Head of R&D, Dr. Houman Ashrafian, announced a simplified structure aimed at reprioritizing the company’s pipeline and transforming Sanofi into an immunoscience leader by reallocating resources to accelerate high-potential programs.

Amylyx Pharmaceuticals has decided to withdraw its amyotrophic lateral sclerosis (ALS) drug, Relyvrio, from the market after it failed to meet the primary and secondary endpoints in its phase 3 trial.

The FDA has approved Basilea Pharmaceutica's Zevtera (ceftobiprole medocaril sodium) for the treatment of several bacterial infections.

In an all-cash payment, the deal will integrate Shockwave’s intravascular lithotripsy (IVL) technology with J&J's existing platforms like Abiomed's Impella as the company looks to build on its leadership in high-growth cardiovascular segments.

Genmab has acquired ProfoundBio for $1.8 bn as it marks its strategic entry into the antibody-drug conjugate (ADC) market. The purchase includes a pioneering ADC platform and three clinical-stage assets aimed at treating ovarian cancer and other solid tumours, with the ADC lead product demonstrating significant potential in advancing cancer ovarian cancer treatment.

SCHOTT Pharma is set to open a new $371 mn manufacturing facility in Wilson, North Carolina, to produce prefillable syringes. The facility is aiming to commence operations in 2027, which will create 401 jobs and focuses on meeting U.S. demands for mRNA and GLP-1 therapy syringes to enhance the domestic supply chain.

Terumo Europe has initiated a study to evaluate the safety and efficacy of BioPearl microspheres, designed for treating unresectable hepatocellular carcinoma (HCC) with doxorubicin.

Terumo Medical Corporation (TMC) is investing $30 mn to expand its manufacturing capabilities in Puerto Rico and meet the increasing global demand for its Angio-Seal vascular closure device.

The COVID-19 pandemic brought its fair share of disruption and uncertainty; propelling biopharma-related topics into the public consciousness.

Lenmeldy, a gene therapy for metachromatic leukodystrophy (MLD), has been priced at $4.25 million in the U.S., becoming the world's most expensive drug. This one-time treatment by Orchard Therapeutics, now part of Kyowa Kirin, is the first FDA-approved therapy for children with early-onset MLD.

Taiwan’s largest CDMO, Bora Pharmaceuticals Co., Ltd. has completed the acquisition of Minnesota-based Upsher-Smith Laboratories, LLC., a generics manufacturer and marketer.

Expanding beyond its COVID-19 vaccines, Moderna reported positive trial results for vaccines against norovirus, Epstein-Barr virus, and Varicella-Zoster virus, aiming for final-stage studies and marketing a positive move towards diversifying its product.

The FDA has approved two groundbreaking treatments for Pulmonary Arterial Hypertension (PAH): OPSYNVI®, a once-daily tablet combining macitentan and tadalafil from Johnson & Johnson, and Merck's Winrevair (sotatercept-csrk), a first-in-class therapy.

The FDA has rejected Regeneron's application for odronextamab, aimed at treating two forms of lymphoma, due to incomplete confirmatory trial enrolment.

Two months after acquiring Mirati Therapeutics for $5.8 billion, Bristol Myers Squibb (BMS) is laying off over 250 employees at Mirati's San Diego headquarters as part of its integration strategy. The deal included the FDA-approved lung cancer drug Krazati.

Illumina's appeal against European Commission’s fine has seen a positive development after it was suggested by the Court of Justice of the European Union (ECJ) that the EC lacked jurisdiction over the Grail takeover, as Grail's revenue did not meet EU turnover thresholds.

Following on from the lead story in this newsletter, BioNTech are facing issues related to their success during the pandemic. The company has received a notice of default from the National Institutes of Health (NIH), the U.S. medical research agency, alleging unpaid royalties on its COVID-19 vaccine Comirnaty, developed in partnership with Pfizer.

French pharmaceutical company, Sanofi, and AI biotech company, Owkin, have further expanded their initial 2021 oncology alliance to include drug positioning within immunology. The partnership will see Owkin's machine learning expertise used to identify optimal disease indications for Sanofi's drugs targeting autoimmune diseases.

Novo says it is set to acquire Cardior for up to $1.1 bn, in a bid to enhance its cardiovascular treatment pipeline, aligning with the company’s focus on diabetes and building on the continued success of its weight-loss treatment, Wegovy.

Amgen's MariTide shows promising results in early-stage trials, offering a novel approach to weight loss by both activating and blocking gastric inhibitory polypeptide (GIP) receptors, potentially mimicking the body's natural regulation process.