RDIF, Hetero agree for 100 million Sputnik V vaccine doses production in India
The Russian Direct Investment Fund (RDIF) and Indian generic pharma firm Hetero, through its biologics arm Hetero Biopharma, have agreed…
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Biogen and Sage Therapeutics to co-develop depression and tremor therapies
Biogen and Sage Therapeutics have entered a global collaboration and licence agreement to jointly develop and commercialise depression and tremor…
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AstraZeneca likely to conduct new global low-dose Covid-19 vaccine trial
AstraZeneca may initiate an additional global trial to evaluate the efficacy of its Covid-19 vaccine candidate, AZD1222, using a lower dosage. Co-invented by the University…
Altimmune submits FDA application for intranasal Covid-19 vaccine candidate
Altimmune has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to start a Phase I clinical study of…
Covaxx announces Covid-19 vaccine purchase deals worth $2.8bn
US company COVAXX has announced $2.8bn advanced purchase commitments of over 140 million doses of its UB-612 vaccine to be…
BioNTech, Fosun Pharma initiate Covid-19 vaccine candidate trial in China
BioNTech and Shanghai Fosun Pharmaceutical (Fosun Pharma) have initiated Phase II clinical trial of their lead mRNA Covid-19 vaccine candidate,…
Roche’s Xofluza gets FDA approval for influenza prevention
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche’s Xofluza (baloxavir marboxil)…
Purdue Pharma pleads guilty to three criminal charges
Opioid maker Purdue Pharma has pleaded guilty in federal court in Newark, New Jersey, to criminal charges over the handling…
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Softigel by Procaps
Contract Pharmaceutical Development Services and Commercial Manufacturing in Advanced Softgel Technologies
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EU approves contract to purchase Moderna’s Covid-19 vaccine
The European Commission (EC) has approved a contract to purchase an initial 80 million doses of US biotech Moderna’s Covid-19…
Companies should be free to bid on federally funded healthcare contracts: Poll
Drug products intended for the US market are increasingly being produced at offshore locations prompting legislators to call for reshoring…
Stability Tests According to ICH Q1A (R2)
In 1990, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was born. This paper…
SenseAnywhere to Monitor Covid-19 Vaccines in Europe During Storage and Transportation
SenseAnywhere is specialised in fully automated temperature monitoring for the Pharmaceutical Industry for years already. Soon our AiroSensors, in combination…
Handling Risks and Errors in Pharma Record Webinars Part I and II
METTLER TOLEDO is pleased to announce that it will be holding its Handling Risks and Errors in Pharma Record webinar,…
Seqirus’ Influenza Vaccine Manufacturing Facility, Melbourne
Seqirus, an influenza vaccine maker, is building a new cell-based influenza vaccine manufacturing facility in Melbourne, Australia. The facility will…