IntellaTurn, LLC

• Johnson & Johnson’s oncology superstar received an FDA approval for a more powerful regimen in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant.

• The Jan. 27 approval enables Darzalex Faspro’s use within a quadruplet combination that includes Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone (VRd), which is altogether referred to as D-VRd.

• Before that, the triplet regimen of D-Rd has been allowed to treat first-line, transplant-ineligible patients since 2019.

• D-VRd is now the only anti-CD38 antibody-based regimen that can treat newly diagnosed patients regardless of transplant eligibility, J&J said in a Jan. 27 press release. (FiercePharma)

• Corcept Therapeutics said its experimental drug relacorilant cut the risk of death by 35% for patients with a challenging form of ovarian cancer when added on top of chemotherapy, notching an important win after the California biotech faced an FDA rejection of its drug in a different disease.

• Corcept reported that platinum-resistant ovarian cancer patients who received relacorilant on top of chemotherapy lived for a median of 16 months. That’s compared to 11.9 months for patients who received chemotherapy alone as part of the Phase 3 ROSELLA study.

• The difference was statistically significant, translating to a p-value of 0.0004 and meeting its second primary endpoint in the trial. (Endpoints)

• Following in the footsteps of its pharma peers, Boehringer Ingelheim took a trip to China in search of new assets—and picked up an investigational bispecific antibody from Shanghai-based Simcere Pharmaceutical for the treatment of inflammatory bowel diseases.

• The companies did not provide a specific financial breakdown of the deal in their release, revealing only that Boehringer could be on the hook for up to €1.058 billion—or approximately $1.26 billion—in total. This sum covers an upfront commitment plus success-based development, regulatory and commercial milestones.

• At the heart of the agreement is SIM0709, a bispecific antibody that can bind TL1A and IL-23, both of which play key roles in promoting inflammation. (BioSpace)

• Shares for Intellia Therapeutics climbed by about 10% early on Tuesday after the company said the FDA cleared it to resume one of two phase 3 trials evaluating its experimental CRISPR-based treatment against the rare genetic disease transthyretin amyloidosis.

• US regulators had halted two studies of Intellia’s nexiguran ziclumeran, or nex-z, last October following the occurrence of serious liver toxicity that resulted in the death of a trial participant.

• Intellia said that FDA has allowed it to restart MAGNITUDE-2, a trial testing nex-z in people with a form of the disease that affects the nerves, by incorporating new risk mitigation measures. It’s also enrolling about 10 more patients in that study. Intellia aims to begin testing again “as quickly as possible.”

• Intellia also revealed, however, that a pause in the MAGNITUDE trial in patients with the cardiomyopathy form of the disease is ongoing. The company will provide an update once aligned with regulators on the program’s path forward there. (BioPharma Dive)

• A central nervous system (CNS) tumor has prompted the FDA to place clinical holds on two Regenxbio gene therapies, including a candidate that is less than two weeks away from an approval decision.

• Regenxbio’s share price fell 32% to $9.16 in premarket trading yesterday.

• Regenxbio said the abnormal growth was found in a recipient of RGX-111, a gene therapy the company is developing for the treatment of severe mucopolysaccharidosis type I (MPS I).

  • Also known as Hurler syndrome, the rare disease can cause developmental delays and shorten life span. RGX-111 is designed to improve outcomes by using an AAV9 vector to deliver the IDUA gene to the CNS.

• While the adverse event occurred in a recipient of RGX-111, the FDA extended the clinical hold to cover RGX-121 because of similarities between the therapies, trial populations and shared risks of the studies. RGX-121 is designed to treat MPS II, also known as Hunter syndrome.

• Last August, the FDA delayed an approval decision for the latter, with a new verdict expected by Feb. 8. (Fierce Biotech)

• Still, the 15 drugs chosen accounted for $27 billion of Medicare spending between November 2024 and October 2025, per the Centers for Medicare and Medicaid Services.

• The negotiated prices would take effect in 2028.

• This is the first time that Medicare can select prescription drugs administered in doctors' offices and other outpatient settings for the negotiations.

• Those that opt out must either pay an excise tax of up to 95% of their US sales or withdraw their drugs from Medicare and Medicaid coverage.

Xolair, an injectable asthma drug from Novartis

Cosentyx, a psoriasis drug, also from Novartis

Kisqali, a breast cancer treatment from Novartis

Verzenio, a breast cancer drug from Eli Lilly

Anoro Ellipta, a COPD drug from GlaxoSmithKline

Biktarvy, an HIV medication from Gilead

Entyvio, a biologic for inflammatory bowel disease made by Takeda

Erleada, Janssen's prostate cancer drug

Lenvima, a cancer drug from Eisai

Orencia, an arthritis medication from Bristol-Myers Squibb

Rexulti, an antipsychotic made by Otsuka

Xeljanz, Pfizer's arthritis drug

Cimzia, a drug for Crohn's disease symptoms made by UCB

• The drugmaker has recruited Will Forte, who appeared on “SNL” for nearly a decade in the aughts, perhaps most memorably as MacGyver parody character MacGruber, to join an ongoing Huntington’s disease awareness campaign.

• Though unbranded, the campaign site does include an external link on one page to learn more about Teva’s Austedo as a treatment for chorea, the uncontrollable movements that typically occur with Huntington’s.

• Modling, whose sister is married to Forte, was diagnosed with the neurological disorder in 2022, following his late father’s own diagnosis. (FiercePharma)