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Home » Authors » Jennifer Boggs

Articles by Jennifer Boggs

FDA approved icons and medical professional

Genmab, Abbvie to join Roche with FDA nod for CD20 bispecific in lymphoma

May 19, 2023
By Jennifer Boggs
Five months after the first anti-CD20xCD3 T-cell engaging bispecific antibody, Roche Holding AG’s Lunsumio (mosunetuzumab), cleared U.S. FDA approval for follicular lymphoma, partners Genmab A/S and Abbvie Inc. won the agency’s approval for epcoritamab as the first subcutaneous CD20xCD3 bispecific antibody for treating diffuse large B-cell lymphoma.
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Adcom backs Pfizer’s RSV vaccine for maternal immunization

May 19, 2023
By Jennifer Boggs
Efficacy data for Pfizer Inc.’s respiratory syncytial virus (RSV) vaccine proved convincing for members of the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee, which voted 14-0 May 18 in favor of Abrysvo’s effectiveness when administered during the second or third trimester of pregnancy to protect infants from birth to 6 months, with the adcom endorsing safety data in a 10-4 vote.
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Radiotherapy of cancer

Bayer on board, too: Bicycle inks second $1.7B radiopharma deal in as many months

May 10, 2023
By Jennifer Boggs
Barely a month and a half after its radioconjugate approach landed a potential $1.7 billion deal with Novartis AG, Bicycle Therapeutics plc drew another big radiopharma player to the table, signing a collaboration agreement with Bayer AG to use Bicycle’s peptide technology to discover and develop radiotherapies against cancer targets. Terms are similar to the Novartis deal, with Bayer paying $45 million up front and Bicycle eligible for development and commercial milestones totaling up to $1.7 billion, and underline the growing interest in the radiopharma space.
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Junshi’s toripalimab gaining more ground via $728M Dr. Reddy’s deal

May 9, 2023
By Jennifer Boggs
Notching another deal in its efforts to extend the global reach of toripalimab, Junshi Biosciences Co. Ltd. granted Dr. Reddy’s Laboratories Ltd. rights to develop and commercialize the PD-1 inhibitor in a regional licensing agreement that could be worth as much as $728.3 million.
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Junshi’s toripalimab gaining more ground via $728M Dr. Reddy’s deal

May 8, 2023
By Jennifer Boggs
Notching another deal in its efforts to extend the global reach of toripalimab, Junshi Biosciences Co. Ltd. granted Dr. Reddy’s Laboratories Ltd. rights to develop and commercialize the PD-1 inhibitor in a regional licensing agreement that could be worth as much as $728.3 million.
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Amyloid plaques forming between neurons

What CRL? After accelerated diss, Lilly to seek full approval on solid phase III Alzheimer’s readout

May 3, 2023
By Jennifer Boggs
In January, a Wall Street analyst predicted the U.S. FDA’s rejection of Eli Lilly and Co.’s application seeking accelerated approval of amyloid beta-targeting Alzheimer’s candidate, donanemab, would be a “mere footnote” in the drug’s development, a forecast confirmed in the wake of positive top-line phase III data showing donanemab significantly slowed cognitive and functional decline in people with early symptomatic disease.
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Thyroid anatomy

CRL offers clarity for Ascendis’ Transcon PTH, as EMA decision remains on track

May 1, 2023
By Jennifer Boggs
It’s not often that getting an NDA rejected by the U.S. FDA is cause for a company’s stock to rise. But in the case of Ascendis Pharma A/S, the agency’s anticipated complete response letter (CRL) for Transcon PTH (palopegteriparatide) offered some much-needed clarity and a potentially optimistic time frame for an NDA resubmission seeking approval of the once-daily hormone replacement therapy for hypoparathyroidism, news that sent the company’s shares (NASDAQ:ASND) up 24%, or $16.78, to close May 1 at $86.74.
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In8bio soars on ‘curative potential’ of gamma-delta T-cell therapy in phase I trial

April 24, 2023
By Jennifer Boggs
The data are early and from only seven evaluable patients, but results from In8bio Inc.’s phase I study of gamma-delta T-cell therapy INB-100 in leukemia patients who have undergone haploidentical hematopoietic stem cell transplant, presented at the European Society for Blood and Marrow Transplantation meeting, were compelling enough to drive the company’s shares (NASDAQ:INAB) up 183% April 24.
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Multiple sclerosis-damaged myelin

Pipeline strikes $1B deal with Janssen for myelin restoration candidate in MS

April 17, 2023
By Jennifer Boggs
Pipeline Therapeutics Inc., which received U.S. FDA approval to move into a phase Ib/IIa study of PIPE-307 in relapsing-remitting multiple sclerosis (RRMS) last year, will be advancing the oral, small-molecule muscarinic M1 receptor antagonist in collaboration with Janssen Pharmaceutica NV in an agreement that could be worth more than $1 billion.
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Ischemic stroke
Newco news

Fast-acting and reversible: Basking seeks to expand options in ischemic stroke

April 11, 2023
By Jennifer Boggs
Acute thrombosis, including heart attack and stroke, is a leading cause of mortality worldwide. Yet only a small fraction of patients can be treated with current therapeutic or surgical interventions. Enter Basking Biosciences Inc., a 2019 startup aimed at developing a short-acting, fast-onset thrombolytic drug alongside a reversal agent for treating acute ischemic stroke.
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