Pharmaceutical Technology

NOVEMBER 27, 2022

Biocytogen Pharmaceuticals and ADC Therapeutics have signed an assessment and option agreement for evaluating antibodies against three tumour targets. Under the deal, ADC Therapeutics will receive a licence from Biocytogen to evaluate the latter’s antibodies against the targets.

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Pharmaceutical Technology

OCTOBER 18, 2022

Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. MGD024 is an investigational bispecific antibody that attaches to CD123 and CD3. The post Gilead partners with MacroGenics for bispecific antibody development appeared first on Pharmaceutical Technology.

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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.

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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.

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pharmaphorum

MAY 18, 2022

Brand new UK startup RQ Biotechnology has been thrust into the spotlight after signing a $157 million licensing deal with AstraZeneca for monoclonal antibodies intended to protect vulnerable and immunosuppressed people from COVID-19. ” The post AstraZeneca buys into startup RQ Bio’s COVID antibodies appeared first on.

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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.

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Pharmaceutical Technology

AUGUST 8, 2022

A HER2-directed antibody-drug conjugate (ADC), Enhertu is co-developed and marketed by AstraZeneca and Daiichi Sankyo. In July, the companies received Priority Review for their supplemental Biologics License Application (BLA) from the US FDA for Enhertu to treat unresectable or metastatic HER2-low breast cancer.

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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.

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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.

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pharmaphorum

MARCH 29, 2021

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.

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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).

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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.

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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.

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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.

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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.

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Delveinsight

AUGUST 17, 2021

Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use.

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The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

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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.

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XTalks

FEBRUARY 12, 2025

In a separate effort, Insilico Medicine reported positive topline results from its Phase IIa trial of ISM001-055 a TNIK inhibitor developed using generative AI which demonstrated a dose-dependent improvement in FVC over 12 weeks.

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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.

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

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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).

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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.

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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.

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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

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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.

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Pharmaceutical Technology

JUNE 9, 2023

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. The single seasonal dosing of the drug is a large advance, he noted.

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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.

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

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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.

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Pharmaceutical Technology

AUGUST 26, 2008

As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines. ” Today most big pharmaceutical companies are pursuing biotechnology either in house or by using an in-licensing strategy.

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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.

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pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

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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.

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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.

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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

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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.

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