https://www.biopharmadive.com/news/ionis-metagenomi-crispr-gene-editing-deal/636338/
Ionis teams with Metagenomi and dives into gene editing | BioPharma Dive
The RNA drug developer is paying the richly funded startup $80 million in a wide-ranging alliance that marks its first foray into DNA editing medicines.
gene editingbiopharma diveionisteamsmetagenomi
https://www.biopharmadive.com/news/allogene-restructuring-strategy-car-t-lymphoma-trial/703643/
Allogene to shift strategy in bid to reposition CAR-T | BioPharma Dive
The company plans to restructure and will start a new late-stage study testing whether its “off-the-shelf” therapy can boost cure rates when used early on.
biopharma diveallogeneshiftstrategybid
https://www.biopharmadive.com/news/fda-drug-shortage-coronavirus-first-impact/573190/
FDA reports first drug shortage due to coronavirus impact | BioPharma Dive
Supplies of the drug, which the FDA did not identify, ran short as a result of issues at a site that produces the active ingredient. Other options are...
due tocoronavirus impactbiopharma divefdareports
https://www.biopharmadive.com/news/als-drug-research-progress-genetic-clinical-trials/611274/
On the hunt for new ALS drugs, researchers see progress, and a long road ahead | BioPharma Dive
The fatal nerve disease has few treatments. But despite continued setbacks, drug developers are hopeful that genetic technologies and a better understanding of...
on the huntlong road aheadbiopharma divenewals
https://www.biopharmadive.com/news/biohaven-vyglxia-spinocerebellar-ataxia-fda-europe/759167/
Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval | BioPharma Dive
CEO Vlad Coric said the company has a patient hub, payer managers and a small sales force set up to ensure a successful launch of Vyglxia, a brain medicine...
rare diseasefda approvalbiopharma divedrugship
https://www.biopharmadive.com/news/epicrispr-fshd-series-b-financing-epigenetic-editing/743366/
Epicrispr banks $68M to test epigenetic editing on rare muscle disease | BioPharma Dive
The startup is using CRISPR tools to stop errant expression of a gene linked to facioscapulohumeral muscular dystrophy, a disorder on the radars of several...
epigenetic editingmuscle diseasebiopharma divebankstest
https://www.biopharmadive.com/news/elicio-angion-reverse-merger-ipo-biotech-startups/640486/
With reverse merger, Elicio becomes latest biotech to bypass an IPO | BioPharma Dive
Elicio’s combination with Angion Biomedica comes months after it abandoned a new stock offering, and is the latest example of how the IPO slowdown has shifted...
reverse mergerbiopharma diveeliciobecomeslatest
https://www.biopharmadive.com/news/biomarin-roctavian-limit-sales-us-germany-italy-hemophilia/723402/
BioMarin pares Roctavian spending as it narrows sales focus | BioPharma Dive
The company plans to limit sales of the hemophilia gene therapy to the U.S., Italy and Germany, while ending most clinical development work.
biopharma divebiomarinparesroctavianspending
https://www.biopharmadive.com/news/provention-diabetes-rejection-fda/602866/
FDA knocks back diabetes prevention drug, crushing its maker's shares | BioPharma Dive
Provention Bio said it expects to collect data that could address the FDA's concerns before the end of September. In the meantime, though, the company's shares...
knocks backbiopharma divefdadiabetesprevention
https://www.biopharmadive.com/news/weird-ingredients-biopharma/428918/
Witch's brew? What drugs contain leech and lizard parts | BioPharma Dive
From Gila monster spit to sloth fur, biopharma has increasingly incorporated strange additions into its drugs.
biopharma divewitchbrewdrugscontain
https://www.biopharmadive.com/news/kailera-triple-G-obesity-drug-phase-1-data-hengrui/821191/
Kailera’s three-pronged obesity shot shows promise in early trial | BioPharma Dive
As Lilly completes the pivotal program for its “triple-G” drug, Phase 1 data from Kailera partner Hengrui suggest their offering might spur greater weight loss.
in earlybiopharma divethreeprongedobesity
https://www.biopharmadive.com/news/ethyreal-bio-graves-thyroid-eye-disease-tshr/822477/
Ethyreal starts up with $101M and takes aim at a pair of immune diseases | BioPharma Dive
The startup is developing a medicine that works differently than available treatments for thyroid eye disease and could benefit people with a related...
