Fierce Pharma

OCTOBER 31, 2024

25 mg presentation of the popular metabolic medicine was the last dose of either Wegovy or its type 2 diabetes sibling Ozempic to be listed as in shortage by the FDA. 25 mg starter dose of Novo’s semaglutide-based obesity med Wegovy is now available in the U.S.

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FDA Medicine 334

Fierce Pharma

AUGUST 2, 2024

This week on “The Top Line,” we discuss two studies in HIV research that were presented at the 25th International AIDS | This week on “The Top Line,” we dive into two studies in HIV research that were presented at the 25th International AIDS Conference in Germany.

Patients 270

Patients 270

Fierce Pharma

APRIL 29, 2024

After last quarter presenting three factors necessary for a more successful launch of hemophilia A gene therapy Roctavian, BioMarin has now added a divestiture to the list of potenti | After last quarter presenting three factors necessary for a more successful launch of hemophilia A gene therapy Roctavian, BioMarin has now added a divestiture to the (..)

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Sales Medicine 275

Fierce Pharma

JANUARY 10, 2024

In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. | In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist.

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Fierce Pharma

OCTOBER 16, 2024

With Gilead sprinting to a likely approval next year for its long-acting pre-exposure | With GSK girding for competition from Gilead Sciences, the company has presented strong results from three real-world studies of its bi-monthly injection for HIV prevention.

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Competition 315

Fierce Pharma

JANUARY 25, 2024

Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Ther | Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Therapeutics was on its way to becoming a “leaner and stronger company.”

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Fierce Pharma

AUGUST 7, 2024

In its quarterly earnings presentation, the Danish company said that after discussions with the FDA, it has pulled its filing and expects to resubmit in early 2025. Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold.

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FDA Patients 316

Fierce Pharma

OCTOBER 17, 2023

23 when the full data of MARIPOSA are presented at ESMO 2023. | Editor's note: This is an evolving story. Please check back on Oct. A drug combination from Johnson & Johnson outperformed AstraZeneca’s Tagrisso in slowing the worsening of newly diagnosed lung cancer.

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Fierce Pharma

APRIL 9, 2024

At an FDA advisory committee meeting this Friday, two teams will present their studies examining the utility of minimal residue disease (MRD) as a potentially approvable endpoint in multiple myeloma. About 15 years ago, Carl Ola Landgren, M.D. noticed an encouraging yet potentially concerning trend in the treatment of multiple myeloma. |

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FDA Pharma Patients 316

Fierce Pharma

MAY 20, 2024

On Monday, Sanofi and Regeneron had their answer to Amgen and AstraZeneca's presentation from the day before. . | At the American Thoracic Society international conference, one of the major themes is the advance of new therapies for COPD.

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Fierce Pharma

FEBRUARY 21, 2024

A federal judge in New Jersey agreed to let Bristol Myers Squibb, Novo Nordisk, Novartis and J&J present oral arguments together in their bid to challenge the government's new Medicare negotiations framework.

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Government 297

Fierce Pharma

MAY 21, 2024

A decade ago, with AstraZeneca in decline and some investors urging the drugmaker to sell out to Pfizer, new CEO Pascal Soriot presented an audacious plan to hike revenue to $45 billion by 2023. After AstraZeneca achieved Pascal Soriot's ambitious $45-billion-by-2023 revenue goal, the CEO is thinking big again.

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MedCity News

APRIL 9, 2024

The post Which Health Tech Startups Will Present in the Payer/Provider Track of INVEST Pitch Perfect? The finalists for the Payer/Provider track are applying their health tech solutions to addressing burnout and operational efficiency. appeared first on MedCity News.

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PharmaTech

MAY 8, 2024

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

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Fierce Pharma

OCTOBER 18, 2023

22 when the full data of EV-302 are presented at ESMO 2023. | Editor's Note: Please check back on Oct. The results are in for a phase 3 bladder cancer trial assessing the combination of Seagen and Astellas' Padcev, plus Merck's Keytruda, versus standard of care chemotherapy.

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Fierce Pharma

SEPTEMBER 6, 2024

Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug.

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FDA Patients 303

Fierce Pharma

AUGUST 8, 2024

As Novavax presented its quarterly earnings, finance chief Jim Kelly said the company was “actively exploring” the sale of its manufacturing facility in the Czech Republic. It was 2020 and Maryland biotech Novavax was thinking big. It had a plan to become a COVID vaccine powerhouse, with enough manufacturing capacity to supply the U.S. |

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Manufacturing Sales Government 319

Fierce Pharma

MARCH 11, 2024

The disease setting currently has no approved treatment options.

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Sales 294

Fierce Pharma

SEPTEMBER 26, 2024

Three months later, the FDA has added its acclamation, signing off on Tagrisso to become the first targeted therapy for unresectable, stage 3 EGFRm NSCLC.

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FDA 298

Fierce Pharma

OCTOBER 30, 2024

As part of the new budget presented Wednesday by the U.K.’s Biopharma production efforts are set to receive a big boost in the U.K. thanks to a new budget rolled out by the Labour Party following this summer’s general election. |

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Manufacturing Biopharma Medical 264

Fierce Pharma

JANUARY 23, 2024

While sales for Johnson & Johnson’s Darzalex continue to boom—as the company reported in its quarterly earnings presentation on Tuesday—the pharma major got more good news about its blockbuster | An appeal arbitrator has rejected Genmab’s claim that it is due additional milestone and royalty payments from Johnson & Johnson for Darzalex.

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Sales Pharma 284

Fierce Pharma

OCTOBER 16, 2024

While radiopharmaceuticals have attracted significant interest in recent years thanks to their cancer-fighting prowess, the unique makeup of the meds has presented a host of production challenges f | SpectronRx has inked an agreement to complete its first European radiolabeling plant at the Belgian Nuclear Research Center in Mol, Belgium.

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Fierce Pharma

FEBRUARY 7, 2024

26, Eisai explained in a third-quarter earnings presentation. were receiving the amyloid-busting antibody as of Jan.

FDA 278

FDA Patients 278

Fierce Pharma

NOVEMBER 6, 2023

At the start of its first-ever conference call to present its quarterly numbers, Krystal Biotech CEO Krish Krishnan was quick to point out that the company’s positive earnings for the third quarter | Krystal Biotech's launch of Vyjuvek, the world's first topical gene therapy, has been so promising that analysts with Evercore ISI increased (..)

Sales 298

Sales FDA 298

Fierce Pharma

SEPTEMBER 11, 2023

In a poster presented over the weekend at Psych Congress 2023, Qelbree was shown to sharpen the focus of children 6 and older when combined with a stimulant. A shortage of attention-deficit/hyperactivity disorder (ADHD) medicines has been ongoing for a year in the U.S.

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Medicine Patients 299

Fierce Pharma

NOVEMBER 7, 2023

That’s because the coming entry of a cheaper copycat presents J&J with an opportunity to elude Medicare price negotiations outlined in the Inflation Reduction Act. . | There might just be a silver lining for Johnson & Jonhson in the FDA's recent approval of Amgen’s Stelara biosimilar.

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FDA 289

Fierce Pharma

FEBRUARY 6, 2024

On a day when Vertex revealed trial data that indicate | On a day when Vertex revealed trial data that indicate its next-generation cystic fibrosis (CF) treatment will soon be ready to grab the baton, the Boston company also presented figures that show Trikafta remains formidable. In the fourth quarter, Trikafta raked in $2.33

Sales 263

Sales 263

Fierce Pharma

OCTOBER 11, 2023

Dermavant has presented evidence that Vtama provides immediate and long-term relief from the severe itch condition pruritus, the most prevalent symptom of atopic dermatitis. In the race to develop nonsteroidal topical treatments for autoimmune skin conditions, Dermavant is charging toward the finish line—again.

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FDA 278

Fierce Pharma

DECEMBER 21, 2023

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. |

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FDA Pharmaceutical Patients 278

Fierce Pharma

OCTOBER 5, 2023

Ahead of its quarterly earnings presentation, Apellis estimated sales of approximately $74 million for the third quarter for Syfovre and a rekindling of demand in recent weeks as doctors get a better handle on the risk of vascular retinitis.

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Doctors Sales 277

Fierce Pharma

FEBRUARY 22, 2024

While the overall theme of Moderna’s quarterly earnings presentation on Thursday was that the company is moving away from its coronavirus vaccine and onto a host of other mRNA products in developme | In the fall vaccination season, Moderna captured 48% of the COVID-19 retail market in the United States versus a 37% showing in 2022, closing the gap (..)

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Marketing Retail 247

Fierce Pharma

NOVEMBER 6, 2023

billion euros in 2022, the company stressed its sound finances on Monday as it presented its third-quarter earnings. billion) versus its previous estimate of 5 billion euros ($5.4 While it’s a huge drop in sales from 19 billion euros in 2021 and 17.3

Sales 286

Sales 286

Fierce Pharma

OCTOBER 27, 2023

On Friday, as AbbVie presented its third-quarter earnings, the company said that it has recorded a $2.1 But what about the impact of the Inflation Reduction Act? In August, Imbruvica was one of the 10 drugs identified by the CMS that will be subject to price negotiations in 2026.

Sales 278

Sales 278

Fierce Pharma

AUGUST 16, 2023

Two pollsters presented results from their recent survey on Tuesday. | Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines, a pollster found.

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Prescription 246

Fierce Pharma

JULY 25, 2023

In a sizable cost-cutting measure, Biogen will lay off 1,000 employees by 2025, it announced in presenting its second quarter earnings. In reporting its first-quarter earnings, Biogen said it would halt the development of at least four investigational drugs to allow the company to focus on more lucrative opportunities. |

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Fierce Pharma

JUNE 26, 2023

Last weekend at the American Diabetes Association Scientific Sessions in San Diego, market leaders Novo Nordisk and Eli Lilly presented data that showed their investigative oral GLP-1 treatments are making progress.

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Marketing Patients 264

Fierce Pharma

OCTOBER 14, 2024

Today, manufacturing biomolecules presents unique challenges, like cost pressure and market uncertainty. The need to develop proprietary processes to differentiate from competitors is higher than ever before.

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Manufacturing Marketing 233