European Pharmaceutical Review

FEBRUARY 22, 2024

A report by Towards Healthcare has forecasted that the advanced drug delivery market will value $375.86 billion, the market witnessed “remarkable advancements that promise to reshape healthcare landscapes across the globe”. In 2023, these systems captured 48 percent share of the market, according to report’s author.

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European Pharmaceutical Review

MARCH 27, 2024

A report by Allied Market Research has predicted that the global pyrogen testing market will value $3.3 The market is predicted to grow at a CAGR of 8.2 A higher incidence of infectious diseases is a major contributing factor for the expansion of the pyrogen testing market. billion by 2032.

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European Pharmaceutical Review

AUGUST 11, 2023

The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. Conditional marketing authorisation is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need.

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European Pharmaceutical Review

AUGUST 4, 2023

According to data and analytics company GlobalData , Boehringer Ingelheim’s Cyltezo has demonstrated the intersection of price and regulation in the biosimilars market. “Of This has developed following numerous adalimumab biosimilar offerings being brought to market. Worldwide sales for Humira peaked at $21.2

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Tribeca Knowledge

NOVEMBER 28, 2023

T he drug-approval slump in major markets that clouded innovation prospects during 2022 seems to be over.

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European Pharmaceutical Review

DECEMBER 5, 2022

GSK has announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for momelotinib, a new oral treatment for myelofibrosis, which, if approved, could be the only medicine available to address myelofibrosis, including anaemia, symptoms, and splenomegaly.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly.

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Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Also, we recognize the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology. Moximed is based in Fremont, California.

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Stelara biosimilars in the US market The first Stelara biosimilars are expected to enter the US market in 2025. “We US sales of Stelara totalled $6.4

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European Pharmaceutical Review

DECEMBER 6, 2022

According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 Quarter-on-quarter (QoQ) market capitalisation analysis. percent from $3.45

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Pharmaceutical Technology

APRIL 3, 2023

The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). With eight marketed biosimilars, Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe, with more than two decades of experience.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. Covis had filed an appeal against CDER’s recommendation.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. Covis had filed an appeal against CDER’s recommendation.

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European Pharmaceutical Review

OCTOBER 17, 2023

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. The alternative tools will help the FDA to meet user fee goal dates and make timely application decisions.

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MedCity News

MARCH 16, 2023

Physicians face a lot of barriers from insurers in completing studies on drugs in the accelerated approval pathway, declared Dr. Robert Califf, commissioner of food and drugs at the Food and Drug Administration. Insurers need to help, he said during the AHIP Medicare, Medicaid, Duals and Commercial Markets Forum.

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European Pharmaceutical Review

JANUARY 3, 2023

A marketing authorisation application (MAA) has been submitted by The Janssen Pharmaceutical Companies of Johnson & Johnson to the European Medicines Agency (EMA) for approval of talquetamab, a bispecific t-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

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European Pharmaceutical Review

FEBRUARY 17, 2023

The US Food and Drug Administration (FDA) has approved Lamzede ® (velmanase alfa-tycv) for non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and paediatric patients. The post Enzyme replacement therapy for alpha-mannosidosis gets FDA approval appeared first on European Pharmaceutical Review.

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Infuse Medical

JULY 4, 2024

If so, it is important to understand the regulatory requirements of the FDA. Do you know the FDA is the Food and Drug Administration? It is essential to understand the FDA’s definition of a medical device. This information is critical for learning how to bring your medical device to market.

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Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

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Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. Rizafilm, the US market name for Rizaport outside of the US, is administered via an oral soluble film.

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European Pharmaceutical Review

DECEMBER 6, 2022

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for tofersen, to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). Clinical data included in the marketing authorisation application. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc. Sign up now !

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Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.

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Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. Dexmedetomidine is commercially available as Precedex, marketed by Pfizer. Recently, the FDA granted approval for Milla Pharmaceutical’s generic version of the drug to help with shortages in the US.

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Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. By 2024, doxorubicin is anticipated to have a market size of $1.38bn and is extensively utilised as a part of the standard of care in various types of cancers. .

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. We expect this important innovation to be commercially available in the US market by the end of June 2023.”

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Pharmaceutical Technology

MARCH 8, 2023

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The regulatory approval marks the company’s first product to receive approval in the US market.

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European Pharmaceutical Review

APRIL 19, 2023

“The approval of Omisirge is a significant development in hematopoietic stem cell transplantation” Omisirge ® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved , is the first allogeneic stem cell transplant therapy to be given marketing authorisation based on results from a global, randomised Phase III clinical study.

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European Pharmaceutical Review

NOVEMBER 28, 2022

Fast Track designation (FTD) has been granted for REM-001 therapy to treat unresectable cutaneous metastatic breast cancer (CMBC) by the US Food and Drug Administration (FDA). If marketed, REM-001, produced by Kintara Therapeutics, could be a potential therapy for advanced breast cancer patients who have limited treatment options.

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Pharmaceutical Technology

OCTOBER 23, 2023

On 2 October, Eli Lilly announced that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the biologic license application (BLA) for its anti-interleukin (IL)-13 biologic lebrikizumab for the treatment of adults and adolescents (12 and older) with moderate-to-severe atopic dermatitis (AD).

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Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. The post FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor appeared first on Legacy MEDSearch. On March 5, the U.S. Are you hiring?

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Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, Elahere is said to be the first ADC to receive FDA approval for platinum-resistant disease.

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Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. The post US FDA approves GSK’s Jesduvroq to treat anaemia of CKD appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.”

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Pharmaceutical Technology

JUNE 8, 2023

The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. Last month, Arexvy received approval from the US Food and Drug Administration (FDA ) for the same indication. “Our

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Legacy MEDSearch

NOVEMBER 3, 2023

Food and Drug Administration (FDA). FOOD AND DRUG ADMINISTRATION FOR STELLAR KNEE Press Release by: POLARISAR Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Food and Drug Administration for Stellar Knee appeared first on Legacy MedSearch | Medical Device Recruiters.

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PM360

JUNE 24, 2024

This is partly due to the limited market potential for drugs in the space, but also due to the sheer volume of rare diseases: approximately 6,000–8,000 have been identified. Marketing to rare disease patient populations is equal parts opportunity and responsibility. Food & Drug Administration (FDA). In the U.S.,

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