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.
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.
The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc. and German partner BioNTech SE’s Covid-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on May 3, citing federal officials familiar with the regulatory agency’s plans.
In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form.
BioNTech expects results by September from trials testing the Covid-19 vaccine developed with Pfizer in babies as young as 6 months old, German magazine Spiegel cited the company’s CEO as saying.
A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
U.S. drugmaker Merck & Co. joined Gilead Sciences Inc. on April 27 in lending support to India as the world’s second-most populous country scrambles to address drug shortages and bring a raging new wave of Covid-19 cases under control.
Roche culled two more Phase II Covid-19 programs, as announced in the Swiss pharma giant’s first-quarter 2021 financial report.
The tenth annual Pharmaceutical Innovation Index, released April 21, sees Eli Lilly top the industry for the first time. The Pharmaceutical Invention Index, a ranking of the industry’s best pipelines, rated Bristol Myers Squibb as No. 1.
