisade Bio cuts staff to save money and focus on sole...

Are biotech SPACs back? Cancer-focused Apollomics next to take blank-check route September 15, 2022 6:48...

Pfizer gears up to submit meningococcal shot for approval this year after phase 3 success...

With Nasdaq delisting threat, IMV drops 3rd of staff in refocus on lead oncology asset...

Alnylam, Regeneron hit go on phase 2 trial of genetic NASH therapy after generating signs...

Eloxx stock slumps lower on failed phase 2 cystic fibrosis trial September 15, 2022 1:19...

The Perils of Biased Data     Data is one of the most essential resources in...

Altimmune sees phase 1 success in tricky NASH indication with GLP-1 agonist September 14, 2022...

CSL Behring unveils its largest R&D site in founder's hometown, slated to open before the...

Larimar's limbo finally ends as FDA removes clinical hold on only asset September 14, 2022...

Racing Moderna, Pfizer starts phase 3 trial of mRNA flu vaccine September 14, 2022 4:15...

Starry syndicate powers $165M bet on in vivo CAR-T therapies, enabling Penn spinout Capstan to...

<!– Medical Innovation Exchange September 13, 2022 1:07 pm Alveoli on a Chip to Reveal...

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices     On September 12,...

Prognosis: Medical Device Security Needs Improvement     The Internet of Things (IoT) has brought many...

Oramed phase 2 insulin drug data ‘paint an exciting picture’ in rocky NASH landscape September...

Acelyrin scores series C that brings total raised in less than a year past $500M...

Rubius makes hard pivot after reviewing clinical data, dumping lead assets and laying off 75%...

Akero hits endpoints in midphase NASH trial, linking candidate to improvements in fibrosis September 13,...

<!– Medical Innovation Exchange September 12, 2022 12:52 pm 3D Printed Tablets for Controlled Drug...

Pres. Biden Issues Executive Order on Advancing Biotechnology and Biomanufacturing     On September 12, President...

<!– Medical Innovation Exchange September 12, 2022 11:52 am Granular Hydrogels for Improved Bioinks

Pfizer among investors flooding Nimbus with $125M for TYK2 programs, phase 3 launch September 12,...

ESMO: Regeneron's plans to take on ovarian cancer with bispecifics boosted with new CD3 data...

ESMO: BioNTech's CAR-T response rate falls in fresh cut of early-phase data September 12, 2022...

ESMO: Daiichi dazzles in lung cancer to dial up hopes for next ADC September 12,...

ESMO: AstraZeneca spinout Dizal planning phase 3 NSCLC study in US before year’s end September...

ESMO: Relay spotlights expanded FGFR2 inhibitor data it hopes will pave accelerated approval September 11,...

ESMO: It’s early days for Pfizer’s EZH2 inhibitor, but there’s a glimpse of hope for...

ESMO: AstraZeneca’s checkpoint inhibitor bispecific may rival Keytruda, but dose change leaves questions September 10,...

<!– Medical Innovation Exchange September 9, 2022 12:36 pm Motion Sensors to Detect Age-Related Disease

<!– Medical Innovation Exchange September 9, 2022 11:55 am Wearable Pneumatic Assistive Tech with Logic...

Sanofi's Michael Streit departs to be cancer-focused Scorpion's first CMO September 9, 2022 8:23 am...

ESMO: GSK keeps the faith in anti-TIGIT plans; it's 'not always about being first' September...

After flunking studies last year, Allakos’ failed phase 3 EoDyssey sinks gastrointestinal program September 9,...

ESMO: Adding bempeg to Opdivo lowered response rate in Bristol Myers-Nektar failed cancer trial September...

Cannabinoid-focused drugmaker InMed blames 'recessionary pressures' for exiting wellness sector September 9, 2022 1:35 am...

Chutes & Ladders—Homology taps new CEO after pipeline restructure September 8, 2022 1:31 pm https://www.fiercebiotech.com/biotech/chutes-ladders-homology-shakes-leadership

Are You Prepared for Next-Gen Biomanufacturing? September 8, 2022 9:29 am https://www.fiercebiotech.com/sponsored/are-you-prepared-next-gen-biomanufacturing-or-embracing-flexible-approach-next-gen

Oxford malaria vaccine maintains bite after booster; Researchers hope for shot approval in 2023 September...

VistaGen gets green light to restart phase 3 trial for social anxiety spray despite past...

