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Home » Authors » Jennifer Boggs

Articles by Jennifer Boggs

Ovarian cancer illustration

GSK’s PARP inhibitor limited in ovarian cancer after FDA OS review

Nov. 15, 2022
By Jennifer Boggs
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
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Ovarian cancer illustration

GSK’s PARP inhibitor limited in ovarian cancer after FDA OS review

Nov. 11, 2022
By Jennifer Boggs
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
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Viruses
Newco news

Atriva taking host-targeted antiviral approach into basket study

Nov. 11, 2022
By Jennifer Boggs
Atriva Therapeutics GmbH, a small firm founded in 2015 to develop a host-targeted antiviral approach for treating respiratory viral infections, seems to have found itself in thick of it. As the U.S. CDC and other health agencies warn of an uptick in respiratory viral infections – the so-called “tripledemic” of influenza, respiratory syncytial virus and COVID-19 – the German company is gearing up to launch a basket trial testing lead candidate zapnometinib in all three indications.
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Heart, DNA and ECG

Caution continues at US FDA as Verve’s gene editing therapy hit by clinical hold

Nov. 7, 2022
By Jennifer Boggs
Verve Therapeutics Inc.’s heart disease candidate, VERVE-101, is the latest gene editing-based therapy to hit a snag at the FDA, which issued a clinical hold, delaying the start of phase I testing in the U.S. News of the hold, which followed preclinical presentations over the weekend at the American Heart Association 2022 meeting, sent shares of Verve (NASDAQ:VERV) falling 30.5% to close Nov. 7 at $21.75.
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Eye and DNA illustration

Nicox glaucoma drug hits endpoint but falls short of peak performance

Oct. 31, 2022
By Jennifer Boggs
Heading into the readout of the phase III Mont Blanc study testing Nicox SA’s NCX-470, a nitric oxide-donating version of prostaglandin analogue bimatoprost, analysts were looking for a superior intraocular pressure-lowering profile vs. latanoprost, predicting such data could position the drug as a new standard of care in a crowded market.
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US still awaiting first HDV drug after FDA hits Gilead’s Hepcludex with CRL

Oct. 28, 2022
By Jennifer Boggs and Michael Fitzhugh
The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022.
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FDA Approved stamp

Janssen’s teclistamab becomes first FDA-approved BCMA bispecific for MM

Oct. 26, 2022
By Jennifer Boggs
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies.
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Liver tumor treatment conceptual illustration

Approval at last, but can Astrazeneca’s tremelimumab hit Stride in liver cancer?

Oct. 24, 2022
By Jennifer Boggs
It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
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Mirum cites ‘compelling dataset’ as it aims to expand Livmarli into PFIC

Oct. 24, 2022
By Jennifer Boggs
Mirum Pharmaceuticals Inc. plans to “move rapidly toward regulatory filings” to expand use of IBAT inhibitor Livmarli (maralixibat) into progressive familial intrahepatic cholestasis (PFIC), President and CEO Chris Peetz told investors during a conference call Oct. 24 to discuss the positive top-line results from the phase III March study, which not only hit its primary endpoint in patients with PFIC2 but showed statistical improvements in pruritis across a range of PFIC subtypes.
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Polymer illustration
Newco news

Bioengineering MVP? Valitor aims to build a better therapeutic

Oct. 21, 2022
By Jennifer Boggs
With roughly a decade of work behind it, Valitor Inc. is ready to put its Multivalent Polymer (MVP) platform to the test, having recently announced its presence with a $28 million series B round and appointment of biopharma veteran Steven Lo as CEO. The next step is IND-enabling studies for its lead ophthalmology candidate, with clinical testing slated to start in 2024.
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