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MONTHLY UPDATE / 19 Nov 2024
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Hello there,
“Small molecule therapies will be with us for the foreseeable future, and will almost certainly continue to be used as first-line therapies for the next 10 years,” said Navin Molecular CCO Jordi Robinson, as part of our 10-year anniversary feature “ The Multifaceted Future of Pharma.” Amongst the highly sophisticated and ever-evolving pipelines of biopharmaceuticals and cell and gene therapies, the stalwarts of pharmaceutical products – the small molecule medicines – remain. And not just remaining but witnessing a comeback as developers are returning to the small molecules modality, according to Adragos Pharma CEO Andreas Raabe: “Another big change the industry has seen is the shift away from biologics and cell gene therapy and back to traditional small molecules … as a scientist at heart, I stuck to my gut, which told me to stick with small molecules, and I am so happy that I did!”
There is much happening in the small molecules world, so keep an eye on our web pages as we launch a new regular feature, “Small World,” which summarizes the ongoing achievements of the industry’s longest serving modality. As always, feel free to connect with me with your own news, views, and “don’ts-and-dos”: rob.coker@texerepublishing.com. |
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Essential Reading
Beat it, breast cancer! The FDA has approved Roche’s metastatic breast cancer treatment Itovebi (inavolisib) with Ibrance (palbociclib) and fulvestrant for adults based on results of the pivotal phase III INAVO120 study. CMO Levi Garraway said, "With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation. Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes today’s approval all the more significant.”
Settle down, schizophrenia! The FDA has approved Bristol Myers Squibb’s schizophrenia treatment Cobenfy (xanomeline and trospium chloride) – the first approval of an antipsychotic with a new mode of action in more than 50 years. Cobenfy’s approach to schizophrenia treatment is through the selective targeting of the M1 and M4 (muscarinic acetylcholine) brain receptors, which it manages without blocking the D2 (dopamine) receptors. BMS CEO Chris Boerner said, “Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm. As we reenter the field of neuropsychiatry, we are dedicated to changing the conversation around serious mental illness, beginning with today’s approval in schizophrenia.” |
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Also in the News...
Pfizer announces positive topline results from TALAPRO-2 study of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) in prostate cancer patients.
AstraZeneca’s non-small cell lung cancer treatment Tagrisso (osimertinib) approved by FDA after showing progression free survival compared to placebo in phase III LAURA trial.
Pharming Group commences phase II trial of leniolisib for primary immunodeficiencies with immune dysregulation.
Hovione and Zerion expand partnership to accelerate development of Dispersome platform to increase solubility and bioavailability of small drug molecules.
Gilead Sciences Ireland UC enters voluntary licensing agreement with six global pharmaceutical companies for manufacture and commercialization of lenacapavir. |
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More Small Molecule coverage from The Medicine Maker
Addressing the Empire of Pain
How the pharma industry can help tackle the opioid crisis and advance treatments. Read the article
Continuous Processing. Continuous Evolution
Continuous processing for small molecule products has been a hot topic for years, but where does the industry stand with it today? Read the article
Disrupting Tradition
Nigel Theobald on why the traditional model of drug development is no longer fit for purpose. Read the article
Dosage Form Innovation with Hot Melt Extrusion What’s going on with hot melt extrusion (HME)? Read the article
Ready for Anything The Alliance for RTU has been founded to accelerate and improve manufacturing quality, consistency, and regulatory efficiency. Read the article
Compounders Confounded Why some stakeholders are not happy about the FDA’s removal of tirzepatide from the drug shortage list. Read the article |
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