
By PharmaCompass
2025-07-24
Impressions: 824 (Article) || 6 (Video)
AstraZeneca and Biogen are the latest drugmakers to announce investments in the US to avoid import tariffs. AstraZeneca is investing US$ 50 billion to expand capacities in the US, while Biogen is investing another US$ 2 billion in North Carolina.
After deaths of two teenagers who were taking Sarepta’s gene therapy Elevidys, there was news of death of a 51-year-old man. He was participating in a phase 1 study for limb-girdle muscular dystrophy (LGMD) and was taking a different gene therapy — Sarepta’s SRP-9004.
Indian drugmaker Dr. Reddy’s Laboratories has said it plans to launch a generic version of Novo Nordisk’s blockbuster weight-loss drug Wegovy in 87 countries next year.
The US is set to remove mercury-based preservative thimerosal from all influenza vaccines distributed in the US. The US Health Secretary Robert F. Kennedy Jr. is also asking CDC to develop a new guidance for treating measles with drugs and vitamins.
In drug approvals, FDA has okayed a pre-filled syringe version of GSK’s blockbuster shingles vaccine Shingrix. And in deals, Sanofi has announced the acquisition of London-based Vicebio for an upfront payment of US$1.15 billion in order to expand its respiratory vaccine portfolio.
AstraZeneca unveils US$ 50 billion US investment to avert pharma tariff
After companies like Johnson & Johnson, Eli Lilly, Novartis, Roche, BMS, Gilead, Takeda and Sanofi, AstraZeneca has announced US investments in the face of looming pharmaceutical tariffs. AstraZeneca plans to invest US$ 50 billion to expand manufacturing and research capabilities in the US by 2030.
Astra will set up a drug substance facility in Virginia and also expand R&D and cell therapy manufacturing in Maryland, Massachusetts, California, Indiana and Texas. AstraZeneca has said the expansion supports its ambition to reach US$ 80 billion in annual revenue by 2030.
Biogen to invest additional US$ 2 bn in North Carolina: In order to avoid tariffs, Biogen has announced an additional investment of US$ 2 billion at its existing manufacturing plants in North Carolina. So far, Biogen has invested around US$ 10 billion in this facility.
Sarepta hit by another death in gene therapy trial; Roche pauses shipments of Elevidys
After the deaths of two teenagers in March and June, who were on Sarepta’s gene therapy Elevidys, there has been news about the death of a 51-year-old man participating in a phase 1 study for limb-girdle muscular dystrophy (LGMD). This person was taking another gene therapy — Sarepta’s SRP-9004.
Like Elevidys, SRP-9004 uses an adeno-associated virus (AAV) vector. Gene therapies that use AAV vectors are known to carry a side effect of acute liver injury. FDA has ordered a clinical hold across all of Sarepta’s LGMD trials.
Post this death, FDA has requested Sarepta to voluntarily halt shipments of Elevidys. The company initially refused to comply. However, this week, Sarepta said it would voluntarily pause US shipments of the gene therapy. Sarepta’s licensing partner Roche has also said it has temporarily halted new deliveries of Elevidys to ambulatory patients in certain countries outside the US.
India’s Dr. Reddy’s to launch generic of Novo’s Wegovy in 87 countries in 2026
Indian drugmaker Dr. Reddy’s Laboratories has said it plans to launch a generic version of Novo Nordisk’s blockbuster weight-loss drug Wegovy (semaglutide) in 87 countries next year. The global obesity market is expected to generate sales of around US$ 150 billion by early 2030s and many drugmakers are eying a slice of this pie. Semaglutide’s patent is expected to expire in several countries next year.
Sanofi to buy Vicebio: Sanofi has announced that it will acquire London-based biotech Vicebio for an upfront payment of US$1.15 billion in order to expand its respiratory vaccine portfolio. The acquisition will give the French drugmaker access to Vicebio’s early-stage non-mRNA candidate vaccine for treating respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The deal is expected to close in the fourth quarter of this year.
FDA okays pre-filled version of GSK’s shingles vaccine; panel votes against Blenrep
It was a mixed week for GSK. In positive news, FDA approved a pre-filled syringe version of GSK’s blockbuster shingles vaccine Shingrix. This version provides patients with a more convenient option to receive the shingles shot.
In negative news, an FDA panel of independent advisers recommended against GSK’s blood cancer drug Blenrep, citing concerns about previously documented risks of eye-related side effects. GSK had sought approval to re-launch Blenrep in combination with other treatments for patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
FDA was scheduled to take the final decision on Blenrep’s use in multiple myeloma by July 23. However, post the panel’s feedback, FDA has extended its review of Blenrep by three months, and has set an action date of October 23, giving itself ample time to review additional information.
US to remove thimerosal from flu shots; RFK Jr asks CDC to develop new measles guidance
The US is set to remove mercury-based preservative thimerosal from all influenza vaccines distributed in the US. This marks the latest move by US Health Secretary Robert F. Kennedy Jr.
RFK Jr will also ask CDC to develop new guidance for treating measles with drugs and vitamins, a CBS News report said. The move comes as RFK Jr is facing widespread criticism for his remarks on measles being easily curable in the midst of this year’s record measles outbreaks, and for spreading myths about measles vaccines.
Advisers vote against Otsuka’s PTSD combo treatment; FDA rejects Roche med for DLBCL
A panel of independent advisors of the FDA has voted 1:10 against the efficacy of Otsuka Pharma’s antipsychotic drug Rexulti (brexpiprazole) in combination with Viatris’ antidepressant Zoloft (sertraline) for treating adults with post traumatic stress disorder (PTSD). The efficacy of brexpiprazole, in combination with sertraline, has not been established for the treatment of PTSD based on the available data, the panel noted.
Rejects Roche’s Columvi for DLBCL: FDA has declined to approve Columvi, in combination with the chemo regimen GemOx (gemcitabine and oxaliplatin), for the treatment of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant. FDA said the phase 3 trial data did not provide enough evidence to support the proposed indication in a US population.
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