Fierce Pharma

AUGUST 12, 2024

Ascendis Pharma should be well prepared for the U.S. After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.

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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,” (..)

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Fierce Pharma

NOVEMBER 4, 2024

As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against its competitors. | As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against competitors.

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Fierce Pharma

OCTOBER 1, 2024

No large pharma company has traversed this decade's ups and downs quite like Pfizer. | No large pharma company has traversed this decade's ups and downs quite like Pfizer. As the company rolls ahead with a large restructuring campaign, some staffers in Ireland will soon feel the effects.

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Fierce Pharma

NOVEMBER 1, 2024

said in an interview with Fierce Pharma. Now, less than a year later, the FDA is reconsidering those serious safety warnings with plans to potentially change them, CBER Director Peter Marks, M.D.,

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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

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Fierce Pharma

OCTOBER 1, 2024

Johnson & Johnson is laying off 231 employees in New Jersey and Bayer is cutting 57 positions in the state, according to separate Worker Adjustment and Retraining Notification (WARN)

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Fierce Pharma

SEPTEMBER 25, 2024

billion acquisition the New York pharma made two years ago. Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4

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Marketing Pharma 340

Fierce Pharma

NOVEMBER 20, 2024

The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics. Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. |

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Medicine FDA Pharma 321

Fierce Pharma

NOVEMBER 26, 2024

German CDMO Adragos Pharma has been on a growth tear this year, drafting plans to boost capacity in Japan, upgrading a facility in France, taking over another from Fresenius Kabi in Norway and more | German CDMO Adragos Pharma has been on a growth tear this year.

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Fierce Pharma

OCTOBER 23, 2024

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and (..)

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Fierce Pharma

DECEMBER 12, 2024

watchdog is taking several pharma majors to task over what it says are "unsupported" price increases. In the Institute for Clinical and Economic Reviews (ICERs) annual price-hike report, the U.S. | But many of the companies have been quick to hit back against ICERs findings.

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Pharma 247

Fierce Pharma

AUGUST 27, 2024

An expert recently discussed the ramifications of the ruling during a Fierce Pharma podcast interview. . | In June, when the Supreme Court voted 6-3 to overturn the Chevron doctrine, it brought significant impact for the healthcare industry and federal regulators like the FDA and the Centers for Medicare & Medicaid Services.

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Biopharma FDA Pharma Healthcare 312

Fierce Pharma

OCTOBER 7, 2024

Mylan Pharmaceuticals and Novo Nordisk have reached a confidential settlement in a patent lawsuit tied to generic Ozempic, also known as semaglutide, India’s Natco Pharma said. With a new patent settlement, generic partners Mylan and Natco have cleared one hurdle to a potential U.S.

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Pharma Pharmaceutical 312

Fierce Pharma

OCTOBER 18, 2024

billion acquisition of pharma manufacturing giant Catalent by the end of the year. | Novo Holdings is encountering more resistance as it aims to close its $16.5 A dozen consumer groups and trade unions penned a letter to Lina Khan, chair of the U.S. Federal Trade Commission, urging the antitrust agency to block Novo Holdings’ proposed $16.5

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Manufacturing Pharma 305

Fierce Pharma

OCTOBER 11, 2024

With reports swirling about potential interest in Sanofi’s consumer health business, the French pharma has confirmed that a deal is indeed brewing. Sanofi has entered negotiations with private equity outfit Clayton, Dubilier & Rice to potentially sell a 50% controlling stake in its consumer health business, Opella.

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Pharma 264

Fierce Pharma

OCTOBER 23, 2024

While Regeneron may have lost its latest bid to block the launch of Amgen’s Eylea biosimilar Pavblu, the New York-based pharma isn’t throwing in the towel just yet. Amgen is preparing to launch its Eylea biosimilar, Pavblu, after another victory over Regeneron in court.

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Pharma 278

Fierce Pharma

SEPTEMBER 24, 2024

Flush with new business, Philadelphia-based CDMO PCI Pharma Services is blueprinting multiple manufacturing outlays on both sides of the Atlantic. |

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Manufacturing Pharma 290

Fierce Pharma

NOVEMBER 21, 2024

Merck and Johnson & Johnson are cutting staffers in China as they face local headwinds | Merck and Johnson & Johnson are cutting staffers in China as they face local headwinds, according to reports. Australia’s CSL is winding down operations at a cell and gene therapy R&D site in California.

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Pharma 244

Fierce Pharma

OCTOBER 14, 2024

Monday, Vanda revealed that it has turned down a second $8-per-share takeover offer from Cycle, which works out to a $488-million deal to buy out the 18-year-old pharma. -based company.

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Fierce Pharma

DECEMBER 20, 2024

Merck in-licensed a preclinical oral GLP-1 candidate from China's Hansoh Pharma. Betta Pharma's Ensacove became the first innovative targeted lung cancer med developed by a Chinese company to win FDA approval. Astellas doubled down in gene therapy with a viral capsid deal with Sangamo Therapeutics. And more.

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Pharma FDA 174

Fierce Pharma

DECEMBER 19, 2024

Following in the footsteps of several Big Pharma companies, another ALK inhibitor has made its entry into the U.S. Following in the footsteps of Pfizer, Roche and Takeda, another ALK inhibitor has made its belated entry into the U.S. The FDA nod comes four years after its initial approval in China.

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FDA Pharma 201

Fierce Pharma

DECEMBER 2, 2024

Kennedy Jr.’s 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 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.

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Sales 359

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.

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Pharmaceutical 328

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 (..)

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Insurance 316

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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Marketing Patients 306

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

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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.

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Sales Pharmaceutical Marketing 312

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 (..)

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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.

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Marketing 363

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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Insurance Patients 363

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

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

NOVEMBER 14, 2024

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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FDA 358

Fierce Pharma

DECEMBER 17, 2024

Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and (..)

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FDA Manufacturing 303

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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