The pandemic and the economic lockdown severely reduced prescriptions for medicines, doctors or hospitals visits by patients and also delayed uses of innovative treatments. With immediate financial consequences on companies' sales and revenues.
The Covid-19 pandemic made deals tumbled down during the second quarter, just as it did during the first quarter of 2020. Global values also plummeted as pandemic spread all over the world.
In the race to bring to market a vaccine against Covid-19, drug companies develop various strategies and focus on specific technologies. According to the World Health Organization, 23 coronavirus vaccines were being evaluated in clinical trials around the world at the end of July. Moreover, more than 100 projects were in earlier stages of development.
Amid the Covid-19 pandemic and the desperate search for either a treatment or a vaccine, companies are doing "business as usual" on others therapeutics fields. This is the case of Biogen and partner Eisaï for the treatment of Alzheimer's disease.
At the halfway point of this year (January to end of June), the FDA has approved 25 new drugs and biological products. That is well above the 18 new arrivals given a greenlight in 2019. But the impact of the Covid-19 pandemic is likely to become more and more evident in the coming months, with delays on several decisions, despite advisory committees going virtual.
As the pandemic still accelerates in several parts of the world (mainly the United States and Latin America, but also in China), vaccine makers face biggest medical challenges for several reasons.
In the race to find either a treatment or a vaccine to fight the Covid-19 pandemic, Gilead obtains accurate results. As time goes by, there is more evidence that its Remdesivir product, originally indicated against Ebola fever, can also help moderately ill patients.
In June, the results from a phase III clinical trial showed that coronavirus patients who were hospitalized, but not sick enough to need oxygen from a ventilator, were more likely to recover after a five-day course of Remdesivir, than those given the current standard of care alone, Gilead said. The study demonstrated that patients in the 5-day Remdesivir treatment group were 65 % more likely to have clinical improvement at day 11 compared with those in the standard of care group.
In the race to develop a Covid-19 vaccine, which laboratory will win the competition? Which one will first launch a product allowing protection for populations as the pandemic has already killed over 420 000 people and put worldwide economies down?
At worldwide level, the unprecedented R&D efforts to develop and manufacture new vaccines have driven strong growth in scientific and industrial collaboration, backed by big financial resources provided by government bodies. Historically, just 6% of vaccine candidates make their way to the market - after several long years of R&D, but the traditional vaccine development rules have been overturned by the spread of the COVID-19 pandemic. The objective is to come up with a vaccine that has been identified, tested and made available in several million doses within just 12 to 18 months.
By definition, the core business of Contract Manufacturing Organizations (CDMOs) is
manufacturing and then selling at “cost+”. Their P&L is therefore impacted directly by any
changes to the rules in such matters.
Annex 1 "Manufacturing of sterile medicinal products" will soon be seeing a major update.
On 20 February 2020, after 6,000 comments submitted to the European Commission,
a further draft for the revision of Annex 1 to the EU GMP Guide to Good Manufacturing
Practices was published and no major or structural changes are expected now before the
publication of the official text.
The Covid-19 outbreak has provided a sharp reminder of the world’s reliance on China for medicines.
Around 88% of the active pharmaceutical ingredients (APIs) used in drugs
for the US market were manufactured overseas in 2018, according to the FDA.
The World Health Organization reckons that China accounts for at least 20% of global output of APIs,
a market growing by annual rates ranging between 6 and 7%, with a total of $155 to 200 billion.
A new phase is beginning for the Groupe Synerlab, with new management aiming to accelerate growth further in high-added-value pharmaceutical forms
Stock market performances of listed CDMOs in Europe and the USA over the first four months of the year have shown little impact of the economic crisis in Q1..
