ICON selected by BARDA to conduct anthrax vaccine clinical trial

This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur.

Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Lupin receives approval from USFDA for Darunavir Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.

Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency

AGC begins study to expand its Bio-CDMO capability in Japan

Sumitovant Biopharma and Sumitomo Pharma to acquire outstanding shares of Myovant Sciences

The proposed acquisition consideration represents an equity value for Myovant of $2.4 billion and an enterprise value of $2.5 billion.

Lupin receives US FDA approval for Mirabegron Extended-Release tablets

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US

Emmes acquires Clinical Edge

The combination of Optym, Emmes' ophthalmology certification unit, and Clinical Edge will make the organization a leader in ophthalmic certification and training services

Lupin launches Sildenafil for Oral Suspension in US

Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses