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Rx Drugs

April 22, 2021 | Daily News

FDA and the pharmaceutical industry want to work together to advance decentralized trials, but to do so they need to figure out how to standardize data collection among health care providers and ensure the data collected are valid and reliable.

April 22, 2021 | Daily News

During its most recent on-site inspection of Emergent BioSolutions’ Baltimore facility, FDA found that the company failed to conduct a thorough investigation into how ingredients from AstraZeneca’s COVID-19 vaccine contaminated Johnson & Johnson’s COVID-19 vaccine, and the agency says there’s also no guarantee that other batches of J&J’s product have not been cross-contaminated.

April 21, 2021 | Daily News

Liberal Democrats are trying to get the president to include major drug-pricing reforms in his upcoming American Families Plan by unveiling bicameral drug pricing legislation Thursday (April 22), while House Republicans Wednesday (April 21) reintroduced their own version that includes dozens of bipartisan measures that are minor compared to what Democrats are expected to attempt.

April 21, 2021 | Daily News

HHS is considering administrative measures to enforce 340B program rules, according to an HHS court filing, and hospitals believe that means the administration will stop drug companies from denying drug discounts when providers use contract pharmacies to obtain drugs.

April 21, 2021 | Daily News

In a bid to ramp up demand for COVID-19 vaccines among working adults, the Biden administration will reimburse small- and medium-sized businesses for any paid time off they give to employees who get vaccinated and need time to recover from any side effects associated with the vaccine.

April 20, 2021 | Daily News

House oversight committee Democrats are investigating whether HHS awarded Emergent Biosciences a $628 million contract to make Johnson & Johnson’s coronavirus vaccine, which it botched, because of personal connections with a then-Trump HHS official when the company lacked the expertise to make the vaccine.

April 20, 2021 | Daily News

Johnson & Johnson will resume shipping its COVID-19 vaccine in Europe, the company announced Tuesday (April 20), after the European Medicines Agency’s pharmaceutical safety panel reviewed blood clot cases experienced by patients in the United States and determined the vaccine’s benefits still outweigh the risks.

April 20, 2021 | Daily News

Senate Democrats this week introduced legislation creating a new Medicare Part E that would be available to individuals on the ACA exchanges and to employers of all sizes.

April 19, 2021 | Daily News

Sixty-plus groups representing patients with disabilities and chronic diseases are objecting to a recent policy change by Cigna that they say the insurer uses to coerce non-medical switching of drugs.

April 19, 2021 | Daily News

A newly approved CAR T drug for multiple myeloma is overpriced in part because, unlike other chimeric antigen receptor T-cell drugs, it might need to be administered more than once, according to the Institute for Clinical & Economic Review.

April 16, 2021 | Daily News

FDA on Friday (April 16) revoked emergency use authorization for Eli Lilly’s COVID-19 monoclonal antibody therapy bamlanivimab, when used as a single therapy, coming nearly one month after HHS stopped distribution of the drug due to increased spread of COVID-19 variants that are resistant to bamlanivimab when it’s administered by itself.

April 16, 2021 | Daily News

A group of GOP lawmakers wants FDA to use real-world evidence from Israel and the United Kingdom to justify extending the amount of time patients can wait between getting their first and second shots of the currently authorized two-dose mRNA COVID-19 vaccines.

April 16, 2021 | Daily News

FDA biologics center director Peter Marks says data coming out of the United Kingdom will be helpful in figuring out whether COVID-19 vaccines can be mixed and matched, but emphasized that until more data emerge from ongoing studies, he doesn’t think it’s a good idea to combine different vaccines in the real world.

April 16, 2021 | Daily News

The Centers for Disease Control and Prevention’s vaccine advisory committee will reconvene Friday (April 23) to discuss whether Johnson & Johnson’s COVID-19 vaccine is OK to use in the United States after vaccinations were paused in light of reports of rare but serious blood clots experienced by six people who received the shot.

April 15, 2021 | Daily News

FDA this week released long-awaited guidance laying out the agency’s plans for tackling remote facility inspections during the COVID-19 pandemic.

April 15, 2021 | Daily News

Destined for the president’s signature are two bipartisan bills that aim to boost generic and biosimilar competition by restricting eligibility for drug exclusivity and by increasing confidence in biosimilars.

April 15, 2021 | Daily News

Nonprofit drug makers are anticipating introduction later this year of legislation aimed at helping their nascent sector with policies that might include reduced FDA user fees, and exemptions from taxes and the Medicaid best price rule. Advocates of non-profit drug makers are also floating regulatory options to boost the sector.

April 15, 2021 | Daily News

There are no drug pricing measures in the discretionary spending outline that the Biden administration released Friday (April 10), but they are expected to appear in the president’s budget request later this spring that senior administration officials said will include offsets.

April 15, 2021 | Daily News

Drug makers are spending much more to invent drugs than they did decades ago, and drug makers base research investments in part on how much they expect to profit from drugs, but they do not set prices to recoup past research spending, the Congressional Budget Office reported Friday (April 9).

April 14, 2021 | Daily News

FDA and the Centers for Disease Control and Prevention’s pause on use of Johnson & Johnson’s COVID-19 vaccine remains in effect after CDC’s vaccine advisory committee on Wednesday (April 14) temporarily put off any interim recommendations or a vote for or against the pause until more information on the rare blood clots linked to the vaccine are available.

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