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We cover topics like clinical trials, drug discovery and development,... biotech and pharma industry news biopharma dive https://www.biopharmadive.com/news/astellas-kelonia-cell-therapy-in-vivo-partnership/707702/ Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies | BioPharma Dive Kelonia will receive $40 million upfront through the partnership, and could receive $35 million more if Astellas opts into another program. https://www.biopharmadive.com/spons/genai-and-real-world-data-in-pharma-4-questions-to-fuel-effective-insights/753774/ GenAI and real-world data in pharma: 4 questions to fuel effective insights | BioPharma Dive To truly unlock the power of RWD, GenAI must go beyond checking a box or staying on trend. https://www.biopharmadive.com/news/neok-bio-bispecific-adc-biotech-startup-launch-abl/804378/ Neok Bio launches with $75M to make dual-targeting ADCs | BioPharma Dive The startup claims its medicines may be able to overcome the limitations of conventional antibody-drug conjugates by simultaneously homing in on “unique pairs”... to make https://www.biopharmadive.com/news/moderna-funding-h5-pandemic-avian-influenza-vaccine/808289/ Moderna gets funding for H5 pandemic influenza vaccine | BioPharma Dive The fresh capital provides another shot for Moderna's candidate against bird flu, which earlier this year lost its government funding. pandemic influenza moderna gets funding vaccine https://www.biopharmadive.com/news/kennedy-rfk-confirmed-senate-hhs-secretary/739855/ RFK Jr. confirmed by Senate as health secretary | BioPharma Dive All but one Senate Republican voted for Kennedy, a controversial vaccine critic whose embrace of the “Make America Healthy Again” movement helped him win one... rfk jr confirmed senate health secretary https://www.biopharmadive.com/news/alys-pharmaceuticals-medicxi-launch-dermatology-drugs/707220/ Alys launches with $100M and a pipeline of skin disease drugs | BioPharma Dive European venture firm Medicxi built the startup by combining six of its portfolio companies, similar to when it merged 10 startups to form Centessa... https://www.biopharmadive.com/news/valneva-chikungunya-vaccine-Ixchiq-pause-lifted-fda-restrictions-labeling/757080/ FDA lifts pause on Valneva’s chikungunya shot, but adds new limits | BioPharma Dive The FDA had halted use in older adults while it investigated reports of side effects. The vaccine’s label now carries new warnings and restricts vaccination to... https://www.biopharmadive.com/news/moderna-FDA-covid-boosters-deal-pfizer/628463/ US secures updated COVID boosters in $1.7B deal with Moderna | BioPharma Dive Health officials are gearing up for a fall vaccination campaign and aim to deploy shots modified to better match circulating omicron subvariants. https://www.biopharmadive.com/news/researchers-are-about-to-launch-the-largest-aids-treatment-trial-ever/402606/ Researchers are about to launch the largest AIDS treatment trial ever | BioPharma Dive Researchers at UCSF are planning a 100-patient trial that determines whether very early treatment of HIV infection, followed by an interruption, can lead to a... https://www.biopharmadive.com/news/merck-chronic-cough-study-data-questions/584835/ Merck details cough drug data, raising questions about its potential | BioPharma Dive Merck's drug could be the first-ever treatment for chronic cough, a condition that afflicts millions. But side effects and modest efficacy may limit its use. drug data https://www.biopharmadive.com/news/bayer-cell-therapy-manufacturing-plant-parkinsons/696096/ Bayer opens California plant to make cell therapies | BioPharma Dive The pharma plans for the new Berkeley facility to produce clinical, and potentially commercial, supplies of a Parkinson’s disease cell therapy being tested by... to make cell therapies bayer opens california https://www.biopharmadive.com/news/novartis-malaria-GanLum-ganaplacide-study-results/805258/ Novartis, with study success, to seek approval of new kind of malaria drug | BioPharma Dive The treatment — which could be the first novel antimalarial in decades — showed the ability in testing to combat drug resistance and slow disease transmission. https://www.biopharmadive.com/news/sanofi-vaccine-sales-third-quarter-earnings-2025/803710/ Sanofi says ‘soft’ start to fall immunizations slowed vaccine sales | BioPharma Dive The French pharma’s overall vaccine sales declined 8% in the quarter, with a key driver being slower-than-usual uptake of flu shots in the U.S. https://www.biopharmadive.com/news/novartis-tourmaline-acquire-deal-il-6-pacibekitug/759599/ Novartis to gain heart drug in $1.4B deal for Tourmaline Bio | BioPharma Dive Tourmaline recently unveiled mid-stage trial data for its anti-inflammatory drug, which is ready for Novartis to advance into Phase 3 testing for heart disease. https://www.biopharmadive.com/news/century-therapeutics-leadership-restructure-ceo-cell-therapy/647433/ Century Therapeutics changes leadership as CEO steps down | BioPharma Dive The resignation of top executive Lalo Flores comes three months after a restructuring, marking the latest change of direction for the once high-flying cell... century therapeutics changes leadership ceo https://www.biopharmadive.com/news/5-fda-approval-decisions-first-quarter-2023/639507/ 5 FDA decisions to watch in the first quarter | BioPharma Dive An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the agency’s... to watch in the first quarter fda decisions https://www.biopharmadive.com/news/eli-lilly-seamless-deal-gene-editing-hearing-loss/810694/ Lilly bets on Seamless, delving further into genetic medicine for hearing loss | BioPharma Dive The potentially $1 billion alliance centered around a flexible gene editing technology adds to a portfolio of cutting-edge treatments the company is developing... https://www.biopharmadive.com/news/hillevax-norovirus-vaccine-negative-study-infants/720685/ HilleVax’s norovirus vaccine ineffective in large trial of infants | BioPharma Dive Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study. norovirus vaccine ineffective https://www.biopharmadive.com/news/fda-expedited-pathway-takeda-denali-stipple-syneron/816670/ FDA floats new clinical trial reforms; Takeda punts Denali brain drug | BioPharma Dive In its budget request, the agency proposed a way to speed up early drug testing and help smaller biotech firms. Elsewhere, two startups raised megarounds. new clinical trial https://www.biopharmadive.com/news/coherus-biosciences-divest-biosimilar-Udenyca-Intas-pharmaceuticals/734431/ Coherus, sharpening immuno-oncology focus, sells another biosimilar for over $500M | BioPharma Dive The company reached a deal to divest its third biosimilar this year, selling a copycat version of Amgen’s Neulasta for up to $558 million. https://www.biopharmadive.com/news/moderna-rsv-vaccine-efficacy-pfizer-gsk/640563/ Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK | BioPharma Dive The biotech’s results appear competitive to past data for RSV shots being developed by GSK and Pfizer. Moderna plans to follow those companies in asking for... rsv vaccine moderna reports positive https://www.biopharmadive.com/news/fda-covid-vaccine-advisers-strain-recommend-jn1/748854/ FDA panel recommends keeping COVID shots targeted to same strain as last year | BioPharma Dive The advisory committee, which met after the agency rolled out new vaccine guidelines, said companies should tailor their booster doses to the “JN.1”... https://www.biopharmadive.com/news/sanofi-gyroscope-gene-therapy-eye/609654/ Eye-focused gene therapy startup gets $60M cash infusion from Sanofi | BioPharma Dive Shortly after postponing a $135 million IPO, Gyroscope has found another way to back a treatment for a disease that's become a top target of multiple... https://www.biopharmadive.com/news/sage-therapeutics-acquired-supernus-deal-zurzuvae/750790/ Sage, following setbacks, to sell to Supernus for $561M | BioPharma Dive In what one analyst described as an “unremarkable” outcome, the brain drug developer is being acquired for just $8.50 per share, plus non-guaranteed additional... to sell sage following setbacks biopharma https://www.biopharmadive.com/news/valneva-chikungunya-vaccine-Ixchiq-pause-fda-cdc-ema/747745/ FDA follows EMA in limiting use of Valneva shot | BioPharma Dive Reports of severe adverse events in some people who received the chikungunya vaccine have spurred regulators in Europe and now the U.S. to suspend use in older... fda follows ema limiting https://www.biopharmadive.com/news/hhs-vaccine-safety-task-force-kennedy-children/757801/ HHS revives defunct task force on childhood vaccine safety | BioPharma Dive The panel’s reinstatement is one of a series of controversial moves made by Robert F. Kennedy Jr. to put vaccines under new scrutiny. task force vaccine safety hhs defunct https://www.biopharmadive.com/press-release/recover-edit-link/ Manage press releases | BioPharma Dive manage press releases biopharma dive https://www.biopharmadive.com/news/cdc-acip-meeting-rescheduled-vaccines-measles/743189/ Delayed CDC meeting on vaccines is rescheduled to April | BioPharma Dive A panel of CDC advisers, who had been set to meet in February, will discuss the current measles outbreak as well as guidelines for several types of shots. delayed cdc meeting vaccines https://www.medtechdive.com/news/baxter-Q3-biopharma-solutions-sale-business-revamp/698621/ Baxter completes biopharma solutions sale, business unit revamp | MedTech Dive The company plans to use most of the $3.7 billion in after-tax proceeds from the biopharma solutions sale to repay debt. biopharma solutions business unit baxter completes sale https://www.biopharmadive.com/news/pfizer-hemophilia-b-gene-therapy-fda-review/653990/ Pfizer’s hemophilia B gene therapy inches closer to regulatory approval | BioPharma Dive The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years. hemophilia b gene therapy https://www.biopharmadive.com/news/moderna-fda-influenza-mrna-refuse-to-file/811909/ FDA refuses to review Moderna’s mRNA flu vaccine | BioPharma Dive Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the... to review flu vaccine fda refuses mrna https://www.biopharmadive.com/news/fda-makena-withdrawal-preterm-birth-drug-covis/644418/ Controversial drug for preterm birth to be withdrawn, maker says | BioPharma Dive Mar 8, 2023 - The decision by Covis Pharma closes a yearslong battle over continued use of Makena, the only treatment available for prevention of early labor. preterm birth to be https://www.biopharmadive.com/news/mifepristone-abortion-access-appeals-court-ruling/647582/ Appeals court rules abortion drug can stay on market — but limits access | BioPharma Dive Apr 13, 2023 - The Department of Justice appealed the order on Thursday, moving the fight over access to mifepristone to the Supreme Court. https://www.biopharmadive.com/news/vir-biotechnology-restructure-layoffs/702513/ Vir to lay off staff, cut costs amid setbacks building on COVID success | BioPharma Dive https://www.biopharmadive.com/news/cidara-stock-soars-as-antiviral-drug-succeeds-in-flu-study/751286/ Cidara stock soars as antiviral drug succeeds in flu study | BioPharma Dive Company shares doubled on Phase 2 study results suggesting its drug could become an alternative to vaccines for flu prevention. antiviral drug https://www.biopharmadive.com/news/johnson-johnson-spravato-depression-monotherapy-application/721959/ J&J seeks expanded approval for antidepressant Spravato | BioPharma Dive The company is seeking a monotherapy approval for Spravato, sales of which have climbed in recent quarters. j seeks expanded approval antidepressant https://www.biopharmadive.com/news/bayer-amgen-back-recodes-plan-to-broaden-genetic-medicines-reach/626289/ Bayer, Amgen back ReCode's