Fierce Pharma

FEBRUARY 12, 2024

With a patent feud settled and its approval application back at the FDA’s desk, Sweden’s Xspray Pharma believes it's on track to launch its first commercial product late this summer. The FDA is now expected to decide on Dasynoc by July 31.

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Fierce Pharma

NOVEMBER 8, 2023

In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. | In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly.

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Fierce Pharma

DECEMBER 18, 2022

2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line. Sun, 12/18/2022 - 17:18.

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Fierce Pharma

SEPTEMBER 19, 2023

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality (..)

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Fierce Pharma

NOVEMBER 21, 2023

Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. | Federal Trade Commission isn't letting up in its effort to crack down on pharma's alleged misuse of a patent mechanism in the FDA's regulatory process.

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Fierce Pharma

DECEMBER 20, 2022

Thea Pharma gets FDA nod for preservative-free rival to Sun and Viatris glaucoma eye drops. Tue, 12/20/2022 - 04:53.

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Fierce Pharma

APRIL 22, 2024

After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S.

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Fierce Pharma

JANUARY 6, 2024

Florida has secured a major win in its yearslong quest to import cheaper drugs from Canada—though the backlash from pharma trade groups on both sides of the border has been swift and fierce. | The FDA on Friday authorized Florida’s drug importation program, which will be valid for two years after it officially begins.

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MedCity News

MARCH 14, 2024

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

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Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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Fierce Pharma

JULY 27, 2023

To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” | To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.”

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Fierce Pharma

SEPTEMBER 12, 2023

Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. Xspray and BMS have settled patent litigation around their potential rivals Dasynoc and Sprycel, Xspray said Tuesday.

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Fierce Pharma

JANUARY 25, 2024

The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. | The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma.

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Fierce Pharma

APRIL 1, 2024

What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA. What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA.

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Fierce Pharma

JULY 13, 2023

Takeda pulled the FDA filing for its dengue vaccine after the FDA requested more data. BeiGene lost its TIGIT inhibitor collaboration with Novartis but signed an antibody-drug conjugate deal with Duality Biologics. Novartis walked away from BeiGene's TIGIT inhibitor. And more.

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Fierce Pharma

APRIL 8, 2024

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.

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Fierce Pharma

FEBRUARY 16, 2024

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA (..)

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Fierce Pharma

MARCH 8, 2024

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. |

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Fierce Pharma

APRIL 5, 2024

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

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Fierce Pharma

APRIL 3, 2024

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

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Fierce Pharma

MARCH 9, 2023

Fierce Pharma Asia—Leqembi's priority review; Enhertu's broad trial win; Cipla's FDA censure aliu Thu, 03/09/2023 - 15:27

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Fierce Pharma

APRIL 23, 2024

Compared with an incumbent offering from Novartis, the newcomer boasts an FDA approval covering a broader patient population. Compared with an incumbent offering from Novartis, Day One's newcomer boasts an FDA approval covering a broader patient population. Another drug is in town for common pediatric brain tumors.

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Fierce Pharma

APRIL 8, 2024

The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The following year, the agency doled out a complete response letter, dashing Supernus' second try.

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Fierce Pharma

MARCH 5, 2024

Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. regulator, the FDA has crushed Vanda’s bid.

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Fierce Pharma

NOVEMBER 28, 2023

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

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Fierce Pharma

MARCH 25, 2024

Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.<

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Fierce Pharma

APRIL 4, 2024

Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. | Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S.

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Fierce Pharma

DECEMBER 27, 2023

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

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Fierce Pharma

JUNE 28, 2023

Pfizer is on an FDA heater. Pfizer is on an FDA heater. With a blessing Wednesday for once-weekly growth hormone deficiency (GHD) drug Ngenla, the New York pharma giant has racked up four approvals from the agency over the last five weeks.

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Fierce Pharma

JUNE 28, 2023

Eton Pharmaceuticals’ dehydrated alcohol injection didn’t pass muster with the FDA, instead receiving a complete response letter (CRL) raising flags the company believes are “addressable.” | The dehydrated alcohol injection was turned down due to problems with its chemistry manufacturing and controls, issues which the company believes are addressable, (..)

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Fierce Pharma

APRIL 11, 2024

After investigations into the FDA’s response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency’s | FDA Commissioner Robert Califf, M.D., The Oversight Committee hearing touched on a range of other issues, too.

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Fierce Pharma

MARCH 6, 2024

Two biosimilars to Amgen’s lucrative bone drugs Prolia and Xgeva have clinched approvals at the FDA, though ongoing patent litigation makes launch timing uncertain. Sandoz has clinched FDA approvals for biosimilars to Amgen’s denosumab.

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Fierce Pharma

APRIL 23, 2024

Dating to a 2019 clinical hold of a phase 3 trial, getting its gene therapy ra | Dating to a 2019 clinical hold, getting its gene therapy pz-cel across the FDA finish line has been a challenge for troubled Abeona Therapeutics. Now the wait continues as the FDA has rejected the treatment due to CMC issues.

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Fierce Pharma

FEBRUARY 12, 2024

Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug’s developer, Takeda, had at one point abandoned the program following | Takeda's Eohilia has surprisingly won over the FDA even after the company had at one point abandoned the program following an FDA rejection.

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Fierce Pharma

APRIL 2, 2024

Four dose strengths are now expected to be in short supply through April, according to the FDA. Amid steadily increasing demand for Eli Lilly’s popular diabetes med Mounjaro, it appears patients on multiple dose strengths may have to wait even longer than anticipated to re-up on supply.

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Fierce Pharma

JUNE 15, 2023

Astellas' new CEO Naoki Okamura talked to Fierce Pharma about the company's business plans. Eisai and Biogen's Leqembi won backing from the FDA's external advisers. Astellas' new CEO Naoki Okamura discussed the company's business plans. AbbVie has brought a BTK patent infringement lawsuit against BeiGene.

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Fierce Pharma

APRIL 10, 2024

The FDA appears receptive to the idea of using the measurement to support accelerated approvals of new drugs, even though the agency has a few questions. New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. |

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