Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Still, navigating such patent issues during drug development can be difficult, and Camargo can assist in finding a safe course. Ken Phelps.

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.

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Drug Discovery World

FEBRUARY 6, 2023

It contains new long-term survival data of children enrolled in a Phase III trial showing durability of treatment effect through at least four years. “There is an urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD” said Dr Silviu Itescu, Chief Executive of Mesoblast.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).

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Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. deliesschef.

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Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. Today, the U.S.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. BOSTON, Nov.

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pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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XTalks

JUNE 6, 2023

Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDA approval. Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. Gauden, CEO of Blue Earth Diagnostics, in the company’s news release.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., times the human dose.

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XTalks

AUGUST 9, 2023

a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. California-based Tarsus Pharmaceuticals Inc., What Is Demodex Blepharitis? How Does Xdemvy Work?

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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XTalks

AUGUST 15, 2023

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. BASEL, Switzerland, Dec.

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The Pharma Data

JULY 8, 2021

Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Patients may report side effects to FDA at 1-800-FDA-1088. Alfred Sandrock, Jr., Please see full Prescribing Information including Medication Guide. About Biogen. For more information about Eisai Co.,

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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The Pharma Data

JUNE 17, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review. Our ambition is to be the world’s leading and most valued generics company.

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XTalks

DECEMBER 5, 2022

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups. Jazz bought out Epidiolex developer GW Pharmaceuticals for the drug in a whopping $7.2

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The Pharma Data

NOVEMBER 2, 2020

“Now is the ideal time to develop nabiximols in the U.S. In addition to MS spasticity, GW expects to develop nabiximols in spinal cord injury spasticity. If nabiximols is approved, this would mark the second cannabis-based product for GW Pharmaceuticals in the United States. The product is administered as an oral spray.

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pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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The Pharma Data

FEBRUARY 1, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History. or visit your respective country’s product website. Source link.

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XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

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Pfizer

SEPTEMBER 27, 2022

That’s why Pfizer invests in research and development: to produce groundbreaking treatments, like the COVID-19 vaccine, that improve people’s lives. Support the development of more treatment options by increasing access to biosimilars. Price controls would base the price of medicines sold in the U.S. Medicines, Research.

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The Pharma Data

OCTOBER 25, 2020

SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test. SQI intends to submit RALI- fast for EUA to FDA in late Q1 2021. About SQI Diagnostics.

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The Pharma Data

APRIL 4, 2023

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

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Drug Discovery World

SEPTEMBER 14, 2023

8 On August 29, Janssen submitted a supplemental New Drug Application (sNDA) to the FDA seeking full approval of erdafitinib in this indication based on Cohort 1 of the Phase III THOR study. References Wong MCS, et al.

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XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. and Roche will develop, manufacture and distribute it outside of the U.S.

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Pfizer

JUNE 30, 2022

To accelerate GHG emission reductions, Pfizer recognizes that bold partner action and innovation is necessary to develop alternate technologies to enable reliable generation of heat and steam production to meet the demand of Pfizer’s manufacturing, R&D and commercial operations without fossil fuels. Recent Announcements. 07.13.2022.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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pharmaphorum

OCTOBER 31, 2021

The approval has been granted to Vuity (formerly AGN-190584 ), a one-daily eyedrop formulation of muscarinic cholinergic agonist pilocarpine developed by AbbVie’s Allergen unit that is now an alternative to reading glasses, contact lenses or laser eye surgery for the disorder. Brimochol is in phase 2 testing.

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Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. The influence of these microbiomes extends to children as well.

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XTalks

DECEMBER 20, 2023

These advancements and trends addressed important industry challenges and offered opportunities to foster innovations and solutions in areas including drug development, healthcare and medical devices. Novo and Lilly are hard at work to expand their manufacturing capacities to meet the skyrocketing demand for their GLP-1 blockbusters.

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