Shots:
Health Canada has approved Vyvgart (efgartigimod alfa; QW, SC, PFS) as a monotx. for adults with chronic inflammatory demyelinating polyneuropathy (CIDP)
Approval was based on the ADHERE trial, showing 69% (221/322) of Vyvgart SC-treated pts had clinical improvement, regardless of prior treatment. The study met its 1EP with a 61% reduction in relapse risk vs…
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argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG)
Trial (n=119) consist of 2 Parts: Part A assessed Vyvgart (QW × 4wks.) vs PBO, followed by 5wk. follow-up, while Part B was an OLE study, where pts received 2 fixed cycles of…
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Unnatural Products (UNP) & argenx have entered into a strategic multi-target research collaboration to identify & develop oral macrocyclic peptide drugs for hard-to-target diseases leveraging UNP’s drug discovery platform
As per the deal, UNP will receive upfront payment, equity investment, near-term, & R&D payments, plus ~$1.5B in research, development, regulatory, & commercial milestones as well as…
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The EC has approved Vyvgart (efgartigimod alfa) 1000mg for SC injection as a monotx. for adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior corticosteroid or immunoglobulin treatment in all 30 EEA states
The EC approval was based on the ADHERE trial, showing 66.5% (214/322) of VYVGART SC-treated pts showed…
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The US FDA has approved Vyvgart Hytrulo (efgartigimod alfa & hyaluronidase-qvfc) prefilled syringe to treat AChR+ adults with generalized myasthenia gravis (gMG) & adults with chronic inflammatory demyelinating polyneuropathy (CIDP)
Approval was based on studies showing bioequivalence to Vyvgart Hytrulo vial, with human factors validation confirming that pts with gMG or CIDP, or their caregivers,…
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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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The EMA approved 3 BLA while 6 New Chemical Entities with 1 recommendation and 1 acceptance in November 2023, leading to treatments for patients and advances in the healthcare industry
In November 2023, the major highlighted drugs were Vyjuvek to Treat Dystrophic Epidermolysis Bullosa (DEB) and Vyvgart with Halozyme’s Enhanze for the treatment of…
The EMA approved 5 New Chemical Entity (NCE) and 4 Biologic Drugs in August 2022, leading to treatments for patients and advances in the healthcare industry
In August 2022, the major highlights drugs were Lynparza’s approval for breast cancer, Imbruvica (ibrutinib) for chronic lymphocytic leukaemia, Sunlenca (lenacapavir) for HIV Infection
PharmaShots has compiled a list…
The second quarter of 2022 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, AstraZeneca’s Farxiga (dapagliflozin) meet its primary endpoints for heart failure with a preserved ejection fraction
Starting with the latest acquisitions, Pfizer acquire Biohaven for ~$11.6B, GSK acquire Affinivax for ~$3.3B. The second quarter of the year…

