Patients taking Takeda’s Entyvio for Crohn’s disease will now have the option of a subcutaneous version. Takeda announced the label expansion on Friday, several months after winning a first approval for the subcutaneous formulation in ulcerative colitis. Entyvio, or vedolizumab, was originally approved as an intravenous drug in 2014 and administered via a roughly 30-minute-long infusion. The new formulation is taken as a maintenance therapy following induction with IV Entyvio. It’s a single-dose, prefilled pen, to be self-administered “at home or on the go,” Takeda’s US gastroenterology busine ..read more

CSL Vifor is looking to close out a European anti-competitive investigation with a proposed marketing campaign. The European Commission began investigating Vifor Pharma, now CSL Vifor, in June 2022 over allegations it illegally disparaged its IV iron infusion competitor, Pharmacosmos’ Monofer. The EC alleged Vifor’s actions were aimed at stifling competition for its own high-dose iron IV brand Ferinject, which is marketed as Injectafer in the US. Vifor was accused of running a “misleading communication campaign, primarily targeting healthcare professionals, which may have unduly hindered Monof ..read more

Novo Nordisk decided to discontinue its long-acting insulin Levemir last November, and three Democrats in the Senate want to know why, laying out their questions in a letter to leaders of the company on Tuesday. Sens. Jeanne Shaheen (D-NH), Elizabeth Warren (D-MA) and Raphael Warnock (D-GA) sought more information on supply constraints and whether Novo would consider producing Levemir until biosimilars are available. They gave Novo until May 1 to respond to the questions. Novo declined to comment on the letter. In November 2023, Novo announced it would discontinue Levemir in the US in 2024 ami ..read more

FDA Commissioner Robert Califf told lawmakers he’s ready to work with them to bring more drug manufacturing to the US and laid out the agency’s progress to ramp up overseas inspections at a congressional hearing Thursday. Appearing before a House Appropriations panel to defend the agency’s budget request for fiscal year 2025, representatives peppered Califf with questions about how the FDA can play a role in reshoring overseas generic drug manufacturing to the US. He also told the panel that while challenging, the FDA has made some progress in conducting more unannounced inspections overseas ..read more

Plus, news about TScan Therapeutics: Histogen files for Chapter 11 bankruptcy: The biotech, which stopped work in September, filed a petition with the US Bankruptcy Court for the Southern District of California. Its next steps include confirming a plan of liquidation to distribute value to stakeholders. — Ayisha Sharma  Barinthus Bio touts Ph1b/2 HPV data: The company’s immunotherapy candidate, VTP-200, met the primary safety endpoint in a trial of 108 women with high-risk HPV-associated low-grade cervical lesions. The group with the highest treatment dose achieved a 6 ..read more

Will Vertex’s “pipeline-in-a-product” pay off? That’s the bet behind the company’s $4.9 billion acquisition of Alpine Immune Sciences and its mid-stage IgA nephropathy drug, which is designed to inhibit two key cytokines. The companies announced the deal last week, touting povetacicept’s potential in IgA nephropathy (IgAN) and hinting at its broader ambitions to treat autoimmune conditions. Jeff Leiden “Pove holds the promise of a pipeline-in-a-product for a number of B cell-driven serious diseases,” Vertex chair Jeff Leiden said during an April 10 investor call. “This reminds me very much of ..read more

An acute competition is emerging among drug developers looking at a rare neurological disorder known as chronic inflammatory demyelinating polyneuropathy, or CIDP, and Wall Street analysts are taking note. At the American Academy of Neurology’s annual meeting this week, argenx and Sanofi both released trial updates for their CIDP programs. And though argenx has at least a three-year lead with its drug Vyvgart already approved in another indication, analysts expect Sanofi and others — particularly Dianthus Therapeutics and Immunovant — to prove worthy competitors. The market opportunity is sign ..read more

Roche’s Genentech said that Alecensa scored a label expansion from the FDA, with the drug now approved as an adjuvant treatment following tumor resection in patients with ALK-positive non-small cell lung cancer. The approval is based on data from the Phase 3 ALINA study that showed Alecensa reduced the risk of disease recurrence or death by 76% compared to those in the control arm who received chemotherapy following surgery. Additional data shared at ESMO last year showed that at 24 months, Alecensa’s disease-free survival was 93.6% versus chemo’s 63.7%. One year later, Roche’s drug hit 88.7 ..read more

Najat Khan Recursion Pharmaceuticals has poached Najat Khan from Johnson & Johnson, where she led AI efforts at one of healthcare’s giants. Khan will serve as chief R&D and commercial officer, along with joining Recursion’s board. The move comes at a critical time for Recursion, as its stock price has fallen 75% since going public in 2021, currently commanding a market capitalization of $1.75 billion. The Utah biotech expects its first Phase 2 readouts later this year for two rare disease drug candidates. Khan’s hiring comes shortly after the departure of Shafique Virani, Recursion’s f ..read more

Trust in the pharma industry is up among consumers, but slipped for the biotech sector in an unusual flip of sentiment about the two industries, according to Edelman’s annual Trust Barometer research. Consumer trust in the pharmaceutical industry rose five points to 54%, while trust in biotech and life sciences dipped two points to 56%, compared to a year ago. But that’s not the only switch this year. The review also found that healthcare providers made a comeback as trusted sources, with a 10% increase year-over-year. However, employers and businesses both fell 9% when consumers were asked ab ..read more