Shots:
Royalty Pharma & Biogen have entered into an agreement for the clinical development of litifilimab in SLE & CLE
As per the agreement, Biogen will receive ~$250M R&D funding over 6 quarters to support the development, whereas Royalty Pharma is entitled to receive regulatory milestones & mid-single digit royalties on global sales
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Shots:
Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodies
In 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
The major highlights were NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…
Shots:
The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19
The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III…
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The EMA’s CHMP has issued a positive opinion recommending approval of Tofidence (Biosimilar, Roactemra; IV) to treat moderate to severely active RA, PJIA, SJIA, and COVID-19
The opinion was based on evidence from extensive analytical characterization and PK, safety & immunogenicity of TOFIDENCE including the P-I study examined healthy volunteers compared to the EU…
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The opinion was based on the results from the P-III (VALOR) trial evaluating the safety & efficacy of Qalsody (100mg) vs PBO in ALS patients (n=108) associated with SOD1 mutations. The 1EPs of the study include changes in ALSFRS-R total score from baseline to wk.28 & 2EPs includes change in total cerebrospinal fluid SOD1…
Shots:
Third quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, Biogen acquired Reata Pharmaceuticals for ~$7.3B and Danaher acquired Abcam for ~$5.7B
The third quarter of the year also showcases multiple clinical trial results which include Janssen reported P-IIb…
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The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023
In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…
Shots:
Kathleen spoke about new long-term SPINRAZA (nusinersen) data presented at the 3rd International Scientific Congress
She then explained the new findings from individuals with infantile-onset SMA who were treated with SPINRAZA in the pivotal ENDEAR study followed by the long-term extension SHINE study for up to 7 years
The interview also discusses Biogen’s advances…
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In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, we bring for our readers a concise yet thorough analysis of the drug Ocrevus
Ocrevus is a prescription medicine used to treat adults with relapsing or primary progressive multiple sclerosis including CIS, RRMS, and SPMS
PharmaShots presents…