Silence sees fast-track tag as proof of FDA confidence in blood cancer drug that faced...

VC firm LifeArc sells first portfolio company as dermatitis-focused Ducentis bought by Arcutis for $30M...

GSK taps Medable for decentralized clinical trials, patient diversity September 7, 2022 6:44 pm https://www.fiercebiotech.com/biotech/gsk-taps-medable-decentralized-clinical-trials-patient-diversity

Disaster Proofing Your Business     As supply chain issues continue to cause delays in production...

CVS Moves Toward Home Health Care with Signify Acquisition     CVS Health is expanding into...

RQM+ Acquires Jordi Labs     RQM+, a provider of regulatory, quality, clinical and laboratory services...

Five Most Common Compliance Problems     Regulatory compliance in health care is a vital part...

GSK helps SpringWorks to double payday from boosted combo deal as it also reels $225M...

Brickell Biotech deviates from old plans, rebrands for fresh start September 7, 2022 6:30 am...

In Orbit: New Beam-buoyed biotech takes flight, gravitating toward the flash of RNA starlight September...

ESMO: Mirati plays the hits, posting colorectal KRAS data that mirror results reported to fanfare...

Equillium sees $26M Metacrine buy as opportunity to boost its balance sheet September 7, 2022...

BioVie gets stock bump on small, midphase Alzheimer's data drop September 7, 2022 3:25 am...

Data drip sheds little light on how Ionis, AstraZeneca compare to Alnylam in rare disease...

Roche snaps up PD-1-focused Good Therapeutics for $250M; 'Sky’s the limit’ for spinout September 6,...

AI Applications     Of all the healthcare data available, medical imaging is among the richest....

<!– Medical Innovation Exchange September 6, 2022 12:03 pm Surface Coating Rapidly Kills Pathogens, Lasts...

<!– Medical Innovation Exchange September 6, 2022 11:26 am Pneumatic Assistive Device for People with...

<!– Medical Innovation Exchange September 6, 2022 11:17 am AI Device Monitors Breathing to Diagnose...

Sarepta picks up momentum as FDA lifts hold on phase 2 DMD trial September 6,...

Murky FDA feedback leaves Eiger COVID treatment in regulatory limbo September 6, 2022 6:15 am...

Synaffix rustles up another ADC deal, allying with Emergence in $360M biobuck pact September 6,...

Iveric hits again in pivotal eye disease program, keeping it on Apellis' tail in race...

BMS-backed Arsenal Bio pulls trigger on $220M series B, touting potential fleet of gene-edited cell...

Precision rejigs leadership team, tasking CSO with managing partnerships in wake of Novartis pact September...

Facing €200M phase 3 bill, Abivax sells stock at knockdown price to keep lights on...

Chutes & Ladders—Novartis R&D chief Jay Bradner leaves after 7 years September 1, 2022 1:03...

Targeting Novo Nordisk in China's obesity market with a unique proposition, LeaderMed eyes US IPO...

Finch axes more than a third of its workforce days after Takeda clips its fiscal...

Novo Nordisk ponies up $1.1B for Forma in effort to shape up sickle cell disease market...

Novartis R&D chief Bradner bids adieu to the Swiss Big Pharma September 1, 2022 6:13...

As activist investor ratchets up pressure, Mereo makes more cuts to extend cash runway into...

AnaptysBio's HARP plays dud note, prompting rethink of imsidolimab strategy September 1, 2022 2:13 am...

Streamlining the Literature Review Process     Literature reviews play an integral role in the regulation...

Guess what’s SPAC? Ocean Biomedical resuscitates Wall Street play all but dead in 2022 August...

Elcam Receives MedAccred Plastics Injection Molding Accreditation     Elcam Medical has achieved MedAccred Accreditation for...

Seeking to accelerate R&D response, philanthropist puts up $171M to create pandemic antiviral center August...

After chat with FDA, ImmunoGen delays pivotal top-line data on blood cancer ADC to 2024...

Jounce gets trounced as phase 2 data disappoint once again, prompting pipeline rethink August 30,...

FDA sparks hope for Curis, lets biotech resume enrollment for part of phase 1/2 leukemia...

Winning the Competition for Top Biotech Talent     Massachusetts has a rich history and is...

Codiak's $2.5M check in July isn’t enough to stave off job cuts and restructuring August...

Beam sheds more light on clinical hold slapped on gene-edited CAR-T August 30, 2022 6:31...

