Fierce Pharma

NOVEMBER 14, 2022

AstraZeneca and Sanofi win big as Europe's human medicines committee endorses approvals, label expansions. fkansteiner. Mon, 11/14/2022 - 08:59.

Medicine 189

Medicine 189

Fierce Pharma

JULY 26, 2024

While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions. While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions.

Medicine 162

Medicine 162

MedCity News

OCTOBER 30, 2024

After the FDA delayed the approval of MDMA-assisted therapy for PTSD, there’s still a way forward for psychedelic medicines, experts said at HLTH. The post What’s Next for Psychedelic Medicines? appeared first on MedCity News.

Medicine 121

Medicine FDA 121

Pharma IQ

APRIL 29, 2024

Discover how artificial intelligence is revolutionizing the field of precision medicine. In this insightful article, Tim O’Connor, Chief Data Scientist at Phenomix Sciences, discusses the pivotal role.

Medicine 130

Medicine 130

Fierce Pharma

OCTOBER 7, 2024

In this interview, Kavitha Lokesh, Vice President of Global Life Sciences R&D Industry Solutions at Cognizant, discusses her role and the impact of precision medicine.

Medicine 130

Medicine Patients 130

Fierce Pharma

OCTOBER 22, 2024

There’s no denying it: the radiopharmaceuticals boom is here to stay. Telix on Tuesday unveiled the spin-off of Rhine Pharma—a new entity born from a collaboration between Telix and Germany’s Heidelberg University Hospital—which is setting out on a mission to expand access to radiopharmaceuticals for cancer treatment and imaging.

Pharma 221

Pharma Medicine 221

Fierce Pharma

JULY 15, 2024

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years.

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FDA Manufacturing Medicine 316

Pharmaceutical Technology

SEPTEMBER 19, 2024

An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.

Medicine 105

Medicine Healthcare Healthcare Medical 105

MedCity News

AUGUST 15, 2024

The post Good Measures, Point32Health Launch Food as Medicine Partnership appeared first on MedCity News. Through a new partnership with Good Measures, some Point32Health members have gained access to nutrition counseling, food tracking and other services.

Food 111

Food Medicine 111

MedCity News

NOVEMBER 15, 2024

To ramp up its food-as-medicine support, NationsBenefits has acquired Good Measures, a company that offers coaching and personalized food prescriptions. The post NationsBenefits Acquires Good Measures to Advance Food-as-Medicine Offerings appeared first on MedCity News.

Food 107

Food Medicine Prescription 107

Fierce Pharma

DECEMBER 17, 2024

| After the recent release of two independent studies from the University of Southern Denmark suggested the use of Ozempic increases patients' chances of developing a rare eye disorder, the Danish Medicines Agency has asked European officials to investigate.

Medicine 276

Medicine Patients 276

Fierce Pharma

MAY 1, 2024

Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen.

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Marketing Sales Medicine Leads 287

Fierce Pharma

JANUARY 5, 2024

Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medi | Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one (..)

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Side effects Medicine FDA Medical 301

Fierce Pharma

AUGUST 3, 2023

As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. | A Louisiana woman is suing Novo Nordisk and Eli Lilly, alleging that her use of Ozempic and Mounjaro caused her to vomit so much that some of her teeth have fallen out.

Medicine 232

Medicine Sales Patients 232

Fierce Pharma

JULY 10, 2023

The regulator will examine Novo’s treatments Ozempic and Saxenda to determine if there was a causal relationship between their use and the adverse events.

Medicine 314

Medicine 314

Fierce Pharma

FEBRUARY 16, 2024

A Novartis subsidiary in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines. | A Novartis subsidiary handling old products in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines.

Medicine 267

Medicine Pharma 267

Fierce Pharma

MAY 17, 2024

last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. | A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.

Safety 268

Safety Medicine 268

MedCity News

APRIL 25, 2024

The post Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines appeared first on MedCity News. The deal marks the third pharmaceutical industry partnership for Mammoth, which initially focused on developing CRISPR-based diagnostics.

Medicine 128

Medicine Pharmaceutical Biopharma Pharma 128

Fierce Pharma

MAY 20, 2024

The biologics market for inflammatory bowel disease is continually getting more competitive, and now Johnson & Johnson’s Tremfya is the latest medicine angling to make a mark in the space. |

Competition 268

Competition Medicine Marketing 268

Fierce Pharma

NOVEMBER 20, 2024

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. | The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics.

