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BioWorld - Monday, December 11, 2023
Breaking News: Topic alerts now available for all BioWorld subscribersBreaking News: Topic alerts now available for all BioWorld subscribersBreaking News: Topic alerts now available for all BioWorld subscribers
  • Samsung-Bioepis lab

    Samsung Bioepis, Intocell partner for ADC drug development

    Samsung Bioepis Co. Ltd. will partner with South Korean biotech Intocell Inc. to develop antibody-drug conjugate (ADC) drugs, continuing the Samsung Group and the wider industry’s hunt for novel ADCs. Under the joint research agreement inked on Dec. 5, the Daejon-based ADC platform technology firm Intocell will supply the Songdo, Incheon-based Samsung Bioepis its linker technology, coined OHPAS, or ortho-hydroxy protected aryl sulfate, upon which Samsung Bioepis will develop ADC drugs for up to five cancer targets.
  • Abbisko out-licenses pimicotinib to Merck KGaA in $605M deal

  • Japan approves first self-amplifying mRNA COVID-19 vaccine from CSL, Arcturus

  • Prism scores up to $660M from Lilly in drug discovery deal

  • Tang Capital’s Concentra offers $465M cash buyout of Lianbio

  • Mesoblast raising AU$97M for registration trials in GVHD, chronic back pain

  • Engeneic dream vector nanocells extend overall survival in end-stage pancreatic cancer

  • News in brief

  • Samsung Bioepis, Intocell partner for ADC drug development

    Samsung Bioepis Co. Ltd. will partner with South Korean biotech Intocell Inc. to develop antibody-drug conjugate (ADC) drugs, continuing the Samsung Group and the wider industry’s hunt for novel ADCs. Under the joint research agreement inked on Dec. 5, the Daejon-based ADC platform technology firm Intocell will supply the Songdo, Incheon-based Samsung Bioepis its linker technology, coined OHPAS, or ortho-hydroxy protected aryl sulfate, upon which Samsung Bioepis will develop ADC drugs for up to five cancer targets.
  • Abbisko out-licenses pimicotinib to Merck KGaA in $605M deal

    Abbisko Therapeutics Co. Ltd. has out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck KGaA in a deal worth up to $605.5 million. Pimicotinib is in phase III trials in patients with tenosynovial giant cell tumors in China, the U.S., Canada and Europe.
  • Japan approves first self-amplifying mRNA COVID-19 vaccine from CSL, Arcturus

    In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology.
  • Prism scores up to $660M from Lilly in drug discovery deal

    Five months since Eli Lilly and Co.’s $2.4 billion buyout of Dice Therapeutics Inc. and its Delscape platform for oral small-molecule inhibitors of protein-protein interactions, Lilly rolled the dice again for novel PPI targets by partnering with Japanese biotech Prism Biolab Co. Ltd.
  • Tang Capital’s Concentra offers $465M cash buyout of Lianbio

    Following its acquisition of Jounce Therapeutics Inc. for $95.6 million, Concentra Biosciences LLC lodged another proposal to acquire the U.S. and China biotech Lianbio Co. Ltd. The unsolicited and non-binding proposal filed Nov. 30 by San Diego-based Tang Capital Partners LP, Concentra’s parent firm, offered a 100% cash equity acquisition of the Shanghai- and Princeton, N.J.-based Lianbio at $4.30 per share, ringing up a deal worth around $465 million.
  • Mesoblast raising AU$97M for registration trials in GVHD, chronic back pain

    Regenerative medicine company Mesoblast Ltd. plans to raise AU$97 million (US$64.5 million) to conduct additional phase III registration trials for its allogeneic stem cell treatment for steroid-refractory acute graft-vs.-host disease and for chronic back pain, as required by the U.S. FDA.
  • Engeneic dream vector nanocells extend overall survival in end-stage pancreatic cancer

    Patients with end-stage pancreatic ductal adenocarcinoma achieved unprecedented survival rates after being treated with the Engeneic dream vector nanocells, with 88% of patients doubling the historical survival rates, Engeneic Ltd. co-CEO Jennifer MacDiarmid told BioWorld.
  • News in brief

