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U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans


SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment
Biotech | September 26, 2021

SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment

Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors


Amaris Clinicals clears U.S. FDA audit
News | September 24, 2021

Amaris Clinicals clears U.S. FDA audit

The company is the Clinical Research Organisation of Caplin Point Laboratories


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster
Drug Approval | September 23, 2021

Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster

Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups


Boehringer Ingelheim acquires Abexxa Biologics to advance its cancer research
Biotech | September 22, 2021

Boehringer Ingelheim acquires Abexxa Biologics to advance its cancer research

The addition of Abexxa’s expertise complements Boehringer Ingelheim’s current approaches to the treatment of difficult-to-treat solid cancers and especially those resistant to available immunotherapies


DCGI approves Ampio Pharma’s Phase II trials to tackle Covid-19 induced respiratory distress
Biotech | September 22, 2021

DCGI approves Ampio Pharma’s Phase II trials to tackle Covid-19 induced respiratory distress

Ampion is directly administered by inhalation and it allows the drug to directly target and attenuate inflammation in the lungs


U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
Drug Approval | September 21, 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States


HUTCHMED initiates a Japan bridging study to Support Surufatinib
Biotech | September 21, 2021

HUTCHMED initiates a Japan bridging study to Support Surufatinib

Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan


AAV Production system enables scalable gene therapy workflows
Medical Device | September 21, 2021

AAV Production system enables scalable gene therapy workflows

New Gibco AAV-MAX Helper Free AAV Production System helps reduce production costs and streamline the transition from research to clinical environments