An obesity drug marketed by Novo Nordisk A/S has been shown to reduce the risk of major adverse cardiovascular events in adults who are overweight. The drug, semaglutide (Wegovy), has been approved in both the US and Europe as an adjunct to diet and exercise for the treatment of obesity. Now its effectiveness as a potential agent for lowering cardiovascular risk has been demonstrated for the first time in a clinical trial.
MorphoSys AG highlighted its expectations for upcoming Phase 3 data for its lead investigational product pelabresib in myelofibrosis during its quarterly results call with analysts on 10 August. Jean-Paul Kress, the chief executive, said the company is focused on completing the trial and getting it approved for marketing. Pelabresib is a small molecule drug which MorphoSys acquired with its takeover of Constellation Pharmaceuticals in 2021. If the data are positive and the drug is approved, pelabresib would be the company’s second wholly-owned drug on the market.
Bactolife A/S, a Danish bioindustrial company, has raised €30 million in Series A financing to develop and commercialise a new protein-based product to strengthen the gut microbiome of humans and animals. The goal is reduce gastrointestinal infections and resistance to antibiotics.
Regeneron Pharmaceuticals Inc, a developer of antibody therapeutics, is to acquire Decibel Therapeutics Inc, giving it ownership of three gene therapy programmes targeting different types of congenital, monogenic hearing loss. The two companies have been collaborating since 2017 and are now taking their lead therapy for congenital hearing loss forward to the clinic. The transaction, announced on 9 August, will involve a cash payment by Regeneron to Decibel of $4 per share for the target company’s common stock.
GSK Plc’s antibody treatment Jemperli (dostarlimab) for solid tumours and endometrial cancer has been given a third indication by the US Food and Drug Administration, this time as a frontline treatment for recurrent endometrial cancer. It is now authorised in combination with carboplatin and paclitaxel chemotherapy, followed by Jemperli as a single agent, for patients with endometrial cancer that is mismatch repair deficient, as shown by an FDA test. Mismatch repair deficient (dMMR) cancers are those where errors arising during DNA replication are not corrected.
The US Food and Drug Administration has approved a new medicine to treat postpartum depression (PPD) – the first oral treatment for a condition that can affect women after childbirth or in the later stages of pregnancy. Zurzuvae (zuranolone), is a neuroactive steroid that is thought to work by rebalancing brain networks responsible for mood and cognition. It is the second drug to be approved for this condition after Zulresso (brexanolone) which was authorised by the agency in 2019 but can only be administered intravenously.
Biogen Inc is to add another marketed product to its portfolio of treatments for neurological diseases with the acquisition of Reata Pharmaceuticals Inc in a deal valued at $7.3 billion. Announced on 28 July, the deal involves a cash payment to Reata’s shareholders of $172.50 per share. The transaction is expected to close in the fourth quarter and will be slightly dilutive to Biogen’s earnings per share in 2023, roughly neutral in 2024, and accretive beginning in 2025. Biogen expects to finance the acquisition with cash on hand, supplemented by the issuance of debt.
AstraZeneca Plc, through its wholly-owned rare disease business unit Alexion, is to buy a portfolio of preclinical gene therapy programmes from Pfizer Inc. The deal will bring together Alexion’s expertise in rare disease medicines with AstraZeneca’s growing presence in the field of cell and gene therapy.
AstraZeneca Plc ended the second quarter with total revenue of $11.4 billion, up by 6% on a reported basis, and by 9% in constant exchange rates (CER). Excluding products developed for the Covid-19 pandemic, the rise was 14% and 17% respectively – figures that underscored the breadth of the company’s product portfolio.
The Roche Group is forecasting a decline in sales by a low single digit percentage at constant exchange rates this year due to a steep drop in sales for its Covid-19 diagnostic products. Excluding the Covid-19 effect, the company expects to show solid growth in the base business. Roche’s pharmaceuticals division continued to be the stronger player, generating three times the sales volume as that of diagnostics.