Now more than ever, it’s im­por­tant for women to have op­tions when it comes to con­tra­cep­tion, said Bay­er’s se­nior VP and gen­er­al man­ag­er of women’s health­care John Berrios. The phar­ma gi­ant’s lat­est ap­proval for its pop­u­lar IUD prod­uct Mire­na should help with that.

Mire­na scored an ap­proval on Thurs­day to pre­vent preg­nan­cy for up to eight years, ex­tend­ing its use by one year. Reg­u­la­tors based their de­ci­sion on a Phase III ex­ten­sion tri­al show­ing Mire­na main­tained its ef­fi­ca­cy of greater than 99% dur­ing years 6 through 8, while ex­hibit­ing no new or un­ex­pect­ed safe­ty risks. It’s al­so ap­proved to treat heavy pe­ri­ods for up to five years.

The move comes as more than a dozen states have banned abor­tions fol­low­ing the Dobbs v. Jack­son Women’s Health Or­ga­ni­za­tion de­ci­sion, and a hand­ful of oth­ers seek to do the same.

“As a com­pa­ny, we do not sup­port any steps that take away con­tra­cep­tive choic­es, and we tru­ly do op­pose any ef­forts that lim­it those health­care op­tions,” Berrios said. “We are for her and we’re go­ing to con­tin­ue to be, like we have been for the last 61 years.”

Mire­na is a hor­mone-re­leas­ing IUD, which is in­sert­ed in­to the uterus dur­ing a clin­ic vis­it. It was first ap­proved back in 2000 to pre­vent preg­nan­cies for up to five years, and the ap­proval for sev­en-year use came last sum­mer. The com­pa­ny al­so has Kyleena, its low-dose T-shaped de­vice ap­proved back in 2016 to pre­vent preg­nan­cy for up to five years.

“Hav­ing that eight-year in­di­ca­tion we re­al­ly be­lieve gives women what they’re look­ing for in re­gards to long-act­ing birth con­trol,” Berrios said.

Bay­er was the first phar­ma to se­cure FDA ap­proval for an oral birth con­trol pill in 1960. In 2020, the com­pa­ny launched its “We’re For Her” cam­paign to ex­pand ac­cess to con­tra­cep­tion, with the hopes of reach­ing 100 mil­lion women by 2030.

“Over the last few months, with a lot of things in the press, there’s been a lot more peo­ple look­ing and search­ing for op­tions for birth con­trol. And we be­lieve that the amount of women look­ing for in­for­ma­tion has grown,” Berrios said. “Have we seen a sig­nif­i­cant in­crease in uti­liza­tion at this point? No. But I think this is a point where women are re­al­ly seek­ing op­tions and that’s our job, is to get the op­tions out.”

Look­ing ahead, the com­pa­ny is putting more em­pha­sis on so­cial me­dia cam­paigns, Berrios said, in­clud­ing through work with mi­cro-in­flu­encers.

“We re­al­ly want to be where peo­ple are and where they’re seek­ing in­for­ma­tion,” he said.

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.