Fabio De Martino

From an accelerated approval, Bristol Myers Squibb's KRAS-inh #KRAZATI obtains the nod for colorectal cancer (with Eli Lilly and Company's Erbitux (cetuximab)) https://lnkd.in/eRFiV9Fw "GlobalData recently predicted that the market for KRAS-targeting drugs in oncology could reach $4 billion by 2029, with Lumakras and Krazati accounting for around $1.4 billion of that total. Morningstar analyst Damien Conover said after the CRC approval that Krazati could become a $1 billion product, justifying BMS’ takeover of Mirati" 📈 As a #strategic milestone and growth potential standpoint, the treatment is only one of two on the market, representing a significant advancement in the treatment of this disease, particularly for patients with a specific genetic mutation. #BMS #Krazati #KRASinhibitors #CRC #Oncology #ColorectalCancer #RegulatoryAffairs #Pharma #Healthcare

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...on strategic collaborations...an announcement from Sanofi and Belharra Therapeutics: 🔬 The union will leverage Belharra’s proprietary non-covalent chemoproteomics platform to "screen and validate hits against undisclosed Sanofi-designated immunology targets". ⏩ "In the company's earnings call in April, Sanofi's head of R&D Houman Ashrafian told analysts: “Our #strategy is one of selectively investing in areas where we believe we have a chance to make a meaningful difference based on our expertise in immunology." " #Strategy #Sanofi #BelharraTherapeutics #Biotech #Biopharma #Immunology #Alliances #Pharma #Healthcare

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Great news that Gilead’s PURPOSE 1 trial has demonstrated 100% efficacy of Lenacapavir, a twice-yearly injectable, in preventing new HIV infections among cisgender women and adolescent girls. These results are especially significant given adolescent girls and young women are particularly vulnerable to HIV. Gilead expects results in late 2024/early 2025 from the program’s other pivotal trial which is assessing twice-yearly Lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States - groups who are underrepresented in HIV prevention trials and are disproportionately affected by the HIV epidemic. https://lnkd.in/e7s-d6f4

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Sanofi pulls off phase 3 LUNA landing, sparking race to regulators for BTK inhibitor Sanofi’s $3.7 billion Principia Biopharma buyout has delivered a phase 3 victory. The BTK inhibitor moved the needle in a clotting disorder, clearing Sanofi to file for approval of a “multi-indication blockbuster” that it predicts (PDF) could contribute to more than 10 billion euros ($11 billion) of drug launch sales.  The candidate, rilzabrutinib, is an oral, reversible BTK inhibitor that was already in phase 3 when Sanofi bought Principia. Researchers designed the candidate to have a lower risk of off-target effects and to be active at lower levels of systemic exposure than other BTK inhibitors, attributes that could support use outside of the B-cell mediated diseases typically targeted by the drug class.  Rilzabrutinib suffered a setback in 2021, when it flunked a phase 3 pemphigus trial, and missed the mark in a phase 2 atopic dermatitis trial last year. Yet, successes elsewhere have encouraged Sanofi to gear up for phase 3 trials in other indications as it enters a crucial run of readouts from rilzabrutinib studies. The first readout was positive, with Sanofi reporting the LUNA 3 trial hit the primary endpoint of durable platelet response in adults with persistent or chronic immune thrombocytopenia (ITP). Sanofi linked rilzabrutinib to a higher rate of durable platelet response than placebo. https://lnkd.in/e9_4VFXc

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Boehringer Ingelheim Partners With GoodRx to Offer #Humira Biosimilar at 92% Discount - BioSpace In a bid to take advantage of Humira’s slow loss of market share, Boehringer Ingelheim is offering its biosimilar at a 92% discount exclusively to patients who buy the product on GoodRx. Boehringer Ingelheim on Thursday announced that it has launched a patient affordability initiative in partnership with prescription savings platform GoodRx to offer its Humira (adalimumab) biosimilar, Adalimumab-adbm, at a steep discount relative to the branded reference product. Both the high- and low-concentration formulations of Adalimumab-adbm—available either as a pre-filled syringe or an autoinjector—will go for $550 per two-pack on GoodRx, representing a 92% discount from Humira’s list cost. This price is only available through GoodRx. “Patients with certain chronic inflammatory diseases who do not have insurance or are underinsured may not be able to afford essential biologic medicines, including biosimilars, to treat their disease,” Chris Marsh, senior vice president of Value and Access at Boehringer Ingelheim, said in a statement. The GoodRx partnership is a “significant step in addressing access and affordability” of medications “in one of the largest therapeutic categories with a high cost burden for patients,” according to the pharma’s announcement. The exclusive GoodRx pricing took effect Thursday. First approved by the FDA in October 2017 for multiple chronic inflammatory diseases, Adalimumab-adbm is also sold under the brand name Cyltezo. It carries the FDA’s interchangeability designation, meaning it can be used in place of the reference product without needing to change a patient’s prescription. In May 2024, the FDA signed off on a high-concentration and citrate-free version of Cyltezo, which could make injections less frequent and less painful. Boehringer Ingelheim is also offering an unbranded version of Cyltezo at an 81% discount relative to Humira’s price. https://lnkd.in/e_-KmNgh

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It's been a turbulent few years for the life-sciences industry. I don't know many who haven't survived or been personally impacted by a layoff. If you've survived a layoff, take a look Angela Justice, PhD's webinar to regain control. It is sure to be insightful and give practical guidance for those who might be experiencing 'Survivor Syndrome'. Link below to register.

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Roche Sees Early ROI on $2.7B Carmot Buy with Phase I Data for Obesity Candidate Roche subsidiary Genentech on Thursday unveiled Phase Ib data for its investigational weight-loss treatment CT-388, demonstrating that a once-weekly subcutaneous shot could significantly lower body weight in healthy adults with obesity. At 24 weeks of follow-up, CT-388 lowered body weight by 18.8% versus placebo. The effect was statistically significant, with a p-value less than 0.001, according to Genentech’s announcement. In addition, 100% of treated patients showed more than 5% weight loss at 24 weeks, while 45% of participants lost more than 20% of their body weight. A subgroup analysis also showed that all pre-diabetic participants at the start of the study achieved normal blood glucose levels after 24 weeks of treatment, while those in the placebo group saw no meaningful change in glycemic status. In terms of safety, CT-388 was well-tolerated in the Phase Ib study with most of its side effects classified as mild to moderate in severity. There were also no unexpected safety signals and CT-388’s adverse event profile was consistent with other medications https://lnkd.in/e22qU9mG

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BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM

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FibroGen, Inc.'s new CMO, Deyaa Adib, MD isn't fazed by the competition in prostate cancer. Their FG-3246 boasts an impressive 8.7 months PFS in Phase 1, and they're calling out others to show their data! Here's the challenge: PSA isn't the only measure that matters, PFS is key. They believe FG-3246 stacks up well against competitors, even Novartis' Pluvicto. Intrigued? Different companies report data differently, making comparisons tricky. Stay tuned as more info emerges, but FibroGen seems confident they're in the fight! #ProstateCancer #ClinicalTrials #ADC #FibroGen FibroGen throws down the prostate cancer gauntlet | ApexOnco - Clinical Trials news and analysis (oncologypipeline.com)

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Last month, USA TODAY profiled a few companies that stood out as Lighthouse examples in the space of sustainability leadership. As part of the issue, I was able to share my insights on the topic, and talk about our overall belief system at Gilead Sciences, which continues to view sustainability leadership as central to our enterprise ambitions. While I briefly touched on the strides we are making towards achieving our climate-science goals, the interview delved deeper into the critical aspect of nurturing a culture where everyone feels integral to our sustainability endeavors. At Gilead Sciences, this ethos starts with our corporate strategy - growing responsibly isn't just a part of of the strategy, it's ingrained in our company culture and embraced by each member of our organization. Together, we're not just striving for sustainability, but building a future where it's integral to everything we do. #SustainabilityLeadership #OperationalExcellence #CorporateCulture

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Great leaders bring in great leaders. People who enrich your work life and beyond. I’ve been lucky to have leaders who have done just that over the last 3-5 years and have benefitted from colleagues and peers who are clearly smarter and more skilled than me. It got me thinking - who are those leaders you would take with you. Make sure you let them know they’re valued, that they are the key to achieving the wider goals. These are the people that will drive your learning and will undoubtedly help you grow. These rare people are the people who will continue to teach you, develop your leadership and point out your areas for improvement. They make you who you will become.

