FDA sched­ules joint ad­vi­so­ry com­mit­tee meet­ing to con­sid­er first over-the-counter birth con­trol pill

The FDA has set a date to re­view what could be­come the first over-the-counter birth con­trol pill ap­proved for use in the US.

HRA Phar­ma, re­cent­ly ac­quired by Dublin-based Per­ri­go, filed back in Ju­ly to make its dai­ly prog­estin-on­ly Opill avail­able with­out a pre­scrip­tion. On Mon­day, the reg­u­la­to­ry agency sched­uled a joint meet­ing of its Non­pre­scrip­tion Drugs Ad­vi­so­ry Com­mit­tee and the Ob­stet­rics, Re­pro­duc­tive and Uro­log­ic Drugs Ad­vi­so­ry Com­mit­tee to re­view the ap­pli­ca­tion on Nov. 18 from 9 am to 5:30 pm ET.

The news comes less than two weeks af­ter CEO David Wright stepped down af­ter five years at the helm, leav­ing chief com­mer­cial of­fi­cer Mar­tyn Hilton to run the com­pa­ny in the in­ter­im. Wright has since found­ed his own con­sult­ing firm called DJW Ad­vi­so­ry, ac­cord­ing to LinkedIn.

David Wright

“Giv­en the sig­nif­i­cant progress HRA has made, along with my per­son­al goals af­ter lead­ing HRA for more than five years, I be­lieve now is the time to step away from the busi­ness,” he said in a news re­lease last month.

Opill was first ap­proved back in 1973, more than a decade af­ter the first birth con­trol pill. But even with a raft of con­tra­cep­tives on the mar­ket, al­most a third of women who’ve ever tried to get ac­cess to birth con­trol pills, patch­es and rings have ex­pe­ri­enced dif­fi­cul­ty, ac­cord­ing to HRA. The com­pa­ny be­lieves an OTC op­tion could help pre­vent some of the near­ly 3 mil­lion un­want­ed preg­nan­cies in the US each year.

“For many, a birth con­trol pill may be the best op­tion for them but re­quir­ing a pre­scrip­tion is an un­nec­es­sary ob­sta­cle that can put it out of reach,” OBG­YN Melis­sa Kot­tke said in a news re­lease a cou­ple of months ago.

Mar­tyn Hilton

HRA’s prog­estin-on­ly pill Hana is al­ready ap­proved for OTC use in Britain, and the com­pa­ny hopes it’s just a mat­ter of time for an OK in the US.

The Amer­i­can Col­lege of Ob­ste­tri­cians and Gy­ne­col­o­gists has pre­vi­ous­ly point­ed out that prog­estin-on­ly hor­mon­al meth­ods are “gen­er­al­ly safe” and car­ry a low risk of blood clot­ting, a po­ten­tial side ef­fect that’s more like­ly af­ter tak­ing es­tro­gen prod­ucts. The re­searchers said about three years ago that “women are ca­pa­ble of us­ing self-screen­ing tools to de­ter­mine their el­i­gi­bil­i­ty for hor­mon­al con­tra­cep­tive use.”

Frédérique Wel­gryn

Most women in the US use con­tra­cep­tives at some point in their life­times, and birth con­trol pills are the sec­ond most pop­u­lar op­tion un­der fe­male ster­il­iza­tion, ac­cord­ing to the CDC.

HRA’s chief strate­gic op­er­a­tions and in­no­va­tion of­fi­cer Frédérique Wel­gryn told the New York Times a cou­ple of months ago that the OTC ap­pli­ca­tion for Opill has been in the works for quite some time, and that the tim­ing of the Supreme Court’s de­ci­sion to over­turn Roe v. Wade was just a “sad co­in­ci­dence.”

While the FDA isn’t re­quired to fol­low an ad­comm’s rec­om­men­da­tions, it typ­i­cal­ly does.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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