starts uptakes aimpair ofbiopharma diveimmune
https://www.biopharmadive.com/news/lilly-morphic-novartis-morphosys-pelabresib-parker-cancer-agenus/721835/
Lilly alone in bidding for Morphic; Novartis won’t yet file MorphoSys drug | BioPharma Dive
Federal filings showed no companies other than Lilly made an offer to buy Morphic, while Novartis executives said they’re still waiting for more data on...
biopharma divelillyalonebiddingmorphic
https://www.biopharmadive.com/news/sanofi-scribe-gene-editing-nk-cell-therapy-cancer/632718/
Sanofi partners with Scribe to gain gene editing tools for cell therapy work | BioPharma Dive
The California biotech will receive $25 million upfront from Sanofi, which plans to use Scribe’s platform to edit natural killer cells for cancer treatment.
gene editingcell therapybiopharma divesanofipartners
https://www.biopharmadive.com/news/abbvie-fda-rinvoq-approval-jak-inhibitor/561112/
Price, safety will test blockbuster billing for AbbVie's new arthritis drug | BioPharma Dive
Rinvoq adds another oral option to rheumatologists' tool kits, but at a list price of $59,000 per year.
biopharma divepricesafetytestblockbuster
https://www.biopharmadive.com/news/merck-epstein-barr-vaccine-opko-modex/644449/
Merck pays $50 million for early-stage Epstein-Barr vaccine | BioPharma Dive
Opko’s acquisition of ModeX paid off with a Merck deal that could earn the vaccine and immunotherapy developer hundreds of millions of dollars.
early stageepstein barrbiopharma divemerckpays
https://www.biopharmadive.com/news/lundbeck-alzheimers-failure-idalopirdine/435747/
Lundbeck brings latest Alzheimer's failure | BioPharma Dive
The Danish drugmaker reported two late-stage failures that put an end to its 5-HT6 antagonist in yet another setback for the space.
biopharma divelundbeckbringslatestalzheimer
https://www.biopharmadive.com/news/lilly-siteone-acquisition-pain-drug-non-opioid-deal/749012/
Lilly to buy pain drug developer SiteOne, challenging Vertex | BioPharma Dive
The acquisition expands Lilly’s pain pipeline with a slate of drugs targeting ion channel proteins like NaV1.7 and NaV1.8.
to buybiopharma divelillypaindrug
https://www.biopharmadive.com/news/merck-keytruda-prostate-biliary-trial-success-setback/641189/
Merck reports one success, one setback from late-stage Keytruda trials | BioPharma Dive
The top-selling immunotherapy bested chemo in treating bile duct cancer, but fell short in a study testing it with other drugs for metastatic prostate tumors.
late stagebiopharma divemerckreportsone
https://www.biopharmadive.com/news/viking-obesity-drug-maintenance-study-results/831004/
Viking shares surge on updated obesity drug data | BioPharma Dive
Trial participants mostly kept their weight down after switching from a weekly shot to less frequent dosing — findings that could strengthen Viking’s...
obesity drugbiopharma divevikingsharessurge
https://www.biopharmadive.com/news/moderna-mflusiva-mrna-flu-vaccine-fda-committee-vote/823275/
Moderna flu vaccine wins unanimous support from FDA panel | BioPharma Dive
The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.
flu vaccinebiopharma divemodernawinsunanimous
https://www.biopharmadive.com/topic/clinical-trials/
Clinical Trial News | BioPharma Dive
The latest clinical trial news for biotech and biopharmaceutical professionals
clinical trialbiopharma divenews
https://www.biopharmadive.com/news/pfizer-duchenne-patient-death-gene-therapy-trial/715450/
Patient dies in Pfizer study of Duchenne gene therapy | BioPharma Dive
Pfizer said the patient, a young boy who was treated earlier last year, died suddenly from cardiac arrest. The company is working with trial researchers to...
gene therapybiopharma divepatientdiespfizer
https://www.biopharmadive.com/news/moderna-canada-vaccine-factory-never-again/604729/
Eyeing future outbreaks, Moderna partners with Canadian government on vaccine plant | BioPharma Dive
While Canada has already secured more COVID-19 vaccine doses than it needs, the factory to be built is geared toward combating future pandemics.
canadian governmentbiopharma diveeyeingfutureoutbreaks
https://www.biopharmadive.com/news/novartis-avidity-acquire-deal-rna-drugs-neuromuscular-disease/803817/
Novartis to acquire Avidity in $12B bet on RNA drugs for neuromuscular disease | BioPharma Dive
The deal, which Novartis expects can “unlock multibillion-dollar opportunities” in the years ahead, hands the company a group of medicines for multiple forms...
