The Pharma Data

MARCH 15, 2022

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing).

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XTalks

JUNE 14, 2023

The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants. The exact cost of Vevye has not been publicly disclosed; however, it is estimated that the price of Vevye may be in the range of similar cyclosporine ophthalmic emulsions, such as brand-name Restasis that carries a list price of $645.63

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XTalks

SEPTEMBER 21, 2023

The company said it cannot “validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” Since the compounded versions of Mounjaro are not FDA approved, Lilly said they may expose patients to potentially serious health risks.

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Some of these approved products contain nicotine as an active ingredient, while others do not. Whenever the branded drugs go off-the-market, it paves the way for the entry of generics in the market.

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FDA Law Blog

JANUARY 11, 2022

In accordance with the statutory “section viii” provision, FDA approved Hikma’s generic product referencing Vascepa in May 2020 omitting information pertaining to the patented CV indication. The procedural background of Amarin v. Hikma (unlike that of GSK v.

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FDA Law Blog

JANUARY 11, 2022

In accordance with the statutory “section viii” provision, FDA approved Hikma’s generic product referencing Vascepa in May 2020 omitting information pertaining to the patented CV indication. The procedural background of Amarin v. Hikma (unlike that of GSK v.

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The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. However, not all forward-looking statements contain these words.

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The Pharma Data

DECEMBER 8, 2020

The majority of this revenue growth is expected to come from the company’s Wave 1 pipeline, which includes 12 unique New Molecular Entities (NMEs), representing potential best-in-class/first-in-class therapies, and its existing 14 global brands. Food and Drug Administration (FDA). For more information, visit [link].

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FDA Law Blog

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form. Teva’s patents do not meet that criterion.

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The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S. On August 13, 2021, the U.S. adults and children against the TBEV when traveling or moving to TBE endemic areas.

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Pharmacy Checkers

NOVEMBER 21, 2019

Eban’s greatest concern is with generic drugs, she hints at potential problems with brand name drugs as well, since the active pharmaceutical ingredients that go into all these medications are made in India and China, where manufacturing problems are greater, relative to the U.S. and other high-income countries. drug supply.

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XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. report indicating that they accounted for half of the most viewed new brands. Notably, pharmaceutical drugs dominated TV ad impressions this year, with an iSpot.tv

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The Pharma Data

DECEMBER 30, 2020

The company has a number of branded products in this space, including Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. Soliris has been approved for paroxysmal hemoglobinuria (PNH), atypical hemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder.

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The Pharma Data

DECEMBER 13, 2020

Although we are disappointed by the delay in timing to bring omidubicel to patients after a potential FDA approval, we are encouraged by the FDA’s reaction to our Phase 3 data as the pivotal trial of omidubicel achieved pre-specified primary and secondary endpoints. chief executive officer of Gamida Cell.

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The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. and Auspex Pharmaceuticals, Inc., affiliates of Teva Pharmaceutical Industries Ltd.

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Pfizer

OCTOBER 20, 2022

“With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

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FDA Law Blog

MARCH 12, 2024

Failing to list the patents, as AstraZeneca points out, “may expose the reference drug sponsor to legal risks,” as “at least one generic applicant has argued that a failure to do so constitutes a violation of the antitrust laws by depriving the applicant of information that would have affected its decision whether to develop a generic product.”

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FDA Law Blog

JANUARY 26, 2022

In its Untitled Letter, FDA cited the “The Journey Forward” ads as including “brought to you by Emgality proud partner of Team USA.” FDA did not otherwise challenge the content of the disease awareness portion of the ad. “By the time I was in college, migraine had me hiding from light and sound, it was isolating” (Allysa Seely TV Ad).

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The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements.

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The Pharma Data

OCTOBER 23, 2020

The Midwest and Rocky Mountains are struggling to contain major outbreaks, while new hot spots are emerging in other parts of the country. Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring.

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The Pharma Data

OCTOBER 24, 2020

” The Midwest and Rocky Mountains are struggling to contain major outbreaks, while new hot spots are emerging in other parts of the country, The New York Times reported. Remdesivir gets full FDA approval to treat COVID-19. Remdesivir’s full approval Thursday by the U.S. California-based Gilead Sciences Inc.

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The Pharma Data

NOVEMBER 30, 2020

“Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products.

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The Pharma Data

NOVEMBER 5, 2020

With these new exclusive and parity formulary positions, Xtampza ER will be the exclusive branded ER oxycodone for more than 92 million lives and will be in a parity position for approximately 22 million lives. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

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The Pharma Data

MAY 13, 2021

Because right now, I’m going to share something BRAND-NEW, backed by mountains of scientific research which will help to treat your pain. Low Level Light therapy (LLLT), is FDA approved for treating conditions such as chronic joint pain and slow to heal wounds. (3). But what actually is “Red Light Therapy”?

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The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. Commenting on this novel immunotherapy regimen, Prof.

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The Pharma Data

OCTOBER 28, 2020

Our results were once again driven by underlying growth of our 14 global brands across the five key business areas, which enabled us to generate strong margins and cash flow. Our 14 global brands, with reported revenue of JPY 595.9 Global Brand Highlights. billion in aggregate, delivered a 15.4%

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Dupixent ® total prescriptions (TRx) increased 51% ( year-over-year ) and new-to-brand prescriptions (NBRx) grew 16% despite fewer in-person physician visits which remain below the pre-COVID level. Sarclisa ® is already approved in the U.S

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The Pharma Data

APRIL 26, 2021

Growth was offset by declines in Established Medicines and mature Ophthalmology brands. USD 108 million, +20% cc) grew TRx share in the US during the quarter driven by an increase in demand due to brand awareness among diagnosed patients. New approvals. Tafinlar + Mekinist. Exjade/Jadenu. Top 20 products total. Entresto. .

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The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). View source version on businesswire.com : [link]. Amy Rose 212.733.7410.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. .

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Cloudbyz

AUGUST 19, 2024

Incident Response: Establishing a plan for responding to cybersecurity incidents, including detection, containment, eradication, and recovery. How does the FDA’s 510(k) clearance process work for medical devices? CE marking in the EU, or TGA approval in Australia.

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Delveinsight

AUGUST 13, 2020

It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler. The analyses being presented at ATS provide new insights on triple therapy and the movement towards personalized treatment.

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The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Citing studies comparing such products, there are no important differences between biosimilars and their branded counterpart, says Arnold Vulto, PharmD, professor of hospital pharmacy at Erasmus University, Rotterdam.

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Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

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