pharmaphorum

SEPTEMBER 17, 2020

There are two antibodies already on the market that target PCSK9 – Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Repatha (alirocumab) – but these require subcutaneous injection every two to four weeks. Novartis paid a hefty $9.7 The post AZ buys oral PCSK9 cholesterol drug from Dogma Therapeutics appeared first on.

Drugs 66

Drugs Antibody Sales Branding 66

pharmaphorum

SEPTEMBER 19, 2021

AstraZeneca and Daiichi Sankyo were clearly excited by data from a trial pitting their HER2 antibody-drug conjugate (ADC) Enhertu against Roche’s rival Kadcyla when they reported top-line results last month – and a look at the full data set reveals why. billion upfront to license rights to Enhertu in a deal that could be worth up to $6.9

Sales 105

Sales Trials Drugs Licensing 105

pharmaphorum

SEPTEMBER 23, 2022

AstraZeneca has taken the decision not to move a PCSK9-targeting antisense drug licensed from Ionis into a phase 3 programme, removing a competitor to Novartis’ rival therapy Leqvio. ” The big pharma is said to be considering the future of the programme. billion in sales by 2027, ahead of Repatha at $2.2

Drugs 59

Drugs Licensing Licensing Sales 59

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. What is a Biosimilar?

Production 78

Production Insulin Branding Generic Drugs 78

pharmaphorum

APRIL 6, 2022

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. The Swiss pharma giant licensed ex-China rights to tislelizumab from BeiGene in February 2021 for $650 million upfront and up to $1.55

Drugs 52

Drugs Licensing Licensing FDA Approval 52

The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2.

Antibody 52

Antibody Clinical Trials Clinical Trials Licensing 52

Velocity Clinical Research

AUGUST 8, 2024

It’s been just over a year since the monoclonal antibody Lecanemab received traditional approval from the FDA as a treatment for Alzheimer’s disease. Donanemab was approved under the brand name Kisunla. So we’re learning about all the different things that have to happen to make someone have Alzheimer’s.

Clinical Trials 105

Clinical Trials Clinical Trials Genetics Clinical Research 105

pharmaphorum

DECEMBER 21, 2020

A first-in-class treatment discovered by Alnylam and then licensed to The Medicines Company, the drug is being developed for treatment for hyperlipidaemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. billion late last year.

Drugs 52

Drugs RNA Manufacturing Licensing 52

pharmaphorum

APRIL 26, 2021

Merck licensed sonelokimab (M1095) from Ablynx in 2013, and four years later formed a partnership with Avillion to carry out phase 2 and 3 testing of the drug. The drug is a nanobody, a molecule around one-tenth the size of a regular antibody derived from camelid species such as the llama. billion in sales last year.

Antibody 52

Antibody Drugs Marketing Licensing 52

XTalks

FEBRUARY 20, 2024

IgA nephropathy is an autoimmune condition characterized by the deposition of clusters of antibodies in the kidneys, resulting in inflammation and kidney impairment. These clusters, primarily comprised of IgA and other antibodies, harm the glomeruli, which are small blood vessels responsible for filtering blood in the kidneys.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

pharmaphorum

SEPTEMBER 18, 2020

The name Zeneca was invented by a branding consultancy who had been instructed to find a name which was memorable, had no associations with other companies, nor was offensive in any language”. The AZD1222 vaccine was invented by the University of Oxford and its spin-out company Vaccitech, then later licensed by AZ.

Pharma Companies 116

Pharma Companies Sales Vaccination Vaccine 116

pharmaphorum

FEBRUARY 5, 2021

The two partners have since started a clinical trial with the first drug from that collaboration – a cancer therapy – and last year 23andMe also licensed a bispecific antibody that blocks IL-36 to Spain’s Almirall. What Virgin has done spectacularly well, is change things like travel.

Genetics 52

Genetics DNA Life Science Clinical Trials 52

The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate. Download this exclusive report here.

Vaccination 52

Vaccination Vaccine Protein Immune Response 52

The Pharma Data

AUGUST 15, 2021

About TICOVAC (Tick-borne encephalitis vaccine) Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun ® and TicoVac in Europe, and TICOVAC in the U.S., 7 It is able to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.

FDA Approval 52

FDA Approval Vaccination Vaccine Containment 52

XTalks

MAY 2, 2024

Among these are Madrigal Pharmaceuticals’ resmetirom (branded Rezdiffra) , which secured FDA approval in March for the treatment of nonalcoholic steatohepatitis (NASH) and sotatercept (commercial name Winrevair) for pulmonary hypertension (PAH). Since January, the FDA has already signed off on more than a dozen novel drugs.

Drugs 52

Drugs FDA Approval Vaccination Vaccine 52

Delveinsight

AUGUST 13, 2020

Except for Provention Bio’s monoclonal antibody, all the companies in the Celiac disease market have successfully met their primary endpoints in their Phase II results and have received Fast Track Designations for early approval. Takeda acquired an exclusive global license for CNP-101 from Cour Pharmaceuticals’in October 2019.

Marketing 52

Marketing Trials Antibody Pharma Companies 52

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. NYSE:PFE) today announced that the U.S.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 20, 2020

Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. The trial will evaluate one or two drugs on COVID-19, currently Eli Lilly’s LY3819253 (also LY-COV555, an antibody from their collaboration with AbCellera).

Trials 52

Trials Gene Therapy Vaccination Vaccine 52

The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 7 About Vabysmo® (faricimab) Vabysmo is the first bispecific antibody approved for the eye.

Antibody 40

Antibody In-Vitro Clinical Development Medicine 40

The Pharma Data

JULY 29, 2021

today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). However, polyps have a strong tendency to reoccur often leading to repeat surgery. About mepolizumab.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

The Pharma Data

AUGUST 3, 2021

New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. In the U.S., Cost of Sales margin increased 1.6 Tax Rate increased 5.6

Sales 52

Sales Production Antibody Development 52

Delveinsight

AUGUST 13, 2020

Approval History: In September 2017, FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm or for the treatment of asthma.

Antibody 40

Antibody Medicine Trials Development 40

The Pharma Data

FEBRUARY 8, 2021

due to decreased sales of Cough & Cold related portfolio in Europe partially offset by Digestive Health brands. Dupixent ® total prescriptions (TRx) increased 65% ( year-over-year ) and new-to-brand prescriptions (NBRx) grew 18% despite fewer in-person physician visits which remain below the pre-COVID level. CHC down 3.0%

Sales 52

Sales Vaccination Vaccine Production 52

The Pharma Data

FEBRUARY 4, 2021

due to decreased sales of Cough & Cold related portfolio in Europe partially offset by Digestive Health brands. Dupixent ® total prescriptions (TRx) increased 65% ( year-over-year ) and new-to-brand prescriptions (NBRx) grew 18% despite fewer in-person physician visits which remain below the pre-COVID level. CHC down 3.0%

Sales 52

Sales Vaccination Vaccine Production 52

The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Dupixent ® total prescriptions (TRx) increased 51% ( year-over-year ) and new-to-brand prescriptions (NBRx) grew 16% despite fewer in-person physician visits which remain below the pre-COVID level. CHC decreased 7.3% In the U.S.,

Sales 52

Sales Vaccination Vaccine Medicine 52

The Pharma Data

MAY 4, 2021

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.; If approved, TicoVac would be the first vaccine in the U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40

The Pharma Data

AUGUST 6, 2020

announced that the companies submitted the Biologics License Application (BLA) to the U.S. for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. In June, the company and Acceleron Pharma Inc.

Production 52

Production Branding Marketing Containment 52