Fierce Pharma

SEPTEMBER 11, 2023

After 10 years of stagnation, a new FDA approval could help more cancer patients become eligible for stem cell transplants. |

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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.

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Fierce Pharma

SEPTEMBER 11, 2023

The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. Out with the old and in with the new: Monday, the U.S. |

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Fierce Pharma

JANUARY 4, 2024

On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro?

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Fierce Pharma

OCTOBER 11, 2024

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B. On Friday the U.S.

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Fierce Pharma

DECEMBER 2, 2024

The FDA is investigating reports of patients develo | The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona and is evaluating the need for “further regulatory action,” the U.S. agency said last week.

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Fierce Pharma

OCTOBER 16, 2023

Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery.

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World of DTC Marketing

DECEMBER 29, 2020

For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. Let’s also remember that pharma is going to make a LOT of money on these vaccines. The post How did pharma develop a vaccine so quickly? That’s a hell of an incentive.

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Fierce Pharma

JUNE 20, 2024

The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. |

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Fierce Pharma

APRIL 2, 2024

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. Four dose strengths are now expected to be in short supply through April, according to the FDA.

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World of DTC Marketing

MARCH 18, 2021

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. The post Dear FDA: WTF?

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Fierce Pharma

MARCH 15, 2024

The FDA questioned whether Carvykti should be approved in an earlier line of multiple myeloma after noticing an early detriment to patient survival in a clinical trial. . | WuXi AppTec left BIO amid alleged biosecurity concerns and as U.S. lawmakers target certain Chinese biotechs. And more.

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World of DTC Marketing

DECEMBER 22, 2020

So should pharma be in the app business? The average cost to make an app ranges from $80K – $250K+, depending on what type of app you want to create: Simple apps cost up to $80,000. ” An app can help patients manage their chronic conditions but there are a lot of variables. This is new to pharma.

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Fierce Pharma

SEPTEMBER 26, 2024

A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.

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Fierce Pharma

NOVEMBER 15, 2024

Azurity Pharmaceuticals has earned an FDA approval for Danziten, a new formulation of Novartis’ chronic myeloid leukemia (CML) blockbuster Tasigna.

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Fierce Pharma

MAY 9, 2024

While Vertex leads in patient starts, bluebird has activated more treatment centers. It’s not an easy question to answer.

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Fierce Pharma

NOVEMBER 25, 2024

With the nod, BridgeBio will challenge Pfizer’s powerhouse Vyndaqel franchise, which dominates the indication.

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World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. government. Natalie Shure, The New Republic.

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Fierce Pharma

AUGUST 16, 2024

AstraZeneca has scored an FDA approval in the advancement of its hi | AstraZeneca has scored an FDA approval in the advancement of its high-flying cancer therapy Imfinzi that comes with some controversy. The nod is for Imfinzi to treat patients with resectable non-small cell lung cancer perioperatively.

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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

NOVEMBER 9, 2022

FDA signs off on Sobi's Kineret for COVID patients with pneumonia who are on oxygen. Wed, 11/09/2022 - 16:21.

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Fierce Pharma

SEPTEMBER 13, 2024

When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. The approval gives patients a more convenient injected way to receive Ocrevus as opposed to the infused formulation.

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Fierce Pharma

SEPTEMBER 20, 2024

The FDA signed off on AstraZeneca's influenza vaccine FluMist for self-administration by adults up to 49 years old and for administration by a parent or caregiver in kids between the ages of 2 and 17. patients can give to themselves. AstraZeneca has just scored big on the quest to make routine vaccinations less of a hassle. |

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World of DTC Marketing

DECEMBER 1, 2020

Walk into any corporate pharma HQ, and you’re likely to see a mission statement that’s pure b t about how patients come first. We all know that Wall Street and sales come well before patients. Just look at any pharma product website that is nothing but a sales brochure in a majority of cases. Want proof?

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Fierce Pharma

DECEMBER 20, 2023

Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit. On Tuesday, the U.S.

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Fierce Pharma

DECEMBER 15, 2023

With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor.

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Fierce Pharma

AUGUST 7, 2024

Novo Nordisk’s attempt to gain an approval to treat heart failure patients with its obesity drug Wegovy has been put on hold. 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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Fierce Pharma

SEPTEMBER 11, 2023

Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin (..)

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Fierce Pharma

FEBRUARY 13, 2024

The FDA has approved Onivyde as part of a combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer. It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017.

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Fierce Pharma

SEPTEMBER 20, 2024

Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday.

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Fierce Pharma

MAY 17, 2024

Seven months after Amgen’s chief medical officer referred to trial | Seven months after Amgen’s chief medical officer referred to trial results for the company's investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC). (..)

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Fierce Pharma

SEPTEMBER 18, 2024

Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off (..)

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Biogen’s failure should be a warning to other pharma companies. It should be a warning to other pharma companies. ” Pharma CEOs are compensated on how their products earn money. .”

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Fierce Pharma

DECEMBER 9, 2023

BCMA-targeted therapies are transforming care for multiple myeloma patients. A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions. But these immunotherapies also come with various potentially dangerous side effects. |

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Fierce Pharma

OCTOBER 10, 2024

In prostate cancer, Pfizer’s Talzenna already holds the broadest FDA approval within the PARP inhibitor class. | In prostate cancer, Pfizer’s Talzenna already holds the broadest FDA approval within the PARP inhibitor class.

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Fierce Pharma

SEPTEMBER 24, 2024

and BeiGene.

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Fierce Pharma

JANUARY 22, 2024

When the FDA converts an accelerated approval into a full nod, it’s typically associated with a wider label for the drug at hand. When the FDA converts an accelerated approval into a full nod, it's typically associated with a wider label for the drug at hand.

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