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Medicine FDA Pharma 318

Fierce Pharma

MAY 8, 2024

On Tuesday, the EMA said it had accepted a request from AZ and withdrawn the company’s marketing authorization for its COVID-19 shot Vaxzevria.

Marketing 337

Marketing Medicine 337

MedCity News

OCTOBER 2, 2024

Lilly Medicine Foundry will research new ways to manufacture medicines. Medicine Foundry to Foster Innovations in Drug Manufacturing appeared first on MedCity News. The post Eli Lilly Plans $4.5B

Manufacturing 105

Manufacturing Medicine Biopharma Pharma 105

Fierce Pharma

OCTOBER 10, 2023

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies.

Prospecting 284

Prospecting Manufacturing Medicine Leads 284

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 301

Fierce Pharma

MAY 28, 2024

A data breach at drug distributor Cencora has left sensitive information vulnerable, with patients on medicines from a dozen drugmakers potentially affected. | The potentially compromised data included patient information such as names and addresses, Cencora disclosed in letters to patients who may have been affected.

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Patients Pharma Medicine 300

European Pharmaceutical Review

NOVEMBER 6, 2024

Dupixent (dupilumab) has been approved by the European Medicines Agency (EMA) as the first treatment for young children with eosinophilic esophagitis in the EU. The medicine has been jointly developed by Sanofi and Regeneron. This result was maintained for up to one year.

Medicine 105

Medicine Patients Pharmaceutical 105

Fierce Pharma

MARCH 22, 2024

With a positive recommendation from Europe’s Committee for Medicinal Products for Human Use (CHMP), Novo has come a step closer to bringing its revolutionary Awiqli (once weekly basal insulin icodec) to the market. But that doesn’t mean the Danish company has moved on from its previous generation of blood sugar modulators.

Medicine 321

Medicine Sales Marketing 321

Fierce Pharma

JULY 12, 2024

Now a study from the University of Oxford indicates that the company’s semaglutide type 2 diabetes drug Ozempic can reduce the risk of dementia compared with another popular diabetes medicine.

Medicine 305

Medicine 305

Fierce Pharma

APRIL 22, 2024

Sanofi will pay $100 million—or approximately $25,000 each—to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (rani | Sanofi will pay approximately $25,000 per person to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that (..)

Medicine 254

Medicine 254

Fierce Pharma

FEBRUARY 16, 2024

The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods. . | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades.

Food 318

Food FDA Medicine Marketing 318

MedCity News

MAY 13, 2024

The post Astellas Pharma CEO Q&a (Part 2): We Have To Have Alternatives for Prescription Medicine Business appeared first on MedCity News. In part 2 of our Q&A, Okamura addresses the need for biopharma companies to leverage digital technologies in disease management.

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Prescription Medicine Pharma Biopharma 120

Fierce Pharma

NOVEMBER 29, 2023

Seeking to identify ways to improve the discovery and production of medicines, Amgen is expanding its partnership with tech giant Amazon.

Manufacturing 328

Manufacturing Medicine Pharmaceutical 328

Fierce Pharma

MARCH 19, 2024

Now, Novo is returning to its roots in China with a $556 million expansion of the flagship medicines factory it opened in Tianjin back in 1994.

Medicine 324

Medicine 324

Fierce Pharma

NOVEMBER 1, 2024

With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study.

Medicine 332

Medicine 332

Fierce Pharma

FEBRUARY 14, 2024

With another quarter exceeding analysts’ expectations, Blueprint Medicines has raised its peak sales estimate for rare disease drug Ayvakit to $2 billion. With another quarter exceeding analysts’ expectations, Blueprint Medicines has raised its peak sales estimate for rare disease drug Ayvakit to $2 billion.

Sales 240

Sales Medicine 240

Fierce Pharma

SEPTEMBER 19, 2024

Respiratory medicine is one frontier of the global healthcare landscape which has undergone significant transformations in recent years. | AstraZeneca's Maria Belvisi explores innovative approaches in respiratory medicine, from AI-driven trials to next-gen therapeutics.

Medicine 236

Medicine Healthcare Healthcare 236

Fierce Pharma

DECEMBER 2, 2024

The FDA notification came seven weeks after the New England Journal of Medicine (NEJM) published a report that seven of 67 children who received Skysona during clinical trials had developed blood cancer. agency said last week.

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FDA Medicine Patients 268