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Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD
Drug Approval | September 27, 2024

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype


Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024
Biotech | September 25, 2024

Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024

These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity


Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19
News | September 23, 2024

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization


Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
Drug Approval | September 23, 2024

Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA


Fermenta Biotech receives EU GMP Certification for its Dahej facility
News | September 23, 2024

Fermenta Biotech receives EU GMP Certification for its Dahej facility

This approval reflects company’s unwavering commitment that the quality assurance


Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
Drug Approval | September 23, 2024

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Pharmaceutical sector set for 8-10% revenue growth this fiscal: CRISIL
News | September 20, 2024

Pharmaceutical sector set for 8-10% revenue growth this fiscal: CRISIL

Stable profits, low leverage to keep credit profiles comfortable


Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers
Diagnostic Center | September 20, 2024

Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers

Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma


10 year data for Merck’s Keytruda demonstrates sustained overall survival benefit versus Ipilimumab in advanced melanoma
Diagnostic Center | September 16, 2024

10 year data for Merck’s Keytruda demonstrates sustained overall survival benefit versus Ipilimumab in advanced melanoma

At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab


Keytruda plus chemotherapy before surgery reduced risk of death by more than 1/3versus neoadjuvant chemotherapy in high-risk early stage TNBC
Diagnostic Center | September 16, 2024

Keytruda plus chemotherapy before surgery reduced risk of death by more than 1/3versus neoadjuvant chemotherapy in high-risk early stage TNBC

KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival