Pharmaceutical Technology

OCTOBER 7, 2022

A decision on the approval of the Biologics License Application (BLA) is anticipated on 17 November. An anti-CD3 monoclonal antibody, teplizumab is in the developmental stage to delay T1D. The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

FDA Approval 299

FDA Approval Licensing Licensing Antibody 299

Pharmaceutical Technology

APRIL 6, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. A recent wave of monoclonal antibodies, including the FDA-approved Eisai / Biogen ’s Leqembi (lecanemab), is expected to shake up the space.

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The recommendation of the European Medicines Agency (EMA) for Roctavian to maintain orphan drug designation permitting a ten-year market exclusivity window was endorsed by the EC.

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

pharmaphorum

MARCH 8, 2021

The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member states. The post EMA backs emergency use of Lilly’s COVID antibodies appeared first on.

Antibody 105

Antibody Licensing Licensing Protein 105

pharmaphorum

MARCH 24, 2022

There’s a rich history of finding useful medicines from fungi, from the antibiotic penicillin to immune suppressant cyclosporine and cholesterol drug lovastatin. The examples remain few and far between, however, as in recent decades the pharma industry has turned its attention to synthetic molecules and biologics like antibodies.

Medicine 105

Medicine Genome Genomics Engineer 105

XTalks

APRIL 1, 2025

Related: Niktimvo (Axatilimab) Approved as First-in-Class Therapy for Chronic GVHD More on Itolizumabs Clinical Data Itolizumab is a humanized anti-CD6 monoclonal antibody that targets the CD6-ALCAM pathway involved in T cell activation and trafficking. The risk limits the number and type of patients who receive HSCT.

Immune Response 94

Immune Response Trials Licensing Licensing 94

Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

Marketing 130

Marketing Antibody Licensing Licensing 130

Pharmaceutical Technology

OCTOBER 31, 2022

The European Medicines Agency (EMA) has validated AbbVie ’s marketing authorization application (MAA) for epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients following two or more lines of systemic therapy.

Antibody 130

Antibody Licensing Licensing Trials 130

Pharmaceutical Technology

MAY 8, 2023

Reddy’s Laboratories have partnered for the development and commercialisation of the anti-PD-1 monoclonal antibody, toripalimab, in 21 countries. The company may also choose to expand the scope to license toripalimab in New Zealand, Australia, and in nine other countries.

Development 130

Development Marketing Licensing Licensing 130

Pharmaceutical Technology

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The BLA covers all indications which are covered by Prolia (denosumab) and Xgeva (denosumab) reference medicines.

Packaging 130

Packaging Packaging Medicine Licensing 130

Pharmaceutical Technology

DECEMBER 28, 2022

Gilead Sciences and Jounce Therapeutics have amended their current license agreement for first-in-class immunotherapy, GS-1811 (formerly JTX-1811). The initial license agreement was signed in 2020. The amended agreement will allow Gilead Sciences to acquire all the remaining rights for GS-1811 from Jounce Therapeutics.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

NOVEMBER 18, 2022

Regeneron Pharmaceuticals has entered a collaboration and licensing agreement with CytomX Therapeutics for developing conditionally-activated bispecific cancer therapies. Under the deal, the companies will work together on the discovery activities for identifying and validating the conditionally active bispecific antibodies.

Development 130

Development Antibody Licensing Licensing 130

Pharmaceutical Technology

NOVEMBER 9, 2022

CSL Behring has a commercialisation and license agreement to develop EtranaDez. Both factor VIII prophylactics and Roche’s bispecific antibody Hemlibra that are used for haemophilia A patients are expensive, and so a gene therapy could save money, says Dr. David Rind, chief medical officer (CMO) of ICER.

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

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. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

Development 161

Development Production Immune Response Licensing 161

BioPharma Reporter

APRIL 20, 2023

CDMO Sterling Pharma Solutions has been granted a Manufacturerâs Authorisation for Investigational Medicinal Products from the UKâs Medicines and Healthcare products Regulatory Agency (MHRA).

Licensing 52

Licensing Licensing Antibody Manufacturing 52

pharmaphorum

JULY 8, 2022

Swedish rare disease specialist Sobi is paying $55 million upfront to license rights to ADC Therapeutics’ lymphoma therapy Zynlonta – approved in the US last year – in Europe and other international markets. The post Sobi bolsters blood division via $435m ADC licensing deal appeared first on.

Licensing 52

Licensing Licensing Sales Marketing 52

Pharmaceutical Technology

NOVEMBER 22, 2022

The US Food and Drug Administration (FDA) has accepted AbbVie ’s Biologics License Application (BLA) of epcoritamab (DuoBody-CD3xCD20) to treat adults with relapsed/refractory (r/r) large B-cell lymphoma (LBCL), for priority review. Epcoritamab is intended for usage in such patients following two or more lines of systemic therapy.

Clinical Trials 130

Clinical Trials Clinical Trials Licensing Licensing 130

Pharmaceutical Technology

SEPTEMBER 28, 2022

Lava Therapeutics president and CEO Stephen Hurly said: “This agreement enables Lava to further validate its platform in a second solid tumour product candidate, bringing us closer toward our goal of generating effective Gammabody medicines for cancer patients. “We

Development 130

Development Licensing Licensing Production 130

XTalks

JULY 25, 2022

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy being studied to treat HER2-positive unresectable locally advanced or metastatic breast cancer. Vic-]Trastuzumab Duocarmazine Mechanism of Action.

Antibody 59

Antibody Drugs Clinical Trials Clinical Trials 59

STAT News

DECEMBER 22, 2022

For those not familiar with the term, “biobucks,” they refer to future payments promised in licensing deals in the pharmaceutical industry. If all the medicines were to prove successful, payments to Kelun-Biotech could total $9.5 billion.

Gene Therapy 98

Gene Therapy Gene Drugs Licensing 98

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. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.

Antibody 52

Antibody Regulation Doctors Doctor 52

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. This often leaves the task to institutions to ensure that licensed drugs are used in their best formulation.

Clinical Trials 289

Clinical Trials Clinical Trials Trials Drugs 289

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. 1 Adapted Bivalent Vaccine Candidate. Tue, 07/19/2022 - 11:22. has a fever.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

MARCH 9, 2021

. (“Biolojic”), a biotechnology company that computationally designs functional antibodies, today announced a research collaboration and license agreement that will leverage Biolojic’s AI-based multibody platform to discover and develop a potential novel antibody-based therapy for the treatment of diabetes.

Antibody 52

Antibody Development Research Engineer 52

XTalks

FEBRUARY 12, 2025

LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. This gives lerodalcibep an edge to approved PCSK9 inhibitors.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, The companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

Pharmaceutical Technology

MARCH 9, 2023

In-vitro T-cell activation is a key innovation area in immuno-oncology T cells can be activated and differentiated in vitro by crosslinking the TCR with CD3 antibodies and PMA treatment. Activation of T-cell proliferation specifically in a tumour is crucial for reducing the autoimmune side effects of antitumour immunotherapy.

In-Vitro 130

In-Vitro Gene Editing Medicine Licensing 130

XTalks

APRIL 17, 2023

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Most TEAEs were mildly or moderately severe and resulted in a low frequency of treatment discontinuation.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. Tue, 09/27/2022 - 16:15. Wednesday, September 28, 2022 - 11:45am.

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

pharmaphorum

JULY 18, 2022

You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. CD4s are present to stimulate B cells, so they keep producing antibodies, whereas CD8 or inner cells go after infected cells, killing them before the virus spreads.

Vaccination 138

Vaccination Vaccine Development Immune Response 138

pharmaphorum

APRIL 20, 2021

The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried. billion in sales in 2028. It was backed by NICE for NHS use in July 2018.

Sales 111

Sales Medicine Drugs Marketing 111

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

pharmaphorum

DECEMBER 23, 2021

Novartis is hoping that with Leqvio it will see rapid take-up, in contrast to the antibody drugs which rolled out slowly amid pushback from payers that wasn’t overcome by substantial price cuts. Novartis added inclisiran to its pipeline after buying The Medicines Company – which had licensed the drug from Alnylam – for $9.7

Drugs 105

Drugs Sales Antibody FDA Approval 105

The Pharma Data

APRIL 12, 2023

Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement Biogen Inc. Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ).

Antibody 40

Antibody Development Engineer Licensing 40

pharmaphorum

JULY 6, 2021

Novartis added inclisiran to its pipeline after buying The Medicines Company, which had licensed the drug from Alnylam, for $9.7 billion in 2019, and will be hoping for a swift response from the FDA to get the programme back on track and recoup its investment.

RNA 105

RNA Manufacturing Sales Drugs 105

pharmaphorum

SEPTEMBER 13, 2022

.” If Lamzede is approved by the FDA, it will be another milestone for Chiesi’s two-year-old rare disease division , based in Boston, which was formed to diversify away from the company’s traditional focus on respiratory medicines and further its ambition to grow in the US.

Drugs 105

Drugs Licensing Licensing Production 105