Caliway Biopharmaceuticals’ Post

♟ Business is identical to chess. One move (within the rules). ⏬ Here's how you make the right one for your pharmacy. -- 🔻 You cannot change the rules of chess. You can only play the best possible move available to you. Much like you cannot change the system. You can only play the best possible move for your pharmacy. --- 👎🏻 You can call out Community Pharmacy England all you want. You will still be dispensing at a loss tomorrow. --- 🏥 The only thing you can do is make the best possible chess move for your business. Offering private services at scale is that chess move. Repeatable. Scaleable. Demand-driven. Highly profitable private services are the future (and only option left) for your pharmacy. -- ✈️ TravelRx builds the future for your pharmacy. We secure your profit, forever. We don't just build websites, or software, or marketing. We build and capture patient demand channels that will bring you 80+ high-paying patients each month (worth £100,000+ annually). And we don't stop working until you hit that level. -- 📬 DM us to see if you're a fit for our zero-risk service. -- Yousif Abass - Follow me directly too #pharmacy #pharmacist #pharma #clinic #gphc #vaccine

Excited to share that Polfa Tarchomin S.A., one of Poland's premier generic pharmaceutical producers with a rich 200-year history, is entering a new era. In 2025, they will unveil a groundbreaking facility dedicated to the development and production of highly potent parenteral preparations, including oncological drugs—marking the first of its kind in Poland. Their core lies in anti-infection, alimentary tract & metabolism, CNS, and dermatological solutions, with a strong emphasis on prescription and hospital drugs. As they expand, they are looking for partners in oncology, anti-infectives, diabetology, CNS, dermatology, and cardiovascular, offering comprehensive contract manufacturing services, dossier portfolios, and support for marketing authorizations. Let's innovate and heal together at PharmaVenue May 23-24 in Madrid. Register at https://lnkd.in/djcXytfm! #PolfaTarchomin #PharmaceuticalInnovation #Oncology #ContractManufacturing #HealthcarePartnerships #InnovationInHealth

Hot topic: new version of the generic GPCR residue numbering system

Thanks, Chris Fisher, for inviting The Rx Save Card to take the 3x3x3 challenge! The Rx Save Card is the perfect solution for self-funded employers that want to access lower prescription drug costs through Mark Cuban Cost Plus Drug Company, PBC, Cash Prices and Discount Cards without needing to change #PBMs. Employers are able to meet their #ERISA #Fiduciary obligations, while reducing their prescription drug spend. Employees get many drugs for free. A true win-win! https://lnkd.in/g-shm9E3

ARE YOU BETTER THAN THIS? $SMMT $18.61. DAC (dollar average cost is $00.00 caused by 60% sale of position, last $31.35 (9.13.24. EXIT $40.00. UPDATE: ^ FDA grants fast track designation for ivonescimab in 2L+ EGFRm NSCLC. ^ HARMONi completed enrollment for summit's first sponsored study evaluating ivonescimab. ^ Topline data from the HARMONi trial is expected in mid-2025.

The CJEU has today issued its long-awaited decision in Joined Cases C-119/22 (Teva) and C-149/22 (Merck), relating to the criteria for assessing the availability of SPCs for “fixed” combination products. Read more in our latest briefing. 

Breaking SPC news: The CJEU has today ruled in Joined Cases C-119/22 (Teva) and C-149/22 (Merck) that a combination medicinal product A+B is a different "product" to the monotherapy A within the meaning of the SPC Regulation, regardless of the subject-matter of the basic patent. Thus, in principle, under Art. 3(c) of the Regulation an SPC to the combination A+B is available, even if an SPC has already been granted to momotherapy A on the same basic patent. There is a big catch, though. The Court has ruled that in order for such an SPC to meet the requirements of Art. 3(a) (that the combination product be "protected by [the] basic patent"), the combination itself must constitute a feature required to solve the technical problem underlying the basic patent. That is to say, there must be an invention associated with the combination which goes beyond the invention of the monotherapy alone. And with that, assessment of Art. 3(a) for combination SPCs in Europe now involves an "invention test". This is a significantly higher burden than had previously been applied by national patent offices. I explore the consequences of this for rights holders in our briefing on the decision.

Some welcome (and overdue) clarification from the CJ-EU on the availability of SPCs (patent term extensions in Europe) for combination products. The CJ-EU continues to monkey around a bit with Art 3(a) of the SPC regulation: the requirement for the product at issue to be "protected by a basic patent in force". It is not good enough that the combination product at issue be claimed in the basic patent. Rather, we have a somewhat nebulous test, whereby the combination product must "fall under the invention covered by the patent". Thus, if the inventive concept is devising a new active, combinations of that new active with other drugs know to treat the target disease may not qualify. To be fair to the CJ-EU, this concept of working out what "the invention" is in general terms, rather than strictly with reference to the claims, is a recurrent feature of patent law. It arises in the operation of the doctrine of equivalents, in the requirement for a sufficient disclosure of the invention in a patent document and in the provisions governing contributory infringement. Our detailed briefing on the new decision is below

Phase 2, open-label (DeLLphi-301) Relapsed/refractory to platinum-based therapy Advanced SCLC Tarlatamamab 10 or 100 mg => Final dose selected as 10 mg https://lnkd.in/eCuvVv_4

Checking boxes, paving the way for OTC with our ED self-selection study ✅ Read our HBW Insight feature: https://lnkd.in/e7UnA6AY #selfselection #positiveresults #otcmarkets