The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
A malaria vaccine has proved to be 77% effective in early trials, and could be a major breakthrough against the disease, says the University of Oxford team behind it.
Pharma companies are set to produce 11.4 billion Covid-19 vaccine doses by the end of the year, according to Goldman Sachs.
India’s second Covid-19 wave pushed the nation's pharma industry growth to 59% in April.
The European Union's drugs regulator has said the Pfizer Covid vaccine can now be stored at fridge temperature for up to a month.
The US Government has vowed to send 20 million doses of US-approved coronavirus vaccines overseas by the end of June.
The Drug Controller General of India has approved the drug 2-deoxy-d-glucose for emergency use among people with moderate and severe Covid-19.
Source: The Hindu
Zynrelef (bupivacaine and meloxicam) Injection
Heron Therapeutics has received approval from the US Food and Drug Administration (FDA) for Zynrelef to provide postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
GlaxoSmithKline (GSK) has received approval from both the European Commission and FDA for Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for treating endometrial cancer.
KLOXXADOTM (naloxone hydrochloride)
The US FDA has approved Hikma Pharmaceuticals’s KLOXXADOTM (naloxone hydrochloride) nasal spray 8mg for the emergency treatment of known or suspected opioid overdose.
Roche’s Tecentriq has been approved by the European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer.
First Alzheimer’s disease drug candidate designed by AI enters Phase I clinical trials
The world’s first Alzheimer’s disease drug candidate designed by artificial intelligence (AI) is entering Phase I clinical trials, thanks to a successful collaboration between Exscientia Ltd and Sumitomo Dainippon Pharma.
Volunteers sought for clinical trial of Covid vaccine made in Scotland
Researchers are recruiting thousands of UK volunteers for the final stage clinical trial of a candidate coronavirus vaccine that is being manufactured in Scotland. Doctors plan to give the Valneva vaccine to 4,000 adults from the beginning of May in a Phase II/III trial that will run from more than 20 sites across England and two hospitals in Edinburgh and Glasgow.
Source: The Guardian
Latest results put Oxford–AstraZeneca Covid-19 vaccine back on track
A key phase III clinical trial found the vaccine to be 76% effective at preventing Covid-19, the company announced on 25 March, two days after it was accused of misrepresenting interim results, which reported a slightly higher efficacy of 79%.
Magenta’s multiple myeloma treatment trial meets primary endpoint
Magenta Therapeutics has reported that Phase II clinical trial of MGTA-145 in combination with plerixafor in multiple myeloma patients met the primary endpoint. All ten subjects met the primary goal of mobilising two million CD34+ stem cells per kg in up to two days of same-day mobilisation and apheresis, preliminary results showed.
Source: Clinical Trials Arena
Inovio reports positive data from Phase II Covid-19 DNA vaccine trial
The Inovio vaccine Phase II trial assessed the safety, tolerability and immunogenicity of two doses of INO-4800 to detect optimal dose(s) for age groups, namely 18 to 50 years and 51 years and above, for the Phase III efficacy analysis.
Source: Pharmaceutical Technology
Orchard’s gene therapy improves overall survival in ADA-SCID trials
Orchard Therapeutics has reported data from three Phase I/II clinical studies of investigational gene therapies, including OTL-101, to treat adenosine deaminase severe combined immunodeficiency (ADA-SCID).
Source: Clinical Trials Arena