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BioWorld - Friday, September 22, 2023
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  • 3D illustration of cancer in crosshairs

    Dato data lack upside for Gilead; Padcev 'must-win' does win

  • Today's news in brief

  • UK tribunal upholds ruling against Actavis, Allergan, for ‘unfair’ hiked hydrocortisone prices

  • Dato data lack upside for Gilead; Padcev 'must-win' does win

  • Today's news in brief

    BioWorld briefs for Sept. 22, 2023.
  • UK tribunal upholds ruling against Actavis, Allergan, for ‘unfair’ hiked hydrocortisone prices

    The U.K.’s Competition Appeal Tribunal has rejected appeals by drugmakers, including Actavis plc and Allergan Inc., against a ruling by regulators that they hiked the price of a life-saving adrenal insufficiency drug excessively for almost a decade, saddling the companies with fines amounting to nearly £130 million (US$159 million).
  • Wuhan YZY raises $15 million in Hong Kong IPO to advance BsAbs

    Wuhan YZY Biopharma Co. Ltd. made its debut on the Hong Kong Stock Exchange, raising HK$121 million (US$15.48 million) in its IPO on Sept. 22, with shares (HKEX:02496) opening at the lower end of its range at HK$16 per share and ending the day at HK$16.60, a rise of 3.75%.
  • US FDA approvals up 16% over last year

    Approvals from the U.S. FDA are up more than 16% from last year, with 113 drugs approved in the first eight months of 2023. New approvals include two different treatments for relapsed or refractory multiple myeloma, two treatments for ultra-rare diseases and a biosimilar to Biogen Inc.’s Tysabri. In August the FDA greenlighted 13 drugs, approving three NDAs, six BLAs, two supplemental NDAs and two supplemental BLAs.
  • Filspari trips in IgAN phase III; data good enough to Protect against FDA withdrawal?

    Travere Therapeutics Inc.’s narrow phase III miss in the study called Protect with the approved endothelin and angiotensin II receptor antagonist Filspari (sparsentan) in IgA nephropathy (IgAN) had Wall Street speculating about the fate of the compound, which is available for the indication by way of accelerated approval in the U.S., having been given the nod in February.

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Analysis and data insight

  • Illustration of big fish eating three smaller fish

    Lilly closes two $1B+ acquisitions in August as M&As pace similar to last year

    Deals and M&A
    Biopharma deal values through August are down 13.05% year-over-year, while the number of deals has fallen by 18.51% compared to 2022. M&A value, meanwhile, is down just 3.6% from last year. Through August, 2023 saw 885 biopharma deals worth $111.87 billion, compared to 1,086 deals totaling $128.66...
  • Coin stacks, dollar signs and up arrow

    Biopharma financings up from last year with $42.8B raised through August 2023

    Financings
    In August 2023 biopharma companies raised a collective $4.02 billion through 86 transactions, down from the previous seven months’ average of $5.53 billion.
  • Nonprofit stamp

    Biopharmas receive $1.43B in BARDA grants in 2023

    Grant
    Biopharma grants are up nearly 150% compared to the same time period last year, largely due to a number of $100 million-plus grants from the Biomedical Advanced Research and Development Authority (BARDA). Meanwhile, nonprofit deal value has declined year-over-year, with the number of transactions...
  • Syringe and capsules atop lab chart

    Clinical trial data down from 2021 but up 18% from 2019

    Clinical
    The first seven months of 2023 saw clinical trial data up 1.43% compared to the same time period last year. From January through July this year, BioWorld reported on 2,064 drugs in phase I-III, compared to 2,035 in the same time period in 2022. The number of trial updates is down 14.07% from the...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for Sept. 22, 2023

  • Financings for Sept. 22, 2023

  • In the clinic for Sept. 22, 2023

  • Other news to note for Sept. 22, 2023

  • Regulatory actions for Sept. 22, 2023

Deals and M&A

  • Inventiva licenses NASH candidate for Japan, South Korea development

  • Everest licenses Asian rights to Kezar’s autoimmune drug zetomipzomib

  • Merck cuts big AI deals with Benevolentai and Exscientia

  • Peptidream, Genentech ink $1B deal for peptide-radioisotope drug conjugates

  • Insilico nabs $80M up front in cancer drug out-licensing deal with Exelixis

  • Hasten licenses Lib’s PCSK9 inhibitor for China rights in $325M deal

  • Vaccine wizard Moderna taking $1.7B shot in cancer with Immatics

  • Twice as nice: With Alexion, Verge cuts another big AI deal

  • Shape, Otsuka ink $1.5B gene therapy alliance targeting ocular diseases

  • In a cancer development deal with Seagen, Nurix could bring in up to $3.4B

Financings

  • Chinabio 2023: Cansino, Gracell, Immuneonco’s C-suites offer IPO insights in China, US

