Insights+: EMA Marketing Authorization of New Drugs in June 2024

Shots: The EMA granted Positive Opinion to 4 Biologics and 3 New Chemical Entities in June 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Winrevair to treat Pulmonary Arterial Hypertension (PAH) and Roche’s PiaSky for Paroxysmal Nocturnal Haemoglobinuria (PNH) PharmaShots has compiled a list of 5 drugs that…

ByDipanshu DixitJuly 23, 2024

INSIGHTS+

Disease of the Month – Small Cell Lung Cancer

Shots: Small cell lung cancer (SCLC) aka Oat cell carcinoma is a rare & fast-growing lung cancer and ~15% of bronchogenic carcinomas are SCLC In this reprise of our Disease of the Month report, we bring an illuminating account of SCLC with a dive analysis of epidemiology, market size, disease management, available therapies, patient advocacy…

ByDipanshu DixitJuly 18, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in May 2024

Shots: The EMA approved or granted Positive Opinions to 5 Biologics and 7 New Chemical Entities in May 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were BMS’ Opdivo + cisplatin & gemcitabine to treat Urothelial Carcinoma and Takeda’s ADAMTS13 for the treatment cTTP PharmaShots has compiled…

ByDipanshu DixitJune 20, 2024

NEWS

Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)

Shots: The CHMP has granted a positive opinion to the company’s Avzivi (bevacizumab), a biosimilar of Avastin to treat metastatic colorectal cancer The opinion was based on a P-I study assessing the PK, safety & immunogenicity of Avzivi vs EU & US reference product among healthy subjects & a P-III confirmatory trial of Avzivi…

ByDipanshu DixitJune 3, 2024

NEWS

The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP) The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK…

ByDipanshu DixitMay 23, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in April 2024

Shots: The EC approved 10 New Chemical Entities in April 2024, leading to treatments for patients and advances in the healthcare industry In April 2024, the major highlighted drugs were Takeda’s Fruzaqla to treat Adults with mCRC and Johnson & Johnson’s Rybrevant for the treatment NSCLC PharmaShots has compiled a list of 5 drugs that have received positive…

ByDipanshu DixitMay 21, 2024

NEWS

Biogen Receives EMA’s CHMP Positive Opinion for Tofidence (Biosimilar, Roactemra)

Shots: 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…

ByDipanshu DixitApril 25, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in March 2024

Shots: The EC approved 1 Biologic and 11 New Chemical Entities in March 2024, leading to treatments for patients and advances in the healthcare industry In March 2024, the major highlighted drugs were Novartis’ Fabhalta to treat PNH and UCB’s Bimzelx for the treatment of Adults with Moderate to Severe Hidradenitis Suppurativa PharmaShots has compiled…

ByDipanshu DixitApril 22, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots: The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis PharmaShots has compiled a list of a…

BySaurabh ChaubeyJanuary 23, 2024

INSIGHTS+

Insights+ Key Biosimilars Events of January 2021

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 the patients. Hence, the providers are more likely to adopt biosimilars as a 'reference…

BySenior EditorFebruary 4, 2021

Insights+: EMA Marketing Authorization of New Drugs in June 2024

Disease of the Month – Small Cell Lung Cancer

Insights+: EMA Marketing Authorization of New Drugs in May 2024

Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)

The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

Insights+: EMA Marketing Authorization of New Drugs in April 2024

Biogen Receives EMA’s CHMP Positive Opinion for Tofidence (Biosimilar, Roactemra)

Insights+: EMA Marketing Authorization of New Drugs in March 2024

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Insights+ Key Biosimilars Events of January 2021

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