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Rx Drugs

May 07, 2020 | Daily News

Sen. Elizabeth Warren (D-MA) urged the Trump administration Thursday (May 7) to increase production of vaccines, therapeutics, diagnostics and medical supplies by creating a federal agency to oversee public-private partnerships for the COVID-19 crisis.

May 07, 2020 | Daily News

House Speaker Nancy Pelosi (D-CA) told reporters Wednesday (May 6) that the chamber’s next stimulus package will include Energy & Commerce health subcommittee Chair Anna Eshoo’s (D-CA) bill that calls for an expert committee to assess the U.S. drug supply chain and recommend ways to reduce dependence on foreign drug manufacturing.

May 07, 2020 | Daily News

Hospitals in pandemic hot spots have been stretched thin, but they would have been worse off had they not recently started their own generic drug maker, Civica Rx, which has averted shortages of drugs used to treat COVID-19 patients, a Civica spokesperson said.

May 07, 2020 | Daily News

Regeneron told investors that it would have hundreds of thousands of doses of its experimental antibody cocktail to treat COVID-19 ready for distribution by the end of the summer, but biotech company executives say it’s too early to talk about whether Regeneron will donate its supply or what the treatment could potentially cost.

May 07, 2020 | Daily News

Pharmaceutical companies anticipate sales returning to normal by the end of the year as life normalizes and people begin returning to doctors’ offices for nonessential procedures and wellness visits, several industry executives said during first quarter investor calls.

May 06, 2020 | Daily News

Former FDA chief Scott Gottlieb and Zeke Emanuel, former special adviser to the Obama White House on health policy, disagree on the timeline for when a COVID-19 vaccine will be available.

May 06, 2020 | Daily News

Health care technology company Aetion is calling for FDA to implement a cloud-based real-world evidence platform with robust data governance to allow for data queries, archiving, access and aggregation.

May 05, 2020 | Daily News

Eton Pharmaceuticals Inc. wants FDA to remove phenylephrine hydrochloride from its list of bulk ingredients that are eligible for compounding, despite numerous requests from pharmacy groups asking the agency to continue to make it eligible.

May 05, 2020 | Daily News

The price of a course remdesivir, the first drug to show modest improvements in severely ill COVID-19 patients, could be set between $10 and $4,500, according to the Institute for Clinical and Economic Review.

May 04, 2020 | Daily News

With a possible second wave of infections for COVID-19 patients looming in the distance, both House lawmakers working on the next CURES bill and Congress’ investigative arm stress a need for post-market financial incentives to spur new antimicrobial drug development. But HHS isn’t convinced.

May 01, 2020 | Daily News

FDA on Friday (May 1) issued Emergency Use Authorization for Gilead’s remdesivir to treat lab-confirmed COVID-19 in hospitalized adults and children.

May 01, 2020 | Daily News

House Energy & Committee Chair Frank Pallone (D-NJ) wants his committee to push key policies he says are critical to reopening the economy.

April 30, 2020 | Daily News

The generic drug lobby is floating a policy proposal to secure the pharmaceutical supply chain under which HHS would identify essential U.S. medicines and then proactively incentivize both individual companies and the entire industry to ramp up domestic manufacturing, including through streamlined FDA regulations, tax incentives, and long-term price and volume guaranteed contracts.

April 30, 2020 | Daily News

The Department of Justice will allow AmerisourceBergen to work with other private suppliers to increase U.S. supplies of COVID-19 drugs without violating antitrust law.

April 30, 2020 | Daily News

Generic drug prices decreased significantly in February, despite a recent trend upward after years of deflation, according to the drug-price-tracking nonprofit 46Brooklyn, though naproxen was a notable exception to that trend.

April 29, 2020 | Daily News

After Gilead Sciences trumpeted positive data emerging from a National Institute for Allergy and Infectious Diseases’ study of remdesivir to treat COVID-19, NIAID chief Anthony Fauci called the results “very optimistic” but not a “knock out,” according to the White House press pool’s rough transcript of his remarks.

April 28, 2020 | Daily News

Key House lawmakers released a concept paper Monday (April 27) outlining FDA and clinical trial reforms they want included in the second iteration of the 21st Century Cures Act, though they say some of the proposals could be wrapped into the next rounds of COVID-19 relief legislation this year.

April 28, 2020 | Daily News

Pfizer could have clinical results of one of its COVID-19 vaccine candidates by late May or June, and the company hopes to make the vaccine available for emergency use by October, Chief Scientific Officer Mikael Dolsten said Tuesday (April 28).

April 27, 2020 | Daily News

Two major pharmacy associations on Monday (April 27) released draft guidelines to help state boards of pharmacy ensure compounding pharmacies comply with FDA’s recent guidance that temporarily eases restrictions on pharmacy compounders and allows pharmacists to compound drugs for hospitals without first receiving a patient-specific prescription.

April 27, 2020 | Daily News

The Indian Pharmaceutical Alliance is urging FDA to conduct desk reviews, including virtual inspections, of certain drug manufacturing facilities in India for the duration of the COVID-19 pandemic as a way to proceed with facility inspections and mitigate future drug shortages.

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