bet onneuromuscular diseasebiopharma divenovartisacquire
https://www.biopharmadive.com/news/novartis-ifm-tre-acquires-immune-disease-drugs/710124/
IFM, an unorthodox biotech startup, scores third buyout with Novartis deal | BioPharma Dive
With a decision by the Swiss pharma to acquire another one of its subsidiaries, IFM Therapeutics has now sold three spin-offs for a total of $700 million...
biopharma diveifmunorthodoxbiotechstartup
https://www.biopharmadive.com/news/biogen-tofersen-fda-confirmatory-trial-advisory-committee/645513/
FDA staff signal support for Biogen ALS drug, but highlight data hurdles | BioPharma Dive
In documents released Monday, agency staff appeared inclined to approve Biogen’s tofersen, which failed in its main trial. Gathering confirmatory evidence of...
support forbiopharma divefdastaffsignal
https://www.biopharmadive.com/news/takeda-fda-sleep-drug-approval-orexin-orzeyful-narcolepsy/827190/?ref=techarcade.io
Takeda approval ushers in new wave of sleep drugs | BioPharma Dive
An FDA nod mostly clears the way for Orzeyful to enter, by Wall Street estimates, a multibillion-dollar market for drugs that boost “orexin” proteins.
ushers innew wavesleep drugsbiopharma divetakeda
https://www.biopharmadive.com/news/fda-oks-spinal-cord-injury-stem-cell-trial-for-asterias/303331/
FDA OKs spinal cord injury stem cell trial for Asterias | BioPharma Dive
The experimental treatment will be used on 13 participants in a safety study.
spinal cord injurystem cellbiopharma divefdaoks
https://www.biopharmadive.com/news/advocates-slam-protracted-uk-negotiations-over-novartis-meningitis-b-vaccin/331135/
Advocates slam protracted UK negotiations over Novartis meningitis B vaccine | BioPharma Dive
UK scientists recommended that all infants should be given the vaccine back in March. But negotiations with Novartis didn't start until August—and dozens of...
meningitis bbiopharma diveadvocatesslamprotracted
https://www.biopharmadive.com/spons/pharmas-real-world-data-dilemma-strategic-asset-or-wasted-resource/801982/
Pharma’s real-world data dilemma: Strategic asset or wasted resource? | BioPharma Dive
To maximize RWD’s potential, pharma companies should begin with their business or clinical goals.
real world databiopharma divedilemmastrategicasset
https://www.biopharmadive.com/news/third-rock-ventures-secures-616m-in-new-biotech-fund/429391/
Third Rock Ventures secures $616M in new biotech fund | BioPharma Dive
The Boston-based venture capital firm has had success with previous funds, backing biotechs such as Bluebird Bio, Editas Medicine and Afferent Pharma.
third rock venturesbiopharma divesecuresnewbiotech
https://www.biopharmadive.com/news/ucb-neurona-deal-acquisition-cell-therapy-epilepsy-biotech/817863/
UCB, betting on seizure cell therapy, to buy Neurona for up to $1.2B | BioPharma Dive
The acquisition helps diversify UCB’s small molecule-centric arsenal of seizure treatments with a potentially one-off therapy in early testing for a...
cell therapyto buybiopharma diveucbbetting
https://www.sutrobio.com/tag/sutro-biopharma-announces-virtual-deep-dive-research-forum-next-gen-innovations-in-adcs/
Sutro Biopharma Announces Virtual Deep Dive Research Forum: Next-Gen Innovations in ADCs | Sutro...
sutro biopharmadeep diveresearch forumnext genannounces
https://www.biopharmadive.com/news/intra-cellular-bipolar-depression-drug-study/584926/
Intra-Cellular roars back on success in bipolar depression | BioPharma Dive
Widening the number of eligible patients could make Intra-Cellular's schizophrenia pill a blockbuster, analysts forecast.
roars backbipolar depressionbiopharma diveintracellular
https://www.biopharmadive.com/news/kaleo-auvi-q-payer-pbm/434765/
Payers balk at price of EpiPen rival | BioPharma Dive
Kaleo Pharma set the list price of Auvi-Q at $4,500 — higher than Mylan's EpiPen — even as it promises low costs for patients.
biopharma divepayersbalkpriceepipen
https://www.biopharmadive.com/news/biogen-mergers-acquisitions-alzheimers-immunology-rare-disease/553370/
Biogen points to M&A power as Wall Street presses for less risky programs | BioPharma Dive
Executives suggested Biogen may find external opportunities in the areas of immunology and rare disease, but cautioned that the company was likely to continue...
