In this week’s news, Gilead Sciences has entered into an agreement to acquire its cancer therapy partner Arcellx for US$ 7.8 billion. Gilead’s cell therapy subsidiary — Kite Pharma — has been working with Arcellx since 2022 on an investigational CAR T-cell therapy, which is the centerpiece of this deal.Novo Nordisk has entered into a US$ 2.1 billion deal with privately-held Vivtex Corp to
develop next-generation oral
drugs for obesity and diabetes. GSK has struck an up to US$ 1 billion licensing
deal with Frontier Biotechnologies to obtain exclusive worldwide rights to develop, manufacture,
and commercialize two small interfering RNA (siRNA) pipeline products that
target kidney diseases. And Astellas Pharma has entered into global
strategic collaboration with
Vir Biotechnology to advance a treatment for prostate cancer. The deal is worth
up to US$ 1.7 billion.The week saw several
approvals granted by the US Food and Drug Administration (FDA). The agency
approved Vanda Pharmaceuticals’ Bysanti (milsaperidone), a first-line therapy for acute bipolar I disorder and schizophrenia in adults. The agency also granted full approval to Pfizer’s Braftovi (encorafenib) in combination with Erbitux (cetuximab) and fluorouracil-based chemotherapy for the treatment of adult patients with a type of metastatic
colorectal cancer (mCRC). The combo therapy had received accelerated approval
in 2024.FDA granted Sanofi and Regeneron’s Dupixent its ninth approval — this time to treat adult and
pediatric patients aged six years and older with a chronic inflammatory
condition known as allergic fungal rhinosinusitis (AFRS).FDA also approved another combination regimen — of AbbVie’s Venclexta (venetoclax) and AstraZeneca’s Calquence (acalabrutinib) — for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). And Eton Pharmaceuticals’ liquid therapy — Desmoda (desmopressin) — for the management central diabetes insipidus also
clinched an FDA approval.Gilead buys Arcellx for US$
7.8 billion for its multiple myeloma CAR-T therapyGilead Sciences has entered into an agreement to acquire its cancer therapy partner Arcellx for US$ 7.8 billion.
The two companies have been in a cell therapy development collaboration since 2022 through Kite Pharma, Gilead’s cell therapy subsidiary. Kite has been co-developing and co-commercializing Arcellx’s lead candidate anitocabtagene
autoleucel (anito-cel), an investigational CAR T-cell therapy for
patients with multiple myeloma. Anito-cel is the centerpiece of this deal.FDA approves Vanda’s antipsychotic pill for bipolar I disorder, schizophreniaFDA has approved Vanda Pharmaceuticals’ Bysanti (milsaperidone) tablets, a first-line therapy for two mental health conditions — acute bipolar I disorder and schizophrenia. Bysanti is a new chemical entity (NCE), and an atypical antipsychotic. It works by blocking dopamine and serotonin receptors in the brain,
which help regulate mood, stress, delusions, and alertness. This is the third FDA approval won by the company in recent months.Dupixent okayed for allergic fungal rhinosinusitis: FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of adult and pediatric patients aged six years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. This is Dupixent’s ninth FDA approval. AFRS is a chronic inflammatory condition that can cause nasal polyps, persistent congestion, thick mucus, and loss of smell. FDA evaluated Dupixent under priority review for the treatment of AFRS, and it is the first treatment approved for the condition. Novo inks up to US$ 2.1 bn deal with Vivtex for its next-gen
obesity, diabetes drugsEarlier
this week, there was news that Novo Nordisk’s next-generation obesity drug CagriSema (cagrilintide and semaglutide) underperformed Eli Lilly’s Zepbound (tirzepatide) in a head-to-head trial. Novo didn’t let the setback weigh it down. It quickly struck
an up to US$ 2.1 billion deal with privately-held American company Vivtex Corp to develop next-generation oral drugs for obesity
and diabetes. Under the partnership, Vivtex
will license some of its oral drug-delivery
technology, while Novo Nordisk will take charge of global development and
commercialization. The deal covers research funding, milestone payments, and tiered royalties on product sales.Frontier strikes up to US$ 1 billion deal with GSK: Frontier Biotechnologies has struck an exclusive licensing
agreement with GSK. Under the terms of the agreement, GSK will obtain exclusive worldwide rights to develop, manufacture, and commercialize two of Frontier Biotechnologies’ small interfering RNA (siRNA) pipeline products that target kidney diseases.Astellas ties up with Vir
Biotech: Astellas Pharma has entered into global strategic collaboration with Vir Biotechnology to advance a T-cell engager targeting
prostate-specific membrane antigen (PSMA) and CD3 proteins for the treatment of
prostate cancer. The deal involves an upfront payment, milestone payments and royalties that could
together add up to US$ 1.7 billion.FDA okays Venclexta-Calquence
combo for untreated chronic lymphocytic leukemiaAbbVie has said FDA has approved a supplemental
new drug application (sNDA) for the combination regimen of Venclexta (venetoclax) and AstraZeneca’s Calquence (acalabrutinib) for the treatment of
previously untreated adult patients with chronic lymphocytic
leukemia (CLL). Venclexta is manufactured by AbbVie and Genentech (a member of the Roche group).Pfizer’s Braftovi combo regimen gets full approval: FDA has granted full approval to Braftovi (encorafenib) in combination with
Erbitux (cetuximab) and fluorouracil-based chemotherapy for the treatment of adult patients with a type of metastatic
colorectal cancer. The combo therapy had received accelerated approval in 2024.FDA approves Eton’s liquid therapy for managing central diabetes insipidusFDA has okayed Eton Pharmaceuticals’ liquid therapy — Desmoda (desmopressin) — for the management of a rare hormonal disorder, known as arginine
vasopressin deficiency (AVP-D), or central diabetes insipidus. In AVP-D,
patients lack the hormone that regulates water
balance, causing excessive urination and thirst. This is the first-of-its-kind
liquid therapy for AVP-D.Zepbound KwikPen okayed: FDA has approved a label
expansion for Eli Lilly’s Zepbound (tirzepatide) to include the four-dose single-patient-use KwikPen
that delivers a full month of treatment in
one device. Rival Novo Nordisk has been selling its weight loss drug Wegovy (semaglutide) as a single-dose weekly
auto-injector pen in the US since 2021.Gossamer’s pulmonary arterial hypertension drug fails late-stage trialGossamer Bio’s experimental treatment seralutinib, which is an inhaled
drug, failed to significantly improve exercise capacity in patients with the rare lung
condition known as pulmonary arterial hypertension (PAH) in a late-stage study. PAH is caused by constriction of the arteries in the lungs, which leads to high blood pressure.FDA proposes framework to
speed up personalized gene therapy approvalsFDA has proposed a new framework to speed up approvals of personalized treatments for rare and life-threatening genetic diseases.
It offers clearer rules for drugmakers to develop genome-editing and RNA-based drugs while requiring them to justify why randomized controlled trials are not feasible.
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