plan to broaden genetic medicine's reach | BioPharma Dive The two drugmakers joined a long list of investors, including Pfizer and Sanofi, that have been funding the startup’s plan to develop a new type of lipid... https://www.biopharmadive.com/news/pfizer-prevnar20-pneumococcal-vaccine-children-study/629613/ Pfizer’s new pneumococcal vaccine meets study goal in children | BioPharma Dive Pfizer, which competes with Merck in this market, plans to ask the FDA for an expanded approval of its 20-valent shot later this year. pneumococcal vaccine new meets https://www.biopharmadive.com/news/latus-huntington-gene-therapy-cln2-biotech-startup/819174/ With $97M, Latus pursues a different kind of Huntington’s gene therapy | BioPharma Dive The therapy is part of a plan to develop gene therapies that can be efficiently delivered at lower doses, enabling them to be used against more than just... https://www.biopharmadive.com/news/gsk-fda-advisers-rsv-vaccine-pfizer/644011/ GSK’s RSV vaccine wins FDA panel backing, matching Pfizer | BioPharma Dive Committee members appeared more confident in their recommendation of GSK's shot, with fewer dissents in separate votes on its safety and effectiveness. rsv vaccine fda panel wins https://www.biopharmadive.com/news/pfizer-merck-launch-large-new-trials-of-oral-covid-19-drugs/605939/ Pfizer, Merck launch large new trials of oral COVID-19 drugs | BioPharma Dive Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year. https://www.biopharmadive.com/news/sanofis-tolebrutinib-cenrifki-ms-europe-recommend-approval/818414/ Sanofi MS drug rejected in US gets an endorsement in Europe | BioPharma Dive Tolebrutinib, which the FDA recently turned back due to safety concerns, received a positive recommendation that positions the therapy for its first regulatory... in us https://www.biopharmadive.com/news/Eli-lilly-indiana-abortion-law-new-jobs/629109/ Lilly criticizes Indiana abortion law, indicating it may look elsewhere to hire | BioPharma Dive After Indiana’s governor signed a near-total abortion ban into law, the drugmaker said it will rethink future hiring in the state. https://www.biopharmadive.com/press-release/purchase-packages/ Purchase a press release package | BioPharma Dive a press release purchase package biopharma dive https://www.biopharmadive.com/news/moderna-rsv-fda-vaccine-decision-delay/715761/ FDA delays decision on Moderna RSV vaccine | BioPharma Dive The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said. rsv vaccine fda delays decision moderna https://www.biopharmadive.com/news/ocean-spac-deal-biotech-IPO/630939/ Biotech startup Ocean pivots from IPO to SPAC merger | BioPharma Dive The blank-check deal gives Ocean another route to public markets after it struggled to price an initial public offering it revealed back in June 2021. spac merger biotech startup ocean pivots https://www.biopharmadive.com/news/avalyn-biotech-ipo-price-pulmonary-fibrosis-esbriet-ofev/818851/ Avalyn, in pursuit of better lung drugs, banks $300M in an IPO | BioPharma Dive The biotech will use the proceeds to develop inhalable versions of therapies already on the market for the “idiopathic” and “progressive” forms of pulmonary... in pursuit of https://www.biopharmadive.com/news/novo-nordisk-wegovy-pill-sales-prescriptions-q1-2026/819418/ Novo hikes guidance on Wegovy pill’s fast sales start | BioPharma Dive In its latest earnings report, the Danish drugmaker said sales and profit should shrink less than the company originally anticipated thanks to strong... novo hikes guidance wegovy https://www.biopharmadive.com/news/merck-clesrovimab-rsv-antibody-pdufa-data-fda/735763/ Merck targets 2025 RSV season with antibody now under FDA review | BioPharma Dive An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus. https://www.biopharmadive.com/news/arsenal-bio-series-b-cell-therapy-bristol-myers/631328/ Backed by Bristol Myers, ArsenalBio raises $220M for its cell therapy research | BioPharma Dive The biotech’s Series B fundraising equips it with new cash just as it prepares to advance its first drug candidate into clinical testing. https://www.biopharmadive.com/news/cdc-panel-johnson-johnson-vaccine-limits-prefer-mrna/611679/ J&J's coronavirus vaccine faces new US limits | BioPharma Dive j s coronavirus vaccine faces new limits https://www.biopharmadive.com/news/survodutide-obesity-drug-results-boehringer-ingelheim-zealand/818664/ Boehringer dual-acting obesity shot hits mark in Phase 3 trial | BioPharma Dive Survodutide spurred weight loss Wall Street analysts referred to as “Wegovy-like,” and showed signs it might help preserve muscle mass as well. https://www.biopharmadive.com/news/vaxcyte-shares-soar-early-stage-readout-pneumococcal-vaccine/725888/ Vaxcyte’s “best-case” data for pneumococcal vaccine boost shares | BioPharma Dive The company's value jumped by several billion dollars as trial results showed its experimental shot could match and, in some cases, even outperform Pfizer's... pneumococcal vaccine data https://www.biopharmadive.com/news/pfizer-seeks-full-fda-approval-of-paxlovid-as-questions-about-its-benefits/626437/ Pfizer seeks full FDA approval of Paxlovid as questions about its benefits grow | BioPharma Dive A standard clearance could further broaden Paxlovid’s fast-rising use. But weaknesses are emerging too, among them unclear benefits in vaccinated people and a... https://www.biopharmadive.com/news/novartis-pluvicto-supply-millburn-factory-fda/648384/ Novartis plant cleared to produce in-demand cancer drug | BioPharma Dive The FDA has approved the pharma, which has had difficulty producing radiopharmaceutical drugs, to make its treatment Pluvicto at a New Jersey site. in demand cancer drug novartis plant cleared https://www.biopharmadive.com/news/vinay-prasad-fda-moderna-covid-vaccine-review-children/753183/ Moderna’s latest approval again reveals FDA rift over COVID vaccines | BioPharma Dive Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in young children. https://www.biopharmadive.com/news/bayer-layoffs-1500-bureaucracy-restructuring-bill-anderson/716011/ Bayer details layoffs as company shake-up continues | BioPharma Dive The reduction of 1,500 roles in the first quarter is part of CEO Bill Anderson’s plan to shrink Bayer’s bureaucracy and “radically realign” its culture. as company bayer details layoffs shake https://www.biopharmadive.com/news/kelun-merck-adc-trop2-first-line-treatment-lung-cancer/806409/ Kelun, Merck tout ADC as potential first-line treatment in lung cancer | BioPharma Dive The partners said a TROP2-targeting antibody drug conjugate succeeded in a late-stage trial, paving the way for potential approval in the first-line setting. https://www.biopharmadive.com/news/novartis-morphosys-germany-us-layoffs-pelabresib/736036/ Novartis shutters MorphoSys sites, lays off staff | BioPharma Dive While the pharma is still developing a MorphoSys drug acquired in its $2.9 billion deal for the biotech, it is closing down sites in the U.S. and Germany. novartis shutters sites lays staff https://www.biopharmadive.com/news/gsks-antibiotic-gonorrhea-study-results-gepotidacin/708471/ GSK drug meets goal in late-stage gonorrhea study | BioPharma Dive The drug, one of several GSK is developing for drug-resistant bacteria, has now succeeded in testing against two different infections. late stage gsk drug meets goal https://www.biopharmadive.com/news/zola-therapeutics-art-krieg-biotech-startup-cancer-immunotherapy/711331/ Biotech veteran Art Krieg postpones retirement to build an unorthodox drug startup | BioPharma Dive With Zola Therapeutics, Krieg plans to design and sell a series of cancer immunotherapies without the help of outside investors, he told BioPharma Dive. https://www.biopharmadive.com/news/takeda-exit-cell-therapy-research/761629/ Takeda, in reversal, abandons cell therapy research | BioPharma Dive The Japanese pharmaceutical