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Rx Drugs

October 28, 2020 | Daily News

HHS announced plans Wednesday (Oct. 28) to pay Eli Lilly up to $1.187 billion for 950,000 vials of a coronavirus antibody drug, on the condition that FDA authorizes it for emergency use, which would come out to $1,250 per treatment, similar to the $1,500 price per treatment of Regeneron’s experimental antibody drug.

October 28, 2020 | Daily News

Former FDA chief Scott Gottlieb warned that the federal government’s COVID-19 vaccine allocation plan could create access issues for underserved communities and older populations, and he urged officials to focus on mitigating any potential disruptions, including weighing how to help states set up mobile vaccination sites.

October 28, 2020 | Daily News

FDA has indicated that it might not conduct pre-approval inspections of sites that are manufacturing COVID-19 vaccines and that are being considered for emergency use authorization, but there’s a lack of clarity about the agency’s alternative approaches to site inspections.

October 28, 2020 | Daily News

A leading pharmacy compounding group predicts that FDA might face lawsuits from states and compounding pharmacies over its final memorandum of understanding, which subjects compounding pharmacies located in states that don’t sign the MOU to a 5% sales cap on the amount of compounded product that can be shipped out-of-state.

October 26, 2020 | Daily News

FDA’s vaccine advisers disagreed with COVID-19 vaccine makers who claim they might have to unblind their placebo-controlled phase 3 trials should a vaccine become available through emergency use authorization.

October 26, 2020 | Daily News

FDA might allow COVID-19 vaccine makers to test the efficacy of their investigational vaccines against any vaccine that gains FDA approval, in a bid to help resolve ethical questions around placebo-controlled studies, although the agency continues to push for sponsors to use placebo-controlled trials for as long as possible.

October 23, 2020 | Daily News

Administration officials are expected to say within days how they plan to make coronavirus vaccines free for everyone, HHS Deputy Chief of Staff for Policy Paul Mango said Friday (Oct. 23).

October 23, 2020 | Daily News

An FDA advisory committee will vote Nov. 6 on whether to recommend that FDA approve the first drug to treat Alzheimer’s, and the Institute for Clinical and Economic Review already is planning the process of recommending a price for what might be a very expensive drug.

October 23, 2020 | Daily News

FDA on Friday (Oct. 23) cleared AstraZeneca to restart its phase 3 COVID-19 vaccine trial, which was put on hold in early September after a trial participant in the United Kingdom experienced a serious neurological adverse event.

October 22, 2020 | Daily News

Community health centers on Wednesday (Oct. 21) sued HHS for not putting forward regulations for a dispute resolution process and, as such, depriving the providers of their only way to take drug makers to task for making them pay full price for drugs through 340B contract pharmacies.

October 22, 2020 | Daily News

FDA approved Gilead Science’s remdesivir therapeutic, Veklury, on Thursday (Oct. 22) for the treatment of hospitalized COVID-19 patients 12 years and older, making it the first fully FDA-approved treatment for the novel coronavirus in the United States.

October 22, 2020 | Daily News

A new World Health Organization-funded study that found remdesivir may not reduce mortality from COVID-19 could put pressure on its maker, Gilead, to cut the price of the antiviral, which is the only pandemic drug to receive an emergency use authorization.

October 22, 2020 | Daily News

Regeneron disputes allegations it did not disclose that the U.S. government funded development of the company’s coronavirus antibody in its patent for REGN-COV2.

October 21, 2020 | Daily News

FDA on Thursday (Oct. 22) will ask its vaccines advisors to consider whether COVID-19 vaccine sponsors should keep their phase 3 trials blinded even after an emergency use authorization is granted, coming as two of the leading vaccine developers, Pfizer and Johnson & Johnson, warn that if granted an EUA they might ethically need to unblind their studies to allow participants to access EUA vaccines or to cross over to the vaccine arm of a trial.

October 20, 2020 | Daily News

FDA’s highly anticipated advisory panel meeting Thursday (Oct. 22) on policies surrounding approval and emergency authorization of COVID-19 vaccines will be streamed on YouTube in an apparent bid to build the public’s trust in an eventual vaccine, coming as polls show skepticism by consumers and also by some states in the agency’s approval process.

October 20, 2020 | Daily News

FDA has brought in seven temporary voting members to fill out its 17-member vaccines advisory committee, which will meet this Thursday (Oct. 22) to discuss general COVID-19 vaccine development and licensure or emergency use authorization data standards and policy issues.

October 20, 2020 | Daily News

The head of the industry-led Antimicrobial (AMR) Action Fund said the group is on track to begin investing in companies that manufacture promising new antibiotics by the first quarter of fiscal 2021, despite the COVID-19 pandemic.

October 19, 2020 | Daily News

The Supreme Court’s recent decision to punt back to a lower court a case over FDA’s in-person prescribing requirements for the abortion pill mifepristone has women’s health advocates, who oppose the requirements, on guard.

October 19, 2020 | Daily News

As FDA continues to urge the courts to reinstate its in-person prescribing restrictions on mifepristone, one women’s health expert is using the opening to proceed with her plans to study the prescribing and dispensing of mifepristone through telehealth without the need for ultrasounds or physical exams.

October 19, 2020 | Daily News

In three separate efforts, two consumer groups filed suits to try to force the government to hand over coronavirus-related contracts with drug makers and another group of government-oversight nonprofits filed Freedom of Information Act requests demanding access to contracts funneled through the private government contract management firm Advanced Technology International.

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