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, A clinical trial of the vaccine to assess its safety, tolerability and immunogenicity in people aged 12 years and above is anticipated to commence this month.

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XTalks

APRIL 17, 2023

In clinical trials, patients experienced significantly clearer skin and less interference with sleep due to itch when taking lebrikizumab compared to placebo. The ADvocate1 and ADvocate2 Phase III studies were published in the New England Journal of Medicine and the British Journal of Dermatology , respectively.

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The Pharma Data

JULY 29, 2021

Additionally, mepolizumab was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and also the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES). With 41 clinical trials, mepolizumab has been studied in over 4,000 patients.

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XTalks

AUGUST 21, 2023

The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Ipsen that can be used for subsequent drug applications that would not qualify for a priority review. The FDA approval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release.

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Drugs FDA Approval Genetics Clinical Trials 98

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif.,

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FDA Approval Genetics Clinical Trials Clinical Trials 52

Triage Cancer

AUGUST 18, 2020

Steven Joffe from the University of Pennsylvania’s Perelman School of Medicine found that the FDA approved 99% of all expanded access requests for almost 9,000 investigational drugs. To apply for Expanded Access: The patient consults with their licensed physician to make sure they have exhausted all other treatment options.

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Clinical Trials Clinical Trials FDA Approval Manufacturing 59

XTalks

FEBRUARY 29, 2024

After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023. The journey of Aduhelm from its accelerated approval and predicted blockbuster status to discontinuation has been fraught with controversy, debate and ultimately, disappointment.

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Drugs FDA Approval Antibody Life Science 59

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

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FDA Approval Trials Licensing Licensing 52

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

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Drugs Hormones FDA Approval Licensing 95

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

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. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”.

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec.

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Licensing Licensing Production Development 40

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis added inclisiran to its pipeline after buying The Medicines Company – which had licensed the drug from Alnylam – for $9.7 It has a long way to go.

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The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s

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Trials Clinical Trials Clinical Trials Medicine 40

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Increases of ALT ?5x

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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. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. About the Phase 2/3 Study.

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Vaccination Vaccine Trials Medicine 52

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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Delveinsight

AUGUST 13, 2020

Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an evaluation of Gilead’s remdesivir clinical trials, which found the studies that flunked to offer an equal representation of Black, Latinx, and Native Americans.

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Trials Research Drugs Protein 52

Drug Discovery World

JULY 2, 2024

Mazzetti and Schneider continue: “The transfer of technologies from the lab to the market, especially in the field of life sciences is no longer purely via IP out licensing, but rather via start-up M&A deals – start-ups being the de-risking vehicle for large corporates, especially in the life sciences and biotherapeutics sector.

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The Pharma Data

MAY 31, 2022

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation.

Genetics 52

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The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The target action date for the FDA decision on this investigational use is August 3, 2022. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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The Pharma Data

MARCH 2, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021. “We The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Johnson & Johnson’s COVID-19 Vaccine.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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 a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine.

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Delveinsight

JANUARY 19, 2021

Thus, the company has decided to wrap up the trials for AD. A Sweet Year For Daiichi/ AZ As Enhertu Gets FDA Approval For Gastric Cancer. The approval is based on the positive results from the randomised Phase 2 trial conducted in Japan and South Korea. This is not something new in the Alzheimer’s disease market.

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pharmaphorum

APRIL 27, 2021

Since then, Merck KGaA and Pfizer have picked up a full FDA approval for their immunotherapy Bavencio (avelumab) as a first-line maintenance therapy for this type of cancer, and that could potentially raise the level of evidence needed to keep Keytruda and Tecentriq available to patients.

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Drug Discovery World

AUGUST 4, 2023

GSK’s Jemperli (dostarlimab) has been approved in the US plus chemotherapy as the first new frontline treatment option in decades for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). As a clinician, I celebrate the practice-changing potential of adding Jemperli to chemotherapy for patients.”

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Licensing 52

The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is approved in the U.S. Dupilumab development program.

Genetics 52

Genetics Medicine Antibody Trials 52

Delveinsight

AUGUST 2, 2020

Helsinn Group , a Swiss pharma player, is evaluating Anamorelin, an orally active selective ghrelin receptor agonist against Cancer cachexia, The company is conducting Phase III trial to test the efficacy and safety of anamorelin for the treatment of weight loss and anorexia in patients with advanced NSCLC with cachexia.

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Delveinsight

DECEMBER 15, 2020

The US FDA decision to grant FTA to ASC42 depicts the potential of the therapy in addressing the unmet medical needs for NASH patients. ASC42 is an oral fatty acid synthase (FASN) inhibitor that has managed to significantly reduce the liver fat in Phase II clinical trial (FASCINATE-1).

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The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. This press release features multimedia. In the U.S.,

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The Pharma Data

FEBRUARY 13, 2022

FDA a ccepts Dupixent ® (dupilumab) for Priority Review in c hildren a ged 6 m onths to 5 y ears with m oderate-to-severe a topic d ermatitis. If approved, Dupixent will be the first biologic medicine available in the U.S. The target action date for the FDA decision on this investigational use is June 9, 2022. In the U.S.,

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Medicine Genetics Antibody Allergies 40

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. CEO and Co-founder of BioNTech.

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XTalks

DECEMBER 29, 2022

As of December 16, 2022, there are seven US Food and Drug Administration (FDA) approved gene therapies. In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. In 2023, a number of gene therapies are expected to get the FDA green light.

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