Pharma news in the second half of June continues to be dominated by the COVID pandemic. Key updates are summarized here, along with some of the latest industry announcements on new partnerships, M&As and regulatory approvals. 

COVID tests
A study from Penn State University (USA) suggests that the number of early COVID-19 cases in the US may have been more than 80 times greater than reported, due to testing issues, asymptomatic cases (up to 45% might be asymptomatic, according to a separate study by Scripps Research Translational Institute), and a failure to identify early cases. Testing is the basis of many ‘track and trace’ strategies, but these strategies rely on accurate and reliable tests. In the UK, a weekly COVID-19 testing model using a new ‘no-swab’ saliva test began pilot tests last week. In the US, Gemini Bio has been awarded a government contract to supply critical products in efforts to support COVID-19 testing.

Vivera Pharmaceuticals has launched two rapid serology tests: one for mass-screening settings such as drive through testing centers, and the other for clinical settings, and the US FDA has issued an emergency use authorization (EUA) for Illumina’s novel test that detects SARS-CoV-2 RNA from respiratory specimens. MBio Diagnostics has also developed a test for an inflammatory protein produced during the COVID-19 ‘cytokine storm’, but this test is for research rather than clinical practice.

The American Red Cross has begun testing all blood donations for COVID-19 antibodies. However, researchers at China’s Chongqing Medical University, a branch of the Chinese Center for Disease Control and Prevention, have discovered that levels of COVID-19 antibodies fall sharply with 2-3 months after infection. These findings raise important questions about the duration of any immunity.

COVID vaccines
AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA) to supply the continent with up to 400 million doses of AZD1222, the vaccine candidate developed by Oxford University, with deliveries starting by the end of 2020. AstraZeneca will be supported in this endeavour by CDMO Emergent BioSolutions.

Sanofi said last week that it expects approval for the vaccine it is developing with GlaxoSmithKline (GSK) by the first half of 2021 – several months faster than previously anticipated. Meanwhile, GSK’s collaboration with Chinese biotech Clover Pharmaceuticals to develop a vaccine is now also being tested in human clinical trials. Elsewhere, Chinese researchers have started a Phase II trial of another possible vaccine at the Institute of Medical Biology at Chinese Academy of Medical Sciences. Therapeutics Solutions is also testing its immune-boosting formulation QuadraMune in 500 volunteers, while Johnson & Johnson (J&J) announced earlier this month that it will initiate a Phase I/IIa trial of its candidate in July.

The UK’s Imperial College London has secured government funding to trial its RNA vaccine, while the European Investment Bank (EIB) has provided support to BioNTech for the development of a mRNA vaccine. Daiichi Sankyo is also set to develop a mRNA vaccine candidate, supported by the Japan Agency for Medical Research and Development.  

With so many candidates advancing at unprecedented rates, UK researchers have formed a consortium to monitor COVID-19 vaccines. Named the Consortium for Monitoring the Safety and Effectiveness of Covid-19 Vaccines, the collaboration will focus on the post-marketing stage to ensure that any launched products work as predicted.

COVID Treatments
The second half of June saw great news from the UK’s large RECOVERY trial, in which dexamethasone reduced death by up to 35% in hospitalized patients with severe respiratory complications. The WHO moved quickly to update its guidance following the results.

Gilead Sciences expects to supply enough of its antiviral drug remdesivir by year end to treat more than two million patients – more than double its previous target. The company also said it is developing an inhaled version of the medicine (it is currently administered intravenously). Meanwhile, Catalent has announced that it will be developing two oral dosage forms of ViralClear’s broad-spectrum anti-viral agent merimepodib.

Other products already on the market that are being evaluated for COVID include Eli Lilly’s baricitinib, Incyte’s ruxolitinib, Pharmstandard’s umifenovir and Celltrion's infliximab biosimilar. In addition, Regeneron Pharmaceuticals announced last week that it is trialling REGN-COV2, its investigational dual antibody cocktail. Other investigational drugs newly under study include Fulcrum Therapeutics’ losmapimod, PTC Therapeutics’ PTC299, Immunic’s IMU-838, and Evgen Pharma’s SFX‐01. Japanese biopharma firm PeptiDream has partnered with Merck (MSD) to discover and develop new peptide therapeutics that could neutralize SARS-CoV-2.

Novartis is stopping its trial of hydroxychloroquine (HCQ) due to a shortage of participants.

The FDA has revoked the EUA for anti-malarials, chloroquine phosphate and hydroxychloroquine sulfate, to treat some hospitalized COVID-19 patients. 

Continue to read:

What’s been happening in pharma? - Updates on M&A, Regulatory approvals and collaborations

Editor's Note:

Information in this article is originated from the Internet. For more details, please search and visit the official website of relevant news sources.

Author biography

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. She subsequently began a new career in publishing as Editor of Speciality Chemicals Magazine, and then Editorial Director at Chemicals Knowledge. She now focusses on providing independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.

-----------------------------------------------------------------------
Editor's Note:

To become a freelance writer of PharmaSources.com,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@imsinoexpo.com.