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Home » Authors » Jennifer Boggs

Jennifer Boggs

Articles

ARTICLES

Geron’s imetelstat IMerges a winner with positive phase III MDS trial

Jan. 4, 2023
By Jennifer Boggs
Geron Corp. executives highlighted a potential billion-dollar market opportunity for imetelstat on the back of positive phase III data for the telomerase inhibitor in patients with lower-risk myelodysplastic syndromes (MDS), news that sent shares (NASDAQ:GERN) rising 36% and could portend the first regulatory win for a scientific approach the company has pursued since the 1990s.
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Briumvi

TG’s anti-CD20 antibody wins FDA nod for MS

Dec. 28, 2022
By Jennifer Boggs
Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).
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Silhouette made of crumpled paper illustrating depression
Newco news

Lusaris tackling treatment-resistant depression with neuroplastogen approach

Dec. 28, 2022
By Jennifer Boggs
Over the past few years, the pandemic clearly has put a spotlight on vaccines and the infectious disease space. But the struggle to adjust in COVID-19’s wake also brought into stark relief another high unmet need. “Coming out of COVID, there was a mental health focus coming into play,” said Andrew Levin, partner and managing director at investment firm RA Capital Management who is also serving as interim CEO at Lusaris Therapeutics Inc., a 2021 startup targeting neuropsychiatric and neurological conditions, with an initial focus on treatment-resistant depression.
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Investors hail big win for Madrigal, NASH field with positive phase III results

Dec. 19, 2022
By Jennifer Boggs
“Far superior to what almost anyone expected,” was how H.C. Wainwright analyst Ed Arce described the top-line readout for Madrigal Pharmaceuticals Inc.’s phase III study of resmetirom, which hit both of its dual endpoints in patients with nonalcoholic steatohepatitis (NASH) and is expected to form the basis of an accelerated approval application to the U.S. FDA in the first half of 2023.
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Mirati’s Krazati to take on first-mover Lumakras after FDA nod in KRAS-mutated NSCLC

Dec. 14, 2022
By Jennifer Boggs
As largely expected, Mirati Therapeutics Inc.’s adagrasib gained U.S. FDA accelerated approval ahead of its Dec. 14 PDUFA date, cleared for second-line use in patients with non-small-cell lung cancer (NSCLC) harboring the KRAS G12C mutation, in which it will go up ahead Amgen Inc.’s Lumakras (sotorasib), which has the advantage of a year and a half head start.
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FDA sign

FDA yanks Oncopeptides’ Pepaxto authorization for multiple myeloma

Dec. 7, 2022
By Jennifer Boggs
Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. The move followed a negative advisory committee vote in September 2022 and is based on the outcome of the confirmatory phase III Ocean study.
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Woman holding contraceptive pill pack

Therapeuticsmd finds licensing partner in $140M Mayne deal

Dec. 6, 2022
By Jennifer Boggs
Six months after a merger deal fell through, leaving the company to face possible bankruptcy, Therapeuticsmd Inc. agreed to license U.S. commercialization rights for its women’s health care products to Australian firm Mayne Pharma Group Ltd. in exchange for $140 million up front plus milestone and royalty payments.
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Woman holding contraceptive pill pack

Therapeuticsmd finds licensing partner in $140M Mayne deal

Dec. 5, 2022
By Jennifer Boggs
Six months after a merger deal fell through, leaving the company to face possible bankruptcy, Therapeuticsmd Inc. agreed to license U.S. commercialization rights for its women’s health care products to Australian firm Mayne Pharma Group Ltd. in exchange for $140 million up front plus milestone and royalty payments.
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Virtual meetings illustration

Venture financing: Less Zoom but still plenty of capital in correcting market

Dec. 1, 2022
By Jennifer Boggs
When the COVID-19 pandemic effectively shut down travel and conferences starting in the first part of 2020, the general lament was that the lack of face-to-face interaction would hamper biopharma companies’ ability to secure deals and investments. Instead, the opposite happened. Now, coming off two years of record-breaking financing, the biopharma sector is facing an inevitable correction, though a handful of venture capital panelists suggested there’s room for optimism.
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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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View All Articles by Jennifer Boggs

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