News

New indication for Blincyto

Country
United States

Blincyto (blinatumomab), a bispecific antibody first approved for cancer in 2014, has received a new indication from the US Food and Drug Administration, extending its coverage for the treatment of B cell acute lymphoblastic leukaemia (B-ALL). B-ALL, an aggressive leukaemia, is the most common type of acute lymphoblastic leukaemia.
The new indication is for the treatment of adults and children from the age of one month for CD19 positive Philadelphia chromosome-negative B cell precursor acute lymphoblastic leukaemia. 

Gene therapy fails in DMD

Country
United States

A gene therapy being investigated in a Phase 3 trial of boys with Duchenne muscular dystrophy (DMD) has failed to reach its primary endpoint of improvement in motor function, the developer Pfizer Inc announced on 12 June. The therapy, fordadistrogene movaparvovec, missed the primary endpoint at one year as well as key secondary endpoints compared with a placebo. The secondary endpoints included an improvement in velocity in a 10 metre run or walk. Participants were boys between the ages of four and seven who were on a daily regimen of glucocorticoids.

The next step for donanemab

Country
United States

Donanemab, an Alzheimer’s disease drug developed by Eli Lilly and Co, is set for a review by the US Food and Drug Administration in the wake of a recommendation by the agency’s outside panel of advisers on 10 June that the drug is both safe and effective. Neither the FDA nor Lilly would comment to MedNous on a date for the final review. Nevertheless analysts who followed discussions by the panel – the Peripheral and Central Nervous System Drugs Advisory Committee – expect that whatever the timing, a formal approval is likely.

Seed funding for Tacalyx

Country
Germany

A 2019 spin-out of the Max-Planck-Institute of Colloids and Interfaces has raised additional seed finance from a venture capital syndicate to progress antibody treatments for cancer.  Tacalyx GmbH announced the funding on 11 June which increases its seed finance to more than €14 million. The company is developing antibody therapeutics that target tumour associated carbohydrate antigens. These are glycan structures often found on cancer cells but which don’t usually appear on other tissues.

Positive data for tirzepatide

Country
United States

Eli Lilly and Co has reported positive data for tirzepatide, an approved drug for obesity and type 2 diabetes, which is now being investigated for metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease. Formerly known as non-alcoholic steatohepatitis, MASH results from an excess of fat in the liver which can lead to liver-related complications and death. The global prevalence of the disease is increasing.

Equity finance for ITM

Country
Germany

ITM Isotope Technologies Munich SE has raised €188 million from a group of investors to prepare for the commercial launch of its lead radiopharmaceutical product and increase its manufacturing capacity for radioisotopes. The equity financing was led by Temasek Holdings Ltd, a Singapore-based investment group, and supported by four other entities including the Qatar Investment Authority. ITM has a pipeline of candidate radiopharmaceuticals and diagnostics for cancer as well as manufacturing agreements to supply medical radioisotopes to others, including Novartis.

Merck to acquire EyeBio

Country
United States

Merck & Co Inc is to spend up to $3 billion to acquire a privately-held ophthalmology company and build a pipeline of candidate drugs for eye diseases. The company, Eyebiotech Ltd, was founded in August 2021 by two physicians and the venture capital group SV Health Investors. It has a lead drug poised to enter Phase 2b/3 for the treatment of patients with diabetic macular oedema. Merck will pay $1.3 billion upfront for the company, with future milestone payments amounting to up to $1.7 billion.

J&J buys antibody asset

Country
United States

Johnson & Johnson Inc is to spend $1.25 billion to acquire the developer of a bi-specific antibody for atoptic dermatitis, a chronic and sometimes life-long skin disease. The antibody, NM26, was developed by a subsidiary of the Swiss biotech, Numab Therapeutics AG and is poised to enter Phase 2. Investors in the asset include the European venture capital companies Novo Holdings A/S and Forbion, which supported its development for autoimmune diseases. J&J will acquire the Numab unit Yellow Jersey Therapeutics.

Evotec to research obesity

Country
Germany

Evotec SE has entered the obesity field under a new partnership with three French institutions where it will identify targets and diagnostic markers for the treatment of metabolic disorders, including over-weight and obesity. This is in response to the prevalence of obesity and the success of the first commercial medicines to treat it. Announced on 30 May, the partnership brings Evotec into an alliance with Inserm, the French National Institute of Health and Medical Research; Lille University Hospital; and Inserm Transfert, a private subsidiary of Inserm.

Asahi Kasei to acquire Calliditas

Country
Sweden

Calliditas Therapeutics AB is set to be acquired by the Japanese conglomerate Asahi Kasei Corp in a transaction that values the Swedish developer of drugs for rare diseases at SEK 11.8 billion ($1.1 billion). The bid comes just six months after Calliditas received full US Food and Drug Administration for its lead product, Tarpeyo (budesonide), for primary immunoglobulin A nephropathy (IgAN), a rare kidney disease.