    Conferences
    Raising capital has always been a challenge for small to medium biotech firms worldwide, but the economic whiplash and the wider downturn across international markets post-pandemic have pushed Chinese biotechs to make-it-or-break-it scenarios for crossing the IPO threshold, speakers at the Chinabio...
  • ADAR on its radar: Airna launches to develop RNA therapeutics

  • Amid hard industry times, Histogen gives up as thinner Kinnate hangs on

  • Pass the (molecular) glue: Magnet school teaches new way with $50M series A

    Cancer
  • Two IPOs launch in a tepid market

    Cancer
More in Financings
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Science

  • Art concept for gene therapy research

    Machine learning tool Alphamissense analyzes human mutations to predict diseases

    Drug design, drug delivery and technologies
    Proteome analysis with artificial intelligence has made it possible to create a catalog of all possible missense mutations in the human genome to predict diseases. The new Alphamissense tool from the technology company Google Deepmind, available online, will allow scientists to refine diagnoses and...
  • Study identifies cause of death for Alzheimer’s neurons

    Neurology/Psychiatric
    By creating a new mouse model of Alzheimer’s disease that better recapitulated how the disease plays out in humans, investigators at KU Leuven have gained new insights into how amyloid plaques, tau tangles and neuronal death are related at the molecular level.
  • Cloning pioneer Ian Wilmut dies at 79

    Scientist Ian Wilmut, who led a team from Scotland’s Roslin Institute and biotech company PPL Therapeutics plc to clone Dolly the Sheep in 1996, died on Sept. 10 at age 79. Dolly was the first mammal cloned from an adult cell taken from the mammary gland of a 6-year-old Finn Dorset sheep and an egg...
  • Methodological, target breadth begets optimism for movement disorder progress

    Conferences
  • Multiple KRAS targeting strategies paving way for combination therapies

    Drug design, drug delivery and technologies
  • Cage fight could make for resistance-resistant antibiotic

    Drug resistance
  • Pan-cancer studies take pan-oramic view on proteogenomics

    Omics
More in Science

Newco news

  • Macrophage releasing cytokines as a part of the body's immune response.

    Not just another cytokine? Simcha looks to rejuvenate IL-18 field with decoy resistance

    Clinical
    Although preclinical studies of genetically engineered interleukin-18 (IL-18) historically indicated its potential in cancer treatment, interest in the cytokine languished after GSK plc shelved its IL-18 therapeutic on lack of responses in a phase II melanoma trial. But in 2020, Yale...
  • Antibody binding to an amyloid beta fibril

    Galimedix targeting misfolded amyloid in retinal disease

    Clinical
    Galimedix Therapeutics Inc. plans to move its lead compound, GAL-101, into a phase IIa proof-of-concept trial next year, in order to test an intriguing hypothesis associated with certain retinal degeneration conditions. GAL-101 selectively binds misfolded amyloid beta species, and the company...
  • Dollar sign inside light bulb

    Precision med startup Actio draws $55M series A investment

    Financings
    “From one to many” is how Actio Biosciences Inc. describes its approach to drug development. The firm emerged with a $55 million series A financing and an eye for biological targets found in both rare and common diseases, starting with TRPV4, a target associated with Charcot-Marie-Tooth disease...
  • mRNA on digital background

    Acuitas tackles mRNA drug delivery challenges with lipid nanoparticles

    Vaccine
    Messenger RNA, or mRNA, represents a relatively new class of therapeutics with the potential to prevent and treat a wide range of diseases. A well-known success story is of the mRNA vaccines that controlled the COVID-19 pandemic, which has fueled enthusiasm for the field. But biotechs are also...
  • Startup key, rocket icon

    Faster than light drug discovery: Superluminal launches with $33M seed round

    Seed
    As its name suggests, Superluminal Medicines Inc. is aiming for speed. The startup, which closed a $33 million seed round led by RA Capital Management, is combining a biology-focused approach with a generative AI platform it says has the potential to create candidate-ready compounds in a matter of...
More in Newco news

Regulatory

  • ITCA-650 beaten down by safety issues at EMDAC hearing

  • Lack of enablement takes down another genus claim

  • US FDA advises sponsors on conducting trials in the face of disasters, PHEs

  • ARS shares dive on CRL for allergy spray Neffy

  • Adcom a make-it-or-break-it hearing for combo diabetes product

  • FDA eyes overhaul of IT system with an emphasis on agency-wide integration

  • US biosimilar labeling distinctions a thing of the past?

