European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. A biosimilar for biologic ophthalmic treatments. STADA is preparing to launch Ximluci ® in the UK during 2023.

Biosimilars 84

Biosimilars Diabetes 84

Big Molecule Watch

APRIL 5, 2023

On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA. The trial is a 52-week trial in 348 patients with diabetic macular edema (DME) across thirteen countries. and Europe later this year.

Biosimilars 57

Biosimilars Diabetes 57

Express Pharma

JULY 23, 2023

Biocon Biologics, a subsidiary of Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar. The European Commission decision on the approval is expected by the end of September 2023.

Biosimilars 88

Biosimilars Diabetes 88

Big Molecule Watch

DECEMBER 21, 2023

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. On December 14, 2023, Celltrion, Inc. On October 20, 2023, the PTAB instituted Samsung’s petition for IPR of U.S. Patent Nos. 10,703,809.

Biosimilars 62

Biosimilars Diabetes 62

Big Molecule Watch

JUNE 30, 2023

On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s

Biosimilars 62

Biosimilars Diabetes 62

Express Pharma

FEBRUARY 21, 2024

The top 20 global biopharmaceutical companies experienced varied year-on-year (YoY) market capitalisation shifts in 2023 amid the macroeconomic headwinds, steep patent cliffs and the commencement of US drug price negotiations under the Inflation Reduction Act (IRA). trillion on 31 December 2023, reveals GlobalData.

Drug Pricing 85

Drug Pricing Diabetes Biosimilars 85

pharmaphorum

JANUARY 28, 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.

Biosimilars 97

Biosimilars Insurance Coverage and Processing Drug Pricing Diabetes 97

European Pharmaceutical Review

AUGUST 21, 2023

For 20 of the leading biopharmaceutical companies, the second quarter (Q2) of 2023 has brought an aggregate market capitalisation growth of 2.3 trillion in the Q1 of 2023 to $3.56 trillion in Q2 2023. Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1

Biosimilars 82

Biosimilars Diabetes Vaccines 82

Express Pharma

AUGUST 22, 2023

Despite the continued inflationary pressures, the second quarter (Q2) of 2023 yielded promising outcomes for the leading 20 biopharma giants. trillion during the first quarter (Q1) of 2023 to an impressive $3.56 trillion in Q2 2023, reveals GlobalData. per cent) recording negative growth exceeding 10 per cent in Q2 2023.

Biosimilars 86

Biosimilars Diabetes 86

Express Pharma

OCTOBER 6, 2023

Biocon has signed a partnership agreement with Juno Pharmaceuticals, a specialty pharmaceutical company in Canada, for the commercialisation of its vertically integrated, complex formulation, Liraglutide, a drug-device combination for the treatment and management of Type 2 diabetes and obesity.

Diabetes 102

Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 102

PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

Diabetes 64

Diabetes Immunity Immunization Biosimilars 64

PharmaShots

FEBRUARY 3, 2023

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)

Biosimilars 40

Biosimilars Diabetes Labelling 40

Big Molecule Watch

NOVEMBER 20, 2023

Biocon Biologics receives approval in the UK for Aflibercept biosimilar : On November 13, 2023, Biocon Biologics Limited announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for YESAFILI, a biosimilar aflibercept.

Biosimilars 62

Biosimilars Diabetes 62

PharmaShots

APRIL 28, 2023

Difficile Infection Date: Apr 27, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, C.

Diabetes 56

Diabetes Biosimilars 56

PharmaShots

JUNE 23, 2023

Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer Date: June 23, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Regulatory, EMA, CHMP, Positive Opinion Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated (..)

Diabetes 40

Diabetes Biosimilars 40

Express Pharma

JULY 3, 2023

As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology. The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025.

Biosimilars 79

Biosimilars Drug Development Generic Medicine Diabetes 79

PharmaShots

APRIL 14, 2023

Ocugen Reports Preliminary Results from the P-I/II Trial of OCU400 for the Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis Date: Apr 14, 2023 | Tags: Ocugen, OCU400, Retinitis Pigmentosa, Leber Congenital Amaurosis, Clinical Trial, P-I/II Trial Candesant Biomedical Receives the US FDA Clearance of Brella SweatControl Patch for Primary (..)

Diabetes 40

Diabetes Biosimilars 40

PharmaShots

JUNE 9, 2023

Quell Therapeutics Signed an Exclusive Option and License Agreement with AstraZeneca to Develop, Manufacture and Commercialize Engineered Treg Cell Therapies Date: June 09, 2023 | Tags: Quell Therapeutics, AstraZeneca, Engineered Treg Cell Therapies, Type 1 Diabetes, Inflammatory Bowel Disease, Biotech, Treg cell engineering modules Astellas and the (..)

Biosimilars 40

Biosimilars Diabetes 40

PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

Diabetes 40

Diabetes Immunity Immunization Biosimilars 40

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. Company: Supernus Pharmaceuticals Generic Name: Topiramate First Approval Date: Aug 16, 2013 Patent Expiration: Jan 2023 2022 Sales: $261.2M Glenmark has also released its generic drug version in the US market.

Biosimilars 49

Biosimilars Diabetes Chemotherapy Immunity 49

Quality Matters

APRIL 4, 2023

USP standards build trust in biologics and biosimilars The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health. kristine.gates… Tue, 04/04/2023 - 14:18 Biologics To learn more about USP’s approach to biologics standards development, click here.

