More than 70 ad­vo­cates — rang­ing from ac­tors to CEOs — signed a let­ter to Vi­iV chief ex­ec­u­tive Deb­o­rah Wa­ter­house on Tues­day re­quest­ing a low­er price for the com­pa­ny’s long-act­ing HIV in­jectable for pre-ex­po­sure pro­phy­lax­is (PrEP) Apre­tude.

The let­ter, pub­lished by the Joint Unit­ed Na­tions Pro­gramme on HIV/AIDS, ar­gues that Apre­tude should be priced “as close as pos­si­ble to that of oth­er HIV pre­ven­tion med­i­cines,” or around $60 per year.

Apre­tude is first giv­en as two in­jec­tions giv­en a month apart from each oth­er, and then every two months af­ter. The list price is cur­rent­ly $3,700 per dose, ac­cord­ing to GoodRx. Vi­iV al­so has a long-act­ing treat­ment for HIV called Cabe­nu­va, which cost around $4,000 a month when it was first ap­proved last year, ac­cord­ing to the New York Times. While the drug was ini­tial­ly ap­proved as part of a month­ly reg­i­men, the FDA cleared it for use once every two months ear­li­er this year.

“We are con­cerned that long-act­ing in­jectable PrEP may not be af­ford­able and avail­able for years to come, in­clud­ing in the very coun­tries and com­mu­ni­ties where stud­ies proved its ef­fi­ca­cy, un­less ac­tion is tak­en soon. But we are con­fi­dent that your col­lab­o­ra­tion can change this,” the let­ter reads.

It was signed by more than 70 ad­vo­cates, in­clud­ing Quar­raisha Ab­dool Karim, co-founder and as­so­ciate sci­en­tif­ic di­rec­tor of the Cen­tre for the AIDS Pro­gramme of Re­search in South Africa; UN­AIDS ex­ec­u­tive di­rec­tor Win­nie Byany­i­ma; Deb­o­rah Gold, CEO of the Na­tion­al AIDS Trust; and British ac­tor David Oyelowo, known best for his por­tray­al of Mar­tin Luther King, Jr. in the film “Sel­ma.”

Vi­iV said in an emailed state­ment:

We have a strong track-record of work­ing with the glob­al HIV com­mu­ni­ty to achieve our com­mon goal of mak­ing our HIV med­i­cines wide­ly avail­able around the world for those who could ben­e­fit from them, ir­re­spec­tive of where they live. We are com­mit­ted to help­ing ex­pand ac­cess to our newest med­i­cine, cabote­gravir long-act­ing for PrEP, which we be­lieve has the po­ten­tial to be a game chang­er in HIV pre­ven­tion, and we are work­ing at speed with part­ners to find so­lu­tions, in­clud­ing rapid­ly fi­nal­is­ing a vol­un­tary li­cence agree­ment with the Med­i­cines Patent Pool.

The Joint Unit­ed Na­tions Pro­gramme on HIV and AIDS set a goal back in 2019 to end the HIV epi­dem­ic by 2030. How­ev­er, progress has been slow­ing, ad­vo­cates say.

Back in May, Vi­iV said it was in talks with the UN-backed Med­i­cines Patent Pool (MPP) for patent rights to its HIV in­jectable in low- and mid­dle-in­come coun­tries.

“We ap­pre­ci­ate Vi­iV’s will­ing­ness to col­lab­o­rate with the HIV com­mu­ni­ty and the com­pa­ny’s re­cent state­ments on its in­ten­tion to ne­go­ti­ate a li­cense with the Med­i­cines Patent Pool and of­fer a low­er price for some key coun­tries,” the let­ter reads. The ad­vo­cates main­tained that Vi­iV should work to “quick­ly fi­nal­ize” those li­cens­es.

“We look for­ward to ap­plaud­ing your de­ci­sions to help pre­vent mil­lions of in­fec­tions and save many lives — and will be watch­ing for your an­nounce­ments to that end,” the let­ter states.

