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.

Eli Lilly's CEO, David Ricks, has reaffirmed the company's commitment to the Chinese market during a meeting with China's Commerce Minister Wang Wentao - stating Lilly's intention to increase investments and enhance R&D cooperation.

J&J has filed a lawsuit against a former employee - Andrew Brackhill - accusing him of illicitly downloading and taking thousands of sensitive documents with him to Pfizer.

To enhance its biologic manufacturing capabilities, Lonza is acquiring Genentech's Vacaville plant from Roche in a $1.2 billion deal. Once completed, Lonza will enhance capacity at the biologics facility, which is already one of the world’s largest, for clinical- commercial-stage manufacturing.

AstraZeneca has announced its intention to acquire Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company developing next-generation radiopharmaceuticals as precision medicines for the treatment of cancer.

As election campaigns in the US begin to ramp up, Big Pharma continues to battle Biden’s plans to introduce negotiations for drug pricing.