September 2025 • PharmaTimes Magazine • 9
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Gedeon Richter launches Nalvee in UK to expand HRT options for menopause
Gedeon Richter UK has launched Nalvee (10mg dydrogesterone) in the UK, marking the return of a dydrogesterone-only formulation for hormone replacement therapy after more than 17 years.
The oral tablet offers clinicians a new progestogen option for non-hysterectomised women receiving oestrogen therapy.
Nalvee is a branded generic of a product first introduced in 1961 but withdrawn from the UK market in 2008 due to declining HRT use. It remains available in other countries and has a favourable safety profile from over 60 years of clinical use.
Dydrogesterone closely mimics natural progesterone and is highly bioavailable. It protects the endometrium from unopposed oestrogen and supports a predictable bleeding pattern. Studies show 97% success in endometrial protection with the 10mg dose.
Its high specificity for progesterone receptors allows efficacy at low doses – ten to 20 times lower than micronised progesterone. Clinical trials confirm its effectiveness and tolerability in postmenopausal women.
A meta-analysis of four studies showed that dydrogesterone combined with oestradiol produced well-tolerated bleeding profiles. Most women reported slight cyclical bleeds with predictable duration, enhancing treatment satisfaction.
Dr Paula Briggs, Consultant in Sexual and Reproductive Health, said: “One of the major reasons given by women for discontinuing HRT is the return of bleeding often requiring further investigation.”
She added: “This dydrogesterone-only treatment, with its favourable endometrial safety profile and predictable, lighter bleeding patterns, gives clinicians another option to personalise HRT to enhance patient satisfaction.”
Moderna wins EU approval for updated COVID-19 vaccine
Moderna has received marketing authorisation from the European Commission for its updated COVID-19 vaccine, Spikevax, which targets the SARS-CoV-2 variant LP.8.1. The vaccine is approved for use in individuals aged six months and older.
The authorisation follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. It applies across all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
Doses will be available ahead of the 2025-2026 vaccination season for eligible populations. The decision aligns with guidance from global health authorities recommending vaccines be updated to target LP.8.1.
Moderna’s chief executive officer Stéphane Bancel said: “We appreciate the EC’s timely review and are pleased that our updated COVID-19 vaccine will be available to protect the public against currently circulating strains.”
He added: “COVID-19 continues to impact individuals and healthcare systems globally and we encourage people to speak to their healthcare providers about receiving an updated vaccine.”
Moderna’s COVID-19 vaccines have generally been well-tolerated. The most common local adverse event is injection site pain. Systemic adverse events include headache, fatigue, myalgia and chills.
Additional regulatory applications for the updated vaccine are under review in other countries.
HOT & NOT
Ovagen has announced a major advance in vaccine manufacturing, with new data showing its germ-free embryonated eggs can produce over 7,600 doses of yellow fever vaccine per egg—18 times more than current industry standards.
The study, conducted at the Pirbright Institute in the UK, compared Ovagen’s eggs with those from two leading suppliers of specified pathogen-free (SPF) eggs. Results showed yields of just 6 and 422 doses per SPF egg, respectively.
AstraZeneca has received a positive recommendation from NICE for the use of Imfinzi with Imjudo in adults with advanced or unresectable hepatocellular carcinoma.
The decision marks the first NICE approval of a dual immunotherapy for liver cancer in the UK.
The recommendation is based on data from the HIMALAYA phase 3 trial, which evaluated the STRIDE regimen. The study showed a statistically significant improvement in overall survival compared to sorafenib.
Everest Medicines has announced a strategic equity investment of US$30.9 million in I-Mab, acquiring 15,846,154 newly issued American depositary shares at US$1.95 per share. Following the transaction, Everest will hold approximately 16.1% of I-Mab’s total issued share capital.
The investment includes Everest’s existing 6,078,571 ordinary shares in I-Mab. Other participants in the offering include Janus Henderson Investors, Adage Capital Partners LP, Woodline Partners and Exome Asset Management.
Microbiotica has completed patient recruitment for its phase 1b trial, COMPOSER-1, evaluating MB310 in adults with ulcerative colitis.
The study has enrolled 29 patients across sites in the UK, Austria, Bulgaria, Poland and Spain. Initial results are expected by the end of 2025.
COMPOSER-1 is a randomised, placebo-controlled, double-blind trial assessing safety, tolerability and early efficacy signals of MB310. The study also measures how well MB310’s bacterial strains engraft into the patients’ gut microbiome.
A study by Guardian Carers reveals that NHS Gloucestershire patients have to wait the longest for a GP appointment in the country.
NHS data from England’s 42 Integrated Care Boards on GP appointments from December 2022 to May 2025 was analysed to identify the one with the longest wait times based on the percentage that took more than 28 days.
NHS Gloucestershire is first on the list, with 408,968 appointments that took over 28 days to occur, which translates into 8.59% of all appointments.
Responding to recent strikes by NHS doctors, Rory Deighton, acute director at the NHS Confederation, said:
“It is bitterly disappointing that the BMA has not taken the decision to call off the strikes and that patients and the public now face five days of widespread disruption. This is in spite of efforts by the government and the NHS to avert the strike.
“While we recognise the concerns that resident doctors have, we believe the strikes are a misjudged course of action.”