Novartis

Novartis

Novartis

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Novartis

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Milano, Lazio, Italy

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Bio-resources and biobanking
  • Cells, tissues and humanized xeno-organs
  • Biosamples
  • Viral, phage or bacterial specimen
Identification of biotherapies
  • Target identification
  • Target validation
  • Screening
Drug design
  • Drug assessment
  • Drug engineering
  • In vitro preclinical studies
Clinical validation
  • Clinical trials
  • In vivo preclinical validation
  • Pre-industrial scale production
Production
  • Upstream processes
  • Downstream processes
  • Quality control
Market access
  • CE mark / market authorisation
  • Payment / Reimbursement
  • Care pathways

Novartis last news

26/01/2024

Pistoia Alliance launches freely available IDMP Ontology 1.0, covering all five standards set by ISO

[...] Ontology will improve substance identification, cross-border prescriptions, regulatory process integration with manufacturers, supply-chain analytics, and pharmacovigilance Boston, US, 24 January 2024. The Pistoia Alliance, a global not-for-profit alliance tha [...]

26/01/2024

Bayer's radiology head plans retirement; Ex-Sanofi chief Olivier Brandicourt joins BeiGene's board

Nelson Ambrogio → Gerd Krueger will retire as head of the radiology business at Bayer 's pharmaceutical division, and Nelson Ambrogio has been named as his replacement. Krueger spent more than 40 years at the German multinational and has been the radiology leader since 2016. Ambrogio earned a promotion to US general manager of oncology in April 2021, when John Berrios was also elevated to US general manager of women's healthcare. Ambrogio's first day in his new position will be April 1. CEO Bill Anderson bluntly described his company's performance as " simply not acceptable " in November, which foreshadowed the substantial organizational changes that Bayer outlined last week. "Our new operating model is designed to make Bayer faster and more innovative. However, its introduction will come at the expense of many managerial employees," Barbara Gansewendt , chair of the Bayer Group Executives' Committee, said in a statement. "This is an extremely bitter development for us, but there is no viable alternative under the current circumstances." Olivier Brandicourt → Ex- Sanofi CEO Olivier Brandicourt has a new gig on the board of directors at BeiGene , succeeding Mossrock Capital president Thomas Malley . Brandicourt has been a senior advisor for Blackstone Life Sciences since 2021 and chairs the board at AvenCell Therapeutics , a CAR-T developer from Blackstone, Cellex Cell Professionals and Intellia Therapeutics . BeiGene's checkpoint inhibitor tislelizumab was approved in Europe last September, but it has struggled mightily to gain any sort of traction with the FDA. Paul Hudson replaced Brandicourt at Sanofi on Sept. 1, 2019. "It feels like a lot longer than four years that we've been on this journey. But we are becoming a new organization," Hudson said at the JP Morgan Healthcare Conference. "It feels very good to be leading Sanofi at this exact moment." Johna Norton → Eli Lilly 's EVP of global quality Johna Norton will retire on July 31. Norton's association with Lilly dates back to 1990, getting her first job as an analytical chemist. She was promoted to her current position after serving as VP, quality for the Indianapolis pharma's API manufacturing network, Puerto Rico manufacturing and product R&D. Long careers are par for the course here; Lilly Diabetes and Obesity president Mike Mason retired after 34 years himself, and Patrik Jonsson — who, like Norton, also started at Lilly in 1990 — succeeded him on Jan. 1. The weight loss race continues to intensify between Lilly and Novo Nordisk , but Dave Ricks ' crew is also placing bets in radiopharma and immunology with the acquisitions of Point Biopharma and DICE Therapeutics , respectively. Jorge DiMartino → Kronos Bio laid off 19% of its employees in November — and three of its top execs are next. Medical chief Jorge DiMartino , CSO Christopher Dinsmore and COO and general counsel Barbara Kosacz will all be out the door by Feb. 16. CEO Norbert Bischofberger will instead have the following on his executive leadership team: Charles Lin (SVP of R&D), Elizabeth Olek (SVP, clinical development), Rocio Martin Hoyos (SVP, corporate strategy and portfolio management) and Allison Frisbee (SVP, corporate operations and legal). "This new leadership structure is designed to streamline our operations and reflects our ongoing effort to advance our pipeline, optimize our resources, and efficiently deliver on our business objectives," Bischofberger said in a statement . Kronos' pipeline has seen some volatility: In November 2022 it stopped work on entospletinib , the acute myeloid leukemia drug Bischofberger brought over from Gilead , when it didn't enroll enough patients for a Phase III study. The next lead program, lanraplenib , didn't make it out of Phase I a year later. The focus now is on CDK9 inhibitor KB-0742 and IRF4 modulator KB-9558 , and the release says there's enough cash to take Kronos "into 2026." Steve Paul → Ex- Karuna Therapeutics CEO Steve Paul has reunited with the folks at Third Rock as venture partner. Paul co-founded such Third Rock biotechs as Sage Therapeutics , Voyager Therapeutics and Rapport Therapeutics , and left Karuna not long after Bristol Myers Squibb shelled out $14 billion for the company. Third Rock is also stacking the roster of venture partners with Tesaro co-founder Mary Lynne Hedley , ex- Beam Therapeutics CBO Courtney Wallace and the promotion of Vyas Ramanan . Meanwhile, the VC has elevated former Constellation Pharmaceuticals president and CEO Jigar Raythatha to partner. Diem Nguyen → Pfizer vet Diem Nguyen is succeeding Phil Gomez as CEO of SIGA Technologies , a central figure in treating the outbreak of mpox in 2022 with its oral antiviral Tpoxx . Endpoints News caught up with Nguyen as she took the CEO job at gene therapy developer Xalud Therapeutics in early 2021. A former employee expressed "major shock" when Xalud announced layoffs last year and moved its ALS program to the front of the queue, but Xalud's website hasn't been updated to reflect the change in direction and there's no leadership page, which makes Peer Review wonder about the state of the company. Nguyen is the ex-global president for the Americas at Pfizer Essential Health and had a two-year run as EVP of biopharma for PPD . Gomez revealed his plans to retire last year. "I wanted to make sure we got SIGA to a place where new skills and new experiences would really help us get to the next level and this seemed like the perfect time," he told Endpoints. Jörg Möller → BenevolentAI has found a permanent CEO after Joanna Shields ' departure last September. Jörg Möller had a 27-year career at Bayer, rising to corporate EVP, head of global R&D in the pharmaceutical division and becoming a board member at BlueRock Therapeutics when Bayer bought the stem cell biotech in 2019. He was named global head of R&D at Leo Pharma in December 2020, but stepped down last June. Three months before his departure, Leo decided to separate its R&D units with Möller as interim development chief and parted ways with research and early development leader Thorsten Thormann . Baroness Shields, who was former UK Prime Minister David Cameron 's technical advisor, left BenevolentAI one day after announcing an AI drug discovery pact with Merck KGaA . BenevolentAI revealed plans to restructure last spring and eliminated 180 jobs . Kaya Pai Panandiker → Neumora Therapeutics continues to make key hires since ex- AbbVie strategy chief Henry Gosebruch took over as CEO last July. ARCH 's "Really Big Neuroscience Company" has welcomed Kaya Pai Panandiker as chief commercial officer, following the appointments of R&D chief Robert Lenz and chief legal officer Jason Duncan . Pai Panandiker led the commercial team at neuro player Cerevel , one of two big M&A prizes for AbbVie in a six-day span toward the end of last year ( ImmunoGen was the other). She spent more than nine years at Lundbeck and was promoted to general manager, neuroscience in 2019. Neumora dressed in layers to brave the IPO wind chill, but the temperature is trying to moderate as we saw with CG Oncology this week. Lisa Olson → Milan-based inflammatory disease specialist Enthera Pharmaceuticals has selected Lisa Olson as CEO. Olson became a member of Enthera's scientific advisory board in 2020 and had been on the board of directors since 2022. The ex- Magenta Therapeutics CSO closed out her 15 years with Abbott and AbbVie as VP, immunology discovery and site head of the AbbVie Bioresearch Center. Sofinnova , along with the venture arms of AbbVie and Roche , contributed to a €35 million raise that Enthera called "the largest VC-backed Series A funding round for an Italian biotechnology company to date." Sanjay Keswani → Alzheimer's-focused ImmunoBrain Checkpoint   has brought in Sanjay Keswani as president and CEO. Keswani also served as chief executive at the now-shuttered Rheos Medicines and as medical chief for Annexon and MiroBio . Earlier in his career, Keswani was SVP of R&D at Roche and VP of exploratory and clinical translational research at Bristol Myers. → Co-founded by Bob Langer and Shaoyi Jiang , WI Therapeutics has named Ed Mascioli as CEO. Mascioli led Pfizer's orphan & genetic diseases unit before a string of CEO roles at Affinium Pharmaceuticals , Karos Pharmaceuticals , Aleta Biotherapeutics and Matrivax . WI raised $10 million for its Series A and its lead candidate for hyperuricemia in severe gout, WI-001 , is still in the preclinical phase. Meanwhile, WI has added Acorda Therapeutics chief Ron Cohen and Apnimed CEO Larry Miller to the board of directors. Graham Goodrich → Apnimed has installed Graham Goodrich as chief commercial officer and Ted Harding as chief human resources officer. Goodrich was in charge of brand marketing strategy for Biohaven 's acute migraine drug Nurtec ODT , and when Pfizer bought Biohaven , he was bumped up to VP of the pharma giant's US migraine franchise. Earlier, Goodrich rose through the ranks at Boehringer Ingelheim from 2008-19, ultimately tackling the role of VP, diabetes marketing. Harding has worked in HR at Alexion (after the Enobia Pharma buyout) and at Jounce Therapeutics , where he was elevated to SVP of human resources during his eight-year tenure. Diana Hausman → Diana Hausman is taking over for Carrie Brownstein as CMO of entalis Pharmaceuticals , which has also enlisted Kyle Rasbach as CBO. Hausman, the ex-medical chief at Link Immunotherapeutics , Lengo Therapeutics and ymeworks , will give up her seat on entalis' board. Rasbach leaps to biotech for the first time after stints at TD Cowen , T. Rowe Price , Pappas Capital and Eventide Asset Management . Brownstein cited personal reasons for her exit. → Chaired by ex- Vertex chief Joshua Boger — who offered pearls of wisdom on a number of topics at one of our #JPM24 panels — Alkeus Pharmaceuticals has appointed Seemi Khan as CMO. Khan had the same role at Reata Pharmaceuticals , the maker of Friedreich's ataxia drug Skyclarys that was acquired by Biogen last year. She also has Big Pharma experience from AbbVie as senior medical director of global R&D. Lauren Wood → Lauren Wood has retired as CMO of PDS Biotech , which has tapped Kirk Shepard as her successor. From 2017-23, Shepard was CMO and SVP, global medical affairs for Eisai 's oncology business group. While Lenvima plus Keytruda has been approved in advanced renal cell carcinoma, Eisai and Merck 's combo has since missed the mark in melanoma and colorectal cancer. PDS is testing its lead asset PDS0101 with Keytruda in recurrent or metastatic HPV16-positive head and neck cancer. James Wentworth → French cancer biotech Transgene has recruited James Wentworth as CBO after finance chief Arnaud Dubarry jumped on board Jan. 1. Wentworth joined Adaptimmune in 2017 as a senior business development analyst and would later be promoted to director, business development and strategy. Transgene's first-year chief executive , Gilead and Novartis oncology vet Alessandro Riva , is the ex-CEO of Ichnos Sciences and Intima Bioscience . → Former Nektar CMO Lorianne Masuoka is taking on the same role at Minneapolis-based DiaMedica Therapeutics . Since her days at Nektar, Masuoka has made several stops as medical chief, including Cubist Pharmaceuticals , Marinus Pharmaceuticals and Epygenix Therapeutics . Enrollment is underway in DiaMedica's ReMEDy 2 trial for acute ischemic stroke. Lauren Budesheim → Rare disease drugmaker Soleno Therapeutics has lined up three new execs, starting with Pfizer and Vertex marketing vet Meredith Manning as chief commercial officer. Manning is the former commercial chief at resTORbio who comes to Soleno from PharmaEssentia , where she was president of the Americas. Dairine Dempsey (VP, Europe) founded orphan drug company Open Orphan and worked for Icon as global VP of strategic regulatory affairs. Finally, Lauren Budesheim (VP of human resources) had a yearlong stay as head of people at Neurona Therapeutics after leading HR at surgical device company Invuity . → Redwood City, CA-based Rezolute has pulled in Daron Evans as CFO. Evans was CEO of AlloRock , Specialty Renal Products and Nephros . He was also finance chief at Nile Therapeutics and managing director of PoC Capital . Samuel Collins → Actio Biosciences has reeled in Samuel Collins as CMO. Collins hops aboard from Edgewise Therapeutics , where he was VP, clinical development. Before that stint, Collins spent several years at Pfizer, culminating in his role as senior director of clinical research. Earlier in his career, Collins had roles at Therachon and Premier Research . Morten Bull → Know Bull: Danish neuro biotech NMD Pharma says Morten Bull has been its general counsel and head of people & business services since Jan. 1. Bull had held a consulting role with NMD since last June and was elevated to executive director and global head of IP and R&D legal at Leo Pharma in late 2020. He also had a brief stint as Bavarian Nordic 's senior legal counsel. → Tris Pharma has rolled out the welcome mat for Franchesca Fowler as chief compliance officer and VP, general counsel. Before her new gig, Fowler was with Demant as head of legal and compliance and global associate general counsel. → Architect Therapeutics president Darcy Mootz has clinched a spot on the board of directors at Elevation Oncology . The former head of Amunix , Mootz was originally the CBO at Angie You 's biotech until it was purchased by Sanofi for more than $1 billion, and the two execs reunited soon after You started Architect. Alvin Shih → Once known as KemPharm , evra Therapeutics has carved out space for Catamaran Bio president and CEO Alvin Shih on the board of directors. Shih has also been CEO of Disarm Therapeutics and Enzyvant . → We've never covered macrophage-based I/O biotech SIRPant Immunotherapeutics — so named because of its emphasis on the SIRPα protein — but there's a first time for everything at Peer Review. Roger Sawhney , the ex-CFO of Garuda Therapeutics and Omega Therapeutics , has made his way to SIRPant's board of directors. → Astraeneca vet Anders Ekblom has joined the board of directors at Dutch chronic pain biotech Synerkine Pharma . Ekblom held a number of roles over 20 years at the pharma giant, replacing John Patterson in 2009 as head of drug development and later becoming CEO of Astraeneca Sweden.

26/01/2024

A meta-analysis and real-world cohort study on the sex-related differences in efficacy and safety of immunotherapy for hepatocellular carcinoma

CONCLUSION: Female phase III trial participants experienced smaller OS benefit following ICI therapy for advanced HCC, while outcomes following A+B treatment were comparable between sexes in a large real-world database. Based on the ambiguous sex-related differences in survival observed here, further investigation of sex-specific clinical and biologic determinants of responsiveness and survival following ICIs are warranted.