company, which had made cell therapy a priority a few years ago, aims to partner its work while prioritizing investments elsewhere. cell therapy research takeda reversal abandons biopharma https://www.biopharmadive.com/news/rfk-kennedy-cassidy-senate-vote-support-vaccine-commitments/739220/ RFK Jr. secured support of key Republican with vaccine pledges | BioPharma Dive Sen. Bill Cassidy, whose “yes” vote advanced Kennedy’s nomination as health secretary, said Kennedy promised to maintain ACIP without change. rfk jr https://www.biopharmadive.com/topic/biotech/?page=2 Biotech News | BioPharma Dive The latest biotech news for biopharmaceutical professionals biotech news biopharma dive https://www.biopharmadive.com/news/fda-hormone-therapy-menopause-black-box-makary-panel/753365/ Panel urges FDA to remove warnings on hormonal menopause therapy | BioPharma Dive A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for hot flashes. https://www.biopharmadive.com/news/celcuity-gedatolisib-breast-cancer-PIK3CA-asco-2026/819173/ Celcuity strengthens case for ASCO-spotlighted breast cancer drug | BioPharma Dive The new data could support a broader approval submission for a therapy that is already under review and set to be showcased at the year’s biggest meeting for... breast cancer case asco https://www.biopharmadive.com/news/rain-oncology-concentra-bid-tang-capital/696649/ Concentra makes bid for struggling biotech Rain | BioPharma Dive The takeout offer, from Concentra owner Tang Capital, comes after a difficult year for Rain, which has cut back its spending and trimmed staff. bid for concentra makes struggling biotech https://www.biopharmadive.com/news/fda-removes-box-warning-six-menopausal-therapies-hrt/812146/ FDA removes box warnings for 6 menopausal therapies | BioPharma Dive The FDA has lifted longstanding and the most severe warnings off of hormone replacement therapies for menopausal women. fda removes box warnings therapies https://www.biopharmadive.com/news/bristol-myers-deucravacitinib-lupus-tky2-trial/624696/ Bristol Myers' autoimmune drug shows potential in lupus | BioPharma Dive Positive Phase 2 results could help boost company executives' arguments that the drug, called deucravacitinib and under FDA review in psoriasis, will become a... bristol myers autoimmune drug shows https://www.biopharmadive.com/editors/jgardner/ Jonathan Gardner | BioPharma Dive jonathan gardner biopharma dive https://www.biopharmadive.com/submit-tip/ Submit A Tip | BioPharma Dive submit a tip biopharma dive https://www.biopharmadive.com/news/pfizer-biontech-mrna-shingles-vaccine-trial/642493/ Pfizer begins plan to challenge Shingrix with an mRNA vaccine | BioPharma Dive The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by... https://www.biopharmadive.com/news/nash-drugs-payer-pushback-price-diet-exercise/554245/ On the path to patients, NASH drugs may hit a payer roadblock | BioPharma Dive Wall Street estimates and clinical data suggest the earliest NASH drugs could come with limited efficacy but high price tags. Healthcare providers fear that... on the path https://www.biopharmadive.com/press-release/20260429-sapio-sciences-brings-claude-cowork-to-the-lab/ Sapio Sciences brings Claude Cowork to the lab | BioPharma Dive to the lab sapio sciences claude cowork brings biopharma https://www.biopharmadive.com/news/gsk-depemokimab-chronic-rhinosinusitis-nasal-polyps/729728/ GSK says antibody drug succeeds in testing for chronic nasal condition | BioPharma Dive The company has set high expectations for depemokimab, which it is also advancing in three other inflammatory diseases, including asthma. https://www.biopharmadive.com/news/bain-beeline-immune-drugs-bristol-myers/817538/ Beeline, a Bain-backed biotech, debuts with immune drugs from Bristol Myers | BioPharma Dive Equipped with $300 million, Beeline has an oral medicine for the treatment of lupus as well as other experimental drugs targeting autoimmune diseases.