The U.S. Food and Drug Administration released a briefing document on May 4 citing concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. ChemoCentryx is seeking approval from the FDA for the drug as a therapeutic agent for anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (AAV).
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India gave emergency use authorization for a Covid-19 antibody drug cocktail developed by Roche and Regeneron, expanding the company’s arsenal of drugs to battle a massive second wave of infections. The decision was taken based on data filed with the U.S. regulators and the scientific opinion of a European regulatory panel, Roche’s India distribution partner for the drug, Cipla, said on May 5.
President Joe Biden on May 4 announced a goal to vaccinate 70 percent of U.S. adults with at least one Covid-19 shot by the July 4 Independence Day holiday and said the government would innoculate 12- to 15-year-olds as soon as allowed. The president had previously announced July 4 as a target date for Americans to gather in small groups to celebrate the holiday and signal a return to greater normalcy in the middle of the pandemic.
Pfizer reported first-quarter 2021 revenue of $14.6 billion, an impressive 42 percent operational growth. The company’s Covid-19 vaccine revenue accounted for $3.5 billion of the total.
Companies across the biotech and biopharma industries reported a slew of new leadership appointments, several of which have been explicitly focused on the fields of oncology and precision medicine.
Next year, people are likely to need an annual Covid-19 vaccination just like they need an annual flu shot. That prediction is made by researchers at six of Australia’s leading medical research institutions, based upon their study of the levels of neutralizing antibodies needed to confer protection against Covid-19.
Germany’s CureVac, which is gearing up to publish results of a key Covid-19 vaccine trial, said U.S. export restrictions on key materials are making it impossible to predict the company’s short-term supply ramp-up in Europe.
BioNTech is working on getting approval for a version of the company’s Covid-19 vaccine which can be stored in fridges of 2 to 8 degree celsius for up to 6 months, Chief Executive Ugur Sahin said on May 4.
Ivy Cohen Corporate Communications (ICCC), eponymously named after founder Ivy Cohen, is celebrating its 20th anniversary in May. Launched in 2001 with Ivy’s belief that a higher level of experience and personal attention from leadership was a formula that was badly needed in the industry, ICCC advises on and executes brand building, public relations and strategic communications (both external and internal) for clients from the Fortune 100 to startups and many growing and pioneering businesses.
An experimental monoclonal antibody treatment for Covid-19 being developed by Eli Lilly and Co. and AbCellera Biologics Inc. can “potently” neutralize numerous coronavirus variants, including those first identified in the UK, Brazil, South Africa, California and New York, scientists found in test tube experiments. According to another study, some Covid-19 survivors infected early in the pandemic still have detectable antibodies against the virus a year later.