Pfizer buys Metsera for up to US$ 7.3 bn, Roche acquires 89bio; FDA okays injectable version of Merck’s Keytruda

By PharmaCompass

2025-09-25

Impressions: 494

In this week’s Phispers, Pfizer announced the acquisition of New York-based biotech Metsera for up to US$ 7.3 billion, marking its biggest push into the fast-growing obesity market. Roche is acquiring San Francisco-based 89bio for up to US$ 3.5 billion to strengthen its metabolic diseases portfolio. And Amsterdam-based VectorY Therapeutics struck a US$ 1.2 billion deal with Shape Therapeutics to explore brain-targeted gene therapies for neurodegenerative diseases.

Meanwhile, Eli Lilly said it will invest US$ 6.5 billion in a Texas plant to manufacture its next-generation, investigational weight-loss pill orforglipron. Moderna opened a vaccine plant in the UK, just when other drugmakers such as Merck, Eli Lilly, Sanofi and AstraZeneca said they are pausing or scrapping major UK investments due to tougher drug pricing rules.

In drug approvals, the US Food and Drug Administration (FDA) approved Merck’s Keytruda Qlex, an injectable version of the blockbuster drug, to speed up cancer treatment. The agency also expanded the approval Incyte’s Opzelura cream to treat eczema in children. And Stealth Biotherapeutics’ Forzinity was approved by the FDA as the first therapy for a rare, life-threatening genetic disorder known as Barth syndrome.

FDA issued a warning letter to a Janssen Vaccines’ plant in South Korea. The agency rejected Biogen’s application for a higher-dose version of Spinraza (nusinersen), its treatment for spinal muscular atrophy (SMA), a rare genetic disorder that causes progressive muscle weakness, and Scholar Rock’s experimental drug apitegromab, aimed at treating SMA and preserving muscle.

In news from trials, Ionis Pharmaceutical’s experimental drug Zilganersen helped patients with the rare Alexander disease improve their ability to walk in an early-to-late-stage study.

Pfizer bets on obesity drugs with up to US$ 7.3 bn Metsera buy; Roche acquires 89bio

Pfizer said it will acquire Metsera in a deal worth up to US$ 7.3 billion, marking its biggest push yet into the fast-growing obesity market. The deal comes after Pfizer scrapped its own obesity pill, danuglipron, due to safety issues. New York-based Metsera brings a pipeline of experimental obesity drugs, including GLP-1 and amylin-based injectables designed for monthly dosing.

Roche to buy 89bio: Roche has agreed to acquire San Francisco-based 89bio for up to US$ 3.5 billion, expanding its presence in liver and metabolic diseases linked to obesity. At the center of the buyout is pegozafermin, 89bio’s late-stage experimental therapy for metabolic dysfunction-associated steatohepatitis (MASH), a severe form of fatty liver disease often seen in obese patients.

VectorY inks deal with Shape Therapeutics: Amsterdam-based VectorY Therapeutics has entered into an option-and-license agreement with Seattle-based Shape Therapeutics that could be worth up to US$ 1.2 billion. Under the deal, VectorY will test Shape’s engineered SHP-DB1 capsid (protein shell of a virus), designed to carry gene therapies deep into the brain.

Eli Lilly to manufacture next-gen weight-loss pill at its US$ 6.5 bn Texas facility

Eli Lilly will invest US$ 6.5 billion in a new plant in Houston, Texas, to produce orforglipron, its investigational, once-daily weight-loss pill being studied for the treatment of type 2 diabetes and obesity. Lilly plans to file for regulatory review of orforglipron later this year. The site will also make ingredients for cancer and autoimmune drugs.

Moderna opens vaccine plant in UK: Just when drugmakers like Merck, Eli Lilly, Sanofi and AstraZeneca are pausing or scrapping major UK investments, citing tougher drug pricing rules, Moderna has opened a new £150 million (approximately US$ 190 million) manufacturing and research facility at the Harwell science campus in Oxfordshire. This is Moderna’s first UK site to produce mRNA vaccines.

FDA approves injectable version of Merck’s Keytruda to speed up cancer treatment

FDA has approved Merck’s Keytruda Qlex (pembrolizumab/berahyaluronidase alfa-pmph), a new formulation of its blockbuster immunotherapy Keytruda that can be given as a quick under-the-skin injection. Unlike the intravenous version, which takes about 30 minutes, the new shot can be administered in just one to two minutes, depending on the dose.

Expands label of Incyte’s eczema cream: FDA has expanded the label for Incyte’s Opzelura (ruxolitinib) cream to treat mild-to-moderate atopic dermatitis, commonly known as eczema, in children aged two and older. This makes it the first topical JAK inhibitor approved in the US for pediatric eczema.

Approves Stealth’s med for Barth syndrome: FDA has approved Stealth Biotherapeutics’ Forzinity (elamipretide) injection as the first therapy for Barth syndrome, a rare genetic disease that primarily affects males. Patients often face severe heart failure in infancy, and those who survive into adolescence can experience fatigue, poor stamina, and difficulty exercising. Forzinity, given once daily under the skin, works by improving the structure and function of the mitochondria, cell organelles responsible for producing energy.

FDA issues warning letter to Janssen plant in South Korea over quality lapses

FDA has issued a warning letter to Janssen Vaccines, a subsidiary of Johnson & Johnson, after inspectors flagged serious quality issues at its plant in Incheon, South Korea. The inspection took place between November 11 and 19, 2024. According to the letter, dated July 18, Janssen failed to properly investigate product complaints and did not consistently follow required quality-control procedures. A key problem was with vial stoppers, which could potentially affect product quality. FDA has now asked Janssen to conduct a three-year review of past complaints, strengthen its quality systems, and provide a corrective action plan.

FDA rejects Biogen’s application for high-dose Spinraza to treat SMA

FDA has rejected Biogen’s application for a higher-dose version of Spinraza (nusinersen), its treatment for spinal muscular atrophy (SMA), a rare genetic disorder that causes progressive muscle weakness. The agency issued a complete response letter asking for updated manufacturing and technical information, but did not raise concerns about the clinical data supporting the regimen. The higher-dose version has already been cleared in Japan and is under review in Europe.

Rejects Scholar Rock’s SMA drug: Scholar Rock’s experimental drug apitegromab, aimed at treating SMA and preserving muscle, hit a roadblock as the FDA cited issues at a third-party manufacturing facility in Indiana.

Ionis’ zilganersen improves mobility in patients with rare Alexander disease

Ionis Pharmaceutical’s experimental drug zilganersen helped patients with the Alexander disease (a rare and often fatal neurological disorder) improve their ability to walk in an early-to-late-stage study. The therapy works by stopping the buildup of a harmful protein in the brain that causes the disease. Ionis plans to apply for FDA approval in early 2026.

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