When gene editing exploded onto the scene over three decades ago, it brought previously inconceivable disease treatment and potentially curative therapies into view. Today, gene editing remains one of the most gripping topics in biopharma — and a recent wave of partnerships may move the industry even closer to broad, curative treatment for genetic disease.

Discoveries across the natural environment deriving in vivo and ex vivo biotechnologies have ushered a floodgate of development possibilities. With giants like Bayer, Moderna, Vertex and others signaling that gene editing will be a key driver of their future pipelines, how will the industry leverage this new frontier of genomic technology?

Roche CEO Severin Schwan will be moving to the board chairman role in a few months, making room for Thomas Schinecker — the current chief of the diagnostics division — to take the helm of the Swiss pharma conglomerate.

The changeover will take place at the company’s annual general meeting in March as Christoph Franz, chairman since 2014, decided not to seek re-election to the board.

The shuffle at the top comes as Roche has steadily beefed up its early-stage pipeline while vigilantly guarding its position as one of the top drugmakers around the world. By Evaluate’s estimate, it is set to rank second on the list of largest pharmas by 2028, falling just a tad behind AbbVie.

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Monica Bertagnolli, an eminent surgical oncologist and physician-scientist, is set to succeed Ned Sharpless as director of the National Cancer Institute.

Although the White House has yet to confirm the appointment, multiple cancer research organizations and patient advocacy groups applauded the choice, including ASCO, where Bertagnolli previously served as president. Currently a professor of surgery at Harvard Medical School, and the chief of the Division of Surgical Oncology at Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Bertagnolli would be the first woman to lead the NCI.

With demand rising for Bavarian Nordic’s smallpox vaccine, European officials have given the thumbs up to expand the label to include monkeypox.

Imvanex, marketed as Jynneos in the US, has been approved in Europe to treat smallpox since 2013. On Friday, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended adding a monkeypox indication to the label, as global cases surge past 15,000. The label expansion still needs to be approved by the European Commission before it’s official.

After Olympic gold medalist Lindsey Vonn’s first major knee surgery in 2013, she couldn’t sleep. That was the beginning of a cycle of more injuries, added anxiety and stress snowballing into an eventual diagnosis of insomnia.

Now Vonn’s teaming up with Idorsia Pharmaceuticals on its sleep drug Quviviq as its newest celebrity patient ambassador. Vonn appeared in media interviews this week, including on the Today Show and People magazine, talking about her struggles with sleep, along with overall mental health issues.

Lonza’s recent building spree and contracts have the manufacturer looking positive as it enters the second half of the year.

According to Lonza’s financial report for H1, which was released on Friday, the Swiss manufacturer posted sales of CHF 3 billion, or $3.1 billion, granting them a total of 16.8% growth in sales.

The first half’s core EBIDTA for Lonza also rose 33.1% according to the company. The company is still targeting low to mid-teen sales and EBIDTA growth for the year.

The room was packed and electric. That’s how it felt hosting an event in person for Endpoints News readers last month in San Diego.

It exceeded all our expectations, which wasn’t a given, with the pandemic changing the nature of live events. We hadn’t done one in over two years. And Endpoints grew a lot during that time. We quickly built a serious virtual events platform and developed big audiences around those online channels. But there’s nothing quite like being with your colleagues at a live event. Endpoints has a tradition of convening our audience of biopharma pros in major hubs worldwide since our start in 2016. And we’re thrilled to jump right back in.

A day after the House passed a bill that would protect Americans’ right to contraceptives, biotech execs say they will keep fighting for better access to novel birth control products.

The big question now is whether the legislation will survive the Senate floor.

The House voted 228-195 on Thursday to pass a law that would ensure the right to obtain and provide contraceptives. It would also allow patients, providers and federal or state governments to bring civil suits against states or officials that violate the law.

As more and more biotechs are looking into the potential applications of using real-world evidence in regulatory submissions, the European Medicines Agency is calling for more widespread adoption.

EMA endorsed a statement published Friday by ICMRA, the International Coalition of Medicines Regulatory Authorities, highlighting the use of both RWE and real-world data in development and regulatory authorizations, noting their role

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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