    BioWorld Asia briefs for December 5, 2023.
  • Redhill shares climb eightfold on Talicia exclusivity

    Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of Helicobacter pylori infection, which affects about 35% of the U.S. adult population.
  • Biopharma grants see 75% growth YOY, while nonprofit deals decline

    Biopharma grants have sustained the upward trajectory noted in August, ending October up nearly 75% compared to the corresponding period last year. In contrast, nonprofit deal value has continued its year-over-year decline, marked by a more than 90% decrease in value.
  • Topic alerts now available for all BioWorld subscribers

    Are you trying to stay on top of developments in CAR T therapies? Drug resistance? Emerging compounds? Updates from certain regulatory agencies? Want to be the first to learn about new biomarkers or business deals? You can still find these articles in the daily BioWorld e-newsletters or on the website, but if you’re laser-focused on a specific topic, we have a way to highlight the news you need as it happens, whether we’ve published a full-length feature story or a brief update.You asked and we listened. Now, in addition to the daily news lineup, you can create topic alerts to be delivered directly to your inbox or via an RSS reader. It’s easy to set up. Instructions can be found here: https://www.bioworld.com/featured-feeds.

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Analysis and data insight

  • Health professional holding stethoscope with health icons

    Clinical trial updates up nearly 5% through October

    Clinical
    Clinical trial updates for the period of January to October 2023 saw an increase of 4.6% compared to the same time period last year. Comparatively, clinical data from January to September 2023 was up 1.79% compared to the same period last year.
  • Digital handshake

    October 2023 sets new record with biopharma deal value nearing $45B

    Deals and M&A
    October marked a historic milestone for the biopharma industry, with deal values hitting $44.91 billion. It was the highest amount ever recorded by BioWorld, topping a deal value of $42.45 billion in December 2022. While the cumulative value of biopharma deals through Q3 lagged behind the previous...
  • Businesswoman pressing dollar sign on touchscreen

    Biopharma financings reach $11.6B in October, highest month since 2021

    Financings
    In October, the biopharma industry secured $11.6 billion in financings, marking the highest monthly amount since June 2021 when value totaled $12.3 billion. Biopharma financings have averaged $6.1 billion per month so far in 2023, an increase from the $5.07 billion monthly average for all of 2022.
  • Handshake with cityscape and businesspeople

    Q3 boasts solid biopharma mega-deals, more mergers, but 2023 falls behind other years

    Deals and M&A
    While biopharma dealmaking remains active, a strong third quarter (Q3) was not enough to bring it to the same level seen during each of the last three years, although values are coming close. At the same time, M&As appear to be rising above 2022, but even with the increase, they still lag behind...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for Nov. 21, 2023

  • Financings for Dec. 5, 2023

  • In the clinic for Dec. 5, 2023

  • Other news to note for Dec. 5, 2023

  • Regulatory actions for Oct. 31, 2023

Deals and M&A

  • Simcere licenses China rights to Connect’s rademikibart in $120M deal

  • Pyramid returns MSP1 inhibitor to Voronoi, ending $846M deal

  • Fosun, Treehill form joint vehicle to invest in US biotechs

  • Beigene gains global rights to Ensem’s CDK2 inhibitor in $1.3B deal

  • Legend signs $1B T-cell therapy deal with Novartis

  • Genequantum collaborates with Aimedbio to develop ADC for brain tumors

  • Chong Kun Dang scores its ‘largest ever’ $1.3B deal with Novartis for CKD-510

  • Biolinerx shares climb after $270M+ motixafortide deal in Asia with Gloria Bio

  • BMS to acquire Orum’s blood cancer DAC candidate in $100M+ deal

  • Merck pens PARP-1, ADC deal with Hengrui for up to $1.5B

Financings

  • Asep, Sansure establish China sepsis diagnostics joint venture

    Asia-Pacific
    Asep Medical Holdings Inc. is expanding operations into China with a joint venture (JV) with Chinese medical diagnostics firm Sansure Biotech Inc., ramping up the race to commercialize sepsis diagnostics in Asia.
  • Flagship launches new offices in APAC, UK to build biotechs overseas

    Asia-Pacific
  • Ausbiotech 2023: Investors riff about bridging gaps in Aussie biotech ecosystem

    Conferences
  • Israel tops up budget for struggling biotechs amid continuing war challenges

    Middle East North Africa
  • Automera launches with $16M series A funding to tackle protein degradation

    Newco news
More in Financings
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Australia

  • Polyactiva implant next to coin

    Polyactiva’s ocular implant shows sustained drug delivery for glaucoma

    Ophthalmic
    Ophthalmology company Polyactiva Pty Ltd.’s biodegradable ocular implant provides six months of sustained drug delivery for patients with glaucoma and is the first biodegradable ocular implant that has the potential to be used safely for repeat dosing, Polyactiva CEO Vanessa Waddell told BioWorld.
  • Ausbiotech 2023: Big pharma sees promise in building mRNA platform in Australia to serve APAC

    Conferences
    Multinational pharma companies like Moderna Inc. and Sanofi SA are setting up mRNA R&D centers in Australia and are banking on the country’s decades of mRNA expertise to bring new therapeutics to the clinic and to serve as regional hubs in Asia Pacific, speakers said during the Ausbiotech 2023...
  • Ausbiotech 2023: Australia invests in mRNA vaccines as biotech industry celebrates DNA milestones

    Conferences
    Australia has a lot to celebrate when it comes to vaccines. The University of Queensland is where Ian Frazer invented the human papillomavirus vaccine Gardasil, and now Australia is projected to be the first in the word to eliminate cervical cancer, Queensland Deputy Premier Steven Miles said...
  • Chimeric surges on first phase I data for CLTX CAR T in glioblastoma

    Clinical
  • Holy grail? Paradigm’s injectable Zilosul shows disease-modifying attributes in osteoarthritis

    Clinical
  • ESMO 2023: Immutep’s LAG-3 immunotherapy shows 35.5 months overall survival in NSCLC

    Conferences
  • Immunotherapy company Arbele banking on cadherin-17 as target for gastrointestinal cancers

    Newco news
More in Australia

China

  • 3D illustration and light micrograph of lung cancer.

    Innovent on a roll: China accepts two new NDAs for lung cancer

    Cancer
    In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and...
  • Polaris begins rolling BLA for ADI-PEG 20 for pleural mesothelioma

    Clinical
    Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by...
  • Apollomics gets China NMPA nod for lung cancer drug vebreltinib

    Regulatory
    The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
  • Immvira moves intravenous oHSV into phase II for cancer

    Clinical
    Immvira Group Co. plans to progress its intravenous oncolytic herpes simplex virus (oHSV) MVR-T3011-IV to phase II trials after completing a phase I study in the U.S. in patients with late-stage solid tumors. The Shenzhen, China-based company is the first to conduct clinical trials via intravenous...
  • BMS pays $350M up front for rights to Lianbio’s heart drug Camzyos in Asia

    Deals and M&A
    American pharma giant Bristol Myers Squibb Co. (BMS) will pick up the rights to Lianbio Co. Ltd.’s FDA-approved drug for obstructive hypertrophic cardiomyopath, Camzyos (mavacamten), in six Asian countries by paying $350 million up front and waiving some outstanding payments.
More in China

Clinical

  • Otsuka’s sibeprenlimab meets endpoints in phase II IgAN trial

  • Oncolys esophageal cancer drug Telomelysin hits phase II endpoints

  • Vim’s vigor in TGCT verified in phase III as Deciphera ‘pex’ at Daiichi’s heels

  • Lianbio says hit-and-miss for co-primary endpoints in Xdemvy’s China trial

  • Players talking TRK-y in NSCLC as ROS1, ALK zones cook up data

  • Abbisko reports first-in-human data for homegrown FGFR4 inhibitor and PD-L1 inhibitor

  • With positive phase II interim data in NSCLC, Abion to advance MET-TKI to combo trial

  • BioWorld tracks 2,314 phase I-III clinical trial updates from Jan-Aug

  • Bionomics stock charges ahead with positive PTSD data

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

Regulatory

  • Antibody-drug conjugate

    Henlius’ EGFR-targeting ADC receives FDA clearance to enter clinic for solid tumors

