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By PharmaCompass
2026-03-12
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In Phispers this week, Eli Lilly announced its plans to invest US$ 3 billion in China over the next decade in order to build production capacity for its experimental type 2 diabetes and obesity treatment orforglipron. Servier acquired Day One Biopharma for US$ 2.5 billion to boost its oncology pipeline. Swiss contract drug manufacturing organization (CDMO) Lonza sold its capsules business to Lone Star Funds for US$ 3 billion. And BioNTech founders said they are quitting the firm to start a new venture.
In drug approvals, the US Food and Drug Administration (FDA) okayed Johnson & Johnson’s Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The agency also expanded the labels of Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, and of Wellcovorin (leucovorin calcium) to treat a rare genetic condition.
In trials, Bristol Myers Squibb’s experimental drug mezigdomide in combination with Amgen’s cancer drug Kyprolis (carfilzomib) and dexamethasone met a phase 3 study’s primary goal by improving survival in patients with relapsed multiple myeloma, a form of blood cancer. Xenon Pharmaceuticals’ experimental epilepsy drug, azetukalner, significantly reduced focal-onset seizures in a late-stage trial. And Roche’s giredestrant failed to meaningfully help newly diagnosed patients with breast cancer in a phase 3 trial.
The FDA issued a warning letter to Novo Nordisk over issues with its procedures for reporting potential side effects of its diabetes drug Ozempic (semaglutide), which is also prescribed for weight loss. And Vinay Prasad, the controversial head of FDA’s Center for Biologics Evaluation and Research (CBER), will leave the agency next month.
Lilly to invest US$ 3 billion in China to build capacity for its new obesity med
Eli Lilly plans to invest US$ 3 billion in China over the next decade to build production capacity for its experimental type-2 diabetes and obesity treatment orforglipron. This drug is under FDA review, with a decision expected in April. Lilly has also filed for marketing authorization for the pill in China.
BioNTech founders to start new venture: BioNTech’s co-founders and leading executives — CEO Ugur Sahin and chief medical officer Özlem Türeci — are quitting the company by the end of the year to start a new venture. BioNTech said it had initiated a search for their successors.
Servier acquires Day One Biopharma for US$ 2.5 bn to boost its oncology pipeline
French pharmaceutical group Servier has announced the acquisition of US-based Day One Biopharmaceuticals for about US$ 2.5 billion. This buyout will expand Servier’s brain tumor portfolio and give it access to FDA-approved Ojemda (tovorafenib), a monotherapy for pediatric low-grade glioma, the most common form of brain tumor in children.
Lonza sells its capsules business: Swiss CDMO Lonza has announced the sale of its capsules and health ingredients business to private equity fund Lone Star Funds for an enterprise value of CHF 2.3 billion (US$ 3 billion).
J&J’s Tecvayli-Darzalex combo wins approval under FDA’s voucher program
FDA has approved Johnson & Johnson’s Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. This decision was issued 55 days after filing and marks the third approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. The new approval is for second-line treatment of the blood cancer.
Sotyktu okayed for psoriatic arthritis: FDA has expanded the label of Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. Sotyktu is the first and only tyrosine kinase 2 (TYK2) inhibitor to be approved for this indication.
Leucovorin approved for rare genetic disorder: FDA has expanded the use of decades-old drug Wellcovorin (leucovorin calcium) to treat cerebral folate transport deficiency, a rare genetic condition in adult and pediatric patients that prevents folate from properly reaching the brain. People with this condition have severe developmental delays, movement disorders, seizures, and other serious neurological complications. The move comes months after the Trump administration touted leucovorin as a potential therapy for a broader group of patients with symptoms of autism spectrum disorder.
Bristol Myers’ mezigdomide enhances survival rates in late-stage blood cancer trial
Bristol Myers Squibb’s experimental drug — mezigdomide — for a rare form of blood cancer met a phase 3 study’s primary goal by improving survival. Mezigdomide, when used in combination with Amgen’s cancer drug Kyprolis (carfilzomib) and dexamethasone, showed significant improvement in patients with relapsed or refractory multiple myeloma without the disease worsening, compared to carfilzomib and dexamethasone alone.
Xenon’s epilepsy drug meets main goal: Xenon Pharmaceuticals’ experimental epilepsy drug, azetukalner, significantly reduced focal-onset seizures in a late-stage trial. Azetukalner also demonstrated a safety and tolerability profile consistent with prior studies.
Roche’s breast cancer drug combo fails trial: Roche said its breast cancer pill, giredestrant, failed to meaningfully help newly diagnosed patients with breast cancer in a phase 3 trial. The investigational drug was being tested in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
FDA issues warning letter to Novo Nordisk over reporting Ozempic side effects
FDA has issued a warning letter to Novo Nordisk over issues with its procedures for reporting potential side effects of its diabetes drug Ozempic (semaglutide), which is also prescribed for weight loss. The agency has cited three deaths among patients receiving semaglutide. Novo Nordisk violated its protocols for reporting adverse symptoms that could potentially be tied to the drug, the letter said. Meanwhile, the company has undertaken an action plan to address the gaps.
Rise in dementia in diabetes patients: According to a study published in The Lancet, newer diabetes medicines, including GLP-1 drugs, provide heart protection along with blood sugar control. Analyzing data from 10 wealthy countries on 2.7 million deaths of patients with type 2 diabetes between 2000 and 2023, the researchers noted overall declines in mortality rates from cardiovascular disease, cancer, and diabetes. However, they reported increases in mortality rates and proportions of deaths from dementia and other causes.
Vinay Prasad to leave CBER in April: Vinay Prasad, the controversial head of FDA’s Center for Biologics Evaluation and Research, will leave the agency next month, FDA commissioner Marty Makary said. A search is currently underway for Prasad’s successor.
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