STAT

NOVEMBER 22, 2022

The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company. The Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder.

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Pharmaceutical Companies Pharmaceutical Companies FDA 138

Pharmaceutical Technology

JULY 11, 2022

Innoviva has signed a definitive merger agreement for the acquisition of all of the outstanding shares of La Jolla Pharmaceutical Company for $6.23 The lead product of the company, Giapreza (angiotensin II) obtained the Food and Drug Administration (FDA) approval in December 2017.

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Pharmaceutical Companies Pharmaceutical Companies FDA 59

Pharmacy Times

JULY 13, 2023

The approval of norgestrel tablets (Opill) could open the door to other prescription-to-OTC contraceptive switches, although that remains to be seen as other pharmaceutical companies weigh their options.

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Pharmaceutical Companies Pharmaceutical Companies FDA 123

STAT

DECEMBER 7, 2023

But like any pharmaceutical company with an eye toward the future, Celgene continued to seek other ways to wring profits from its development work. Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid.

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Pharmacy Times

AUGUST 14, 2023

Niraparib and abiraterone acetate (Akeega; Janssen Pharmaceutical Companies of Johnson & Johnson) is the first-and-only dual action tablet that combines a PARP inhibitor with abiraterone acetate administered with prednisone.

Pharmaceutical Companies 123

Pharmaceutical Companies Pharmaceutical Companies FDA 123

STAT

MARCH 7, 2023

BOSTON — FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

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STAT

JULY 6, 2023

The drug, called Leqembi , was developed by Eisai , the Japanese pharmaceutical company, and sold in partnership with Biogen. The FDA’s decision will broaden patient access to the drug under the Medicare program and is likely to boost sales, even as Leqembi’s benefits and safety risks continue to be a source of debate.

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STAT

OCTOBER 31, 2024

With all doses now listed as available, the FDA may soon pull it off the list, depending on its conversations with Novo about whether the company can sufficiently meet demand going forward. The number of layoffs in the U.S. A total of 424 jobs were eliminated in October, far below the 3,073 positions that were cut in September.

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Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharmaceutical Technology

MAY 31, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH).

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European Pharmaceutical Review

JANUARY 8, 2024

Commercial manufacturing of Novartis’ radioligand therapy Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA).

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The Checkup by Singlecare

APRIL 15, 2025

Mounjaro (tirzepatide) is a brand-name prescription medication that is approved by the Food and Drug Administration (FDA) to improve blood sugar levels in people with Type 2 diabetes. The FDA recently approved generic versions of two other GLP-1s , Victoza (liraglutide) and Byetta (exenatide). Is there a generic for Mounjaro?

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Compounding Dosage Compounding Pharmacies FDA 59

Pharma Mirror

OCTOBER 4, 2021

Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.

Pharmaceutical Companies 119

Pharmaceutical Companies Pharmaceutical Companies FDA 119

pharmaphorum

JULY 21, 2022

Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. Throughout the pandemic, the lack of FDA inspections has created new challenges and heightened existing problems, largely due to delays in upgrading legacy facilities. Implementing Pharmaceutical Quality systems.

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Pharma Marketing Network

MARCH 19, 2025

Unlike traditional consumer brands, pharmaceutical companies face unique challenges on social media, including strict regulations, compliance concerns, and the need for factual accuracy. For pharmaceutical companies, this can provide insights into public perception of drug launches, patient experiences, and industry discussions.

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HIPAA Pharmaceutical Companies Pharmaceutical Companies FDA 52

STAT

JANUARY 6, 2023

The drug, called Leqembi, was developed by Eisai , the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago. Read the rest…

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Pharmaceutical Companies Pharmaceutical Companies FDA 98

STAT

SEPTEMBER 14, 2023

The Federal Trade Commission warned pharmaceutical companies they could face legal action if they improperly list patents for brand-name medicines in a Food and Drug Administration registry, the latest effort by the federal government to scrutinize patent moves by drugmakers.

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The FDA Law Blog

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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Pharmaceutical Companies Pharmaceutical Companies FDA 59

Pharma Marketing Network

MARCH 8, 2025

Introduction Pharmaceutical companies are investing heavily in digital advertising , and PPC campaign optimization is key to maximizing ROI while staying compliant. Optimize landing pages to ensure message consistency and compliance with FDA regulations. For more PPC advertising solutions, explore eHealthcare Solutions.

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HIPAA Pharmaceutical Companies Pharmaceutical Companies FDA 59

STAT

JANUARY 19, 2023

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.

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STAT

SEPTEMBER 26, 2022

In an effort to sway the Food and Drug Administration not to withdraw accelerated approval of Makena, a drug developed to prevent preterm birth that does no such thing, a pharmaceutical company owned by a private equity company is making the specious argument that the drug should be kept on the market because it may — the emphasis is mine — (..)

Pharmaceutical Companies 106

Pharmaceutical Companies Pharmaceutical Companies FDA 106

Pharmaceutical Technology

JULY 1, 2024

The US FDA has approved speciality pharmaceutical company Shorla Oncology’s NDA for TEPYLUTE to treat breast and ovarian cancer.

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pharmaphorum

JANUARY 17, 2022

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. We are excited to join forces with the world-leading pharmaceutical company in the cardiometabolic space and together lead innovation to transform the standard of care.”.

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STAT

OCTOBER 17, 2024

As Election Day 2024 gets closer, STAT’s First Opinion asked executives from leading biotech and pharmaceutical companies to reflect on how their industry is being portrayed in the presidential campaign — and what their hopes are for a new presidential administration. You

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Digital Pharmacist

OCTOBER 24, 2022

CDER relies on its understanding of science and regulatory procedures to support and provide advice to pharmaceutical companies in testing and manufacturing, to then bring these new therapies to the market to aid patients and their health. The FDA granted the approval of Relyvrio to Amylyx Pharmaceuticals Inc.

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The Checkup by Singlecare

MARCH 10, 2025

It is the active ingredient in the brand-name , FDA-approved drugs Ozempic , Wegovy , and Rybelsus. Novo Nordisk is the only pharmaceutical company that makes FDA-approved medications containing semaglutide. Like Ozempic , Rybelsus is sometimes prescribed off-label for weight loss.

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Pharmaceutical Technology

AUGUST 14, 2023

The FDA has granted approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s AKEEGA for mCRPC.

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STAT

AUGUST 22, 2023

German drugmaker Boehringer Ingelheim is the latest pharmaceutical company to sue the federal government over a law that would allow Medicare to negotiate certain drug prices, Reuters reports.

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Pharmafile

AUGUST 29, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for full approval of Balversa (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC).

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Pharma Marketing Network

NOVEMBER 24, 2024

Use relatable metaphors: Think of content as a bridge connecting pharma companies with patients and HCPs. Navigating Regulatory Compliance Pharmaceutical advertising operates under strict regulations. Always adhere to FDA guidelines and include clear disclaimers in campaigns. Non-compliance can cost dearly.

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Pharmaceutical Companies Pharmaceutical Companies FDA 52

STAT

OCTOBER 25, 2022

… Pharmaceutical companies promise that online prescribing will improve access for patients, but health policy experts worry that gaps in regulatory oversight leave patients vulnerable to the unique risks of the approach , STAT explains. We will leave it up to you to decipher this blend.

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STAT

SEPTEMBER 9, 2022

… Running clinical trials remotely or virtually can provide substantial financial savings for pharmaceutical companies, STAT writes, citing a new pilot study. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

Pharma Marketing Network

MARCH 18, 2025

Brand Authority: By appearing at the top of search engine results, pharmaceutical companies increase brand credibility among HCPs. Use a mix of: Branded Keywords: Drug names, pharmaceutical companies, or treatment-specific terms. Competitive Keywords: Terms related to rival brands, helping capture market share.

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Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 52

STAT

DECEMBER 21, 2023

WASHINGTON — Medical marijuana companies sell medicine, just like pharmaceutical companies. But they’re not playing by the same rules — and that’s putting patients at risk.

Pharmaceutical Companies 144

Pharmaceutical Companies Pharmaceutical Companies FDA 144

STAT

NOVEMBER 23, 2022

The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company. Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder , STAT writes.

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STAT

OCTOBER 7, 2022

… The drug-pricing law will still penalize pharmaceutical companies if they hike prices on medicines for patients who have private insurance, STAT says. Or you could make time to reach out to someone special and make them feel important. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon.

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