    Cancer
    Shanghai Henlius Biotech Inc. has announced IND approval by the FDA for HLX-42 for injection, an antibody-drug conjugate (ADC) developed under a collaboration between Henlius and Medilink Therapeutics.
  • FDA chides Otsuka for making false or misleading claims in Rexulti advertising

    Neurology/psychiatric
  • Takeda wins second FDA approval in two days with Adzynma for rare clotting disorder

    Hematologic
  • US Senate patent reform bill draws mixed reviews

    U.S.
  • FDA approves Takeda’s fruquintinib in colorectal cancer

    Cancer
More in Regulatory
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Newco news

  • Peter Fedichev, CEO and co-founder, Gero

    Longevity AI-biotech Gero raises $6M in series A round for aging research

    Series A
    “Aging is not only slow, but it is irreversible, and that is what most people have been suspecting,” Gero Pte Ltd.’s CEO Peter Fedichev recently told BioWorld. “[But] aging is not an inevitable part of human existence.” By setting limits to what science can do – and not do – for aging, the Palo...
  • Peeling back the mysteries of nature: US-Israeli biotech progresses tree toxin in phase I

    Cancer
    Peel Therapeutics believes evolutionary biology holds the key to developing new therapeutics for cancer and inflammation, a relatively unique approach in the world of biotech, but one that is bearing fruit: Its lead molecule is derived from camptothecin, a compound originating from the Chinese...
  • Angitia advancing musculoskeletal pipeline with $46M series B

    Musculoskeletal
    Angitia Biopharmaceuticals raised $46 million in a series B round extension, bringing the total raised under the series B to $170 million led by Morningside Group and will enable the company to advance its pipeline of musculoskeletal therapies.
  • Dotbio emerges with $5.6M pre-series A to advance multifunctional antibodies

    Cancer
  • China’s Biocity expands to US with pipeline of bispecific antibodies and ADCs

    Cancer
  • Connext to kick off phase I/II trial for ‘high-quality, affordable’ Dupuytren’s contracture drug

    Clinical
  • Viage to advance gut-drug for cognitive impairment to phase II

    Neurology/psychiatric
More in Newco news

Science

  • 1st chimeric monkey born with large embryonic stem cell contribution

    Drug design, drug delivery and technologies
    Investigators at the Chinese Academy of Sciences have generated a chimeric monkey by injecting an embryonic stem cell into the morula, which is an extremely early embryo consisting of 16 to 32 cells. The animal survived for only 10 days, and it is...
  • ESMO 2023: New approaches to old targets, including HER2 and p53

    Conferences
    Some cancers with a poor prognosis have had no new treatments in decades. Advances in the genetic characterization of these tumors now offer a range of possibilities for the development of new therapies that could completely change the quality of...
  • Nobel Prize in Chemistry 2023 goes to quantum dots, which illuminated the path to nanotechnology

    Drug design, drug delivery and technologies
    Quantum dots, a phenomenon in quantum physics that alters the energy of electrons and changes the properties of particles, caught the attention of the Royal Swedish Academy of Sciences (KVA) for the 2023 Nobel Prize in Chemistry.
  • Perseverance on mRNA therapy research wins the 2023 Nobel Prize in Medicine after saving millions of lives

    Drug design, drug delivery and technologies
    Researchers who follow their instincts and achieve slow results while trying to break barriers have little support. They replace it with persistence. This is the story of Katalin Karikó and Drew Weissman. What was once a dream in their minds was...
  • Pan-cancer studies take pan-oramic view on proteogenomics

    Omics
    The vast variety of tumors makes each cancer a world. For researchers, understanding the commonalities and divergences in their molecular underpinnings could help find successful treatments. Scientists from the Clinical Proteomic Tumor Analysis...
  • In Zoonomia project, evolutionary lens hones search for functional genomic variants

    Genetic/congenital
    A base-by-base comparison of the genome sequences of 240 species of mammals has pinpointed sites in the human genome where mutations are likely to cause disease. The sites are all perfectly conserved across the mammalian family tree over 100...
More in Science

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:

  • Six biopharma executives consider a tough 2023 and are hopeful for a better 2024
  • 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

View all

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