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Home » Authors » Jennifer Boggs

Articles by Jennifer Boggs

Analysis ongoing as top-line data disappoint for Vanda’s gastroparesis drug

Feb. 4, 2022
By Jennifer Boggs
Citing potential confounding factors, Vanda Pharmaceuticals Inc. is hoping further analysis might explain the top-line miss for its phase III study testing tradipitant in gastroparesis, hinting that regulatory submissions could still be in the offing. Investors, unsurprisingly, were less optimistic, sending shares of the Washington-based company (NASDAQ:VNDA) down nearly 18% to close Feb. 4 at $12.03.
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Biktarvy pill

Gilead paying $1.25B, plus royalties, to Viiv to resolve HIV drug patent claims

Feb. 2, 2022
By Jennifer Boggs
Gilead Sciences Inc. is making a one-time $1.25 billion payment, with a commitment for a royalty that analysts predict could add as much $1.5 billion more, to Viiv Healthcare Ltd., in a deal designed to resolve all global pending or potential patent infringement claims relating to sales of HIV drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). The initial payment, recorded in the fourth quarter of 2021, put a significant dent in Gilead’s earnings per share but removes the uncertainty of a trial outcome and clears the way for future bictegravir-containing products.
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Recent PI3K-delta troubles don’t deter confidence in drug class, says MEI Pharma CEO

Feb. 1, 2022
By Jennifer Boggs
Last week, Incyte Corp. said it was pulling its NDA seeking accelerated approval for the PI3K-delta inhibitor parsaclisib in three non-Hodgkin lymphoma subtypes, a move that followed recent decisions by Gilead Sciences Inc. and Secura Bio Inc. to withdraw from U.S. commercialization their respective PI3K-delta inhibitors in indications for which they’d received accelerated approval. But the recent spate of headlines is hardly “a condemnation” on the entire class of drugs, said Dan Gold, CEO of MEI Pharma Inc., which is aiming for a potential accelerated approval filing of its own PI3K-delta drug, zandelisib, this year.
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Close-up of eye with digital focus

Immunocore wins US FDA approval for pioneering uveal melanoma drug

Jan. 26, 2022
By Richard Staines and Jennifer Boggs
Touting a series of firsts and a premium price tag to match, Immunocore Holdings plc is poised to launch the uveal melanoma drug tebentafusp in the U.S. following FDA approval for the medicine. The regulatory nod makes the drug, branded Kimmtrak, the first T-cell receptor-based therapy to reach the market, the first approval for a drug targeting gp100, and the first drug approved in 40 years for the cancer, which is the most common eye cancer in adults, though still rare.
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Multiple myeloma illustration

Despite limited info, investors optimistic as Oncopeptides pulls voluntary FDA withdrawal for myeloma drug

Jan. 24, 2022
By Jennifer Boggs
In late February 2021, Oncopeptides AB scored a big win on the FDA’s accelerated approval for the first cancer peptide-drug conjugate, Pepaxto (melphalan flufenamide), in multiple myeloma. Less than eight months later, it was shutting down commercial operations and heading back to the drawing board after safety issues emerging in the confirmatory Ocean study prompted the Stockholm-based firm to pull Pepaxto from the market, just ahead of what was likely to be a negative FDA advisory panel vote.
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Joint pain

UCB’s bimekizumab notches more phase III wins; still awaiting first FDA decision

Jan. 21, 2022
By Jennifer Boggs
UCB SA anticipates submitting regulatory applications in the third quarter for IL-17-targeting bimekizumab in psoriatic arthritis and ankylosing spondylitis, after chalking up second successful phase III trials in both indications. Meanwhile, the high commercial hopes for the would-be blockbuster remain at least temporarily deferred as pandemic-related travel restrictions have delayed FDA action on the BLA for plaque psoriasis.
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FDA website and logo

Levo hit with expected CRL for PWS drug after negative adcom

Jan. 18, 2022
By Jennifer Boggs
Not heeding earlier FDA advice has earned Levo Therapeutics Inc. a complete response letter (CRL) for its NDA seeking approval for intranasal carbetocin (LV-101) in hyperphagia associated with Prader-Willi syndrome (PWS). The CRL followed a 12-1 negative advisory committee vote in November.
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FDA approved metal stamp

Recorlev wins FDA nod for Cushing’s syndrome patients

Dec. 31, 2021
By Jennifer Boggs and Michael Fitzhugh
Less than three months after completing its acquisition of Strongbridge Biopharma plc, Xeris Biopharma Holdings Inc. secured FDA approval of Recorlev (levoketonconazole), a second-generation drug cleared for use in Cushing’s syndrome, just ahead of its Jan. 1 PDUFA date. Indicated specifically for patients with endogenous forms of the disease for whom surgery isn’t an option or hasn’t worked, the therapy is expected to be available commercially in the first quarter of 2022.
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FDA Approved stamp

First FcRn antagonist approved as Argenx’s Vyvgart gets FDA nod in myasthenia gravis

Dec. 20, 2021
By Jennifer Boggs
Argenx NV’s Vyvgart (efgartigimod), approved late Friday by the FDA for treating generalized myasthenia gravis, became the first FcRn antagonist to cross the finish line. But the best news may be the drug’s broad label, which company executives highlighted during an investor call.
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FDA approves Calliditas’ Tarpeyo as first drug to treat IgAN

Dec. 16, 2021
By Jennifer Boggs
Calliditas Therapeutics AB expects its oral version of budesonide to be available early in the first quarter of 2022, following FDA approval for treating patients with progressive kidney disease primary immunoglobulin A nephropathy (IgAN). Branded Tarpeyo, the delayed-release capsules were cleared for use in reducing proteinuria in adults with primary IgAN at risk of rapid disease progression, usually determined as a protein-to-creatinine ration (UPCR) of 1.5 g/g or less.
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