Women seek­ing the abor­tion pill mifepri­s­tone dur­ing the pan­dem­ic will be able to or­der it through the mail and will no longer have to go in­to a clin­ic in per­son, act­ing FDA com­mis­sion­er Janet Wood­cock wrote Mon­day in re­sponse to a se­ries of con­cerns from the Amer­i­can Col­lege of Ob­ste­tri­cians and Gy­ne­col­o­gists and the So­ci­ety for Ma­ter­nal-Fe­tal Med­i­cine.

Mifepri­s­tone is a drug that can end a preg­nan­cy that is less than 10 weeks along, and has cre­at­ed a whirl­wind of po­lit­i­cal and le­gal ques­tions re­lat­ed to this in-per­son re­quire­ment.

In an­nounc­ing the change, Wood­cock said that based on a re­view of the med­ical lit­er­a­ture, there does not ap­pear to be “in­creas­es in se­ri­ous safe­ty con­cerns (such as he­m­or­rhage, ec­topic preg­nan­cy, or sur­gi­cal in­ter­ven­tions) oc­cur­ring with med­ical abor­tion as a re­sult of mod­i­fy­ing the in-per­son dis­pens­ing re­quire­ment dur­ing the COVID-19 pan­dem­ic.” She al­so not­ed that the re­quire­ments of the drug’s risk eval­u­a­tion and mit­i­ga­tion strat­e­gy still need to be met.

This means that many pa­tients in need of ter­mi­na­tion of ear­ly preg­nan­cy will be able to ac­cess safe, ef­fec­tive mifepri­s­tone by mail, rather than hav­ing to risk avoid­able COVID ex­po­sure to them­selves and their clin­i­cians. 2/

— ACOG Ac­tion (@ACO­GAc­tion) April 13, 2021

Mifepri­s­tone has been en­snared in le­gal chal­lenges re­lat­ed to this in-per­son re­quire­ment for ac­cess­ing the drug since the pan­dem­ic be­gan.

The Supreme Court in Oc­to­ber did not al­low the for­mer Trump ad­min­is­tra­tion to re­strict ac­cess to mifepri­s­tone via this in-per­son re­quire­ment but said low­er courts should con­tin­ue hear­ing on­go­ing ar­gu­ments.

But Jus­tice So­nia So­tomay­or, joined by Jus­tice Ele­na Ka­gan, ex­plained how FDA and HHS waived in-per­son re­quire­ments for sev­er­al oth­er drugs dur­ing the pan­dem­ic, in­clud­ing con­trolled sub­stances like opi­oids, but still re­quired women to go in­to health care clin­ics to ob­tain mifepri­s­tone.

“Be­cause the FDA’s pol­i­cy im­pos­es an un­nec­es­sary, un­jus­ti­fi­able, ir­ra­tional, and un­due bur­den on women seek­ing an abor­tion dur­ing the cur­rent pan­dem­ic, and be­cause the Gov­ern­ment has not demon­strat­ed ir­repara­ble harm from the in­junc­tion, I dis­sent,” So­tomay­or wrote.

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.