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Takeda
NEWS

Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer 

Shots:  The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights  The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best…
April 26, 2024

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NEWS

Norgine’s NPJ5008 (Dantrolene sodium hemiheptahydrate) Receives CHMP’s Positive Opinion for the Treatment of Malignant Hyperthermia 

Shots:  Norgine received a positive CHMP opinion for NPJ5008 (Dantrolene sodium hemiheptahydrate) for the treatment of Malignant Hyperthermia  With NPJ5008, dantrolene is prepared and administered quickly using novel formulation vs. Dantrolene IV (dantrolene sodium). NPJ5008 (IV) contains 120 mg of dantrolene in each vial and is reconstituted in 20 mL of water  For its final…
March 26, 2024

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NEWS

Outlook Therapeutics’ Lytena Gains the CHMP’s Positive Opinion for the Treatment of Wet AMD 

Shots:  Outlook’s Lytenava has received CHMP’s positive opinion to treat Wet AMD. If approved Lytenava expected to gain 10 yrs of market exclusivity in EU  The opinion was supported by 3 wet AMD clinical programs (NORSE ONE, NORSE TWO & NORSE THREE) assessing ONS-5010 along with retrospective bibliographic literature   Lytenava, an ophthalmic formulation of bevacizumab,…
March 22, 2024

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Novartis
NEWS

Novartis Reports the CHMP’s Positive Opinion for Fabhalta (iptacopan) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots:  The opinion was based on the P-III (APPLY-PNH) & (APPOINT-PNH) trials of Fabhalta (200mg, oral, BID) in PNH patients with residual anemia who switched from Anti-C5 and complement inhibitor naïve (incl. anti-C5 therapies) respectively for 24wks.  In the APPLY-PNH study, 82.3% vs 2.0% had a ≥2 g/dL increase in Hb levels without transfusions while…
March 22, 2024

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Pfizer
NEWS

Pfizer’s Emblaveo (aztreonam-avibactam) Receives Positive CHMP Opinion for the Treatment of Patients with Multidrug-Resistant Infections 

Shots:  Pfizer’s Emblaveo has received a positive CHMP opinion for the treatment of patients with cIAI, HAP (incl. VAP), and cUTI (incl. Pyelonephritis).   The MAA was supported by results from the P-III study comprising the REVISIT and ASSEMBLE studies evaluating the efficacy, safety, and tolerability of Emblaveo in treating serious bacterial infections due to Gram-negative…
March 22, 2024

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NEWS

Bio-Thera Solutions and SteinCares Collaborate for Marketing Biosimilars Across LATAM 

Shots:  Bio-Thera Solutions and SteinCares have entered into a new licensing agreement for marketing two biosimilars as per which SteinCares gains exclusive distribution and marketing rights to Bio-Thera's products across Brazil and the rest of the region  Under the agreement, Bio-Thera will handle the biosimilars’ development & regulatory submissions with the US FDA & the…
March 18, 2024

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A Complete Account of EMA Approvals in 2023
INSIGHTS+

A Complete Account of EMA Approvals in 2023

Shots:  In 2023, EMA approved around 45 drugs in various therapy areas, ranging from cardiology, oncology, hematology, neurology, and dermatology to infectious diseases, genetics, pulmonary, otolaryngology, gastroenterology, ophthalmology, and endocrinology  PharmaShots, in an illuminating report, brings a condensed analysis of the approved drugs with the most explored areas being Oncology, Hematology, Neurology, & Dermatology  For…
March 5, 2024

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