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Congratulations to Bristol Myers Squibb, BMS’ Augtyro Wins FDA Accelerated Approval for NTRK-Positive Solid Tumors Bristol Myers Squibb on Thursday announced that its tyrosine kinase inhibitor Augtyro (repotrectinib) was granted accelerated approval by the FDA for the treatment of NTRK-positive, locally advanced or metastatic solid tumors. Under the new indication, Augtyro can be used in patients aged 12 years and older whose disease has progressed after initial treatment. Augtyro can also be used in patients with no satisfactory alternative therapies or in those who are likely to suffer from “severe morbidity” due to surgical resection, according to the company. Under the FDA’s accelerated pathway and to keep Augtyro’s approval, BMS will need to run a confirmatory study to validate the clinical benefit of the drug in this indication and patient population. Nick Botwood, senior vice president of medical oncology at BMS, in a statement called Augtyro’s approval a “milestone” that “helps address this area of unmet need” and underscores the drug’s “clinical value for more people across multiple genetic markers.” “Previously, there was not an FDA-approved treatment option for NTRK-positive cancers that was studied in both TKI-naïve and TKI-pretreated patients across solid tumors,” Botwood said, noting that Augtyro can now provide these patients with an effective treatment option. The FDA’s approval of Augtyro is backed by data from the Phase I/II TRIDENT-1 trial, which enrolled patients who had been exposed to prior TKI treatment and those who were naïve to this drug class. A total of 15 different types of cancer were represented in the study. https://lnkd.in/e8eKHHvp

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🚀 Biotech Q3 Scorecard: 19 Stock-Moving Events to Watch! 📊 Exciting times ahead in the biotech world! Here are key developments to keep on your radar: Alnylam Pharmaceuticals vutrisiran vs BridgeBio acoramidis for ATTR-CM: ESC presentation in August Novo Nordisk's monlunabant for obesity: Phase 2 results (watch Skye Bioscience Inc. and Corbus, LLC too!) Viridian Therapeutics, Inc.'s VRDN-001 for thyroid eye disease: Phase 3 readout in September Sage Therapeutics' Sage-324 for essential tremor: Mid-stage study results Apellis Pharmaceuticals' Empaveli for kidney diseases: Phase 3 VALIANT study results early Q3 Eli Lilly and Company's bimagrumab for obesity: Phase 2 results mid-year UCB and Biogen's dapirolizumab for lupus: Phase 3 results Neurocrine Biosciences's NBI-1117568 for schizophrenia: Phase 2 results Elevation Oncology's EO-3021 for gastric/pancreatic cancers: Data update Plus: • AstraZeneca's Imfinzi FDA panel (July 25) • Potential approvals for Alzheimer's drugs: Eisai US/Biogen's Leqembi (EU) • Multiple FDA decisions including Gilead Sciences, Regeneron, Syndax Pharmaceuticals, Roche, and Bristol Myers Squibb 🔬 The biotech sector is buzzing with potential breakthroughs. Which company or development are you most excited about? Share your thoughts below! 👇 #Biotech #PharmaTrends #ClinicalTrials #DrugDevelopment

