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Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urot...

Dr Reddy’s informed the Indian National Stock exchange on 28 October 2023 that the FDA issued a Form 483 with ten observations for Dr Reddy’s biologics manufacturing facility in Hyderabad.  The observations were issued as part of a routine cGMP inspection of the facility by...

Sanofi announced that it will separate its Consumer Healthcare Business as soon as the end of Q4 2024, creating a publicly listed company headquartered in France.  Sanofi intends to focus on its biopharma business.

The Department of Health and Aged Care has published the public summary documents considered at the July 2023 PBAC meeting.  Documents include:

Cipla’s public summary document for Ardalicip®, biosimilar to AbbVie’s Humira® (adalimumab), which was developed by Alvot...

Coherus BioSciences announced that the FDA has approved its Loqtorzi® (toripalimab) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal cancer (NPC), and as monotherapy for the tre...

Roche announced that the FDA has approved Vabysmo® (faricimab) to treat a new indication: macular oedema following retinal vein occlusion.  The clinical trials demonstrated non inferiority against aflibercept (marketed by Bayer/Regeneron’s as Eylea®).  The FDA accepted Roch...

Novartis announced that the National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending Cosentyx® (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults in England and Wales.   It will be recommended fo...

It has been reported that the Munich Regional Court has issued a preliminary injunction against Formycon’s manufacture of FYB202, its Stelara® (ustekinumab) biosimilar, in Germany until expiry of Janssen’s SPC on its basic ustekinumab patent on 20 July 2024.  According to t...

Eli Lilly announced that the FDA has approved its Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

On 1 April 2023, Eli Lilly launched its insulin glargine (Rezvoglar®) biosimilar to Sanofi’s Lantus®, in ...

Samsung Biologics has announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated revenue of ₩1.034T, marking an 18% increase from Q3 2023.  Samsung attributed this revenue hike to an increase in the operating rate of Plant 4 and a sales b...