Women's Health
The Copenhagen-headquartered group is taking its antibody-drug conjugate rinatabart sesutecan into Phase III and chief medical officer Tahi Ahmadi tells Scrip that it has the potential to treat far more women than the only currently marketed FRα-targeting ADC, AbbVie's Elahere.
The US FDA updated labeling for Astellas’ drug for hot flashes after a postmarketing report of a single patient with signs and symptoms of liver injury taking the medicine.
CEO Bill Anderson would not be drawn on whether the drug, currently approved for chronic kidney disease associated with type 2 diabetes, will hit a previous forecast of €3bn peak sales, but expansion into heart failure may make that figure look conservative.
As sales of the Japanese drugmaker’s non-hormonal treatment for menopausal symptoms Veozah finally take off, the German major has filed its potential competitor, elinzanetant, with the US Food and Drug Administration.
While its European licensee is preparing for an imminent launch, Kissei has also been expanding its partnerships in Asia for female health product linzagolix. A new alliance is also being sought in the US to assist with a new trial and NDA refiling there.
The Japanese pharma’s new US commercial head Michael Petroutsas talked to Scrip about the launches of Veozah and Izervay.
Two top-50 Indian firms are speculated to be on the block with valuations expected to be richer than past multiples paid by buyers. A small, less known life sciences solutions provider is also keen to rope in a CDMO partner. Scrip speaks to a cross-section of experts on the action in deal street.
Bayer will submit its non-hormonal treatment for vasomotor symptoms associated with menopause for approvals this year, still eyeing €1bn-plus in peak sales despite a rival’s slow start.
The pharmaceutical division is expected to be the three-pillared German group's primary growth driver for the foreseeable future and the launch of new cardiovascular and woman's health products should help manage the loss of exclusivity on Bayer's biggest earner.
Organon's commercial director and lead for the South Asia region, Anjan Sen, discusses with Scrip the prospects of contraceptive Implanon NXT with its inclusion in India’s historic family planning program. The Merck spin-out is also on course to debut its Jada System this year, opening up new growth avenues as it disentangles and builds out operations in the region.
Multiple factors were behind Merck & Co’s rise to ace AstraZeneca and others to become the leading pharma multinational in the world’s second-largest pharma market in 2023, including partnerships and competition and a strong position in the growing HPV vaccine sector.
A mention in India’s interim budget of support for HPV vaccination is heartening for Serum Institute and Merck as it is seen as a precursor to the vaccine’s inclusion in the country’s Universal Immunization Program, one of the largest public health programs globally. As Serum plans to expand capacity, will Merck drop Gardasil prices for a piece of the UIP pie?
Astellas’s fezolinetant is already on the market but Bayer is confident its non-hormonal menopause drug elinzanetant will be able to catch up on the back of demonstrating significant reductions in the frequency and severity of hot flashes in a couple of Phase III trials.
In this week's podcast edition of Five Must-Know Things: Pfizer’s cost improvement and COVID outlook; Roche CEO outlines M&A criteria; Organon maintains women’s health focus; will Indian pharma families sell their stakes; and a look at new therapies in the pipeline for multiple myeloma.
The major’s PD-L1 inhibitor is the first to win US approval for the treatment of first-line endometrial cancer in combination with chemotherapy, but an unsurprisingly narrow label means rival Merck & Co.’s Keytruda could still make a splash in this indication.
Veozah received approval from the US FDA for a common symptom of menopause, a therapeutic area that has lacked pharmaceutical advancements.
The German major has pinned its early-stage research colors to the masts of oncology, cardiovascular, neurology, rare diseases and immunology, representing a shift away from rather than an abandonment of women’s health.
While reproductive medicine and maternal health remains the mainstay for the Swiss group, Ferring president Per Falk says the approvals of the microbiome treatment Rebyota and bladder cancer gene therapy Adstiladrin represent "important avenues for exploration and growth."
The Danish biotech has secured more funding for a late-stage program to advance its vaccine against Group B streptococcus, which is in a race for approval with Pfizer's product.