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Bristol Myers Squibb and Cellares Announce a $380M Worldwide Capacity Reservation and Supply Agreement for the Manufacture of CAR T Cell Therapies to Bring the Promise of Cell Therapy to More Patients, Faster Bristol Myers Squibb will utilize Cellares’ proprietary Cell Shuttle, a next-generation end-to-end, fully automated cell therapy manufacturing platform, for the clinical and commercial-scale manufacturing of select CAR T cell therapies Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the U.S., EU and Japan for Bristol Myers Squibb’s use This agreement strengthens Bristol Myers Squibb’s existing global network of state-of-the-art cell therapy manufacturing facilities and provides increased agility, improved scalability and potential to improve turnaround time to support the company’s CAR T inline and pipeline assets Manufacturing cell therapies is both operationally and technically complex. Because cell therapies are rapidly transforming the way many different diseases are treated, the demand for these treatments is increasing significantly. This collaboration enables Bristol Myers Squibb to expand its manufacturing capacity, meeting the growing demand for its diverse range of cell therapies through a platform that is scalable and has the potential to improve turnaround time, bringing the promise of cell therapies to more patients faster. “The agreement with Cellares is our latest step forward in support of our comprehensive strategy to unlock the full potential of CAR T therapy to deliver transformative treatments to as many patients as possible, as quickly as possible,” said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. “Our collaboration with Cellares strengthens our existing internal manufacturing capabilities for CAR T cell therapies by giving us access to the first end-to-end fully automated cell therapy manufacturing platform, to help ensure we meet the high demand for these differentiated treatments, now and in the future.” This agreement expands upon the existing collaborations between Bristol Myers Squibb and Cellares. In August 2023, Bristol Myers Squibb participated in Cellares’ Series C financing to launch the first IDMO Smart Factory in an effort to meet the demand for cell therapies globally. That same month, Bristol Myers Squibb joined Cellares’ Technology Adoption Partnership (TAP) Program to evaluate the Cell Shuttle’s automated manufacturing capabilities. https://lnkd.in/e7MG4Kvc

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Build an intentional career path that is unique, enjoyable, and adaptive to change. Create a trajectory based on your core values and continuously grow through learning. #CareerDevelopment #PersonalGrowth

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Following big news acquisitions, and in what they are referring to as a '#strategic productivity initiative', Bristol Myers Squibb announces cuts through various parts of their organization, by EO 2025. We saw that Bayer announced a similar contraction of management layers as part of its global restructuring plan. Here, we see that BMS will follow that model to some degree. Insofar as pipeline, much like several other big pharma companies, BMS is also taking a hard look at its assets, to scrutinize for and prioritize the most promising opportunities. #CorporateAffairs #BMS #PharmaCuts #Pharma #Healthcare

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With all of the dystopian thinking in the world today, it's important to celebrate when humans do something magical and amazing. Today is a day we can do that. I remember a time when HIV was a death sentence like ALS, and I had the honor of learning from and working with some of the early leaders in HIV when I started the ALS Therapy Development Institute. At the time, we dreamed of a result like this, and that was our goal at ALS TDI and for my brother Stephen. Gilead's result is frankly incredible. Over 40 years, a lethal viral condition, through continuous discovery, development, and care delivery, has gone from almost universally lethal to the point where today, there is a drug that prevents infection 100% (At least in this study). I believe that it was the discovery and deployment of viral load as an effective proxy measure of patient outcomes that enabled this amazing and relentless advance. I will quote Lord Kelvin: "I often say that when you can measure what you are speaking about, and express it in numbers, you know something about it;" What a testament to what we can do with biology today when we have good targets and good measures and as Lord Kelvin asserted we "know something about it". I am so excited about what this says about the future of health, longevity, and disease management. We imagine and are working toward the day when health measurement is cost-effective, broadly available, and tuned to each individual. We know we can do this, and bio-assessment technology and AI are about to transform what we understand about health and life and how we intervene. That is why Jeff Cole and I started Alden Scientific. Advances like this are the result of government, academics, philanthropy, and companies working together over time. Most of all this result is a testament to the dedication of patients, advocates, scientists, clinicians, and funders to build a better world. Congratulations to Gilead Sciences and everyone who has been part of this and thank you for the inspiration and gift of life. https://lnkd.in/eAxVGeXC

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How robust is your control of materials? Is your product allogeneic cell-based? Do you use human and/or animal derived materials in your CGT or TEMP or its manufacturing process? This week, FDA/CBER issued TWO new draft CMC guidances applicable to certain CGTs and TEMPs. Sponsors must provide adequate SAFETY and QUALITY information of materials used in manufacturing in their regulatory submissions. Bigger picture - the key considerations in these guidances are also critical to quality risk management and assurance of potency! Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products https://lnkd.in/eP-S2rYe

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