In this week’s Phispers, China’s Innovent Biologics signed one of the largest cross-border biotech deals in Asia. Under this up to US$ 11.4 billion deal, Innovent will co-develop immuno-oncology and antibody-drug conjugate (ADC) therapies along with Japan’s Takeda. In the US, Merck broke ground on a US$ 3 billion manufacturing facility in Virginia. And French drugmaker Ipsen announced the acquisition of ImCheck Therapeutics for up to €1 billion (US$ 1.16 billion) to strengthen its oncology pipeline.In drug approvals, the US Food and Drug Administration (FDA) cleared Novo Nordisk’s Rybelsus (oral semaglutide) to reduce cardiovascular risk in adults with type 2 diabetes. The agency also approved Glaukos’ Epioxa for treating keratoconus, a progressive eye disorder. It expanded the approvals of Roche’s blood cancer drug Gazyva to treat active lupus nephritis (a severe kidney complication) and Amgen-AstraZeneca’s Tezpire as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps.In clinical trials, Novartis’ intravenous (IV) therapy delayed disease progression in early-stage metastatic prostate cancer. Similarly, the combination of Pfizer-Astellas’ Padcev and Merck’s Keytruda cut the risk of death by 50 percent in muscle-invasive bladder cancer. And AstraZeneca-Daiichi’s Datroway extended survival in patients with triple-negative breast cancer.In other news, the Novo Nordisk Foundation has moved to take control of Novo Nordisk’s board. And Kenvue has urged US regulators to reject a petition seeking an autism warning on Tylenol’s label for use during pregnancy, citing insufficient scientific evidence.China’s Innovent inks up to US$ 11.4 bn cancer drug deal with Japan’s TakedaInnovent Biologics has signed an up to US$ 11.4 billion deal with Takeda Pharmaceutical to co-develop next-generation cancer therapies. Under the agreement, China’s Innovent Biologics will receive US$ 1.2 billion upfront and up to US$ 10.2 billion in milestone payments from Takeda to co-develop immuno-oncology and ADC therapies. The deal covers late-stage drugs for non-small cell lung cancer and colorectal cancer, with Takeda taking rights outside the US and Greater China, and Innovent co-commercializing in the US.Ipsen to acquire ImCheck
Therapeutics:
French drugmaker Ipsen is acquiring ImCheck Therapeutics for up to €1 billion (US$ 1.16 billion) to strengthen its oncology pipeline. The deal
centers on ICT01, a potential first-in-class monoclonal antibody being tested in acute
myeloid leukemia.Merck breaks ground on drug
plant in US: Merck has broken ground on a US$ 3 billion pharmaceutical manufacturing
facility at its Elkton, Virginia, campus, which is part of a broader US$ 70 billion US investment in manufacturing,
R&D, and capital projects.FDA approves Novo’s Rybelsus to reduce risk of adverse heart events in diabeticsFDA
has approved Novo Nordisk’s Rybelsus (oral semaglutide), making it the first and only oral GLP-1 therapy to reduce the risk of major adverse cardiovascular events (MACE) — including heart attack, stroke, and cardiovascular death — in adults with type 2 diabetes who are at high cardiovascular risk, regardless of whether they have had a prior event. It is approved for both primary and secondary prevention in this population. Rybelsus was first approved in 2019 to improve glycemic control in adults with type 2 diabetes.Foundation seizes board control: Novo Nordisk’s majority shareholder, the Novo Nordisk Foundation, is taking control of the company’s board after a disagreement between the board and the foundation
over its future governance. Following the disagreement, the chairman and six
other independent board members resigned. The move comes as sales of
weight-loss drug Wegovy and
diabetes drug Ozempic (both semaglutide) have
fallen due to competition from Eli Lilly and US pricing pressures. The foundation wants a sharper focus on the US market and backs incumbent CEO Mike Doustdar’s restructuring efforts, including 9,000 job cuts, to restore growth.FDA approves Glaukos’ Epioxa to treat keratoconus, a rare, eye-disorderFDA
has approved Glaukos’ Epioxa (riboflavin 5'-phosphate) for treating
keratoconus, a rare, progressive eye disorder that thins and bulges the cornea,
causing distorted vision and increasing the risk of blindness. Epioxa provides
an incision-free alternative to surgery.Roche’s Gazyva approved for lupus nephritis: FDA has approved Gazyva (obinutuzumab), developed by Roche’s Genentech, for adults with active lupus nephritis (a severe kidney complication), marking the drug’s first non-cancer indication. Gazyva is
approved for certain blood cancers.Expands use of Amgen-Astra’s Tezpire: FDA has approved Amgen and AstraZeneca’s Tezspire (tezepelumab) as an
add-on maintenance treatment for adults and children aged 12
and older with inadequately controlled chronic rhinosinusitis with nasal
polyps. This condition causes long-term sinus inflammation and noncancerous
growths, leading to congestion, facial pain, and loss of smell. Tezspire is already
approved for severe asthma.Novartis’ Pluvicto shows benefit in metastatic prostate cancerNovartis’ Pluvicto (lutetium (177Lu) vipivotide tetraxetan), an intravenous therapy that delivers targeted radiation directly to prostate cancer cells,
significantly delayed disease progression in patients with metastatic hormone-sensitive prostate cancer. In the phase 3 trial, combining Pluvicto with standard hormone therapy reduced the risk of progression or death by 28 percent.Padcev-Keytruda combo shows benefit in bladder cancer: Pfizer and Astellas’ Padcev (enfortumab vedotin-ejfv), combined with Merck’s Keytruda (pembrolizumab), significantly improved outcomes in patients with
muscle-invasive bladder cancer who cannot take cisplatin (intravenous route)
chemotherapy. In a late-stage trial, the combination reduced the risk of cancer
recurrence, progression, or death by 60 percent and cut the risk of death by 50
percent compared with surgery alone.Datroway extends survival in metastatic breast cancer: AstraZeneca and Daiichi Sankyo’s drug Datroway (datopotamab
deruxtecan) significantly improved survival in patients with metastatic
triple-negative breast cancer compared to chemotherapy in a late-stage trial.GSK’s oral antibiotic drug matches intravenous treatment for complicated UTIsGSK and Spero’s experimental oral antibiotic tebipenem HBr proved as effective as
intravenous treatment in a phase 3 trial for complicated urinary tract infections, including drug-resistant cases.Moderna halts birth defect
vaccine program: Moderna said it will discontinue the development of its experimental vaccine — mRNA-1647 — to prevent cytomegalovirus (a virus that can cause birth defects) after the shot failed to meet the main goal in a phase 3 trial.Kenvue seeks rejection of ‘autism warning’ request on Tylenol labelKenvue,
maker of Tylenol (acetaminophen), has asked US regulators to reject a request to add
an autism warning to its painkiller’s label for use during pregnancy. The petition cites studies suggesting a link between acetaminophen and neurodevelopmental disorders. Kenvue and the FDA, however, note that no causal relationship has been proven.
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