It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. Women’s health has traditionally focused on what Seema Kumar, the CEO of Cure, coined as the “bikini zone.” However, reproduction and breast health are a drop in the bucket when it comes to women’s health. There are many conditions that disproportionately impact women. Other conditions and diseases affect women in different ways than men. Decades of research excluding women from clinical trials and investment decisions in male-dominated board rooms have ignored these facts. In fact, women were often excluded from clinical trials because of their complex physiology. Though an increasing number of women are now managing investments and driving the research, it’s all still woefully behind. In BioWorld’s new report, Healing the health divide, we’ve highlighted the disparities.

The science of gender-based medicine: many reasons, many manifestations

At the BioFuture 2024 conference held in New York in November, Seema Kumar, the CEO of Cure, described women’s health as something that has been directed at the “bikini area.” That “bikini” bias extended to both diseases and their causes – women’s health covered the breasts and reproductive system, and its causes were hormonal. Both concepts are far too narrow. Women’s health can be broadly split into three categories. The “bikini area” category of conditions that are specific to women is one. But there are also many diseases that affect women disproportionately, such as Alzheimer’s disease and many autoimmune conditions. And there are diseases, with cardiovascular disease the most prominent one, that look different in women than they do in men. Overall, the three categories add up to worse health for women.

Despite women’s health inroads, lackluster funding impedes progress

While women make up half the world’s population and own two out of every five businesses, there are substantial knowledge gaps about conditions affecting their health – mostly due to decades of research excluding women from clinical trials and investment decisions. Those that have tried to advance the women’s health field recall blank stares in male-dominated boardrooms. But an increasing number of women are now holding the purse strings for investment, driving the research, and envisioning improvements for women’s health and their quality of life. More conversations are turning the heads of venture capitalists, biopharma companies and government leaders. Still, some of the momentum appears to be stalling. BioWorld data show that only 26 biopharma companies with a women’s health asset in their pipelines have secured VC money so far in 2024, representing only 8% of all those funded.

FDA clears PTC’s Kebilidi for rare AADC deficiency

PTC Therapeutics Inc. won U.S. FDA accelerated approval of its gene therapy for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency. The drug, Kebilidi (eladocagene exuparvovec-tneq), is indicated for the treatment of children and adults with AADC deficiency including the full spectrum of disease severity. It’s the first-ever gene therapy cleared in the U.S. that is given directly to the brain. AADC deficiency is a highly morbid and life-shortening rare genetic disorder that results in the inability to synthesize dopamine. As part of the FDA green light, Warren, N.J.-based PTC gained a priority review voucher. Shares (NASDAQ:PTCT) were trading at $42.30, down $1.72.

Biontech acquiring PM-8002 through $950M Biotheus buyout

Biontech SE is extending its relationship with Biotheus Inc. from a licensing deal to a full-scale acquisition, agreeing to pay $800 million cash and up to $150 million in milestone payments for the Chinese oncology specialist. The acquisition will give Biontech full rights to PM-8002 (also designated BNT-327), a bispecific antibody targeting PD-L1 and VEGF-A, a combination that has been shown to be more effective than monotherapy with the PD-1 blockbuster Keytruda (pembrolizumab), in non-small-cell lung cancer. PM-8002 has “potential to set a new standard of care in multiple oncology indications, surpassing traditional checkpoint inhibitors,” said Ugur Sahin, CEO of Mainz, Germany-based Biontech.

BioWorld Insider podcast: Modifi gets creative on the rocky road to a multibillion-dollar buyout

Modifi Biosciences Inc. was recently acquired by Merck & Co. Inc. for $30 million up front. Modifi shareholders could receive milestones of up to $1.3 billion. It all happened in the dizzyingly short span of a little more than two years. Modifi’s founder, Ranjit Bindra, and a small group of advisers brought the company through preclinical work on DNA repair for treating glioblastoma and then twice faced running out of money and shutting down the company. Confounding the typical wisdom, Bindra and co-founder Kevin Rakin ended up putting the Merck deal together all by themselves. “People would actually ask, ‘Who is your banker that did the M&A deal?’ I said, ‘You're looking at them. It's me and Kevin Rakin.’ I learned a lot.” Bindra talks more about Modifi in the newest episode of the BioWorld Insider podcast.

Also in the news

89bio, Adaptimmune, Aileron, Atsena, Biontech, Biorestorative, Biotheus, Creative Medical Technology, Cullgen, Entero, Eupraxia, Genascence, Genesis, Gensight, Gilead, Healx, Immunic, Immuno Cure, Inovio, Journey, Keza, Lexicon, Marinus, Mediprint Ophthalmics, Metsera, Microbion, Nippon Shinyaku, Organogenesis, Ovid, Pulmatrix, Sanofi, Sparian, Syros, Theravance, Travere, Trexbio, Virpax, X4