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Rx Drugs

May 15, 2020 | Daily News

FDA on Thursday (May 14) unveiled a final Memorandum of Understanding (MOU) on interstate distribution of drugs by pharmacy compounders that gives state pharmacy boards a key monitoring role and gives states a year to decide whether to sign the pact, which requires FDA be notified when more than 50% of a compounded drug is sold out-of-state.

May 14, 2020 | Daily News

Forty Democratic senators, led by Sen. Dick Durbin (D-IL), unveiled a resolution to urge the United States to get involved with global efforts to fund and develop COVID-19 vaccines and treatments, including the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and the World Health Organization’s Solidarity clinical trial.

May 14, 2020 | Daily News

The Biotechnology Innovation Organization has appointed drug industry executive Michelle McMurry-Heath, a former senior FDA official, as its new president and CEO effective June 1, when current BIO President and CEO Jim Greenwood steps down, the organization announced Thursday (May 14).

May 14, 2020 | Daily News

Consumer and union lobbies worry that AbbVie will use its acquisition of Allergan to construct rebate walls that block competition to Allergan’s migraine drugs.

May 14, 2020 | Daily News

The federal government will need to help pay for COVID-19 vaccine production and determine who gets limited supplies, Moderna Therapeutics executives said Thursday (May 7), but they declined to say whether there is a profit-sharing agreement with the government or what the company would eventually charge for Moderna’s vaccine, which the company plans to start in phase three clinical trials this summer.

May 14, 2020 | Daily News

Members of the Senate health committee failed to get administration officials to commit to making COVID-19 drugs and vaccines affordable for everyone or to ensure their equitable distribution.

May 13, 2020 | Daily News

House Democrats’ latest COVID-19 relief legislation, unveiled Tuesday (May 12), calls for the United States to participate in a global consortium that was set up to develop vaccines for high-priority epidemics, known as the Coalition for Epidemic Preparedness Innovations (CEPI).

May 13, 2020 | Daily News

European Union trade officials on Friday (May 15) will discuss EU-U.S. trade relations as the bloc’s trade commissioner, Phil Hogan, looks to refresh the trans-Atlantic relationship and address some irritants between the two on the path to economic recovery.

May 12, 2020 | Daily News

Hospitals scored a win Monday (May 11) when CMS proposed a new national unadjusted pay rate for hospitals that administer chimeric antigen receptor T-cell (CAR-T) treatments for cancer that would increase the reimbursement rate.

May 12, 2020 | Daily News

Drug sponsors should initiate COVID-19 drug development discussions using a pre-investigational new drug meeting request instead of a pre-Emergency Use Authorization request, FDA says in guidance out Monday (May 11) that lays out a consolidated, streamlined version of the typical pre-IND meeting request and package development process.

May 12, 2020 | Daily News

FDA is urging drug and biologic sponsors to study potential COVID-19 drugs in randomized, placebo-controlled trials that include high-risk individuals and patients with renal impairment, according to a Monday (May 11) guidance document.

May 12, 2020 | Daily News

FDA Commissioner Stephen Hahn sent out a memo Monday (May 11) laying out a process to return to in-person surveillance inspections that have been delayed by the COVID-19 pandemic.

May 11, 2020 | Daily News

HHS announced Saturday (May 9) that state health departments will have authority to decide which hospitals receive doses of Gilead’s investigational COVID-19 drug, remdesivir, adding that health care providers who want to administer the drug should contact their state health departments.

May 08, 2020 | Daily News

The American Society of Health-System Pharmacists on Friday (May 8) asked the Trump administration to give hospitals flexibility to reallocate Gilead’s investigational COVID-19 drug remdesivir to meet changing needs, coming as doctors express concern that there’s not enough supply of the drug to go around.

May 07, 2020 | Daily News

CMS on Thursday (May 7) expanded a copay policy to let Obamacare plans exclude brand drug makers’ coupons from out-of-pocket calculations even when there are no generics available.

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.

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