Fierce Pharma

OCTOBER 28, 2024

Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.

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Fierce Pharma

OCTOBER 15, 2024

Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-ba | GSK is targeting Moderna in a pair of lawsuits claiming the mRNA specialist violated multiple patents with its vaccines Spikevax and mRESVIA. In the complaints, GSK says it hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales, plus damages.

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Fierce Pharma

OCTOBER 31, 2024

Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, the agency has done the same for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a d | The FDA this week revised its shortage list to note that the.25 mg starter dose of Novo’s semaglutide-based obesity med Wegovy is now available in the U.S.

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Fierce Pharma

NOVEMBER 1, 2024

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

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What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

Sales Management

Fierce Pharma

DECEMBER 2, 2024

Robert F. Kennedy Jr.’s appointment last month to lead the U.S. Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%.

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Fierce Pharma

OCTOBER 31, 2024

Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potentia | Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potential blockbuster Rezdiffra. In its second full quarter on the market, the fatty liver disease drug racked up sales of $62 million, which routed Wall Street's expectations and triggered a 16% surge in Madrigal's share price.

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Fierce Pharma

NOVEMBER 8, 2024

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

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Fierce Pharma

DECEMBER 4, 2024

AstraZeneca’s Daiichi Sankyo-partnered antibody-drug conjugate Enhertu has made it onto China’s national insurance program despite the star med being a part of an ongoing investigation in the count | AstraZeneca’s Daiichi Sankyo-partnered antibody-drug conjugate Enhertu has made it onto China’s national insurance program despite the star med being a part of an ongoing investigation in the country.

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Fierce Pharma

DECEMBER 3, 2024

Over the last two-plus years, as Eli Lilly and Novo Nordisk have battled for their share of the massive weight loss market and patients wondered which company’s products were more effective, there | Eli Lilly revealed results from a study that showed its obesity drug Zepbound was 47% more effective than Novo’s Wegovy in helping patients lose weight.

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Fierce Pharma

SEPTEMBER 5, 2024

AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case. | AstraZeneca has found its employees’ practices under the microscope of Chinese law enforcement years after an insurance fraud case.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Patients

Fierce Pharma

AUGUST 5, 2024

The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from | The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from the discoveries they made using her genetic material.

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Medical 363

Fierce Pharma

AUGUST 5, 2024

While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market. | While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market.

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Fierce Pharma

NOVEMBER 13, 2024

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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Fierce Pharma

NOVEMBER 6, 2024

Novavax has inked another settlement for a past COVID-19 vaccine supply deal. | Novavax has inked another settlement for a past COVID-19 vaccine supply deal. The Maryland biotech has agreed to pay $123.8 million to end a COVID vaccine supply pact with the U.K.

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Fierce Pharma

SEPTEMBER 8, 2024

The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.

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Fierce Pharma

JUNE 18, 2024

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

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Fierce Pharma

OCTOBER 28, 2024

Earlier this year, EyePoint Pharmaceuticals’ drug-device combo Duravyu missed the mark in a non-proliferative diabetic retinopathy (NPDR) study, raising doubts about the product’s potential in seve | EyePoint released new diabetic macular edema data Monday that a Mizuho Securities analyst described as "very promising." The trial win provides a needed turnaround for the company's lead candidate Duravyu, which failed a study in non-proliferative diabetic retinopathy earlier this yea

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Fierce Pharma

AUGUST 23, 2024

Bayer’s latest round of layoffs has reportedly hit Basel, Switzerland, home of the international headquarters of the company's consumer health division. | The layoffs are the latest in Bayer's massive restructuring plan that has so far impacted more than 3,000 staffers since the start of the year.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

Fierce Pharma

NOVEMBER 8, 2024

AstraZeneca's China president has been detained by Chinese authorities amid investigation into illegal importation and improper collection of patient data. | AstraZeneca confirmed its China president has been detained by Chinese authorities. Pfizer plans to invest $1 billion in China in the next five years. Sun Pharma's JAK inhibitor Leqselvi was slapped with an injunction in a lawsuit with Incyte.

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Fierce Pharma

JUNE 20, 2024

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

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FDA 360

Fierce Pharma

OCTOBER 22, 2024

Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. | Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. The layoffs come three months after the company axed 150 positions in Sanford following a high-profile phase 3 trial failure for its Duchenne muscular dystrophy gene therapy candidate.

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Fierce Pharma

JULY 15, 2024

While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.

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Pharma 356

Advertiser: ZoomInfo

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

Competition

Fierce Pharma

AUGUST 20, 2024

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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Safety 352

Fierce Pharma

OCTOBER 18, 2024

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.

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Fierce Pharma

MARCH 15, 2024

Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.

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Fierce Pharma

MARCH 6, 2024

AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing a big chunk of money into the Big Pharma’s home country. | AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing £650 million into the Big Pharma’s home country.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Fierce Pharma

MAY 8, 2024

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.

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Leads Pharmaceutical 359

Fierce Pharma

NOVEMBER 4, 2024

Despite winning an alopecia areata approval for its drug Leqselvi in July, Sun Pharma will have to wait a while longer to launch its JAK inhibitor competitor to Eli Lilly and Incyte’s Olumiant and | Sun Pharma, which had been plotting a mid-October launch for its JAK inhibitor Leqselvi, has been slapped with in an injunction blocking the rollout of the alopecia areata drug.

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Fierce Pharma

NOVEMBER 20, 2024

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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Fierce Pharma

DECEMBER 2, 2024

Shortly after a similarly sized venture from Pfizer, French pharma juggernaut Sanofi has unveiled a major manufacturing outlay in China, marking its biggest investment in the country to date. | Sanofi is laying out roughly 1 billion euros ($1.04 billion) to establish a new production base in the Beijing Economic and Technological Development Zone. The new manufacturing site, which will become Sanofi’s fourth in China, is being designed to beef up local end-to-end insulin production.

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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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