m awall streetbiopharma divebiogenpoints
https://www.finanznachrichten.de/nachrichten-medien/risknet-8.htm
BioPharma Dive | Nachrichten
Aktuelle BioPharma Dive News: Scribe's Benjamin Oakes on a rare IPO and bringing CRISPR to the masses
biopharma divenachrichten
https://www.biopharmadive.com/news/lilly-cfo-smiley-resigns-ashkenazi/594784/
Lilly CFO steps down after investigation found 'inappropriate' behavior | BioPharma Dive
Josh Smiley had engaged in "consensual though inappropriate" personal communications with certain employees, according to Lilly. He's being replaced by Anat...
steps downinappropriate behaviorbiopharma divelillycfo
https://www.biopharmadive.com/
Biotech and Pharma Industry News | BioPharma Dive
BioPharma Dive provides news and analysis for biotech and biopharmaceutical executives. We cover topics like clinical trials, drug discovery and development,...
pharma industrybiopharma divebiotechnews
https://www.biopharmadive.com/news/oncomed-hit-with-another-mid-stage-failure/440579/
OncoMed hit with another mid-stage failure | BioPharma Dive
The company's shares plummeted further after another Phase 2 trial flopped.
hit withbiopharma diveoncomedanothermid
https://www.biopharmadive.com/news/bridge-bio-oncology-launch-kras-cancer-drug-theras/714885/
BridgeBio spinout launches with $200M for KRAS cancer drugs | BioPharma Dive
The company, BridgeBio Oncology Therapeutics, has one drug in the clinic and hopes to soon advance two other candidates.
cancer drugsbiopharma divebridgebiospinoutlaunches
https://www.biopharmadive.com/news/amgen-pfizer-biosimilar-growth-herceptin-avastin/571502/
Amgen, Pfizer biosimilar sales pressure top drugs | BioPharma Dive
Competition is heating up for copycats to Roche's top-selling cancer drugs, as the U.S. biosimilar market shows some modest signs of shifting.
biopharma diveamgenpfizerbiosimilarsales
https://www.biopharmadive.com/news/sanofi-multiple-sclerosis-btk-inhibitor-troubles/809443/
What Sanofi’s multiple sclerosis troubles could mean for the space | BioPharma Dive
Regulatory and clinical roadblocks have set back its oral BTK inhibitor tolebrutinib, but the drug class still has many opportunities to make an impact.
multiple sclerosisfor thebiopharma divetroublescould
https://www.biopharmadive.com/news/biotech-reverse-mergers-public-markets-ipo/829197/
A booming business on Wall Street would love more biotechs to quietly die | BioPharma Dive
booming businesswall streetlove morebiopharma divewould
https://www.biopharmadive.com/news/tariffs-trump-impact-medical-devices-manufacturing/740040/
How Trump’s trade fight could impact the medical device industry | BioPharma Dive
Relocating manufacturing would require substantial capital investment, but the timespan for the president’s new tariffs is unclear, supply chain experts said.
the medicalbiopharma divetradefightcould
https://www.biopharmadive.com/news/coronavirus-gilead-remdesivir-orphan-drug/574882/
In rare move, Gilead gives up 'orphan' status for experimental coronavirus drug | BioPharma Dive
After sparking controversy, the biotech asked the FDA to rescind a designation designed to encourage research into therapies for rare diseases.
gives uporphan statusbiopharma diveraremove
https://www.biopharmadive.com/news/insulin-makers-targeted-in-pricing-inquiries/441879/
Insulin makers targeted in pricing inquiries | BioPharma Dive
Eli Lilly disclosed it is under investigation by the attorneys general of Washington and New Mexico. Rival Novo Nordisk is under similar scrutiny.
biopharma diveinsulinmakerstargetedpricing
https://www.biopharmadive.com/news/ohio-voters-knock-down-drug-pricing-initiative/510383/
Ohio voters knock down drug pricing initiative | BioPharma Dive
About 80% of voters cast ballots against Issue 2, which would have prevented the state from buying prescription drugs at prices higher than what the Department...
knock downdrug pricingbiopharma diveohiovoters
https://www.biopharmadive.com/news/lipocines-testosterone-drug-rejected-again/523165/
Lipocine's testosterone drug rejected again | BioPharma Dive
The biotech confirmed receipt of an FDA complete response letter, but insisted the issues thwarting approval are not insurmountable.
biopharma divetestosteronedrugrejected