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CHMP recommends approval for Pfizer, BioNTech’s updated Covid-19 vaccine in EU
The CHMP’s opinion was based on the full body of prior clinical, non-clinical, and real-world data supporting the safety and efficacy of the Covid-19 vaccines produced by the two pharma majors
Emergent announces OTC access to Narcan Nasal Spray for opioid emergency
According to Emergent BioSolutions, the expanded access will give people the ability to respond in an opioid emergency, thus saving lives and keeping loved ones and communities safe
BioMarin Announces First Person Treated Commercially with ROCTAVIAN for Severe Hemophilia A in Europe
In the U.S., ROCTAVIAN Now Commercially Available and Hemophilia Treatment Centers Have Begun Screening Eligible Individuals
Ginkgo partners with Google Cloud to boost biological engineering and biosecurity
Ginkgo will develop large language models (LLMs) for genomics, protein function, and synthetic biology on Google Cloud’s Vertex AI platform to help its customers across drug discovery, agriculture, industrial manufacturing, and biosecurity fields
NHS England to launch seven-minute cancer treatment injection
The anti-cancer injection, which takes around seven minutes to administer, has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA)
RS BioTherapeutics and NIAAA partner on RSBT-001 evaluation for IPF
The partnership is intended to study the anti-inflammatory and anti-fibrotic potential of the life sciences company’s RSBT-001 in a preclinical pulmonary fibrosis model
US FDA clears Bristol Myers Squibb’s Reblozyl for anaemia treatment
The approval was based on the findings from the Phase 3 COMMANDS trial in which 58.5% of patients administered with Reblozyl against 31.2% of patients treated with epoetin alfa met the primary endpoint of RBC-TI of at least 12 weeks
Sandoz acquires antifungal agent Mycamine from Astellas Pharma
Mycamine is said to be a preferred treatment in hospitals and intensive care units around the world for use as a preventative in patients with haematological and oncology conditions
L Catterton to acquire Thorne HealthTech in $680m deal
Upon completion of the transaction, Thorne will transition into a privately held entity, and its common stock shares will no longer be publicly listed on any stock exchange
AbbVie Submits Regulatory Applications to FDA and EMA for Risankizumab in Ulcerative Colitis
Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment