Fierce Pharma

NOVEMBER 16, 2023

Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Watch out, Pfizer and Roche. Watch out, Pfizer and Roche.

FDA 303

FDA Marketing 303

Fierce Pharma

NOVEMBER 18, 2022

With Sanofi as its marketing partner, Provention Bio grabs long-awaited FDA nod for diabetes drug. Fri, 11/18/2022 - 10:21.

Marketing 253

Marketing FDA 253

Fierce Pharma

FEBRUARY 23, 2024

Following a contentious advisory committee meeting and an FDA request for the withdrawal of Oncopeptides’ multiple myeloma drug Pepaxto from the U.S. Following a contentious advisory committee meeting and an FDA request for withdrawal of Oncopeptides’ multiple myeloma drug Pepaxto from the U.S.

FDA 256

FDA Marketing 256

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

Fierce Pharma

AUGUST 30, 2023

After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S.

FDA 342

FDA Marketing 342

Fierce Pharma

SEPTEMBER 15, 2023

A “surprised and extremely disappointed” PTC Therapeutics is scrambling to keep its Duchenne muscular dystrophy therapy Translarna on the European market after a detrimental review. |

Marketing 258

Marketing FDA 258

World of DTC Marketing

AUGUST 10, 2022

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. But, in pharma marketing, the changes affect every product category. However, DTC marketing is different, much different. So what’s the opportunity for DTC marketers?

Marketing 252

Marketing Media Side effects Pharma 252

MedCity News

APRIL 6, 2023

FDA withdrawal of Makena from the market comes four years after the drug, granted accelerated approval in 2011, failed a post-marketing study to confirm the drug’s benefit. The FDA decision also affects generic versions of the drug.

FDA 112

FDA Marketing Biopharma Pharma 112

Fierce Pharma

OCTOBER 13, 2023

Bristol Myers Squibb’s Zeposia is no longer the only S1P receptor modulator on the market for ulcerative colitis, thanks to an FDA approval for what appears to be a more effective drug from Pfizer.

FDA 251

FDA Marketing 251

Fierce Pharma

JANUARY 19, 2024

Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA. | Use of Amgen’s osteoporosis drug Prolia by those with advanced chronic kidney disease (CKD) can increase the risk of calcium loss in the blood, according to the FDA.

FDA 204

FDA Marketing 204

Fierce Pharma

AUGUST 7, 2023

billion buyout of Iveric Bio, the FDA has signed off on the main asset acquired in the deal, the geographic atrophy treatment Izervay. Less than four months after Astellas’ $5.9 billion buyout of eye disease specialist Iveric Bio, the deal is already making the Tokyo-based company look visionary. Less than four months after Astellas’ $5.9

FDA 246

FDA Marketing 246

Fierce Pharma

SEPTEMBER 21, 2023

While the results bode poorly for a full FDA approval anytime soon, Travere can take some solace in the fact that the drug’s removal from market looks unlikely, according to analysts.

Marketing 246

Marketing FDA Patients 246

Fierce Pharma

JUNE 2, 2023

But the lack of evidence for contribution from Imfinzi and a regulatory concern over the use of PARP inhibitors outside BRCA-mutant tumors could make it hard for AstraZeneca to win over the FDA.

FDA 272

FDA Marketing 272

Fierce Pharma

OCTOBER 24, 2023

On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year.

FDA 266

FDA Marketing 266

MedCity News

OCTOBER 2, 2023

The FDA awarded marketing authorization for a new Invitae test that uses next-generation sequencing to assess multiple genes to identify variants indicating a person’s predisposition for certain cancers. The regulatory action creates a new regulatory classification making Invitae’s test the predicate device for future cancer tests.

Marketing 112

Marketing FDA Biopharma Medical 112

Fierce Pharma

AUGUST 10, 2023

As Regeneron anxiously awaits an FDA decision on a high-dose version of Eylea (aflibercept), the company has continually referred to its durability compared to that of Roche’s upstart Vabysmos—whic | As Regeneron anxiously awaits an FDA decision on a high-dose version of Eylea (aflibercept), the company has continually referred to its staying power (..)

FDA 241

FDA Marketing 241

World of DTC Marketing

JULY 21, 2021

SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. The FDA needs to study what people do when they see a DTC ad. The voices in Washington DC are once again calling for a moratorium on DTC marketing but lawmakers need to understand what DTC marketing actually does as upped to what people believe it does.

Marketing 285

Marketing Prescription Side effects Doctors 285

Fierce Pharma

AUGUST 21, 2023

Regeneron pulled off a rare double play on Friday afternoon as it scored two FDA approvals—one under the radar and the other highly anticipated. With the FDA signing off on Regeneron and Bayer’s high-dose Eylea, the companies are set to take on Roche’s Vabysmo in a high-stakes battle for the massive eye disease market.

FDA 246

FDA Marketing 246

World of DTC Marketing

APRIL 22, 2021

QUICK READ: More TV DTC spots are airing, but DTC marketers are losing the battle between awareness and conversion because of all the noise online. I’ve spent the last six months analyzing clients’ DTC marketing campaigns and they are, for most ineffective. One of the most underused tactics is your product website.

Marketing 265

Marketing Side effects Prescription Media 265

Fierce Pharma

SEPTEMBER 21, 2023

market with ulcerative colitis drug mirikizumab, the company’s launch is gaining steam overseas. | Lilly's mirikizumab is one of several launches the company is counting on for growth in the near term. Even after an FDA rejection, the launch is gaining steam overseas.

FDA 250

FDA Marketing 250

Fierce Pharma

OCTOBER 17, 2023

As Elevar Therapeutics and Hengrui Pharmaceuticals await an FDA decision on their combination therapy for newly diagnosed unresectable liver cancer—approved in China back in February—the partners a | As Elevar Therapeutics and Hengrui Pharmaceuticals await an FDA decision on their combination therapy for newly-diagnosed unresectable liver cancer—approved (..)

Marketing 262

Marketing FDA Pharmaceutical 262

World of DTC Marketing

APRIL 6, 2022

DTC marketing has evolved. Challenge #1 – DIGITAL MARKETING. Pharma companies are increasing digital budgets, but they are wasting too much money because of internal staffing issues and inexperience with online marketing. Paid Media – The most commonly used KPI in marketing is essentially worthless.

Marketing 196

Marketing Sales pitches Pharma Media 196

Fierce Pharma

OCTOBER 27, 2023

Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too. Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too.

Marketing 273

Marketing Pharma FDA 273

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?

FDA 180

FDA Prescription Physicians Pharma 180

Fierce Pharma

JUNE 6, 2023

But first the partners will need to pass several regulatory milestones, including an FDA advisory committee discussion set for later this week.

Prospecting 237

Prospecting FDA Marketing 237

MedCity News

MARCH 31, 2024

Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020. The FDA rejected the drug two years ago due to concerns about cardiovascular safety.

FDA 111

FDA Safety Marketing Biopharma 111

Fierce Pharma

APRIL 1, 2024

With AstraZeneca’s dominance in the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) threatened by the recent approval of the first pill on the market for the condition, Novartis’ Fabha | With AstraZeneca’s dominance in the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) threatened by the recent approval of the first pill on (..)

FDA 255

FDA Marketing 255

MedCity News

APRIL 8, 2024

The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

FDA 117

FDA Patients Marketing Biopharma 117

Fierce Pharma

OCTOBER 5, 2023

Judgment Day has come for Amgen’s first-in-class KRAS inhibitor Lumakras as the FDA’s Oncologic Drugs Advisory Committee (ODAC) gathered Thursday to weigh the merits of the cancer med’s phase 3 cli | Judgment Day has come for Amgen’s first-in-class KRAS inhibitor Lumakras as the FDA’s Oncologic Drugs Advisory Committee gathered Thursday to weigh the (..)

Marketing 244

Marketing FDA 244

World of DTC Marketing

JUNE 11, 2021

Key Points: Trust in the CDC and FDA has decreased dramatically during the COVID-19 pandemic among health care professionals, according to a new WebMD/Medscape poll. doctors surveyed in the same time period, 77% said their trust in the CDC has decreased and 48% said their trust in the FDA has decreased. Out of nearly 450 U.S.

Marketing 187

Marketing Doctors FDA Pharma 187

pharmaphorum

MARCH 25, 2024

FDA has turned down a pair of marketing applications for Regeneron’s CD20xCD3 bispecific antibody odronextamab to treat two common forms of non-Hodgkin lymphoma

FDA 109

FDA Marketing 109

World of DTC Marketing

FEBRUARY 15, 2022

Biotechs need to think like marketers to cut through the noise and attract investors. CEOs have to think like marketers to cut through the clutter with all the biotech startups out there. One biotech had to lay off over 100 people because of a setback with the FDA. Hire people as you need them, not before.

Marketing 224

Marketing Medical Pharma FDA 224

Fierce Pharma

JANUARY 11, 2024

Dermavant’s topical cream Vtama, already on the market for plaque psoriasis as a steroid-free treatment, is compiling impressive data in pursuit of an FDA approval in atopic dermatitis (AD).

FDA 294

FDA Marketing 294

World of DTC Marketing

JUNE 17, 2021

SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product. Medpage Today.

FDA 164

FDA Physicians Marketing Doctors 164

European Pharmaceutical Review

MAY 7, 2024

A new report by MarketsandMarkets has predicted that the injectable drug delivery market will reach an 8.6 The market is anticipated to value $1139.4 In 2023, North America accounted for the biggest market share due the region’s readiness to invest in innovative solutions such as injectable drug delivery systems.

Food and Drug Administration 67

Food and Drug Administration Marketing Government Food 67

PharmExec

FEBRUARY 8, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Jonathan Miller, General Counsel, US Hemp Roundtable, discusses recent efforts that urge the House Energy and Commerce Committee to expedite an FDA hearing on the hemp market.

Marketing 52

Marketing FDA 52

Fierce Pharma

FEBRUARY 5, 2024

If a new package of pivotal data satisfies the FDA, GSK could have another run at the U.S. | If a new package of pivotal data satisfies the FDA, GSK could have another run at the U.S. multiple myeloma market with its previously withdrawn BMCA-targeted antibody-drug conjugate, Blenrep.

FDA 284

FDA Marketing 284