Biosimilars 52

Biosimilars Vaccines Drug Development Diabetes 52

PharmaShots

MARCH 17, 2023

5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted

Biosimilars 40

Biosimilars Labelling Diabetes 40

Big Molecule Watch

DECEMBER 28, 2023

As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. At trial, Regeneron asserted infringement of claims 6 and 25 of U.S.

Biosimilars 67

Biosimilars Diabetes 67

Big Molecule Watch

MAY 4, 2023

According to the petition, the claims are directed to the use of aflibercept to treat angiogenic eye disorders, including diabetic macular edema and age-related macular degeneration. On March 2023, the PTAB issued its Final Written Decision, denying institution of Apotex’s petition.

Biosimilars 73

Biosimilars Diabetes 73

PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. results from the P-III clinical trial of CT-P42, a biosimilar referencing Eylea. results from the P-III clinical trial of CT-P42, a biosimilar referencing Eylea. Ximluci is supplied as a 2.3mg/0.23 mL single-use vial inj.

Biosimilars 56

Biosimilars Labelling Diabetes 56

pharmaphorum

JULY 29, 2021

The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy under a standard review. The post FDA starts review of Roche’s eye disease drug, setting up 2022 verdict appeared first on.

Diabetes 98

Diabetes Biosimilars 98

Pharmaceutical Technology

JANUARY 30, 2023

However, non-NME and biosimilar approvals increased in 2022. In 2023, there will be opportunities for a wider range of CMOs that can offer services for less innovative drugs requiring reformulation or biosimilar production. There were 38 innovator and biosimilar orphan drug approvals for the US in 2022.

Biosimilars 52

Biosimilars Diabetes Chemotherapy Vaccines 52

Pharmaceutical Technology

DECEMBER 20, 2022

Eli Lilly saw strong global drug sales of $187m in Q3 for Mounjaro (tirzepatide), its new type 2 diabetes therapy, which was approved by the FDA in May 2022, according to GlobalData’s Drugs Database Pharma Intelligence Center. and 10%, respectively. GSK moved four places down the top 20 list to 17th place.

Vaccines 52

Vaccines Diabetes Drug Pricing Biosimilars 52

PharmaShots

JUNE 7, 2023

Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023 1. based on change from baseline on a standardized DAS28-CRP which evaluates the severity of RA using clinical and laboratory data Additionally, the company initiates PK study for AVT05 in Jan 2023. 84% vs 64%) & 2yr. (60%

Biosimilars 40

Biosimilars Packaging Diabetes Pharmaceutical Companies 40

STAT

APRIL 24, 2024

In particular, expenditures on Novo Nordisk’s semaglutide — sold as Ozempic for diabetes and Wegovy for obesity — doubled to $38.6 billion, making the drug the top-selling medicine in 2023. Continue to STAT+ to read the full story…

Biosimilars 202

Biosimilars Compounding Diabetes Hospitals 202

PharmaShots

APRIL 3, 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Date - Jan 04, 2023 Product – N/A The acquisition is completed from a shareholder group led by Nordic Capital, in an all-cash transaction valued at $2.8B per ADS up front & CVR of ~$2.50

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

pharmaphorum

MARCH 3, 2022

Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling with the cost of the drugs. Cheaper options are meanwhile becoming available.

Biosimilars 52

Biosimilars Diabetes Mayo Clinic 52

PharmaShots

MARCH 10, 2023

Vertex Receives the US FDA’s IND Clearance of VX-264 for the Treatment of Type 1 Diabetes Date: Mar 10, 2023 | Tags: Vertex, VX-264, Type 1 Diabetes, Regulatory, US, FDA, IND Alnylam Expands its Collaboration with Medison Pharma to Commercialize RNAi Therapies Date: Mar 10, 2023 | Tags: Alnylam, Medison Pharma, RNAi Therapies, Onpattro, patisiran, (..)

Diabetes 40

Diabetes Biosimilars Vaccines 40

PharmaShots

FEBRUARY 27, 2023

Some of their thoughts are: Mr. Mekala Rao (Chairman – Technology Global PHT Expo & Summit – 2023 and President – Atachi Systems, USA) – “motivation to attend Global PHT is to understand the cultural gap in the production of innovative medicine, healthcare systems between eastern and western world.

Biosimilars 40

Biosimilars Diabetes Packaging Hospitals 40

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. This trial is anticipated to begin in the second half of 2023.

Biosimilars 88

Biosimilars Diabetes Immunity Immunization 88

pharmaphorum

MARCH 23, 2022

If passed, the Affordable Insulin Now Act would apply the cap across both private health insurance and Medicare plans, and according to Schumer would cut the cost of a 30-day supply of insulin for people with diabetes from a current range of $200 to $600 per person. Some companies are already taking steps to provide lower-cost insulin.

Diabetes 75

Diabetes Biosimilars Drug Pricing 75

pharmaphorum

MAY 13, 2022

It has filed a lawsuit that accuses the drugmakers and pharmacy benefit managers Express Scripts, Caremark and OptumRx of conspiring to manipulate and inflate insulin prices in the state, inflating their profits and making the drugs unaffordable for many diabetics. Some companies are already taking steps to provide lower-cost products.

Diabetes 59

Diabetes Biosimilars Drug Pricing 59