Company News

Merck, Orna Therapeutics to collaborate on RNA

Thursday 18 August 2022
Country
United States

Merck & Co Inc has entered into a collaboration with the Cambridge, US biotech company Orna Therapeutics Inc to discover new therapeutics using engineered RNA molecules. Simultaneously, Orna has raised $221 million in a Series B financing round to accelerate development of its technology platform which includes a proprietary lipid nanoparticle delivery system. Orna calls its engineered RNA molecules circular RNA therapeutics (oRNA) because they have been transformed from a linear format into a circular format.

Gene therapy for beta thalassaemia

Thursday 18 August 2022
Country
United States

The first cell-based gene therapy for the treatment of patients with beta thalassaemia, an inherited blood disorder, was approved by the US Food and Drug Administration on 17 August. Zynteglo (betibeglogene autotemcel) is a one-time treatment administered as an ex vivo lentiviral vector gene therapy. A functional beta globin gene is added into a patient’s cells outside of the body and then infused back into the patient. The treatment process is comprised of several steps and will be administered at qualified treatment centres in the US.

Lundbeck to seek new indication for Rexulti

Wednesday 17 August 2022
Country
Denmark

H. Lundbeck A/S and its Japanese partner Otsuka Pharmaceutical Co Ltd expect to make a regulatory filing for a new indication for Rexulti, an approved drug for schizophrenia and depression, before the end of the year. The proposed indication, for agitation in patients with Alzheimer’s dementia, would be supported by positive data from a Phase 3 study showing a statistically significant reduction in agitation in patients receiving the drug compared with placebo. The trial results were reported in June.

Enhertu approved for lung cancer in US

Wednesday 17 August 2022
Country
United States

Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration to treat non-small cell lung cancer whose tumours have activating HER2 mutations. The accelerated approval comes just a week after Enhertu, an antibody-drug conjugate (ADC), was authorised by the FDA for a new breast cancer indication. The decision, announced on 12 August, brings the total number of US regulatory approvals for the drug up to five, all of which are for cancers expressing the HER2 protein.

Verona Pharma raises $150 million

Wednesday 17 August 2022
Country
United Kingdom

Verona Pharma Plc has raised $150 million from a public share offering on Nasdaq in order to support development of ensifentrine, its small molecule drug for chronic obstructive pulmonary disease. The UK company recently completed the first of two Phase 3 trials of ensifentrine in preparation for a possible regulatory submission to the US Food and Drug Administration in the first half of 2023.

Novartis lung cancer trial misses endpoint

Tuesday 16 August 2022
Country
Switzerland

A Phase 3 trial of canakinumab in patients with non-small cell lung cancer failed to meet its primary endpoint of disease-free survival compared with placebo despite earlier positive signals of the drug’s potential in the disease. The developer, Novartis, announced the results on 15 August. Canakinumab (Ilaris) is an approved treatment for arthritis and periodic fever syndromes and was being studied as an adjuvant treatment in patients with stages 2 to 3A and 3B lung cancer. The Phase 3 trial did not throw up any unexpected safety signals.

GSK gets option on ADC targeting HER2

Sunday 14 August 2022
Country
United Kingdom

GlaxoSmithKline Plc has obtained an exclusive option to co-develop and commercialise an experimental antibody-drug conjugate (ADC) that is designed to activate the innate immune system in order to fight cancers expressing the HER2 protein. The partner is Mersana Therapeutics Inc of Cambridge, US which has a pipeline of clinical and preclinical ADCs.

Genmab raises financial guidance

Sunday 14 August 2022
Country
Denmark

Genmab A/S has raised its forecast for revenue and operating profit in 2022 after seeing a sharp increase in royalty income in the first half from Darzalex (daratumumab), a CD38 monoclonal antibody for multiple myeloma. Revenue is now expected to be between DKK 12,000 to 13,000 million and operating profit between DKK 3,800 to 5,400 million. In 2021, revenue was DKK 8,482 million (€1,140 million) and operating profit was DKK 3,018 million.

US clinical hold on MaaT Pharma drug trial

Thursday 11 August 2022
Country
France

The US Food and Drug Administration has extended a clinical hold on a proposed Phase 3 clinical trial of a microbiome-based therapeutic developed by MaaT Pharma SA of France because it requires more information about the composition of the faecal-derived product. MaaT Pharma announced the clinical hold extension on 10 August.

Evotec increased revenue in H1, expands alliances

Thursday 11 August 2022
Country
Germany

Evotec SE increased revenue and expanded its drug discovery and development alliances in the first half of 2022 even as some sectors of the pharma industry experienced a slowdown. Group revenue was €336.9 million, up by 24% from a year earlier. More than three quarters of group revenue, or €258.8 million, was generated by the company’s fee-for-service business while €78 million came from partnered drug discovery.