Sanofi, seeking to stem bleeding at hemophilia A unit, gets FDA priority review for rival...

Arch builds bridge to new class of medicines, leading $50M investment in the AI-enabled Vilya...

<!– Medical Innovation Exchange August 29, 2022 7:48 am Fingertip Sensor Measures Lithium Levels in...

Alnylam clears phase 2 test for Regeneron-partnered nephropathy med, as it looks to play catch-up...

ESC 2022: Bayer, like its rivals, hopes it made a big enough splash after phase...

BMS, J&J's secondary stroke med falls short in phase 2 but companies see enough potential...

Takeda returns two inflammatory bowel prospects back to Finch's nest August 26, 2022 6:27 am...

ACRO posts diversity and inclusion principles to tackle age-old clinical trial problem August 26, 2022...

Blanchard abseils down from Everest, walking out as CEO with immediate effect August 26, 2022...

Chutes & Ladders—Former Takeda exec takes reins at Tessa August 25, 2022 12:43 pm https://www.fiercebiotech.com/biotech/chutes-ladders-former-takeda-exec-takes-reins-tessa

<!– Medical Innovation Exchange August 25, 2022 8:28 am Smart Socks Help Prevent Falls Among...

In new editorial, FDA’s Califf says biomedical field should prioritize chronic illness, addiction August 25,...

Chasing GSK, Pfizer races to regulators after RSV vaccine paints positive impression in RENOIR phase...

Westlake backs 3T to use Stanford tech to land one-two punch on TCR challenges August...

Innovaccer Health Cloud Certified by NCQA     Innovaccer is now a certified data partner for...

Novartis suspends dosing in phase 2b Huntington's trial after side effects reported August 24, 2022...

Technology’s Role in Improving Clinical Trial Equity     It has been reported that as few...

Bluebird exec spreads wings, heads over to Tessera for ‘irresistible opportunity’ August 24, 2022 6:30...

A broken PACT? Biotech’s lone clinical asset put on ice as more staffers culled August...

Aeglea culls workers, shifts pipeline focus after knockback by FDA August 24, 2022 4:27 am...

Third Harmonic, with an old Novartis drug in hand, braves frosty IPO waters in a...

<!– Medical Innovation Exchange August 23, 2022 12:58 pm Mining Ultrasound Data to Improve Liver...

Device Labeling: Best Practices     EU MDR required companies to make significant changes to their...

Aktis makes waves with $84M extension as 3 big pharmas channel funds to radiopharmaceutical pipeline...

Empowering Patients Through RPM     As more and more healthcare activities take place from home,...

Windtree takes weight off branches, enters near $80M biobucks deal for acute pulmonary pipeline platform...

Foghorn downgraded to full clinical hold, with more patient deaths clouding AML, MDS trial August...

Merck, seeking XI factor in race with Bayer, gets FDA fast-track tag for anticoagulant August...

Alcon swoops on Aerie, striking $770M buyout to expand eye drug pipeline August 23, 2022...

Moderna co-founder helps finance Belgian mRNA shop August 22, 2022 3:11 pm https://www.fiercebiotech.com/biotech/moderna-co-founder-helps-finance-latest-series-b-belgian-mrna-shop

<!– Medical Innovation Exchange August 22, 2022 10:13 am EEG Caps for Brain Organoids

<!– Medical Innovation Exchange August 22, 2022 9:34 am Magnetic Microrobots Assist with Root Canal...

2 biotechs swoop into monkeypox scene with new R&D licensing pact August 22, 2022 7:02...

Bright Uro, a medtech company based in California, has created the Glean Urodynamics System, a...

Researchers at New York University have created a wearable system that can measure electrodermal activity,...

Immuron culls COVID drug work as new variants, a competitive market renders asset DOA August...

As Sanofi's SERD falls, Menarini’s advances with EU review August 19, 2022 4:21 am https://www.fiercebiotech.com/biotech/sanofis-serd-falls-menarinis-advances-eu-review

Ex-Takeda leader to provide steady hand as Tessa's CEO after C-suite churn August 18, 2022...

Enovis, a medtech company based in Delaware formerly known as DJO, recently announced the launch...

Curis gets FDA green light to restart lymphoma trial, though partial hold on leukemia study...

Scientists at Linköping University in Sweden have developed a collagen-based corneal implant that can restore...

Bayer parts ways with Exscientia, leaving one target in AI drug hunter's hands August 18,...