  • FDA grants broad label for GSK’s momelotinib in myelofibrosis with anemia

  • Repeat defender: PTC to appeal Translarna case in Europe – again

  • US FTC prepares for more scrutiny of Orange Book patents

U.S.

  • Bipartisan momentum gathering for reforms of US Medicare program

    CMS
    The U.S. Centers for Medicare & Medicaid Services is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.
  • Alnylam posts an adcom win but shares slide

    Regulatory
  • ‘Comfort blanket’ of biosimilar efficacy studies still needed?

    Regulatory
  • US congressional hearing for third-party litigation funding gets contentious

  • MITA sees issues for radiopharmaceuticals in draft Medicare rules

    Imaging
More in U.S.
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Europe

  • EMA icons

    One trial, two regulators, two opinions on Oncopeptides drug

    Regulatory
    Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA...
  • Corteria closes $70.7M series A to advance heart failure candidates

    Financings
    As part of its quest to advance its three first-in-class heart failure drug candidates toward the clinic, Corteria Pharmaceuticals SAS has closed an oversubscribed €65 million (US$70.7 million) series A, co-led by investors Orbimed and Jeito Capital, companies based in the U.S. and Europe,...
  • UK Phosp study finds biomarkers predictive of long COVID cognitive defects

    Clinical
    Blood biomarkers have been found in patients hospitalized with acute COVID-19 that are predictive of the cognitive defects of long COVID. Post COVID-19 deficits in cognition, including brain fog, are common and debilitating. They are also clinically complex, with both objective and subjective...
  • Cochlear and Sensorion combine drug and implant to enhance patient hearing

    Cochlear implant
  • Prizes in place of Rx patents not the cure needed

    Regulatory
  • New UK vaccine center targeting pandemic-potential pathogens

    Regulatory
  • Advanz still on UK hook for excessive Rx price increases

    Regulatory
More in Europe

Clinical

  • Starpharma’s dendrimer platform delivers impressive results in bowel, ovarian cancer

    Cancer
    Starpharma Holdings Ltd.'s nanoscale drug delivery technology shows enhanced safety and durable responses in phase II trials compared to standard of care therapies in patients with advanced colorectal and ovarian cancer.
  • Let there Belite: Alkeus, Kubota help in Stargardt orals genesis

    Ocular
    Iveric Bio Inc.’s regulatory win Aug. 4 drew attention to the already hot eye-disease space, where intriguing new developments include the possibility of an oral therapy for Stargardt disease. Belite Bio Inc. in late July finished enrollment of a...
  • Anthos’ phase II in afib hits primary endpoint and makes an early stop

    Cardiovascular
    Anthos Therapeutics Inc.’s phase II study of abelacimab in treating atrial fibrillation in patients at moderate to high risk of stroke has met its primary endpoint. The data monitoring committee stopped the study early as the fully human...
  • Hanmi unveils new obesity pipeline under new strategy leadership

    Obesity
    Hanmi Science Co. Ltd. is rolling out a new obesity pipeline with five candidates under its relatively new leadership with Lim Ju-hyun, the eldest daughter of Hanmi Pharmaceutical Co. Ltd. founder Lim Sung-ki, who serves as president of Hanmi’s...
  • The more the Mereo as AATD lung space keeping busy

    Gene therapy
    Though data won’t be available for a few years, the disclosure in mid-July that Grifols SA completed enrollment in the phase III study called Sparta caused some ears to perk up in the alpha-1-antitrypsin deficiency (AATD) space, where a number of...
  • Ignition: Rocket Pharma offering and phase II launch the stock

    Financings
    The combination of new U.S. FDA phase II study guidance and a $175 million underwritten public offering sent gene therapy developer Rocket Pharmaceuticals Inc.’s stock soaring on Sept 13. Shares (NASADQ:RCKT) closed 38.8% upward to $21.23 each on...
More in Clinical

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.


Recent episodes:

  • AI: driving drug development from effective to remarkable
  • The struggle is real: The first half of 2023 was an uphill climb
  • The biosimilars challenge to Humira revs up
  • Preventing opioid overdoses with a smart patch
  • Better times ahead for the biopharma sector? Could be, the new numbers say
  • Radiopharmaceuticals: The next big disrupter?
  • Cambrian carves out a new niche as it works to keep people from getting sick
  • Rethinking obesity: Fitness may be more directly linked to health than weight
  • Looking ahead to 2023: CEOs contemplate the new normal
  • $1B+ biopharma deals keep values afloat, even amid muted volume

View all

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